Abbott’s Meridia approved since 1997 pulled from Market

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Avandia, a block buster drug for diabetes manufactured by GlaxoSmithKline, GSK was in news due to risk of heart attack.  Recently, US Food and Drug Administration restricted use of Avandia and European Medical Agency stopped its use.  Now the FDA’s axe has fallen on Abbott’s obesity drug Meridia for its risk of increasing heart attack and stroke.  Abbott is completely pulling the drug from market. Meridia was approved by FDA in November 1997 for weight loss and maintenance of weight loss in obese people, and in overweight people with other risks for heart disease. 

What are the main reasons for pulling Meridia from Market?
Meridia is manufactured by Pharmaceutical giant Abbott Laboratories, which has voluntarily agreed to pulled the drug from market.  The main reasons for this move are:

  • Data reviewed by FDA showed a 16 percent increased risk for heart attack, stroke and death among people taking Meridia (sibutramine), compared with those taking a placebo.
  • Sibutramine Cardiovascular Outcomes Trial (SCOUT) review trial found only a small difference in weight loss among those taking the drug and those receiving a placebo. 

Dr. John Jenkins, director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research, said that “FDA requested this withdrawal after concluding that the continued availability of this product is not justified since patients taking the drug are at an increased risk of suffering a heart attack or stroke.” 

What advisory was released by FDA regarding Meridia?
FDA director, Jenkins said that

  • Physicians are advised...



    to stop prescribing Meridia to their patients, pharmacists are advised to stop dispensing Meridia, and patients are advised to stop taking this drug and dispose of any remaining product
  • those taking Meridia, which is a stimulant, to discuss with their doctor other ways to lose weight 

Was Meridia banned in US only?
Other countries have taken similar action:

  • Health Canada, the nation’s health department acknowledged that Abbott would voluntarily pull the drug from the market
  • Abbott has pulled off Meridia from Australian market as well
  • The EMA required Abbott to undertake the post-approval SCOUT trial, and in January that agency banned all anti-obesity drugs containing sibutramine 

FDA is not overlooking another weight-loss drugs like Slimming Beauty Bitter Orange Slimming Capsules.  It has issued warning against Slimming Beauty as it contains same active ingredient as Meridia, sibutramine and has similar heart health risks.  

Looks like FDA is seriously looking at the drugs and trials and is not willing approve drug for small symptomatic benefit or mild improvement in a lab value, if the drug has long term side effects.

Source: Business Week

 

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