As a defective medication lawyer, I was interested to read that the U.S. Food and Drug Administration will convene an expert advisory panel in September to determine whether to allow Meridia (sibutramine), a weight-loss pill produced by Abbott, to remain on the market. Abbott’s own company-sponsored study has shown that Meridia increases the risk of nonfatal heart attack and stroke in patients who have underlying heart disease. European drug regulators have already banned the drug, known in Europe under the brand name Reductil. Given the drug’s modest-at-best effectiveness in helping patients lose weight, it hardly seems worth the increased risk to patients to keep it on the market — except perhaps to the company who stands to profit from the drug’s sales.
Meridia, an appetite suppressant, gained FDA approval 13 years ago. A monoamine reuptake inhibitor, Meridia works in a way similar to Prozac and some other anti-depressants, using the neurotransmitter serotonin to help patients feel full for a longer time after they’ve eaten. Before approval, the FDA was concerned that the drug significantly raised blood pressure and heart rate, and increased patients’ risk for developing cardiovascular disease. But the argument for the drug was that if it helped patients to lose weight, that in itself would benefit their heart health.
As it turns out, not only does Meridia increase patients’ risks of nonfatal heart attack and stroke, but studies show that it also doesn’t help them lose weight. A study that followed nearly 10,000 overweight or obese people for 3.5 years found that Meridia helped patients lose an average of nine pounds, or 4.5% — which is below the 5% threshold that the FDA considers the minimum for weight loss drugs. Worse, it increased patients’ risk of heart attack by 28% and stroke by 36% compared to a sugar pill. That’s why an editorial in the New England Journal of Medicine has called for the drug to be pulled from the market. Abbott has defended Meridia by saying that the drug’s label advises doctors not to prescribe it to patients who have known cardiovascular disease. But this wouldn’t help people who have undiagnosed cardiovascular problems. About half of all patients who die suddenly from heart attacks do not have a known history of such problems, and many overweight and obese patients do face cardiovascular health problems, whether they are aware of them or not.
Patients depend on drug manufacturers, doctors, and the FDA to ensure their safety when they take medications. We can’t all have the medical training that would equip us to make our own fully informed decisions about drugs that we might take to improve our health and save our lives. That’s why, as a pharmaceutical liability attorney, I think that when a medical journal as highly respected as the New England Journal of Medicine calls for Meridia’s removal from the market, doctors, patients and especially the FDA should listen.
Unfortunately, sometimes the system we depend on to ensure our safety doesn’t work. Even though drug manufacturers are required by law to warn consumers of risks that they know to be linked to their products, sometimes drug manufacturers fail to live up to this responsibility, and patients are harmed by defective, dangerous drugs. When that happens, patients can recover financial compensation from the drug manufacturer whose product harmed them. When consumers incur medical costs, miss work and/or are unable to work, and their quality of life suffers because of negative effects of an over-the-counter or prescription drug, they can require the drug manufacturer to pay these costs, which the manufacturer ultimately caused. Consumers who trust that a medication is safe should not have to bear all the consequences alone if they find that the medication is actually unsafe, especially if the manufacturer knew about it.
The dangerous medication attorneys at Carey, Danis & Lowe work hard to help people who have been hurt by over-the-counter and prescription drugs. If you or someone you love have been seriously harmed by a medication, please come to us for advice about making the company that caused your injury pay for your injuries and expenses. In a legal claim, you can recover compensation for medical expenses, lost wages, permanent injuries, lost quality of life, pain and suffering and more. If you have been hurt by a defective drug, please call Carey, Danis & Lowe for a consultation, toll-free, at 1-877-678-3400 or contact us through our website.