Suspend manufacture, import of anti-obesity drug: DCGI. Sibutramine was found to have serious side effects…

NEW DELHI: The Drugs Controller General of India (DCGI) on Friday ordered the “suspension” of the manufacture and import of anti-obesity drug Sibutramine after the medicine showed serious side effects, including heart attack, among some users. The DCGI also recommended to the Ministry of Health and Family Welfare a total ban on the sale of the drug.

It proposes the setting up of various committees to oversee the safety of drugs and also the feasibility of introducing new drugs in India.

The suspension order was issued under Section 26 (A) of Drugs and Cosmetic Act, with immediate effect, with the DCGI also seeking a total prohibition on its manufacture and sale in the open market. The ban has to be formally notified by the Health Ministry on the recommendation of the DCGI.

The decision was taken following recommendations of an expert committee comprising pharmacologist Y.K. Gupta (All-India Institute of Medical Sciences), endocrinologist A.C. Ammini (AIIMS) and S.D. Seth (Institute of Clinical Research) and Anoop Misra (Fortis Hospital).

Orlistate is now the only drug in the market for obesity-management and weight loss, though many new drugs are expected to be in the market shortly.
The decision to ban Sibutramine, sold under different brand names, was taken after studies found it increased the risk of heart attack, stroke and death. The drug has already been banned in the United States, Canada and Australia and was withdrawn in China on Tuesday. The European Medicine Agency (EMA) too has recommended complete withdrawal of this drug.

The preliminary reports of the “scout trials” on Sibutramine showed increase in heart rate and blood pressure among users. This was further confirmed in the final finding of the trial, promoting the government to take prohibitory action.
This is the third drug relating to diabetes and obesity that has been banned in India in the last one-and-half years.

Last month, the government banned the import and manufacture Rosiglitazone, an anti-diabetic drug. Rosiglitazone is already banned in Europe after users experienced serious side effects, including cardiovascular events and adverse effects on lipid profile.

Prior to that, anti-obesity pill Rimonabant was banned in March 2009 after it was found to cause depression and suicidal tendencies.

One of the most commonly prescribed medicines for weight loss and obesity management, Sibutramine has been available in India since 1999. It is manufactured and marketed by over 20 generic companies under various brand names.

Special Correspondent, The Hindu
© Copyright 2000 - 2009
Date:13/11/2010

URL: http://www.thehindu.com/2010/11/13/stories/2010111368382400.htm

Stop taking this drug…

This is a very good and wise decision…Thanks to the authorities and to The Hindu…

Dr. K. Padmanaban, Clinical Toxicologist

What is your opinion about the diet pills?

There are so many, the people who sell it, promise you earth and sky come together and the success is always there. In the last four decades several chemicals are allowed, then banned, it is an unending story.

Medicines are effective only in very high amount and the side-effects are also correspondingly high. Abused drugs such as amphetamine, methamphetamine and their derivatives, the so called designer drugs or party drugs have all these effects to lose the appetite, but in course of time they will cause damage to central nervous system (brain, and spinal cord). Moreover, possessing these illegal narcotics is a crime.

A chemical carcinogen, called 2,4-dinitrophenol, increases the rate of metabolism by increasing body temperature, but highly poisonous to us. If you want to spoil your health completely, take any one of these. I say, no to all these drugs and pills and your liver has to eliminate all these chemicals and too much strain is not good for liver cells. If these are damaged it could not be regenerated further.

What about the clinically tested medicines used to reduce the weight? Sibutramine decreases appetite but approximately 4.3 kg weight is reduced in a year and the side-effects are increase in blood pressure and heart rate, constipation, insomnia and dry mouth.

Orlistat inhibits pancreatic and gastrointestinal lipase to prevent the absorption of 30% dietary fat and the average weight loss is 2.7 kg after one year. It has also positive effects on cholesterol, LDL and blood sugar. Few of the possible side-effects are faecal urgency, oily spotting, liquid stools, abdominal cramp and flatulence. Moreover, orlistat can impair the absorption of fat soluble vitamins.

Phentermine is a short term drug, used up to three months and users often lose 2 kg to 10 kg than others taking placebo. The side-effects are euphoria, nervousness, restlessness, increased blood pressure, increased pulse rate, insomnia, dry mouth and constipation.

Leptin – the clinical studies are disappointing.

The above mentioned chemicals may have some properties of weight loss, but the side-effects are dangerous to your health.

If we know everything about this, it is better to try with conservative methods which have more possibilities if they are done properly and professionally. If nothing helps, drugs may be used and there must be medical assistance and supervision.

Conservative, individual, metabolism based on diets with enough physical activity, are the best methods to reduce weight.