On October 8, the US Food and Drug Administration (FDA) requested a voluntary withdrawal of the diet drug Meridia (sibutramine). The withdrawal was requested because the drug had been associated with an increased risk of stroke and heart attack. Unfortunately, the action comes more than a decade after the drug’s 1997 approval. There are many who argue that the drug should never have been approved in the first place, since the approval was given over the objections of the FDA’s own advisory panel. The advisory panel voted 5-4 that the Meridia’s benefits did not outweigh its risks, and 8-0 that the drug’s side effect of increasing blood pressure a “clinically important” risk. During his review of the drug, the FDA’s medical officer further commented that the drug “has an unsatisfactory risk-benefit ratio” and that it “does not improve and in some cases it aggravates major obesity-related co-morbidities.” However, the FDA, perhaps prompted by a desire to replace the even more deadly Fen-Phen diet drugs, approved Meridia anyway.
Despite restrictions and despite a petition by the consumer advocate group Public Citizen in 2002, Meridia went on the market and remained on the market until now. What prompted the change was the publication of the results from the Sibutramine Cardiovascular OUTcomes (SCOUT) study. These results showed that sibutramine use increased the risk of:
· All major cardiovascular problems by 16%
· Non-fatal heart attack by 28%
· Non-fatal stroke by 36%
At the September 15 advisory committee considering the SCOUT results, Public Citizen noted that since the group’s original petition, doctors have written over 3.6 million Meridia prescriptions. They also made the conservative estimate that nearly 3000 people have suffered a heart attack or stroke as a result of Meridia.
If there is one thing we can learn from the Meridia “fiasco,” we should not wait 12 years after a drug’s approval before we get results from the first large-scale, long-term trial of a drug. We need studies like this conducted before a drug is marketed, especially if there are signs that it is a dangerous drug, with numerous “clinically important” side effects. Trials like this are necessary to keep dangerous drugs like Avandia and Accutane from becoming popular before their risks are fully known.
If you or a loved one has suffered a heart attack, stroke, or other cardiovascular effect as a result of taking Meridia or another dangerous drug, the mass tort lawyers of Robert W. Kerpsack, CO, LPA can help. Please call or email us today to learn how we can help you.