FDA News: Meridia to be Withdrawn from US Market
Maintaining constant awareness of medications that are being reviewed by the Food and Drug Administration (FDA) as well as those which have been recalled or have been voluntarily removed from the market is an important aspect of a pharmacist’s career. By knowing about potential concerns, and the eventual results of those concerns, pharmacists are able to warn patients about the possible side effects associated with their medications.Meridia (sibutramine) is an appetite suppressant which has been prescribed for people who wanted to lose weight. The product was approved by the FDA in 1997. A capsule is taken once a day by mouth either with or without food at the same time every day. The manufacturer of the product recently, in deference to the FDA’s recommendations, stopped offering the product in the United States.
What is the problem with Meridia?
In October of 2010, the FDA recommended that Meridia no longer be prescribed in the United States because of the concern that the product might be increasing cardiovascular risk unnecessarily in patients. The FDA requested that the manufacturers of Meridia, Abbott Laboratories, voluntarily withdraw the product, which they agreed to do. The recommendation was the result of a test which concluded in 2009, which indicated a 16% increased risk of a major cardiovascular even in patients taking Meridia. Additionally, the weight loss achieved by the individuals in the study was minimal compared to the patients in the group who were given a placebo.
How was the study performed?
Between 2003 and 2009, about 10,000 participants in Australia, Europe, and Latin America under the age of 55 and with a BMI of between 25 and 45 were recruited to join the study. The participants were required to have some history of cardiovascular disease or type 2 diabetes, along with another risk factor. After an initial six week lead-in on Meridia 10mg, patients were transferred to the primary test group or the placebo group where they remained for about 3.5 years. The weight loss difference between the two groups at the end of the trial period was only about 2.5%.
What should patients do who are taking Meridia?
If a patient has already filled a prescription for Meridia, they should be advised of the new findings of the FDA and should stop taking the product immediately. They can dispose of the product by emptying the capsules from their original container and mixing them with an unpleasant substance such as cat litter or coffee grounds to prevent animals and other people from finding and taking the medication. If a patient has been taking the medication, they should be aware of any cardiovascular symptoms such as dizziness, abnormal heart rate, chest pain, heart palpitations, or lightheadedness, and should contact a medical professional at the onset of these symptoms.
What do you do for patients when a drug comes under review by the FDA or when it is removed due to concerns about the adverse effect it is having on patients?