Meridia Diet Drug Withdrawn From Market by Abbott | Meridia Lawyer
Meridia Diet Drug Withdrawn From Market by Abbott
Abbott Laboratories will voluntarily withdraw its popular diet drug, Meridia (generic name Sibutramine) from the U.S. market at the FDA's request. This, after much has been made in the news in recent months concerning a six-year study to evaluate cardiovascular safety which confirmed an excess risk of cardiovascular problems associated with Meridia use.
Meridia (sibutramine hydrochloride monohydrate) is a prescription medicine used to help overweight or obese people lose weight. Meridia should be used together with a low-calorie diet.
The Meridia voluntary withdrawal follows almost a year of back-and-forth between the FDA and Abbott concerning suspension of marketing efforts, study and testing results and appropriate use of the abti-obesity medication.
Abbott submitted label changes to FDA in January 2010, and also this year conducted and provided numerous analyses to FDA and other global regulatory authorities regarding the appropriateness of the current label: that people with preexisting cardiovascular disease should not take the medication. These analyses also confirmed there was no excess risk in the approved patient population.
Abbott believes sibutramine has a positive risk/benefit profile in the approved patient population, but will comply with the FDA's request.
Patients should discontinue use of sibutramine and consult their physician for alternatives. Patients can call Abbott's medical information line in the U.S. at 1-866-257-8909 or visit http://www.sibutramine.com/.
Meridia Side Effects
Meridia can cause serious side effects including:
- Increased blood pressure
- Increased heart rate (pulse)
- Symptoms of high blood pressure such as headache, dizziness, blurred vision
- Serotonin syndrome
- Feeling weak, restless, confused or anxious lose consciousness (faint)
- Fever
- Vomiting
- Sweating, shivering or shaking
- Convulsions
- Bleeding
- Pulmonary hypertension
- Shortness of breath
- Dry mouth
- Loss of appetite
- Trouble sleeping
- Constipation
- Headache
More Dangerous Reported Meridia Side Effects
- Stroke
- Seizures
- Heart disease
- Mental impairments
- Dramatically increased perspiration
