Meridia Recalled Based on Cardiac Risks
After further investigation into a study published about a link between the diet drug, Meridia, and cardiac problems, the FDA requested that Abbot Laboratories pull the obesity drug from the U.S. market. The company announced a voluntary recall of Meridia Oct. 8, 2010.
Abbot says it plans to stop selling the drug in Canada and Australia as well. It is marketed and sold under the brand name Reductil. An increased risk of heart attack, stroke and other life-threatening cardiac problems has been confirmed.
FDA Members Were Previously Split on Decision to Ban Meridia
Members of the U.S. Food and Drug Administration (FDA) are split on a decision whether to withdrawal the diet drug Meridia from the market. The debate is based on study results that link Meridia (sibutramine) to heart attack, stroke and other cardiac problems.
The agency’s endocrinologic and metabolic drugs advisory committee debated whether to ban the diet drug in September 2010.
Eight of the 16 panel members voted to withdraw the drug from the U.S. Six panel members say stricter warnings should be added to the drug’s label and should only be prescribed to certain patients. Two panel members say the drug should remain on the market, but should include a black box warning regarding the potential cardiac side effects.
Whether the FDA will withdraw the medication is unclear. Should the FDA decide to keep the drug on the market, doctors will, reportedly, be encouraged to take caution when prescribing it.
Study Links Meridia to Dangerous Cardiac Problems
The debate surrounding the diet drug is based on study results that found Meridia (sibutramine) increases a risk of heart attack, stroke, cardiac arrest and cardiac death by 16 percent in users. The study involved 9,804 participants. All participants had a history of cardiovascular disease and were overweight.
Meridia Risks – Increased Heart Attack and Stroke Risks
Patients using the prescription drug Meridia are being asked to contact the Food and Drug Administration (FDA) and report any side effects. This comes after a new study revealed that Meridia, (sibutramine hydrochloride) prescribed to overweight patients who may be at risk for diabetes, high cholesterol and high blood pressure, may increase the risk of heart attack, stroke or other cardiovascular problems.
The study is currently being reviewed by FDA regulators who have released an early communication based on the data. Although the FDA has promised to announce any regulatory action as soon as possible, the agency has advised doctors and their patients to follow the current guidelines, which recommend against using Meridia in people with a history of cardiovascular conditions.
The study included approximately 10,000 people aged 55 or older, with a history of heart disease or diabetes, and one additional risk factor for cardiovascular problems. Approximately 5,000 people were asked to take Meridia while the other half received a placebo pill. Serious cardiovascular events occurred in:
- 11.4% of people taking Meridia
- 10% of individuals taking a sugar pill
The difference is higher than expected and strongly suggests that sibutramine is associated with an increased cardiovascular risk.
The manufacturer of sibutramine says that Meridia is safe when used as recommended. The analysis of the data is ongoing and is being conducted by the FDA as well as the manufacturer.
The FDA is asking patients who are currently using Meridia to consult their doctor before discontinuing use.
Meridia Side Effects
Meridia is generally prescribed to people with a body mass index of 30 and higher to assist in weight management. The drug affects the patient’s brain to help them feel full, thus eat less.
A number of patients who have taken Meridia have developed side effects, the most common of which include:
- Increased heart rate and blood pressure
- Throbbing heart beat
- Difficulty breathing
- Abdominal pain
- Anxiety and mood swings
- Tingling skin sensation
If you or your loved one experienced a heart attack, stroke or a similar cardiovascular problem while on Meridia, you may be entitled to receive compensation. If the data is confirmed by the FDA, the manufacturer may be held liable for negligence.
The Pensacola personal injury attorneys of Aylstock, Witkin Kreis & Overholtz handle national litigation across the United States for victims injured by defective pharmaceuticals and medical devices. Contact AWKO Law today at 844-794-7402 to learn more about your rights as a victim of this potentially harmful product.