FDA, European Drug Regulators Disagree on Meridia's Benefit
Posted on behalf of Phillips Law Group on Jan 26, 2010 in Defective Drug
The obesity drug Meridia has been in the news for all the wrong reasons lately, and the emerging reports of serious Meridia side effects have led to differing actions between entities charged with regulating the safety of prescription medications.
Meridia is manufactured by Abbott Laboratories, and it's been on the market in the United States since its approval by the FDA in 1997. Recent reports of problems associated with Meridia have led to the involvement of Meridia side effects lawyers in the United States and regulatory steps taken by the FDA and European authorities. However, an interesting contrast is developing between the actions taken by these regulators. This difference is described below.
Meridia Side Effects Lawyers - The Latest Study
Meridia side effects had been reported in recent years that included heart problems and the development of Primary Pulmonary Hypertension, or PPH. While these problems have led to several lawsuits being filed against Abbott Laboratories in the United States, the drug was never removed from the market. However, the FDA did make a statement in recent months that the agency would review the findings of a massive study that was ongoing in order to make a determination of whether the benefits of keeping Meridia on the market outweighed the risks encountered by those who used it.
This ongoing study, known as the Sibutramine Cardiovascular OUTcomes, or SCOUT study, has released its preliminary findings, and they are troubling. Basically, SCOUT found that those patients taking Meridia who had a history of heart problems encountered a higher risk of suffering from heart attacks, strokes and other serious heart-related problems than those who did not have the same histories. When this information was released and coupled with the previous reports of Meridia side effects, regulatory agencies in the United States and in Europe were prompted to act.
Meridia Side Effects Lawyers - The Regulatory Contrast
It was the release of this preliminary information from the SCOUT study that led to the contrast in steps taken between regulatory agencies in the United States and in Europe. The FDA handles these regulations in the United States, and the agency recently took the step of ordering a 'Black Box Warning' to be affixed to all containers of Meridia. This warning requires the manufacturer to place a clear and strong warning message on Meridia containers that detail the risks of Meridia side effects. The FDA also appears content to wait until the final results of the SCOUT study are publicized, and those results are expected in March.
However, the European Medicines Agency (EMA), which can loosely be compared with the role that the FDA plays within the European Union, took a decidedly different approach in response to these preliminary findings. The EMA published a 'Dear Doctor' letter that was intended to be disseminated to both doctors and pharmacists in Europe. This letter recommended that medical professionals stop prescribing the European equivalent of Meridia that's sold under different brand names, including Reductil. While this letter is not the same as a recall of the drug, it is clearly a stronger step than the one taken by the FDA.
Meridia Side Effects Lawyers - How to Proceed
It will be interesting to see how the FDA proceeds when the final results of the SCOUT study are made available later this year. In the meantime, if you or someone you love has been harmed as a result of using Meridia, you should not wait to assert your legal rights. It's clear that the drug has caused problems for many people around the world, so you should contact the Meridia side effects lawyers at Phillips Law Group today to schedule a free initial consultation.