For years, the FDA has reassured everyone who prescribes, dispenses or pays for prescription medicine that generic drugs are absolutely equivalent to brand-name drugs. Because brand name medications are so expensive, most people embrace the opportunity to save money.
If generic fluoxetine is only $4 per month at a discount drug store while brand name Prozac costs $175 for a month’s supply at a neighborhood pharmacy, it is understandable why consumers would opt for the cheaper generic.
Insurance companies are enthusiastic about generic drugs. They encourage patients to accept generic prescriptions by lowering the co-payment for these medicines and raising it for brand names. They may even refuse to pay for certain brand-name products.
But are generic drugs truly identical to their brand-name counterparts? Patients, physicians, pharmacists, nurses, hospitals and insurance companies all depend on the FDA to ensure that generic drugs will work just like the originals.
We used to recommend generic drugs as a great way to save money. We were convinced that the FDA had a rigorous approval process.
Several years ago, however, we began getting reports from readers of this column that their generic medicines weren’t always working as expected. We heard from people who suddenly experienced seizures after being switched from the brand-name epilepsy drug Dilantin to the generic phenytoin. Others reported problems with the generic blood-thinner warfarin when it was substituted for Coumadin.
An avalanche of complaints started last year, from patients reporting problems with the generic antidepressant Budeprion XL 300. Many had had their depression well controlled while taking the brand Wellbutrin XL 300 (bupropion). On the generic formulation, however, they reported side effects such as agitation, anxiety, nausea, headache and insomnia.
Patients taking the generic frequently reported feelings of despair, hopelessness and depression. Some said they started crying for no apparent reason and others described thoughts of suicide occurring for the first time.
We forwarded many of these reports to the FDA and asked the agency to investigate. The report is now in and the FDA has announced that everything is fine with generic Budeprion XL 300 mg. Or is it?
The FDA appears to explain the return of depression on Budeprion XL 300 as a natural recurrence of depression. Oddly, relatively few people have complained about depression recurring on other generic formulations of bupropion.
We had always assumed that all generic products were tested before approval. To our surprise, the FDA revealed that it did not require tests on Budeprion XL 300. The generic manufacturer submitted data for a 150 mg formulation, not a 300 mg tablet. Based on the data, the agency approved Budeprion XL 300.
Even the 150 mg formulation differs noticeably from the brand name in the way in which it enters the blood stream. The FDA says it doesn’t think this matters. We disagree, and hundreds of readers seem to as well.
Anyone who would like to report a problem with a medication may do so at www.peoplespharmacy.com. We will pass your information along to the FDA. To report directly to the agency go to www.FDA.gov/MedWatch.