The U.S. Food and Drug Administration (FDA) approved Meridia, the brand name of the generic drug sibutramine hydrochloride monohydrate, in November 1997 for the long-term treatment of obesity. It is manufactured by Abbott Laboratories, who also sells the drug in Europe under the brand names Reductil, Reduxade, and Ectiva.
Meridia affects the appetite control centers in the brain. It reduces food intake by increasing satiety, or the feeling of fullness, but it is not 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 5 to 9 percent within six months, Abbott Laboratories warns that obesity is a chronic condition. Since weight is regained quickly when medication is withdrawn, most patients must take Meridia permanently (either constantly or in cycles) in order to maintain weight loss.
People Who Should Not Take Meridia
Currently, Meridia is one of only two pharmacologic options for long-term (up to 2 years) weight management approved by both the FDA and the European regulatory agencies. An individual cannot take Meridia if he or she is taking a prescription medicine that falls in a group of drugs called monoamine oxidase inhibitors (MAOIs), which are sometimes used to treat depression or Parkinson's disease. Meridia also cannot be taken if patients have anorexia nervosa, are taking other weight loss medications that act on the brain, or are especially sensitive to any of the ingredients in Meridia.
Meridia should not be used in patients with a history of coronary artery disease, arrhythmias, congestive heart failure, or stroke. Meridia substantially increases blood pressure in some patients, and regular monitoring of blood pressure is required when taking the drug. Meridia should be prescribed with caution to those patients with a history of hypertension, and should not be given to patients with uncontrolled or poorly controlled hypertension.
Common Side Effects of Meridia
The most common side effects of Meridia include headache, dry mouth, anorexia, constipation and insomnia. Meridia is a controlled substance, which means that abuse may lead to dependency. If you or a loved one has taken or are taking Meridia, and have any concerns regarding any of the above, you should contact a physician immediately. Patients being treated with Meridia should see their doctor for regular follow-up visits, during which the doctor can carefully monitor their overall health, including regular monitoring of blood pressure and pulse rate.
Health Concerns Raised Regarding Meridia
In March 2002, Public Citizen, a national nonprofit consumer advocacy group founded by Ralph Nader, submitted a petition to the Department of Health and Human Services (HHS), to which the FDA reports, 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 Meridia increased the blood pressure of some patients, and experts had warned that people with heart disease should not take the drug.
The FDA acknowledged that it was concerned about the events noted in Public Citizen's petition, but it felt that the cautions on the drug's label were sufficient warning for anyone at risk for cardiac complications.
On May 21, 2002, Public Citizen announced that it had examined the recently released FDA inspection report of one of the Abbott factories. The report stated that one death associated with Meridia had not been reported to the FDA and that reports to the FDA on seven other deaths were either inaccurate or incomplete, based on case files found. Public Citizen then called for criminal charges to be pressed against Abbott for illegally withholding information from the FDA regarding these deaths and negative side effects in Meridia patients.
On June 4, 2002, Abbott responded to Public Citizen's new accusations, insisting that the unreported death was an unconfirmed rumor, and that Abbott had "fully responded" to all of the other findings in the FDA report.
Nonetheless, on July 19, 2002 the FDA issued a formal warning letter to Abbott, concerning delays in reporting adverse drug events.
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.
Get Help Now
While almost all medications have some anticipated side effects, a drug manufacturer has a duty to adequately inform physicians regarding the known risks associated with its drugs. 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 unusual side effects or suffered injury, you should contact a physician for proper medical attention. Your next step should be to contact an experienced attorney, who will assess and protect your legal rights.
- Go here to learn more about an attorney's role in a pharmaceutical liability case.
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