Meridia Sibutramine Side Effects

The weight-loss drug Meridia sibutramine continues to be sold in the US, despite serious Meridia side effects, including Meridia heart attack and Meridia stroke.

Sibutramine, which is marketed as Meridia (sibutramine hydrochloride) in the US, was approved by the FDA in 1997 for management of obesity, including weight loss and maintenance of weight loss, to be combined with diet and exercise. In 2009 a major study found that patients with a history of cardiovascular disease who took the medication had an elevated risk of heart attacks and strokes.The side effects of Meridia also include uneven heart beat and shortness of breath.

The FDA requested that the manufacturer add a new warning to the sibutramine drug label stating that sibutramine is not to be used in patients with a history of cardiovascular disease, including:

• History of coronary artery disease (e.g., heart attack, angina)
  
  
• History of stroke or transient ischemic attack (TIA)
  
  
• History of heart arrhythmias
  
  
• History of congestive heart failure
  
  
• History of peripheral arterial disease
  
  
• Uncontrolled hypertension (e.g. > 145/90 mmHg)

The study, named the Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT) began in 2002. The FDA was made aware of the findings in November 2009.

Sibutramine is the key ingredient in Meridia, which is related to the amphetamine family of stimulants. It was recently found in pai you guo, a Chinese weight-loss drug sold over-the-counter, even though the FDA has warned that the appetite suppressant is linked to increased risk of heart attack and stroke for those with a history of caridovascular disease.

The European Medicines Agency pulled Meridia (sold as Reductil, Reduxade and Zelium in Europe) from the market and on January 21, 2010 Abbott Laboratories stopped marketing its weight loss pill in Europe after regulators there said the drug increases the risk of heart attack and stroke when used by heart disease patients. The European Medicines Agency said that the risks of these medicines are greater than their benefits, yet it is still sold in the US, but with a stronger warning label.

The consumer advocacy group Public Citizen asked the FDA to ban Meridia in 2002 due to increasing numbers of deaths and cardiovascular adverse effects attributable to Meridia. According to Public Citizen, Meridia has been linked to more than 80 deaths, including 30 people under age 50. In December 2009 it issued a second request to remove Meridia from the market.

In a letter to Abbot dated July 19, 2002, the FDA said that information about seven deaths associated with Meridia was not reported properly to the agency, that one death was not reported to the FDA at all, and that Abbott's reports on three other Meridia deaths were incompletely reported.

The letter further said that Abbot violated rules to provide the agency with data on serious adverse events involving Meridia within 15 days of receiving the information. Drug companies must report adverse reactions to the FDA because later reports can often show adverse side effects that don't appear in clinical trials.

The FDA is currently evaluating whether regulatory action needs to take place. The agency will hold its public advisory meeting in September 2010. Abbot's global sales of sibutramine drugs in 2009 were about $300 million.

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Last updated on Jun-27-10