The U.S. Food and Drug Administration has released a new warning to the makers of the prescription weight-loss drug Meridia, contending that it is dangerous to users with previous heart conditions. Abbott Laboratories has been cautioned that Meridia, also known as sibutramine, should no longer be prescribed to anyone who has experienced previous cardiovascular issues such as heart attacks, heart disease, angina, heart arrhythmias, congestive heart failure, peripheral arterial disease, and uncontrolled hypertension, among others.
The FDA’s warning comes on the heels of the European Medicines Agency issuing an immediate suspension of the sale of all medications containing sibutramine. The EMEA released a statement to doctors and various other medical professionals throughout Europe insisting that these specific weight-loss drugs carry a far greater risk than benefit. A clinical trial known as Sibutramine Cardiovascular OUTcomes, provided evidence that patients using the weight-loss drugs showed a great risk to the aforementioned cardiovascular problems, despite any of the drug’s clinical successes in weight loss.
In reflection of the findings of the SCOUT trial, Abbott Laboratories – manufacturer and distributor of Meridia – will create a stronger-worded warning label for American consumers. This new label, as impressed by the FDA, will detail the drug’s cardiovascular risks to people who have previously suffered heart ailments.
The SCOUT trial began in 2002 and at that time there was already one petition to have Meridia pulled from shelves, however the FDA denied that petition in favor of waiting for the SCOUT results. In November 2009, the FDA began this recent investigation based on the SCOUT findings.
Meridia first received FDA approval in 1997, after trials showed that the drug induced weight loss of 10 to 14 pounds on average within one year.
If you or a loved one has experienced cardiovascular complications while taking prescription Meridia or similar weight-loss drugs featuring sibutramine, contact Newsome Law Firm and fill out a case evaluation form today. Our team of attorneys has experience specific to complications associated with health complications caused by prescription medication. Not only can they give you the legal guidance you need, they can help you get the compensation you deserve.