Meridia was a prescription medication used for the long-term treatment of obesity. It was manufactured by Abbott Laboratories, who also sold the drug in Europe under the brand names Reductil, Reduxade, and Ectiva. The generic name is sibutramine hydrochloride monohydrate.
Meridia was approved by the U.S. Food and Drug Administration (FDA) in 1997, but then withdrawn from the market by Abbott in 2010 for the reasons discussed below. The FDA, often in partnership with manufacturers, will recall a drug when it poses health risks that make it unsafe for the public to use. For more on this process, see the Why Drugs Get Pulled from the Market article.
How Meridia Works
Meridia affects the appetite control centers in the brain. It reduces food intake by increasing satiety, or the feeling of fullness, but it isn’t an appetite suppressant. Meridia hinders the reabsorption in the brain of two chemicals that make people feel full. By not allowing these chemicals to be absorbed by the nerve cells in the brain, a feeling of fullness occurs sooner, which should lead to reduced food intake and, subsequently, to weight loss.
While the average weight loss from Meridia use is five to nine percent within six months, obesity is often a chronic condition. Since weight is regained quickly when medication is withdrawn, most patients were directed to take Meridia permanently, either constantly or in cycles, in order to maintain weight loss.
Meridia Market Withdrawal
The trouble for Meridia started in March 2002 when Public Citizen, a national nonprofit consumer advocacy group, submitted a petition asking that Meridia be removed from the market because of doubts about its safety and benefits. According to Public Citizen, Meridia had been involved in 29 deaths (19 heart related) and hundreds of other negative reactions between February 1998 and September 2001.
In the petition, Public Citizen alleged that of the 397 serious adverse reactions reported to the FDA since Meridia was approved, 152 required hospitalization; 143 of those hospitalized had irregular heartbeats. The group also pointed out that the Ministry of Health in Italy had just suspended sales of the drug because of two deaths there, and its safety was being reviewed by other countries. Public Citizen believed that Meridia had no evidence of long-term benefit, and major evidence of short-term risk and death.
In response, experts cautioned that it was difficult to determine if people died because they were taking Meridia or because they were already suffering from obesity-related diseases. In fact, when Meridia was approved studies had shown that it increased the blood pressure of some patients, and experts had warned that people with heart disease shouldn't take the drug. The FDA acknowledged concern in their August 2005 response to Public Citizen's petition, but felt the cautions on the drug's label were sufficient warning for anyone at-risk for cardiac complications.
On September 3, 2003, Public Citizen submitted an updated petition to the FDA, reiterating its position that Meridia should be banned from the marketplace, and updating to 49 the number of cardiovascular deaths among users of the diet drug.
Six years later, in November 2009, the FDA had communicated to healthcare professionals that it was reviewing data suggesting patients using sibutramine have a higher risk of heart attacks, stroke, or death that patients who took a placebo. At the time, they urged doctors and patients to report side effects to the FDA MedWatch Adverse Event Reporting program. After this announcement, Public Citizen again petitioned the FDA to ban sibutramine.
Finally, in October of 2010 Abbott agreed to voluntarily withdraw the obesity drug from the market, that is to not sell it anymore, because clinical data showed it lead to an increased risk of heart attack and stroke. The FDA said that the modest weight loss people achieved with the drug didn't justify risk of heart attack or stroke. Doctors were advised to stop prescribing the drug and patients were advised to stop taking it.
Around the world, sibutramine drugs like Meridia were pulled from the shelves. Medicines containing sibutramine were suspended in Europe in August 2010 because the European Medicines Agency found the health risks didn't outweigh the benefits. These drugs, marketed as Reductil, Ectiva, and Reduxade were also suspended in Singapore in 2010.
Getting Legal Help
Prescription drug manufacturers have a duty to adequately inform the medical community and patients regarding the known risks associated with its drugs, even if there are known side effects. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as "product liability."
If you or a loved one have taken Meridia and experienced any severe side effects or suffered injury, you should contact a doctor for proper medical attention. Your next step should be to consult with an experienced attorney, who can discuss your options and help you protect your legal rights to compensation for injuries suffered by using Meridia.
An important legal concept you will want to discuss with your attorney is the statute of limitations. A product liability case like one for side effects of Meridia use must be brought within a certain time period, depending on your state. For most states, the clock doesn't start until the injured person discovered or should have discovered his or her injury.
Contact a qualified product liability attorney to make sure your rights are protected.