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What are bupropion hydrochloride and Budeprion?
“Bupropion hydrochloride was first approved under the brand name Wellbutrin as an antidepressant drug indicated for the treatment of major depressive disorder (MDD) and for the prevention of seasonal affective disorder. Budeprion is a generic drug manufactured by Impax and distributed by Teva that contains the same active ingredient as Wellbutrin (bupropion hydrochloride). Other companies also make generic versions of bupropion hydrochloride”.
Budeprion Extended Release 300 mg dosage Recalled by the FDA
Back in October 2012, after many years of complaints (including suicidal thoughts and worsen depression) from Budeprion users, the FDA finally recalled a certain dosage of the drug. In 2006, shortly after Budeprion hit the market, the FDA were notified of these complaints from people who’d taken the drug. They then contact the drugs’ manufacturers Impax/Teva and asked them to perform follow-up studies. Impax/Teva reported that they could not find enough users suffering from adverse side-effects to conduct those studies.
Four more years past before the FDA decided to do those studies itself. The results are that one form of Budeprion, the extended release 300 mg dose, has been recalled. The study found that, “while blood levels of the generic drug spike almost immediately, after three hours they drop below the levels maintained by Wellbutrin, and remain lower for 24 hours… Absorption of the generic drug is also just 86 percent of the name-brand, a number that fails to meet FDA criteria for bioequivalence, explains study co-author Lawrence Yu, Ph.D., deputy director for science at the FDA”.
What you need to know: Only the extended-release, 300-milligram dose of the generic drug Budeprion, manufactured by Impax Laboratories for TEVA Pharmaceuticals, has been recalled. If you’re checking your medicine cabinet, look for the name BUDEPRION XL 300 mg, as well as TEVA or Impax, on your bottle’s label. If you think you might have the recalled drug, call your pharmacist, Yu advises.
What is depression?
Depression may be described as feeling sad, blue, unhappy, miserable, or down in the dumps. Most of us feel this way at one time or another for short periods.
Clinical depression is a mood disorder in which feelings of sadness, loss, anger, or frustration interfere with everyday life for weeks or longer.
Other options for treating depression
Depression is commonly treated with antidepressants like Prozac, Zoloft, or Paxil with psychotherapy. Individuals with more severe cases of depression are usually prescribed an antidepressant and recommended to attend therapy sessions.
To find out more about the Budeprion recall please visit FDA.gov.
If your loved one is in need of addiction treatment and has a co-occurring disorder like depression please give us a call at 800-951-6135.
Sources:
http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001941/