Meridia, a diet and weight loss maintenance drug, emerged in 1997. Also known by names Reductil and Sibutrex, the medication saw discrepancies from the start and was eventually recalled.
Prior to Meridia’s entrance into the market, clinical data allegedly indicated the drug assisted participants with losing 5.9 percent of their body weight on average when incorporated with a low-calorie diet, compared with those who used diet and exercise alone.
However, the FDA’s outside advisors opposed Meridia because of potential health problems that emerged in these early tests.
After a year, 2 million people had a prescription for Meridia.
Recalls and Warnings
Health issues first came to light last decade, when 50 reports of adverse reactions caused Meridia to be suspended in Italy in 2002. That same year, Public Citizen petitioned the FDA to recall it, citing 397 adverse reactions, 152 hospitalizations, and 29 associated deaths.
The FDA didn’t respond until the Sibutramine Cardiovascular Outcomes Trial (SCOUT), a five-year study. Results revealed that Meridia increased incidents of major adverse cardiovascular events by 16 percent when compared to the placebo.
As well, researchers found that patients given Meridia only lost about 2.5 percent more body weight than those given the placebo.
After putting Meridia through Risk Evaluation Mitigation Strategies (REMS) and a label change, the FDA took the medication off the market. Statements claimed the diet pill’s risks greatly outweighed the benefits, with patients potentially more susceptible to increased blood pressure and heart rates. As well, the FDA believed that REMS wouldn’t lessen its risks.
Side Effects
SCOUT revealed patients prescribed Meridia had a greater chance of experiencing the following symptoms:
- Chest pain
- Heart palpitations
- Abnormal heart rate
- Dizziness
- Lightheadedness
- Non-fatal heart attacks
- Non-fatal strokes
- Resuscitation after cardiac arrest
- Cardiovascular death
Meridia has further been associated with other potentially-harmful side effects:
- Anxiety
- Depression
- Stomach pain
- Nausea
- High level of excitement
- Shortness of breath
- Confusion
- Abnormal movements
- Seizures
- Excessive sweating
- Vision changes and eye pain
- Difficulty speaking or swallowing
- Hoarseness
- Swelling of the face, tongue, throat, eyes, lips, hands, feet, lower legs, and ankles
- Unusual bruising and breathing
Lawsuits
Lawsuits, which lawyers filed as early as 2002, have focused on product liability: Specifically, that manufacturer Abbott Laboratories knew of the drug’s dangers before introducing it on the market and pushing it on doctors. As well, lawsuits allege Abbott failed to notify the public.
Even though the drug is no longer available in the U.S., roughly 8.6 million have taken Meridia since 1997. If you fall within this group and were never alerted to its potentially-fatal side effects, you may be eligible for an existing lawsuit or to begin a new claim. For direction, bring your product liability or dangerous drugs case to our Connecticut law firm.
