The Food and Drug Administration has ordered Abbott Laboratories to take its diet drug Meridia off the market in the U.S. The company has said it will comply, even though it maintains the drug is safe and effective in some patients. Meridia has been a source of controversy since studies linked the diet drug to increased chance of stroke or heart attack in some patients.
Meridia was approved in 1997, reports Bloomberg, even though there was some evidence at the time the drug could raise blood pressure and heart rate. In January of this year, Meridia was taken off the market in Europe. The FDA did not follow suit, waiting to review more data from the study which linked the drug to a 16 percent increase of major cardiovascular side effects in 10,000 high risk patients. The agency also waited for the review of a panel of outside experts.
According to Bloomberg, warnings on prescribing information for Meridia were added in January to prevent the drug from being given to patients with a high risk of heart attack. Finally in September, the FDA advisory panel voted 8-8, when asked if the drug should be withdrawn or remain available with additional warnings or restrictions.
In a related warning, the FDA also said on October 8 that “several reports of serious side effects” have been tied to Slimming Beauty Bitter Orange Slimming Capsules. This diet treatment also contains sibutramine, which is the main ingredient in Meridia.
The recall of Meridia from the market may result in higher safety standards being applied to those diet drugs that follow, reports Bloomberg. No doubt new diet drugs will come up for approval, because the market is there. One third of American adults are obese, raising their risk of diabetes, heart disease, and cancer.