Meridia ban sought as heart risks from diet drug emerge

Wigglesworth/AP

Dec. 4--A consumer group yesterday asked federal regulators to order Meridia off the U.S. market, claiming that the prescription weight loss capsules cause more heart and other health problems among obese people than they prevent.

Public Citizen cited newly published evidence that Meridia "has caused a significantly increased number of heart attacks, strokes, resuscitated cardiac arrests or deaths" in its petition for a ban on the drug to the Food and Drug Administration.

The FDA-approved prescribing information for Meridia capsules already includes warnings that the drug's active ingredient sibutramine can cause spikes in blood pressure and rapid heartbeats. Those warnings appear in boldface, all-capitalized text, indicating that both Meridia's manufacturer, Abbott Laboratories, and FDA have long recognized serious cardiovascular risks from the drug.

The new evidence pointed to by Public Citizen comes from an international study of health benefits and side effects among 10,724 Meridia users launched in 2002. Data from the Sibutramine Cariovascular OUTcomes--SCOUT--trial began appearing in medical journals in November.

Researchers wrote in the European Heart Journal that six weeks of Meridia use led to an average weight loss of 2.2 kg (about 5 pounds) and a reduction in waist measurement of 2 cm (a little more than 3/4 of an inch). All the patients also followed a prescribed expercise program and a reduced-calorie diet. In addition to weight loss and slimming, the researchers recorded "two consecutive increases in blood pressure or pulse rate of more than 10 mmHg/bpm ... in 4.7 and 3.5 percent of subjects, respectively. Fifteen subjects (0.1 percent) died; 10 deaths were attributed to a cardiovascular cause, equivalent to 1.2 and 0.8 deaths per 100 years of exposure."

The researchers concluded that this constituted an acceptable safety and efficay profile. Public Citizen disagrees.

The consumer advocacy group's health research director Sidney Wolfe said in a press release that "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."

Wolfe's group first sought a ban on Meridia in 2002. The FDA allowed Abbott to continue marketing the drug in 2005, however, pending, in part, the results of the SCOUT trial.