An ongoing review of the side effects of Meridia, a prescription weight-loss drug that has been linked to an increased risk of heart attack and strokes in patients with a history of cardiovascular disease, has led the FDA to warn against its use for people suffering from heart problems.
The FDA announced new contraindications for the Knoll Pharmaceutical Co. drug on Thursday, saying that Meridia should never be given to patients with a history of cardiovascular disease, including:
- Heart attack
- Heart arrhythmias
- Congestive heart failure
- Peripheral arterial disease
- Uncontrolled hypertension
The new contraindications were based on the “serious nature” of findings in an ongoing review of Meridia heart attack and stroke risks. According to the FDA, the manufacturer has already agreed to change the label.
FDA officials recommend that healthcare professionals carefully monitor the blood pressure and heart rate of patients given the drug, and that the use of Meridia be discontinued immediately if there are signs of a substantial increase of either. In addition, the agency said that Meridia should be discontinued if a patient does not lose at least 5% of their baseline body weight within the first three to six months of being on the medication. If an individual has not experienced substantial weight loss by that point, te FDA determined that continued Meridia treatment was unlikely to be effective and exposed the user to unnecessary Meridia health risks.
Meridia (sibutramine) was approved by the FDA in 1997 as a prescription-only weight loss supplement for obese patients with other risk factors such as diabetes, high cholesterol and controlled blood pressure.
In November 2009, the FDA announced that they were reviewing potential heart problems from Meridia after data suggested that side effects of the drug may cause users to suffer a higher number of cardiovascular events, such as heart attacks, strokes, resuscitated cardiac arrest or death.
The review was announced after FDA began examining data from a 10,000-patient study conducted in Europe known as the Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of Cardiovascular Event (SCOUT). The latest recommendations came after further review of that data.
The same data led the consumer activist group Public Citizen to petition FDA to issue a Meridia recall in early December. The petition is the group’s second attempt to get Meridia recalled. A 2002 petition to FDA to have Meridia pulled from shelves was denied because FDA said it was still waiting for the results of the SCOUT study.
The FDA said it anticipates finishing its review on Meridia and issuing a final report in March.