Patients on the prescription diet drug Meridia (sibutramine) should stop taking the medication according to the U.S. Food and Drug Administration (FDA) and the company that distributes it. The seller of the drug, Abbott Laboratories, has issued a recall after being asked by the FDA on Oct. 8, 2010 to pull it off the market.
The recall is based on a research study showing a very poor risk-to-benefit ratio for the medication, which the FDA termed unacceptable. The drug carries an inordinately high risk of non-fatal heart attack and non-fatal stroke compared to its modest benefits.
The research, a five-year study by the Sibutramine Cardiovascular Outcomes Trial (SCOUT) showed that the average difference in body weight for patients on Meridia versus patients on a placebo was about 2.5 percent. This compared with a 16 percent risk of heart attack and stroke.
Maker of Meridia defends itself, saying that persons taking the drug are overweight and therefore already at high risk of heart attack and stroke.
Consumer Group Urges U.S. Officials to Bring Criminal Charges Against Meridia Manufacturer
When Meridia diet pill was FDA approved in 1997, the manufacturer pledged they would educate doctors and patients to use Meridia responsibly. Meridia was the first diet pill to follow the "breakthrough" diet pills Fen Phen and Redux that were banned after 6-7 million Americans took the dangerous drugs that caused life-threatening heart conditions like primary pulmonary hypertension.
Back in May 2002 Public Citizen consumer group urged U.S. officials to bring criminal charges against Meridia diet pill manufacturer Abbott Laboratories, alleging the pharmaceutical company withheld information from regulators regarding eight Meridia deaths in addition to other Meridia side effects.
Public Citizen's information was based off of a report from a recent FDA inspection of the pharmaceutical company's facilities that indicated Abbott did not report one death associated with Meridia diet pill and records regarding seven other Meridia deaths were inaccurate, unsupported, or incomplete, which is required by law. This information indicates that Abbott has been allowing Meridia patients to continue taking the diet pill while not allowing them complete access to the safety indications surrounding the drug. According to their 1997 "pledge" Abbott would not be consistent in their claims to educate Meridia doctors and patients by not allowing those very people to fully learn about their diet pill and its adverse effects.