Ban Meridia Now, Public Citizen SaysDec 4, 2009 | Parker Waichman LLP
Meridia, a weight loss drug marketed by Abbot Laboratories, should be banned by the U.S. Food & Drug Administration (FDA) immediately, according to the consumer advocacy group Public Citizen. In a press release announcing that it has filed its second petition with the FDA to have Meridia banned, Public Citizen said the drug has caused a significantly increased number of heart attacks, strokes, resuscitated cardiac arrests or deaths in obese patients.
Meridia (sibutramine) was approved by the FDA in 1997 for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with a reduced calorie diet. It is only recommended for obese patients with an initial body mass index (BMI) ≥ 30 kg/m2, or BMI ≥ 27 kg/m2 with other risk factors (e.g., diabetes, high cholesterol, controlled high blood pressure). About 294,000 prescriptions for Meridia were filled in the past 12 months, according to Public Citizen.
As we've reported previously, Meridia is already the subject of an FDA safety review. The review was announced after preliminary analysis of a study known as SCOUT (Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event) suggested that patients using Meridia experienced a higher number of cardiovascular events compared to those using a placebo.
Public Citizen first sought to ban sibutramine, the active ingredient in Meridia, in 2002, stating that results of pre-approval clinical trials had demonstrated increases in blood pressure, pulse rate and palpitations in obese patients taking the drug. But the FDA rejected the petition four years ago because it was awaiting results of a large, randomized study that could provide more conclusive results. According to Public Citizen, the SCOUT trial has provided the data the FDA was waiting for.
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.”