FDA warning to Glaxo in regard of Wellbutrin side effects
Wellbutrin was approved by U.S. Food and Drug Administration in 2003 for treatment of depression. It was approved to treat major depressive disorder in patients 18 and older. It is manufactured by GlaxoSmithKline.
Wellbutrin SR mainly contains bupropion hydrochloride. Wellbutrin SR comes in 100-mg blue colored, 150-mg purple colored and 200-mg light pink colored tablet. Tablets are film-coated. It also contains carnauba wax, cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, and titanium dioxide as inactive ingredients.
Wellbutrin XL is not suited for patients having seizure disorder as it may show contraindication in them. It should not be taken with other bupropion drug. Patients being treated were found to have seizure disorders; hence it was called off from market one year after its approval by FDA. Later it was found that these disorders were related to high dosage. It was reintroduced in 1996 with a specific and lowered daily dosage formulation. In 2003, an extended-release tablet Wellbutrin XL was approved by FDA.
In 2006 generic versions of Wellbutrin were also approved for treating depressive disorders. Later a review was done for the same. The generic drug reported many severe side effects and was found to be more dangerous than Wellbutrin. In 2007 FDA re examined both the data on the bioequivalence of Wellbutrin XL and Teva’s bupropion XL. Generic drugs approved by FDA should have the same active ingredient, dosage form, route of administration, and labeling as the branded product according to the law.
In July 2009 FDA issued stronger warnings for Wellbutrin. FDA asked Glaxo to strengthen warnings regarding serious side effects of Wellbutrin on its label. It asked Glaxo to put boxed warning on the label of the drug. Through boxed warning it intended to inform patients and healthcare practitioners about severe risks of side effects of this drug.
FDA warned people about mood and behavioral changes in patients due to use of Wellbutrin and asked them to have regular monitoring for the same. In case of severe changes it asked patients to seek immediate help.
Healthcare professionals were asked to prescribe Wellbutrin with caution after evaluating pros and cons of the drug. It also asked for the medication guide for the drugs from Glaxo.
The FDA ordered the drug manufacturers to have new clinical trials to find out the extent of risk of side effects with use of Wellbutrin. Studies revealed several side effects of Wellbutrin including chest pain, fainting, fast, pounding or irregular heartbeat, hearing problems, ringing in the ears, severe headache, mental/mood changes, tremor, unusual weight loss or gain, muscle pain, tenderness or weakness, change in the amount of urine, seizures or allergic reactions such as rash, itching, swelling of the face, tongue or throat, severe dizziness, and breathing troubles.
Wellbutrin came under scanner as a report in the American Journal of Obstetrics & Gynecology associated it with increased risk in pregnant women and unborn children. FDA asked to take care while prescribing this medicine to pregnant women.