Prescription weight loss medication <"http://www.yourlawyer.com/topics/overview/meridia">Meridia (sibutramine) has long been linked to cardiac risks. Now, says Reuters, an Abbott Laboratories study provided additional proof that the medication leads to increased heart risks, which has prompted heightened requests to have the drug banned.
Preliminary data from the Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT) study showed that cardiovascular events were reported in 11.4 percent of patients using Meridia compared to 10 percent of patients using a placebo. According to a US Food and Drug Administrationâ€™s (FDA) Early Communication issued in November, this difference was higher than expected, suggesting Meridia is associated with an increased cardiovascular risk in the study population. Also, based on the SCOUT findings, the European Medicines Agency found that â€œthe risks of these medicines are greater than their benefits.â€ Meridia has since been banned in Europe.
Recently published final data indicate that Meridia increases heart attack and stroke risk in patients with cardiac disease, said Reuters noting that those patients on Meridia lost an average of 8.8 pounds from an average weight of 211 pounds. Patients taking Meridia experienced a 16 percent increased risk of heart problems versus those taking a placebo, the study showed, said Reuters. While an increased risk of death was not seen, there was an increased risk of blood pressure and heart rate, noted Reuters.
Meanwhile, an FDA hearing is scheduled in two weeks to determine what future action should be taken against the medication, said Reuters.
“When you put those … things together, you have to wonder if the drug should be on the market any longer,” said Dr. Gregory Curfman, executive director of the New England Journal of Medicine, which published the study, quoted Reuters. “That’s what you’re trying to prevent through weight loss. You’re trying to prevent people from having heart attacks, and here this drug caused more,” said Curfman, a cardiologist, wrote Reuters.
Preliminary study results were released to US and European health officials late last year, which led to the European ban and to strengthening of the FDAâ€™s warning concerning risks to patients with preexisting heart disease, said Reuters. The agency asked for a public meeting with external advisors.
New England Journal of Medicine editors just wrote an editorial describing Meridia as “another flawed diet pill,” asking if the drug should remain on the market, wrote Reuters.
SCOUT, which began in 2002, involved patients 55 years of age or older, who were overweight or obese, and with a history of heart disease or type 2 diabetes plus one additional cardiovascular risk factor. Patients who recently had a heart attack or stroke, or had poorly controlled congestive heart failure were not included. The trial looked at 10,744 patients and ran to March 2009, noted Reuters.
Abbott claims Meridia is safe, arguing that Abbott only studied the medication in riskier demographics due to regulatory approval mandates, said Reuters.
According to Public Citizen’s Health Research Group Director Sidney Wolfe, the FDA took too long to act. “FDA has unconscionably allowed this drug, which should not have been approved in the first place, to stay on the market,” said Wolfe, quoted Reuters previously. “The agency appears immobilized to act against drugs that have no unique benefits but unique, serious dangers.” The FDA denied Wolfeâ€™s request pendingâ€”in partâ€”SCOUT trial results, said Reuters.