Abbott Laboratories voluntarily withdraws its obesity drug Meridia from market
Abbott Laboratories is voluntarily withdrawing its obesity drug Meridia (sibutramine) from the U.S. market since it is found from the data from the clinical trial that there is an increased risk of heart attack and strok .
Physicians are also advised not to prescribe drug Meridia to their patients. Patients are also requested to stop taking this medication as well. Patients requiring weight loss drug and currently on Meridia must talk to their health care provider for an alternative weight loss and weight loss maintenance programs.”
In November 1997 Meridia was approved by the US FDA for weight loss and maintenance of weight loss in obese people, and for certain overweight peoples having high risks for getting heart disease.
US FDA had approved Meridia drug containing active ingredient sibutramine , based on clinical trial data out come findings . About five percent of weight was lost compared to their body weight was observed in peoples who received sibutramine as compared to peoples people on placebo who relied on diet and exercise alone.
US FDA had requested the to withdraw Drug Meridia from market after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). Sibutramine Cardiovascular Outcomes Trial SCOUT was carried out as requirement of post market drug safety monitoring study to assess cardiovascular safety of sibutramine after the European approval of this drug.
Results of clinical trial in a group of patients given sibutramine compared to another given placebo ,showed an increase by 16 percent in risk of getting serious heart events including non-fatal heart attack, non-fatal stroke, and the requirements of being resuscitated once the heart stopped, and death,. It was found that there is a little difference in weight loss between the placebo group and the group that received sibutramine as well.
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