Carpal Tunnel Syndrome

Carpal tunnel syndrome is a painful progressive condition caused by the compression of a key nerve in the wrist. Carpal tunnel syndrome is characterized by numbness, tingling, pain and weakness. The carpal tunnel is caused by increased pressure on a nerve in the hand entering the confined space carpal tunnel. There are many causes of carpal tunnel include heredity, the reverse use over time, hormonal changes associated with pregnancy and menopause and medical conditions, including diabetes, rheumatoid arthritis, and of thethyroid gland imbalance. It can occur at any age, but it tends to affect those in their 40s and 50s.

This condition is more common in women than in men. Many people with carpal tunnel syndrome have gradually symptoms increasingly over time. Carpal tunnel syndrome typically begins gradually to a vague pain in the wrist which can be extended to your hand or forearm. The first symptoms of CTS include numbness and paresthesia in the fingers, especially the thumb. Symptoms usually start gradually, with pain, weakness, or numbness in the hand and wrist, radiating up the arm. As symptoms worsen, people might feel tingling during the day, and decreased grip strength may make it difficult to form a fist, grasp small objects. 

Several types of drugs have been used in the treatment of carpal tunnel syndrome. Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen. Corticosteroid injections, given in the area of the carpal tunnel, it may provide relief spectacular symptoms.Vitamin B6 (pyridoxine) has been reported to relieve some symptoms of carpal tunnel syndrome. Corticosteroids may be administered by mouth or injected directly into the affected joint wrist. Physiotherapy provides several ways to treat and monitor carpal tunnel syndrome. Many of prevention is also useful for you. Losingweight if you are overweight.

Carpal Tunnel Syndrome Treatment and Prevention Tips 

1. Cool (ice) packs and prednisone or lidocaine can relieve swelling.

2. Corticosteroids can be given directly into the involved wrist joint.

3. Ultrasound treatment can relieve symptoms in some people.

4. Surgery may be required if the symptoms of carpal tunnel syndrome persist.

5. Nonsteroidal anti-inflammatory drugs, such as aspirin, ibuprofen may ease pain. 

6. Exercises can reduce the risk of a double crush of the median nerve.

7. Mecobalamin/Methylcobalamin has been helpful in some cases of CTS. 

8. If you use a keyboard a lot, adjust the height of your chair so that your forearms are level with your keyboard 

Article Source: http://www.articlesbase.com/ - Carpal Tunnel Syndrome Information and Prevention

Male circumcision shown to help prevent HIV transmission

By Dr Ananya Mandal, MD

According to a new study published in the Medical Journal of Australia, male circumcision can be seen as a “surgical vaccine” in the fight against heterosexual HIV transmission. The study based on spread of the virus in Africa showed that there was a reduced rate of transmission in regions where male circumcision was the norm.

According to co-author St Vincent's Hospital Alcohol and Drug Service director Alex Wodak this practice could be introduced as a long-term strategy in reducing heterosexual HIV transmission. He explained, “A wealth of research has shown that the foreskin is the entry point that allows HIV to infect men during intercourse with an infected female partner…Soon after the HIV pandemic was first recognized, much lower HIV prevalence was found in areas of sub-Saharan Africa, where more than 80 per cent of males had been circumcised than in areas where the circumcision rate was less than 20 per cent…Circumcision of males is now being referred to by many as 'surgical vaccine' against a wide variety of infections and adverse medical conditions over a lifetime.”

Speaking on Australia Dr. Wodak said that in the 50’s and 60’s more than 80 per cent of infant males were circumcised and recent Medicare statistics revealed circumcision among Australian boys had increased from 13 per cent in 1998 to 19 per cent in 2009. He said, “If Australia returned to the patterns we had in the 1950s and 1960s, I think that would be beneficial.”

Studies have failed to show similar benefits of male circumcision when it comes to sex between men. According to the World Health Organization there is “compelling evidence that male circumcision reduced the risk of heterosexually acquired HIV infection in men by approximately 60 per cent.”

Dr. Wodak went on to say that this simple surgical procedure also protects from some common sexually transmitted infections and other conditions such as urinary tract infections. He added, “The prospect of the availability of a (HIV) vaccine over the next 20 years is unlikely… Condom use remains essential, with promotion of condom use plus circumcision of males being analogous to seatbelts plus airbags for reducing the road toll.”

However Australian National University department of pediatrics and child health associate Professor Graham Reynolds feels this surgery is not imperative for prevention of infections. He said, “In order to prevent one infection, you circumcise unnecessarily a huge number of children who will never get a urinary infection, who will never get HIV, who will never get any other infection…if we paid proper attention to cleanliness in non-circumcised boys, we would get no problems.”

courtesy-http://www.news-medical.net/news

Dengue fever vaccine in the pipeline

By Dr Ananya Mandal, MD

Australians researchers are moving towards producing the first ever vaccine for dengue fever, the potentially life-threatening infection spread by mosquitoes in the tropics. At present late stage clinical trials are underway for a vaccine that would protect against all four known strains of the disease. Participants are now being recruited in Perth, Adelaide and Brisbane.

According to Associate Professor Peter Richmond, from Perth's Telethon Institute for Child Health Research, participants would be injected with the vaccine and their blood later checked for protective antibodies. He said that this vaccine once developed would be a boon for South east Asia where the disease is a true menace. “There are more than two hundred million infections annually, that's the estimate, and a couple of million (infected people) get a very severe form of Dengue hemorrhagic fever…From a global perspective, having an effective vaccine is very important,” he said.

Considering world population, over fifty percent live in areas at high risk of dengue fever that is usually fatal in children and adults alike. It causes fever and severe headache, vomiting, muscle and joint pain and skin rash. Australia also has sporadic outbreaks of the infection both from travelers and in the northern Queensland range of its specific type of carrier mosquito.

The vaccine is developed and the trials are being sponsored by pharmaceutical company Sanofi Pasteur. The vaccine is expected in five years.

courtesy- http://www.news-medical.net/news/20100920/Dengue-fever-vaccine-in-the-pipeline.aspx

Dilation Of Blood Vessels Restores Muscle Synthesis In Elderly

University of Texas Medical Branch at Galveston researchers believe they've found a way to use widely available blood pressure drugs to fight the muscular weakness that normally accompanies aging.

The discovery draws on research linking the loss of muscle mass with age-related changes in the behavior of the hair-thin blood vessels, or capillaries, which supply muscles with the amino acids they need for growth.

"When a young person eats food, insulin secretion causes the blood vessels in the muscle to dilate, so a lot of blood goes into the muscle and a lot of amino acids are available to build muscle proteins," said UTMB professor Elena Volpi, senior author of a paper on the work ("Pharmacological vasodilation improves insulin-stimulated muscle protein anabolism but not glucose utilization in older adults") now available in the "Online Ahead of Print" section of the journal Diabetes. "Older people's blood vessels have far less response to insulin, but we found that if you give them a drug that causes them to dilate, you can increase the nutritive flow to the muscles and completely restore normal growth."

Drugs that induce blood vessels to widen, called vasodilators, are commonly used to control high blood pressure and prevent angina. The UTMB study used sodium nitroprusside, a drug used in hospitals and administered intravenously.

The researchers enrolled 12 healthy older volunteers for the study, and separated them randomly into two six-person groups. Working in UTMB's Clinical Research Center, the investigators performed the delicate task of inserting catheters into the arteries and veins feeding and draining the subjects' leg muscles, and then used the arterial catheter to infuse the muscles with insulin at levels similar to those generated by a meal. One group of volunteers was given the vasodilator drug, while the other received a placebo.

Blood sample and muscle biopsy analysis produced estimates of muscle protein synthesis and breakdown. The results were impressive: virtually normal muscle growth in the older subjects given the vasodilator with insulin.

"By giving them this vasodilator, we were able to make our 70-year-olds look like 30-year-olds, at least in terms of muscle growth," said postdoctoral fellow Kyle Timmerman, a lead author of the paper. The study was co-led by medical student and graduate research fellow Jessica Lee.

While the researchers cautioned that larger studies would be needed to confirm their findings, they expressed optimism about vasodilator drugs' potential as tools for keeping older people from falling into frailty, and living happier, healthier and more independent lives.

"If by improving blood flow during and immediately after eating we can improve muscle growth in response to meals in older people, then we're going to have a major new tool to reduce muscle loss with aging," Volpi said. "By itself, that could mean a substantially decreased risk of physical dysfunction and disability."

Other authors of the paper include assistant professor Satoshi Fujita, senior study coordinator Shaheen Dhanani, assistant professor Hans Dreyer, graduate student Christopher Fry, assistant professor Micah Drummond, professor Melinda Sheffield-Moore and professor Blake Rasmussen.

The National Institute on Aging, the UTMB Claude D. Pepper Older Americans Independence Center and the UTMB Clinical and Translational Science Award supported this research.

Source:
Jim Kelly
University of Texas Medical Branch at Galveston

courtesyhttp://www.medicalnewstoday.com/articles/198549.php -

Development Of New Drug Treatment For Malaria

As part of the £1.5 million project, researchers are now testing the drug to determine how the treatment could progress to clinical trials. The drug is made from simple organic molecules and will be cheaper to mass produce compared to existing therapies.

Malaria is the world's most deadly parasitic infection, resulting in nearly one million deaths a year. The team at Liverpool have created a synthetic drug based on the chemical structure of artemisinin, an extract of a Chinese herb commonly used in malaria treatment. The new drug, which can be taken orally, is more potent than naturally derived artemisinin.

Artemisinin is known to interact with a substance inside parasite-infected red blood cells, causing a chain of events that destroys malaria. The treatment, however, is difficult to mass produce and can be chemically unstable in the body. Scientists have now found a way of creating the most reactive part of artemisinin synthetically and fusing it with a cage-like structure made of organic molecules to make the drug more chemically stable. The stability of the chemical structure in the body makes the drug last longer, reducing the chance of the parasite reappearing.

Professor Paul O'Neill, from the University's Department of Chemistry, explains: "Malaria affects the world's poorest countries and hospitals are unable to afford expensive treatments. The problem with current artemisinin-based therapies is their limited availability, poor oral absorption and high cost. We have created a new drug that is easily absorbed by the body, chemically stable and highly potent. It is made from very simple organic materials and therefore will be more cost-effective to mass produce than current therapies."

The research is funded by the European Commission and published in Angewandte Chemie Int Ed.

Source:
Samantha Martin
University of Liverpool

courtasy-http://www.medicalnewstoday.com/articles/197982.php

FDA Allows Lupin To Apply To Sell Copies Of Pfizer's Lipitor

cortasy :- First Published Thursday, 2 September 2010 09:19 pm - © 2010 Dow Jones

By Peter Loftus

Of DOW JONES NEWSWIRES

The U.S. Food and Drug Administration has given permission to Indian generic-drug maker Lupin Ltd. (500257.BY) to seek approval for a generic version of Pfizer Inc.'s (PFE) blockbuster cholesterol drug Lipitor with a different formulation than the original drug.

The FDA decision, however, isn't likely to result in the introduction of the Lupin product anytime soon. Lupin still must go through the normal generic-drug approval process before it can launch its proposed capsule version of Lipitor--the original product is a tablet--and agency reviews can take upwards of two years.

New York-based Pfizer said in a written statement Thursday that it believes the FDA decision on Lupin's request has no effect on its prior Lipitor patent settlement with Ranbaxy Laboratories Ltd. (500359.BY), which is expected to keep generic copies of Lipitor off the U.S. market until November 2011.

A Lupin spokeswoman declined to comment.

Lupin is one of several generic-drug manufacturers eyeing a piece of what promises to be a big market opportunity. The original Lipitor is the top-selling prescription drug in the world, with $11.4 billion in global sales last year and $5.7 billion in the U.S. alone.

Lipitor's impending loss of U.S. market exclusivity will be a major financial blow to Pfizer, which has cut costs and diversified its business lineup in preparation.

In 2008, Lupin filed a citizen petition with the FDA asking for permission seek approval of the capsule version of Lipitor. Lupin said it wanted to market a capsule version for people who have difficulty swallowing a tablet or prefer a capsule form.

The FDA last week granted Lupin's request, according to a letter posted online by the agency. The agency said Lupin's proposed capsule version of Lipitor wouldn't pose questions of safety or effectiveness, since the uses and oral route of administration are the same as the original tablet.

A capsule typically has a gelatinous exterior with the active ingredient inside, sometimes in powder form. Currently, Pfizer sells solid-tablet versions of Lipitor, which is approved to lower cholesterol and reduce the risk of heart attacks.

Because Lupin's product would be a different formulation, pharmacies wouldn't be able to automatically substitute it for branded Lipitor prescriptions, Pfizer said. Instead, doctors would have to specifically prescribe the capsule version if they or patients wanted the Lupin product.

Pfizer has U.S. patents for Lipitor that expire this year and in 2011, 2016 and 2017. The company had sued Ranbaxy after Ranbaxy challenged the patents' validity, and in 2008 the companies settled their litigation. Pfizer granted Ranbaxy a license to begin selling generic Lipitor in the U.S. effective Nov. 30, 2011.

Other generic-drug companies have filed for FDA approval to sell generic Lipitor, and Pfizer has filed patent-infringement suits that are pending in U.S. courts. Under federal law, Ranbaxy is expected to have a 180-day period of exclusivity to sell a third-party generic Lipitor.

In addition, Pfizer has granted Watson Pharmaceuticals Inc. (WPI) exclusive rights to sell what is known as an authorized generic version of Lipitor in the U.S. for five years, beginning in November 2011. Pfizer will manufacture and sell Lipitor's active ingredient, atorvastatin, to Watson for use in the authorized generic product, the company disclosed in a recent regulatory filing.

-By Peter Loftus, Dow Jones Newswires; +1-215-656-8289; peter.loftus@dowjones.com

New Oral Contraceptive

The U.S. Food and Drug Administration today approved ella™ (ulipristal acetate) tablets for emergency contraception. The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive.

ella is a progesterone agonist/antagonist whose likely main effect is to inhibit or delay ovulation. Since May 2009, the prescription product has been available in Europe under the brand name ellaOne.

An FDA Advisory Committee for Reproductive Health Drugs discussed ella in June, 2010. The committee unanimously voted that the application for ella provided compelling data on efficacy and sufficient information on safety for the proposed indication of emergency contraception.

The safety and efficacy of ella were demonstrated in two Phase III clinical trials. One study was a prospective, multi-center, open-label, single-arm trial conducted in the United States; the other was a randomized, multi-center, single-blind comparator-controlled trial conducted in the United States, United Kingdom and Ireland.

Side effects most frequently observed with ella in the clinical trials include: headache, nausea, abdominal pain, pain/discomfort during menstruation (dysmenorrhea), fatigue, and dizziness. The profile of side effects for ella is similar to that of FDA-approved levonorgestrel emergency contraceptives.

According to the product’s labeling, women with known or suspected pregnancy and women who are breastfeeding should not use ella. A patient package insert also will be provided to ensure that women are fully informed of the benefits and risks involved in the use of ella.

LIST OF DRUGS PROHIBITED FOR MANUFACTURE AND SALE THROUGH GAZETTE NOTIFICATIONS UNDER SECTION 26A OF DRUGS & COSMETICS ACT 1940 BY THE MINISTRY OF HEA

DRUGS PROHIBITED FROM THE DATE OF NOTIFICATION

1. Amidopyrine

2. Fixed dose combinations of vitamins with anti-inflammatory agents and tranquilizers.

3. Fixed dose combinations of Atropine in Analgesics and Antipyretics.

4. Fixed dose combinations of Strychnine and Caffeine in tonics.

5.Fixed dose combinations of Yohimbine and Strychnine with Testosterone and Vitamins.

6. Fixed dose combinations of Iron with Strychnine, Arsenic and Yohimbine.

7. Fixed dose combinations of Sodium Bromide/chloral hydrate with other drugs.

8. Phenacetin.

9. Fixed dose combinations of antihistaminic with anti-diarrhoeals.

10. Fixed dose combinations of Penicillin with Sulphonamides.

11. Fixed dose combinations of Vitamins with Analgesics.

B12.Fixed dose combinations of any other Tetracycline with Vitamin C.

E13.Fixed dose combinations of Hydroxyquinoline group of drugs with any other drug except for preparations meant for external use.

ccc14. Fixed dose combinations of Corticosteroids with any other drug for internal use.

ccc15. Fixed dose combinations of Chloramphenicol with any other drug for internal use.

16.Fixed dose combinations of crude Ergot preparations except those containing Ergotamine, Caffeine, analgesics, antihistamines for the treatment of migraine, headaches.

17.Fixed dose combinations of Vitamins with Anti TB drugs except combination of Isoniazid with Pyridoxine Hydrochloride (Vitamin B6).

18. Penicillin skin/eye Ointment.

19. Tetracycline Liquid Oral preparations.

20. Nialamide.

21. Practolol.

22. Methapyrilene, its salts.

c 23. Methaqualone.

& 24. Oxytetracycline Liquid Oral preparations.

& 25. Demeclocycline Liquid Oral preparations.

T 26. Combination of anabolic Steroids with other drugs.

cc 27.Fixed dose combination of Oestrogen and Progestin (other than oral contraceptive) containing per tablet estrogen content of more than 50 mcg (equivalent to Ethinyl Estradiol) and progestin content of more than 3 mg (equivalent to Norethisterone Acetate) and all fixed dose combination injectable preparations containing synthetic Oestrogen and Progesterone. (Subs. By Noti. No. 743 (E) dt 10-08-1989)

* 28.Fixed dose combination of Sedatives/ hypnotics/anxiolytics with analgesics-antipyretics.

J*29.Fixed dose combination of Rifanpicin, isoniazid and Pyrazinamide, except those which provide daily adult dose given below:

Drugs Minimum Maximum

Rifampicin 450 mg 600 mg

Isoniazid 300 mg 400 mg

Pyrazinamide 1000mg 1500 mg

* 30. Fixed dose combination of Histamine H-2 receptor antagonists with antacids except for those combinations approved by Drugs Controller, India.

* 31.The patent and proprietary medicines of fixed dose combinations of essential oils with alcohol having percentage higher than 20% proof except preparations given in the Indian Pharmacopoeia.

* 32. All Pharmaceutical preparations containing Chloroform exceeding 0.5% w/w or v/v
whichever is appropriate.

** 33.Fixed dose combination of Ethambutol with INH other than the following: INH
Ethambutol 200 mg. 600 mg. 300 mg. 800 mg.

** 34. Fixed dose combination containing more than one antihistamine.

B**35.Fixed dose combination of any anthelmintic with cathartic/purgative except for
piperazine/Santonim.

**36. Fixed dose combination of Salbutamol or any other bronchodilator with centrally acting anti-tussive and/or antihistamine.

** 37.Fixed dose combination of laxatives and/or anti-spasmodic drugs in enzyme preparations.

G** 38.Fixed dose combination of Metoclopramide with systemically absorbed drugs except fixed dose combination of metoclopramide with aspirin/paracetamol

** 39.Fixed dose combination of centrally acting, antitussive with antihistamine, having high atropine like activity in expectorants.

** 40.Preparations claiming to combat cough associated with asthma containing centrally acting antitussive and/ or an antihistamine.

** 41.Liquid oral tonic preparations containing glycerophosphates and/or other phosphates and / or central nervous system stimulant and such preparations containing alcohol more than 20% proof.

** 42.Fixed dose combination containing Pectin and/or Kaolin with any drug which is systemically absorbed from GI tract except for combinations of Pectin and/or Kaolin with drugs not systemically absorbed.

*** 43. Chloral Hydrate as a drug.

b 44. Dovers Powder I.P.

b 45. Dover’s Powder Tablets I.P.

A 46.Antidiarrhoeal formulations containing Kaolin or Pectin or Attapulgite or Activated Charcoal.

A 47.Antidiarrhoeal formulations containing Phthalyl Sulphathiazole or Sulphaguanidine or Succinyl Sulphathiazole.

A 48.Antidiarrhoeal formulations containing Neomycin or Streptomycin or Dihydrostreptomycin including their respective salts or esters.

A 49.Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing Diphenoxylate Lorloperamide or Atropine or Belladona including their salts or esters or metabolites Hyoscyamine or their extracts or their alkaloids.

A 50.Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing halogenated hydroxyquinolines.

A 51. Fixed dose combination of antidiarrhoeals with electrolytes.

C 52. Patent and Proprietary Oral Rehydration Salts other than those conforming to the following parameters:
(a) Patent and Proprietary Oral Rehydration Salts on reconstitution to one litre shall contain:- Sodium - 50 to 90 millimoles. Total osmolarity - 240 - 290 milli osmoles. Dextrose : Sodium molar ratio - Not less than 1:1 and not more than 3:1
(b) Patent and Proprietary cereal based Oral Rehydration Salts on reconstitution to one litre shall contain :- Total osmolarity - Not more than 2900 milli osmoles. Precooked rice- Equivalent to not less than 50 gm and not more than 80 gm as total replacement of Dextrose.
(c) Patent and Proprietary Oral Rehydration Salts (ORS) may contain aminoacids in addition to Oral Rehydration Salt conforming to the parameters specified above and labeled with the indication for "Adult Choleratic Diarrhoea" only.
(d) Patent and Proprietary Oral Rehydration Salts shall not contain Mono or Polysaccharides or saccharin sweetening agent.

D 53. Fixed dose combination of Oxyphenbutazone or Phenylbutazone with any other drug.

H.D54. Fixed dose combination of Analgin with any other drug.

D 55. Fixed dose combination of dextropropoxyphene with any other drug other than anti-spasmodics and/or non-steriodal anti-inflammatory drugs (NSAIDS).

D 56. Fixed dose combination of a drug, standards of which are prescribed in the Second Schedule to the said Act with an Ayurvedic, Siddha or Unani drug.

F 57. Mepacrine Hydrochloride (Quinacrine and its salts) in any dosage form for use for female sterilization or contraception.

F 58. Fenfluramine and Dexfenfluramine.

I 59. Fixed dose combination of Diazepam and Diphenhydramine Hydrochloride .

K 60. Rimonabant.

LIST OF GAZETTE NOTIFICATION PUBLISHED

The Principal Notification GSR 578 (E) dt.23.7.83.

c Added b GSR 4(E) dated 31.01.1984

& Added b GSR 322(E) dated 03.05.1984\

T Amended by GSR 863(E) dated 22.11.1985

cc Amended by GSR 743(E) dated 10.08.1989

ccc Amended by GSR 1057(E) dated 03.11.1988

* Added by GSR 999(E) dated 26.12.1990

* Added by GSR 69(E) dated 11.02.1991

xxx Added by GSR 304(E) dated 7.06.1990

@ Added by GSR 444(E) dated 7.06.1992

b Added by GSR 111(E) dated 22.02.1994

A Added by GSR 731(E) dated 30.09.1994

B Added by GSR 848(E) dated 7.12.1994

C Added by GSR 57(E) dated 7.02.1995

D Added by GSR 633(E) dated 13.09.1995

E Added by GSR 793(E) dated 13.03.1995

Added by GSR 93(E) dated 25.05.1997

F Added by GSR 499(E) dated 14.08.1998

G Added by GSR 394(E) dated 19.05.1999

H Added by GSR 405(E) dated 3.06.1999

I Added by GSR 169(E) dated 12.03.2001

J Added by GSR 290(E) dated 16.04.2008

K Added by GSR 885(E) dated 11.12.2009

List of Drugs Prohibited for Import

1. Nialamide

2. Practolol

3. Amiopyrine

4. Phenacetin

5. Methapyrilene and its salts

a 6. Methaqualone

b 7. Chloral Hydrate as a drug

c 8. Mepacrine Hydrochloride (Quinacrine and its salts) in any dosage form for use for female sterilization and contraceptive.

9. Fenfluramine and Dexfenfluramine

d 10. Rimonabant

List of Gazette Notification Pblished

a Added by GSR 48(E) dated 31.1.1984

b Added by GSR 303(E) dated 7.6.1991

c Added by GSR 498(E) dated 14.8.1998

d Added by GSR 884(E) dated 11.12.2009

DRUGS PROHIBITED FOR MANUFACTURE , SALE AND DISTRIBUTION FROM SUBSEQUENT DATE

Drugs Formulation Effective date Notification

1.Cosmetics Licensed as toothpaste/tooth With immediate GSR 444(E)

powder containing tobacco. effect dt.30.4.92

2.Parenteal Preparations fixed dose Jan 1,1998 GSR 93(E)

combination of streptomycin with dt.25.2.97

Pencillin

3.Fixed dose combination of Vitamin B1, Jan 1,2001 GSR 702(E)

Vitamin B6 and Vitamin B12 for dt.14.10.99

human use

4.Fixed dose combination of haemoglobin Sep 1,2000 GSR 814(E)

in any form (natural or synthetic). dt.16.12.99

5.Fixed dose combination of Pancreatin or Sept. 1,2000 GSR 814(E)

Pancrelipase containing amylase, protease dt.16.12.99

and lipase with any other enzyme.

6. Fixed dose combination of Nitrofurantoin Jan 1,2002 GSR 170(E)

and trimethoprim. dt.12.3.01

7.Fixed dose combination of Phenobarbitone Jan 1,2002 GRS 170(E)

with any anti-asthmatic drugs. dt.12.3.01

8.Fixed dose combination of Phenobarbitone Jan 1,2002 GSR 170(E)

with Hyoscin and/or Hyoscyamine dt.12.3.01

9.Fixed dose combination of Phenobarbitone Jan 1,2002 GSR 170(E)

with Ergotamine and/or Belladona dt.12.3.01

10.Fixed dose combination of Haloperidol Jan 1,2002 GSR 170(E)

with any anti-cholinergic agent including dt.12.3.01

Propantheline Bromide.

11.Fixed dose combination of Nalidixic Acid Jan 1,2002 GSR 170(E)

with any anti-amoebic including Metronidazole. dt.12.3.01

12.Fixed dose combination of Loperamide Jan 1,2002 GSR 170(E)

Hydrochloride with Furazolidone dt.12.3.01

13.Fixed dose combination of Cyproheptadine Jan 1,2003 GSR 170(E)

with Lysine or Peptone. dt.12.3.01

14.Astemizole Apr.1,2003 GSR 191(E)

dt.5.3.03

15.Terfinadine Apr.1,2003 GSR 191(E)

dt.5.3.03

16.Fenformin Oct.1,2003 GSR 780(E)

dt.1.10.03

17.Rofecoxib Dec 13,2004 GSR 810(E)
dt. 13.12.04

18.Valdecoxib July 25,2005 GSR 510(E)
and it's formulation dt. 25.07.05

National Pharmacovigilance Program (INDIA)

 

            India has more than half a million qualified Doctors and15,000 hospitals having bed strength of 6,24,000.  It is the fourth largest producer of pharmaceuticals in the world. It is emerging as an important Clinical trial hub in the world. Many new drugs are being introduced in our country. Therefore, there is a need for a vibrant pharmacovigilance system in the country to protect the population from the potential harm that may be caused by some of these new drugs.

 

            Clearly aware of the enormity of task the Central Drugs Standard Control Organization (CDSCO) has initiated a well structured and highly participative National Pharmacovigilance Programme. It is largely based on the recommendations

made in the WHO document titled “Safety Monitoring of Medicinal Products –

Guidelines for Setting up and Running a Pharmacovigilance Centre”.

 

            The National Pharmacovigilance Program was officially inaugurated by the Honorable Health Minister Dr.Anbumani Ramadoss on 23 November, 2004 at New Delhi.

            The specific aims of the Pharmacovigilance Programme are to:

·        contribute to the regulatory assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective(including cost effective) use

·        improve patient care and safety in relation to use of medicines and all medical and paramedical interventions

·        improve public health and safety in relation to use of medicines

·        promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public 

 

            The Programme aims to foster the culture of ADE notification in its first year of operation and subsequently aims to generate broad based ADR data on the Indian population and share the information with global health-care community through WHO-UMC

Under the program 26 peripheral centers, 5 Regional Centers and 2 Zonal Centers were established. The Peripheral centers will record the Adverse Events (AE) and send to the Regional Centers. They in turn collate and scrutinize the data received from the Peripheral Centers and submit to the Zonal Centers. The Zonal Centers will analyze the data and submit consolidated information to the National Pharmacovigilance Centre. The Zonal Centre will also provide training, general support and coordinate the functioning of the Regional Centers.

The National Pharmacovigilance Advisory Committee (NPAC) oversee the performance of various Zonal, Regional and Peripheral Pharmacovigilance centers as well as recommend possible regulatory measures based on the data received from various centers. It also oversees data collection and assessment, interpretation of data as well as publication of ADR monitoring data. The Committee also periodically evaluates their protocol compliance levels to ensure that the data received is homogenous and can be scientifically pooled for informed regulatory decisions. Wherever necessary, NPAC also seeks the opinion of experts in various specializations.  

NATIONAL PHARMACOVIGILANCE POLICY

 

            Since there are considerable social and economic consequences of adverse drug reactions and the positive benefit/cost ratio of implementing appropriate risk management – there is a need to engage health-care professionals and the public at large, in a well structured programme to build synergies for monitoring adverse drug reactions.

           

            The purpose of the programme is to collate data, analyze it and use the inferences to recommend informed regulatory interventions, besides communicating risks to healthcare professionals and the public.

 

The National Pharmacovigilance Programme will have the following milestones:

 

• Short-term objectives: To foster a culture of notification

 

• Medium-term objectives: To engage several healthcare professionals and

            NGOs in the drug monitoring and information dissemination processes.

 

• Long-term objectives: To achieve such operational efficiencies that would make

      Indian National Pharmacovigilance Programme a benchmark for global drug

            monitoring endeavors.

 

NATIONAL PHARMACOVIGILANCE PROGRAMME

 

            Before a product is marketed, experience of its safety and efficacy is limited to its use in clinical trials, which are not reflective of practice conditions as they are limited by the patient numbers and duration of trial as well as by the highly controlled conditions in

which Clinical Trials are conducted.

 

            The conditions under which patients are studied during the pre-marketing phase do not necessarily reflect the way the medicine will be used in the hospital or in general

practice once it is marketed. Information about rare but serious adverse drug reactions,

chronic toxicity, use in special groups (e.g. pregnant women, children, elderly) and drug

interactions are often incomplete or not available. Certain adverse drug reactions may

not be detected until a very large number of people have received the medicine.

Pharmacovigilance is therefore one of the important post-marketing tools in ensuring the safety of pharmaceutical and related health products.

 

            Pharmacovigilance is defined as the detection, assessment and prevention of adverse drug reactions in humans. It is the process of:

 

• Monitoring medicines as used in everyday practice to identify previously

            unrecognized adverse effects or changes in the patterns of their adverse effects

• Assessing the risks and benefits of medicines in order to determine what action,

      if any, is necessary to improve their safe use

• Providing information to users to optimize safe and effective use of medicines
• Monitoring the impact of any action taken

 

FRAMEWORK FOR PHARMACOVIGILANCE IN INDIA

 

            The Central Drugs Standard Control Organization (CDSCO) has initiated a country-wide Pharmacovigilance programme under the aegis of DGHS, Ministry of Health & Family Welfare, Government of India.

 

            The programme is coordinated by the National Pharmacovigilance Centre at

CDSCO. The National Centre is operating under the supervision of the National

Pharmacovigilance Advisory Committee to recommend procedures and guidelines for

regulatory interventions.

 

THE NATIONAL PHARMACOVIGILANCE CENTRE AT CDSCO

 

The National Pharmacovigilance Centre is based at CDSCO and shall:

 

1. monitor the adverse drug reactions of medicines in order to identify previously unexpected adverse drug reactions or indicate that certain reactions occur more commonly than previously believed. This will include the collation, review and evaluation of all spontaneous ADR reports received by the unit on a nation-wide basis. This information will then be keyed into the ADR database for use in           aggregate analysis. These reports shall also be submitted to the WHO International             Drug Monitoring Programme for international collaboration on drug safety.

 

2. review Periodic Safety Update Reports (PSURs) submitted by pharmaceutical companies. Pharmaceutical companies are required to submit the PSURs of all new chemicals drugs. PSURs shall be expected to be submitted every 6 monthly for the first 2 years of marketing in India, and annually for the subsequent 2 years.

 

3. maintain contacts with international regulatory bodies working in pharmacovigilance and exchange information on drug safety.

 

4. assess the regulatory information relating to safety in order to determine what             action, if necessary, needs to be taken to improve safe use. Based on the available data, the Advisory Committee shall make recommendations on product label amendments, product withdrawals and suspension.

 

5. provide information to end-users through adverse drug reaction news, bulletins, drug  alerts and seminars.

 

For further information please contact:

 

The National Pharmacovigilance Centre

Office of Drugs Controller General of India,

Central Drugs Standard Control Organization,

Room No. 347-A,

D.G.H.S., Ministry of Health & Family Welfare

Nirman Bhawan, New Delhi 110 011.

Tel: (11) 23018806 Fax: (11) 23012648

Email: dci@nb.nic.in www.cdsco.nic.in

 

Glossary of terms

 

National Pharmacovigilance Programme (NPP)

The nation wide programme, sponsored and coordinated by the country’s central drug

regulatory agency – Central Drugs Standard Control Organization (CDSCO) – to

establish and manage a data base of Adverse Drug Reactions (ADR) for making

informed regulatory decisions regarding marketing authorization of drugs in India for

ensuring safety of drugs.

 

Peripheral Pharmacovigilance Centers (PPC)

Primary pharmacovigilance centers. Relatively smaller medical institutions including

individual medical practitioners’ clinics, private hospitals, nursing homes, pharmacies

etc. First contact ADR data collection unit at a health care facility. They would be identified and coordinated by RPCs / ZPCs in consultation with CDSCO.

 

Regional Pharmacovigilance Centers (RPC)

Secondary pharmacovigilance centers. Relatively larger healthcare facilities attached

with medical colleges. They would act as second level centers in the administrative

structure of the NPPI. They will function as first contact ADE data collection units also.

They would be identified and coordinated by ZPCs in consultation with the CDSCO.

 

Zonal Pharmacovigilance Centre (ZPCs)

Tertiary pharmacovigilance centers. Large healthcare facilities attached with medical colleges in metro cities identified by the CDSCO for the purpose. They would act as third level centers in the administrative structure of the NPPI. They will function as First contact ADE data collection units also.

 

Coordinator

Designated in-charge of a particular participating PVig centre

 

Investigator

A healthcare professional involved in investigation of drug related adverse events.

 

Notifier

Any person who suspects to have experienced / observed an ADE and informs any

participating Pharmacovigilance centre about it.

 

Reporter

A healthcare professional reporting ADR on the ADR form.

 

Monitoring

The process of overseeing drug related adverse events at the PVigC participating in

the PVig Programme.

 

Reporting

The process of providing ADR information by filling in the ADR form appropriately and

forwarding the same to the appropriate level.

 

Notification

Process of informing by a notifier to any participating pharmacovigilance centre about the occurrence of a suspected ADR. The process may involve informing over telephone, in person, email, fax or any other means of communication-verbal or written. All notifiers must give their contact details. Appropriate and adequate measures must be taken to keep track of the notifier. Any follow up action will be initiated on a notification only after the due verification of the notifier. If the notifier cannot be traced back, it will be recorded on the notification slip before closing the case.

 

Notification slip

A pre-designed structured form made available by the NPPI for written communication of a suspected ADR by the notifier duly signed by him/her wherever feasible.

 

ADR Form

It’s the pre-designed structured form issued by NPPI to record ADR.

 

Archiving

This is to be done at the Regional / Zonal Centers for a period of 5 years

 

Audit

A systematic and independent examination (conducted by personnel, independent of the centre) of center’s activities and documents to determine whether center’s activities were conducted and the data were recorded, analysed and accurately reported according to the protocol

 

Confidentiality

In a confidential / secretive manner.

 

Side Effect

Any unintended effect of a pharmaceutical product occurring at doses normally used in

man which is related to the pharmacological properties of the drug.

Comment: This is an old term and is broad enough to include both positive and negative effects of a drug apart from its main properties or indications. Some use the term as synonymous with 'adverse reaction', but the proposed definition will improve clarity of use of this term.

 

Adverse Event / Adverse Experience

Any untoward medical occurrence that may present during treatment with a pharmaceutical product at the same time, does not necessarily have a causal relationship with this treatment.

Comment: This is a more recent term which some use interchangeably with 'adverse reaction', but, as indicated, it is better reserved for clinical phenomena occurring during drug treatment where causality cannot be or is not ascertained.

 

Signal

Reported information on a possible causal relationship between an adverse event and

a drug, the relationship being unknown or incompletely documented previously. Usually

more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information.

Comment: This describes the first alert of a problem with a drug. By its nature a signal cannot be regarded as definitive but indicates the need for further enquiry or action. On the other hand it is prudent to avoid a multiplicity of signals based on single case reports since follow up of all such would be impractical and time consuming. The definition allows for some flexibility in approach to a signal based on the characteristics of individual problems. Some would like a 'signal' to include new information on positive drug effects, but this is outside the scope of a drug safety Programme.

 

Adverse Reaction

WHO Technical Report No 498 (1972); 'A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.

Comment: This basic definition includes all doses prescribed clinically, but is intended

to exclude accidental or deliberate overdose. The sub classification of 'unexpected' was

included to facilitate understanding of the type of adverse reaction which is most

important to report to drug monitoring agencies.

 

Unexpected Adverse Reaction

An adverse reaction, the nature or severity of which is not consistent with domestic

labeling or market authorization, or expected from characteristics of the drug.

 

Serious Adverse Event or Reaction

A serious adverse event or reaction is any untoward medical occurrence that at any dose:

• results in death
• requires inpatient hospitalization or prolongation of existing hospitalization
• results in persistent or significant disability/incapacity
• is life-threatening

To avoid any confusion or misunderstanding of the difference between the terms

'serious' and 'severe', the following note of clarification is provided:

The term 'severe' is not synonymous with serious. 'Severe' is used to describe the

intensity (severity) of a specific event (as in mild, moderate or severe); the event itself,

however, may be of relatively minor medical significance (such as severe headache).

Seriousness (not severity) which is based on patient/event outcome or action criteria

serves as guide for defining regulatory reporting obligations.

(Source: National Pharmacovigilance Protocol, Ministry of Health & Family Welfare, Govt. of India)

FDA REGULATORY AND DRUG APPROVAL . . .

Regulatory and Drug Approvals News

Regulatory Affairs and Drug Approvals News

FDA Approves Embryonic Stem Cell-Based Therapy For Patients With Acute Spinal Cord Injury

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Eisai Announces U.S. Fda Approval For New Higher Dose Aricept® 23 Mg Tablet For The Treatment Of Moderate-To-Severe Alzheimer's Disease

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Shionogi Inc. Announces FDA Approval Of CUVPOSA™ For The Treatment Of Chronic Severe Drooling In Pediatric Patients With Neurologic Conditions

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ACT Files Documentation With FDA For Clinical Trials Using ES Cells To Treat Eye Disease.

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Encap Drug Delivery Receives Patent Approval For DuoCapTM Capsule System

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Abbott's SIMCOR(R) (Niacin Extended-Release / Simvastatin) Receives FDA Approval For New Dosage Strengths

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Abraxis BioScience And Specialised Therapeutics Announce Approval To Market ABRAXANE For Metastatic Breast Cancer In New Zealand

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Abbott's SIMCOR ® ( Niacin Extended-release / Simvastatin ) Receives FDA Approval For New Dosage Strengths

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Advanced Life Sciences Applies For FDA Fast-Track Designation For Restanza In CABP

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FDA Approves Drug For Chronic Drooling In Children

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New Early Detection System Helps FDA Identify More Than 100 Food Safety Problems In First 7 Months

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FDA RECALLS . . . .

FDA Recalls

Lundbeck Inc. Announces the Voluntary Nationwide Recall of Two Lots of NeoProfen® (ibuprofen lysine) Injection

– Lundbeck Inc. has voluntarily recalled two lots of NeoProfen® (ibuprofen lysine) Injection that failed to meet a visible particulate quality requirement. These two lots are the only lots currently available to prescribers and therefore the recall will result in a temporary drug shortage.

Lundbeck Inc. Announces the Voluntary Nationwide Recall of Two Lots of NeoProfen® (ibuprofen lysine) Injection Recall will Result in Temporary Product Shortage

– Lundbeck Inc. has voluntarily recalled two lots of NeoProfen® (ibuprofen lysine) Injection that failed to meet a visible particulate quality requirement. These two lots are the only lots currently available to prescribers and therefore the recall will result in a temporary drug shortage. This voluntary recall is the result of the company’s inspections of the two product lots of NeoProfen.

Bay Valley Foods Issues Allergy Alert on Undeclared Egg and Wheat in Cans of Mislabeled Chef's Cupboard Chicken with Rice Soup

Bay Valley Foods is voluntarily recalling 10.5 oz cans of Chef's Cupboard Chicken with Rice Soup because some cans are mislabeled and may contain Vegetarian Vegetable Soup. The mislabeled product contains undeclared egg and wheat.

Nutraloid Labs Inc. Conducts Voluntary Nationwide Recall of Two Dietary Supplements Found to Contain Undeclared Drug Ingredient

Nutraloid Labs Inc. announced today that it is conducting a voluntary nationwide recall of two dietary supplement products sold under the names: ejaculoid XXTREME and stimuloid II.

Nutraloid Labs Inc.

Specialty Farms, LLC Expands Recall of Organic Alfalfa Sprouts Blend and Organic Sprout Salad in the North Eastern United States Because of Possible Health Risk

Specialty Farms is voluntarily recalling certain Alfalfa sprout products with a best if sold by date of “8/3/2010” and “8/1/2010” that has the potential to be contaminated with Listeria Monocytogenes (LM). Listeria Monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Dulcería Chepito Emite una Alerta por Alergenos en Sus Productos "Almejas"

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Biggers & Callaham, Llc Dba Mice Direct Recalls Frozen Reptile Feed Because Of Possible Health Risk

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Voluntary Recall of PreserVision® Eye Vitamin AREDS 2 Formula in the United States

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P&G Recalls Two Lots of Prescription Renal Diet Cat Food due to a Possible Health Risk

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Airgas South Initiates Precautionary Voluntary Recall of Medical Gas Products at Chattanooga, TN Facility

Airgas South, Inc., a distributor of industrial, medical, and specialty gases, today announced an expanded voluntary recall of medical gas products filled at its Chattanooga, Tennessee facility.

Pasco Processing LLC, Announces Voluntary Product Recall Because of Possible Health Risk

Pasco Processing, LLC, Pasco WA is recalling 2087 cases of 20lb. bulk packaged Corn and Poblano peppers, (SKU 10071179017738) because of the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems.

Specialty Farms, LLC Recalls Organic Alfalfa Sprouts Blend and Organic Sprout Salad in the North Eastern United States Because of Possible Health Risk

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Quong Hop & Co. Recalls Raquel's Products (Because Of Potential Health Risk)

South San Francisco, CA - Quong Hop & Co.

Oregon Ice Cream Company Issues Allergy Alert on Undeclared Peanuts in Denali Bear Claw Ice Cream

Oregon Ice Cream Company LLC of Eugene, OR is voluntarily recalling 641 tubs of 3 gallon Denali Bear Claw ice cream, because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products...

DeBoles® Nutritional Foods, Inc. Voluntarily Recalls One Lot Code of DeBoles® Kids Only! Gluten Free Tubettini Corn Pasta Due to the Presence of an Undeclared Allergen, Lot Code 30JUN11D1

DeBoles Nutritional Foods, Inc. announced that it is recalling one lot code of DeBoles® Kids Only! Gluten Free Tubettini Corn Pasta because it may contain undeclared whole wheat alphabet pasta. People who are allergic to wheat run the risk of an allergic reaction, which may be serious or life-threatening if they consume the recalled product.

J & H Besta Corp. Issues a Voluntary Nationwide Recall of Joyful Slim Herb Supplement Found to Contain an Undeclared Drug Ingredient

J & H Besta Corp. of Hicksville, NY, has been informed by the Food and Drug Administration (FDA) that FDA lab analysis of Joyful Slim Herb Supplement distributed by the company was found to contain undeclared Desmethyl Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss.

Cook Initiates Voluntary Recall of Certain Ciaglia Blue Rhino and Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays that Contain a Covidien 6PERC or 8PERC Shiley™ Tracheostomy Tube

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Good Health, Inc. Issues a Nationwide Voluntary Recall of Product Marketed as Dietary Supplement

Good Health, Inc. announced today that it is conducting a voluntary nationwide recall of the company's dietary supplement Vialipro for sexual enhancement sold under the Lot Numbers listed below .

This product is currently being sold as a dietary supplement throughout the U.S. Good Health, Inc.

J & H Besta Corp. Issues a Voluntary Nationwide Recall of Slim- 30 Herb Supplement Found to Contain an Undeclared Drug Ingredient

J & H Besta Corp. of Hicksville, NY, has been informed by the Food and Drug Administration (FDA) that FDA lab analysis of Slim-30 Herb Supplement distributed by the company was found to contain undeclared N-Desmethyl Sibutramine and traces of Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss.

D & M Smoked Fish, Inc. Issues an Allert on Uneviscerated Schmaltz Herring

D & M Smoked Fish, Inc. located in Queens, New York, is recalling Haifa brand vacuum packaged Schmaltz Herring with the lot number 168, because the product was found to be uneviscerated.