Article Research Paper
Meridia: Is the risk worth it
Meridia (Sibutramine) is one of the many diet pills out there on the market that promise help with weight loss. It is becoming increasingly aware, however, that the pill will increase your risk for heart attacks and strokes, especially in people with cardiovascular disease. Taken with the fact that the potential for weight loss is pretty small, the question rises whether it’s worth it to be on the market. I could not help but think about my Aunt after reading an article on this extensive study done with Meridia patients. My Aunt passed away a while ago from a brain hemorrhage while taking Celebrex. Celebrex was known for serious increased chances for cardiovascular problems and gastrointestinal bleeding. While Celebrex was never taken off the market, similar drugs (Vioxx and Bextra) were. Celebrex was given a “black box” warning, the strongest warning the FDA can give to doctors prescribing the drug. The case was made that while the risks for Celebrex are great, they don’t outweigh the incredible relief it provides to the few serious arthritis sufferers who aren’t prone to the side effects. I wondered whether Meridia should have the same view from the FDA.
This study that showed the scary side effects of Meridia was actually done by Meridia’s makers, Abbott Labratories, on over 10,000 obese or overweight older people. “Patients on Meridia lost about nine pounds in the first year; those who received placebos lost about four pounds. The Meridia patients suffered 28 percent more heart attacks and 36 percent more strokes, although there was no difference in heart-related deaths” (Harris).
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The European Medicine’s Agency already removed Meridia from the European Market after seeing the preliminary results from the study. However, the Food and Drug Administration decided to only add a label to the drug stating it should not be used with patients with a history of cardiovascular disease. The problem, Doctor Curfman says, is many patients “have cardiovascular disease and don’t know it. How are you supposed to identify those patients who might be put at risk by putting them on drugs like sibutramine?” The article also mentions the FDA planned to vote on the drugs future on September 15 of this year. It turned out the vote was evenly split eight to eight, meaning for now Meridia will remain on the market. I wanted more information on the study to decide whether I thought this was a good thing or bad thing.
The second article I searched for then showed the results of the study more carefully. It turned out there was a 4 week period and a 44 week period. After continuously taking Meridia it showed only modestly additional weight loss at about 8 lbs. The results also concluded that Meridia just isn’t safe to take over a year. This made me greatly question whether the FDA was accurate in its split vote to keep Meridia off the market.
Doctor Rudolph L. Leibel, an obesity researcher at Columbia University, also acknowledges how a small number of people benefit enormously from the drug. “The question is do you withdraw the drug to protect the large number of individuals who have no benefit and could have a bad response and thereby eliminate the opportunity for that small number of people who respond well?” (Leibel).
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After researching both articles, my answer is yes, Meridia should be withdrawn from the market. Especially after acknowledging in our class how today’s number one killer is by far cardiovascular disease and it being the silent killer, I strongly believe it isn’t a safe product to be on the market, even with its “black box” warning. Doctors just aren’t being careful enough to keep every patient on Meridia safe. With many people looking for easy ways to lose weight today, and especially many of these people being overweight and probably not having average, healthy hearts, it just isn’t a safe idea to have such a product open to the public. The European Medicine’s Agency already made their decision. I personally hope the FDA reviews their vote and saves the potential lives lost from taking Meridia.
Harris, Gardiner. “Study Sees Heart Risk in Meridia Diet Pill.” NY Times. Sept. 1, 2010.
“FDA Panel Split on Withdrawing Diet Pill Meridia” Associated Press, MSNBC. Sept. 15, 2010.