If you are taking weight-loss drug Meridia, stop now. This is the message the FDA gave on October 8, 2010 when it issued a rare advisory recommending that patients stop taking a drug. The announcement came after a nearly year-long appraisal of the drug's safety and the banning of the drug in Europe in January 2010. The FDA decided that the drug's modest weight-loss improvement over a placebo was not worth the drug's significantly increased risk of heart attack, stroke, and other cardiovascular injuries. According to the large SCOUT trial, the drug increases overall cardiovascular risks by up to 16%, heart attack risk by up to 28%, and stroke risk by up to 36%.
If you have been taking Meridia and have suffered a heart attack, stroke, or other heart or circulatory problems, you may be able to get compensation for your injuries. Please contact a Meridia injury lawyer today to find out if you have a case.
The Promise of Meridia
Obesity is a growing epidemic not just in the United States, but across the entire western world, including Europe and Canada. Obesity puts people at a risk for serious health conditions like diabetes, elevated blood pressure, heart attack, stroke, and obstructive sleep apnea--not to mention the serious psychological effects it causes. Unfortunately, there are few options for successfully treating obesity. Behavior modification (dieting and exercise) alone often shows little promise, and when it fails it can lead to dangerous weight cycling and a worsened self image and failure complex. Bariatric surgery can be a successful treatment option, but the expense and likelihood of serious complications makes surgery a less desirable treatment for most patients.
Diet drugs are appealing to both users and health officials because they have the potential to provide reliable and significant health benefits without major sacrifices on the part of users. When fenfluramine and dexfenfluramine were withdrawn in September 1997 due to heart valve damage, health officials looked for a replacement and found one seemingly made-to-order in Meridia (sibutramine), which was approved just two months later, over the objections of the FDA's advisory committee and medical officer. The hope was that Meridia could seriously impact the growing epidemic of obesity without the serious health drawbacks of fenfluramine.
The Real Dangers of Meridia
However, even before its approval, there was evidence that Meridia was a drug with serious risks. Pre-approval studies showed that the drug increased blood pressure and caused irregular heartbeats in many patients, which undermined a large part of the purpose of controlling obesity--to prevent cardiovascular injury and death.
As a result of these findings, the FDA's original approval panel voted 5-4 that Meridia's risks outweighed its benefits. Further, the FDA's medical officer reviewing the drug wrote that Meridia "has an unsatisfactory risk-benefit ratio and therefore this reviewer recommends non-approval."
And shortly after Meridia's approval, people began to experience its ill effects. From 1997-2002, the FDA received reports of 29 deaths associated with Meridia, 19 due to the cardiovascular injuries such as heart attack that had shown up in the pre-approval studies, including ten people under age 50, and three women under age 30, even with obesity one of the lowest-risk groups for cardiovascular death. In addition 143 patients taking Meridia reported that they experienced irregular heartbeats.
Although Public Citizen, a consumer advocate group, petitioned in 2002 for the drug's removal, the FDA decided to postpone a decision on the drug until the results of the Sibutramine Cardiovascular OUTcome (SCOUT) trial was completed.
The Results of SCOUT
The SCOUT study was initially recommended by European regulators in 1999 as a condition of Meridia's approval in the European Union. The first subjects were enrolled in 2003, and the study ran through March 2009. SCOUT enrolled patients at a high risk for cardiovascular problems. The Primary Outcome Event (POE) of the study was any of the following:
- Nonfatal heart attack
- Nonfatal stroke
- Resuscitated cardiac arrest
- Cardiovascular death
Overall, the SCOUT study showed that patients had a 16% increased risk of suffering any of these events when taking Meridia than when taking a placebo. In addition, SCOUT showed that some conditions had even higher likelihood: nonfatal heart attack risk increased by 28% and nonfatal stroke risk increased by 36%. The risk of cardiovascular death seemed to decrease by 1% and the risk of resuscitated cardiac arrest seemed to increase by 58%, but neither of these figures were deemed statistically significant.
Furthermore, the SCOUT study showed only modest weight loss gains: patients taking Meridia only lost 2.5% more of their weight than those on placebos.
Withdrawals of Meridia
When the SCOUT data was published, European regulators rushed to withdraw the drug from the market, completing the withdrawal in January 2010. However, the FDA acted slower, beginning a review of the drug's safety that culminated in a September 15, 2010 advisory committee meeting. Given three options, half the 16-member committee voted to remove the drug from the market, while six voted to keep it on the market with serious restrictions, and two voted that current labeling and screening were sufficient to protect people from the drug's dangers.
Unlike with the drug's initial approval, the FDA listened to its advisory committee and on October 8, 2010 it "recommended" that Abbott Laboratories "voluntarily" withdraw Meridia from the market.
Meridia Injuries and Compensation
As a result of the approval of Meridia, thousands have likely suffered increased blood pressure, irregular heartbeats, heart attacks, and strokes. Based on the SCOUT data, Public Citizen estimated that nearly 3000 people suffered heart attack or stroke due to taking Meridia from 2003-2010, and with the high numbers of people who took the drug immediately following its approval, it is likely that many more suffered similar injuries.
If you are one of these people, you have likely incurred increased medical expenses, and may now be facing a dramatically shortened lifespan due to a heart attack and/or serious disability due to a stroke. If so, you may be able to get compensation for your expenses and injuries. And if you have lost a loved one due to Meridia-related health conditions, you may also be eligible for compensation. To learn what compensation you may be able to receive, please contact a Meridia injury lawyer for a free case evaluation today.