Meridia Faces European ScrutinyDec 21, 2009 | Parker Waichman LLP
Sibutramine, the prescription diet drug sold in the U.S. as Meridia, is being reviewed in Europe because it may be associated with an increased risk of heart attack and stroke.
In a press release issued December 18, the European Medicines Agency (EMEA) said it is reviewing data from a study known as SCOUT (Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event) that indicate an increased risk of serious cardiovascular events, such as stroke or heart attack, with medicines containing sibutramine. In Europe, such products are sold under the brand names Reductil, Reduxade and Zelium.
The EMEA reminded doctors and patients to use sibutramine-containing medicines with caution, and only in accordance with the currently approved product information. In particular, the agency said these medicines should not be used in patients with coronary artery disease, congestive heart failure, peripheral arterial occlusive disease, arrhythmia and cerebrovascular disease (stroke or transient ischemic attack). All patients should be regularly monitored for increases in blood pressure and heart rate. Patients who do not lose at least 5% of their body weight within 3 months should stop treatment. The maximum treatment duration should not exceed one year.
The announcement by the EMEA comes nearly a month after the U.S. Food & Drug Administration (FDA) said it was reviewing the safety of Meridia because of similar concerns raised by the SCOUT study. The SCOUT study also prompted the consumer advocacy group Public Citizen to file a second petition with the FDA to have Meridia banned, claiming that has caused a significantly increased number of heart attacks, strokes, resuscitated cardiac arrests or deaths in obese patients.
Based on the new findings from the SCOUT study and Public Citizen’s updated figures based on an analysis of FDA data, the group calculates that there have been 84 post-approval cardiovascular deaths of patients taking Meridia. This includes 32 patients who were 50 or younger and 11 patients 30 or younger.
“If the FDA truly intends to operate as a public health agency, then it should acknowledge that the continued approval of this drug cannot be justified based on science,” Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said in the press release. “The FDA should therefore tell Abbott to pull Meridia from the market immediately.”