Meridia Problems for Patients with History of Cardiovascular Disease
As part of an on-going FDA review of potential problems with Meridia, the regulatory agency announced this week that the warning label for the weight-loss drug will be updated to add a new contraindication, indicating that it should not be used among people with a history of cardiovascular disease. The agency also recommends that any individuals taking the drug be closely monitored for signs of a substantial increase in blood pressure and heart rate, due to concerns that the side effects of Meridia may increase the risk of a heart attack or stroke.
>>FDA UPDATE: Meridia Warning Update
Meridia (sibutramine) is a prescription weight-loss drug that was approved by the FDA in 1997 for obese patients with other risk factors, such as diabetes, high cholesterol and controlled blood pressure. However, a recent European study indicated that some Meridia users may face an increased risk of serious and potentially fatal health problems, such as a heart attack, stroke and resuscitated cardiac arrest.
Last month, the consumer group Public Citizen filed a petition with the FDA calling for a Meridia recall to be issued, claiming that the limited weight-loss benefits provided by the drug were outweighed by the substantial risk it poses for consumers.
Although the FDA investigation into the potential Meridia problems is continuing, the agency issued a follow-up statement on January 21, 2010, which states:
FDA notified healthcare professionals that the review of additional data indicates an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using (Meridia) sibutramine. Based on the serious nature of the review findings, FDA requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label stating that sibutramine is not to be used in patients with a history of cardiovascular diseas, including:
- History of coronary artery disease (e.g., heart attack, angina)
- History of stroke or transient ischemic attack (TIA)
- History of heart arrhythmias
- History of congestive heart failure
- History of peripheral arterial disease
- Uncontrolled hypertension (e.g., > 145.90 mmHg)
Patients currently using (Meridia) sibutramine should talk with their healthcare professional to determine if continued use of sibutramine is appropriate and discuss any questions they may have about their treatment.
MERIDIA LAWSUITS
The product liability lawyers at Saiontz & Kirk, P.A. are continuing to review and evaluate the potential for Meridia lawsuits, to determine if individuals with a history of cardiovascular problems who suffered a heart attack, stroke or death while taking the drug may be entitled to compensation. The prior warning label about potential Meridia side effects did contain warnings against the use of the drugs among people with cardiovascular disease, but it is being evaluated whether this contraindication should have been added earlier.
