Meridia is an orally administered weight-loss drug used to treat obesity. It was removed from the U.S. market in October 2010 after a request was made by the United States Food and Drug Administration (FDA).
The drug, which is also known as sibutramine hydrochloride monohydrate, affects chemicals in the brain that influence weight management. Intended to treat obesity that is associated with diabetes, high cholesterol, or high blood pressure, Meridia was originally meant to be taken in addition to proper diet and exercise.The drug was approved for this use in 1997. When disapproving the use of Meridia, the FDA claimed that the drug increased the risk of heart attack and stroke while offering little of the benefit claimed.
John Jenkins, MD, Director of the FDA’s drug evaluation branch said, “Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke.”
The manufacturer of Meridia, Abbott Laboratories, is an American global pharmaceuticals and health care products company. Headquartered in Abbott Park, North Chicago, Illinois, the company aims to “advance leading-edge science and technologies that hold the potential for significant improvements to health and to the practice of health care.” Despite being in disagreement with the FDA’s evaluation of Meridia, Abbott agreed to comply with the agency’s request. In a press release, the company said, “Abbott believes [Meridia] has a positive risk/benefit profile in the approved patient population, but will comply with the FDA’s request.”
The Drug Enforcement Agency (DEA) warns consumers that many distributors of Meridia are in violation of the Controlled Substance Act, which regulates the manufacturing, importation, possession, use, and distribution of certain substances.
In 2010, an estimated 100,000 U.S. patients were taking Meridia. Following the removal of the drug from the market, the FDA advised patients to discard any remaining pills as well as to seek their doctor’s guidance on alternative and safer weight loss plans.
Many users of Meridia have experienced signs of allergic reaction including hives; difficulty breathing; and swelling of the face, lips, tongue, and throat. More serious side effects include the following:
- Fast, pounding, or uneven heartbeats;
- New or worsening shortness of breath;
- Agitation, hallucinations, fever, tremor, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, dilated pupils;
- Stiff (rigid) muscles, high fever, sweating, confusion, feeling like you might pass out;
- Easy bruising or bleeding (nosebleeds, bleeding gums, or any bleeding that will not stop);
- Dangerously high blood pressure (severe headache, blurred vision, buzzing in the ears, anxiety, seizure);
For those continuing to take Meridia, the FDA offers the following advice:
- Stop taking Meridia and speak to your doctor about safer weight loss management programs
- Contact your health care professional immediately if you experience any pain or dizziness
- Properly cispose of any unused Meridia and abide by the Federal Drug Disposal Guidelines, which can be found on the FDA website
- Report any side effects associated with Meridia to the FDA’s MedWatch program
It is important to pay close attention to the ingredients labeled on your drugs. The FDA warns that various supplements contain sibutramine, the active ingredient in Meridia. Many products falsely label themselves as “100% herbal,” despite containing artificial ingredients that can cause various and sometimes severe side effects.
Our experienced lawyers at Sheff Law encourage you to explore your legal rights if you or a loved one has suffered a serious or fatal injury as a result of the use of Meridia. Patients across the state of Massachusetts as well as throughout the country have realized some of the potential harmful consequences of using the Meridia for weight loss purposes. If you or a loved one has been injured as a result of Meridia, contact an attorney at Sheff Law today by filling out a free consultation form, or call at (888) 423-4477 or 617-227-7000.
February 23rd, 2016 | Posted in Blog