FDA, European Drug Regulators Seem to Disagree on Meridia’s Benefits
The United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) play similar roles in regards to regulating the safety of drugs and prescription medications. While the FDA’s jurisdiction falls within the United States, the EMA oversees the countries within the European Union. Recent events have revealed an interesting contrast in their reaction to news that Meridia side effects appear to be a real risk. Meridia side effects lawyers have already filed claims in the United States on behalf of their injured clients, but as of now those claims have been filed in the absence of the strongest regulatory step from the FDA. Below is a look at the contrast in positions between the two regulatory agencies.
Meridia Side Effects Lawyers – Reasons for Reaction
Meridia side effects have been reported with increasing frequency in recent months, and it was only last year that the FDA stated that it would make a decision regarding how to handle Meridia when the results of a massive ongoing study became available. This study, known as the SCOUT study, is expected to be finalized in March, but preliminary conclusions have already been released.
Aside from the previous reports of Meridia side effects that included the risks of developing such problems as heart valve damage and Primary Pulmonary Hypertension, or PPH, these new preliminary conclusions draw a troubling connection between those patients who have a history of heart problems and the higher risk of suffering from a heart attack, stroke or other heart-related side effect if these patients use Meridia to fight obesity.
Meridia Side Effects Lawyers – The Contrast
In the wake of the most recent news regarding the SCOUT study, the FDA has announced that it was requiring Abbott Laboratories, the manufacturer of Meridia, to place what’s known as a ‘Black Box Warning’ on all labels of the medication. This warning must clearly alert medical professionals and patients of the risks involved with taking this drug and the potential Meridia side effects that could develop. The FDA has also indicated that it would wait to make a final decision regarding Meridia until the final results of the SCOUT study are available in March.
Meanwhile, the EMA has already released the text from a ‘Dear Doctor’ letter that it is sending to doctors and pharmacists in the European Union. This letter basically states that medical professionals are hereby recommended to cease and desist with the prescription and administration of Meridia to their patients given the clear risks of Meridia side effects that are involved. Meridia is sold under different brand names in Europe that include Reductil.
Meridia Side Effects Lawyers – How to Proceed
As can be seen, the analysis regarding Meridia’s benefit vs. its risks is beginning to turn towards the negative for Abbott Laboratories. More importantly, it’s seen as a risk for patients across the world. Even though the FDA has not yet taken the strongest action possible, that does not affect a claim that’s filed by someone who has suffered from Meridia side effects. If this includes you or someone you love, you need to contact the Meridia side effects lawyers at Phillips & Associates today to schedule a free initial consultation.