Are generic drugs the same as their brand-name counterparts?
The Food and Drug Administration (FDA) would argue that the differences are miniscule. Generic drugs go through rigorous testing and are only approved if they are deemed bioidentical. In other words, the active ingredients are required to be the same as the brand name. It is the inactive ingredients – the fillers and dyes – that take up space inside those pills that can, and often, differ. While seemingly insignificant, those slight changes can have a tremendous effect on how drugs work.
For example, generic versions of the anti-epileptic drug Keppra have caused patients with seizure disorders unnecessary problems when they were switched from brand-name Keppra. It turns out that patients with sensitive systems react differently to subtle changes in the so-called inactive ingredients of drugs.
Refer to a Drugs.com forum and you’ll see similar complaints on the generic version of Xanax, known as alprazolam. Many people complain that when they switched from brand-name Xanax to the generic alprazolam, the effects of the pills took longer to kick in. Some forum contributors reported feeling overly drowsy, and another reported having seizures after switching to a generic that was much lower in dosage.
These effects may be seem trivial to drug companies, but consider the recent death of singer Whitney Houston. She is reported to have been on a cocktail of at least three prescription benzodiazepines at the time – Xanax, Ativan and Valium.
Xanax and its generic equivalents are by far the most prescribed anti-anxiety sedatives on the market with nearly 50 million prescriptions in the United States alone. Generic varieties can cost more than three times less than the brand name, and are often required above brand-names by health insurance companies.
Now consider that Whitney Houston was, as reported by the Courier Mail, “pulled from the bath by members of her staff.” Could she, like her daughter days before, have fallen asleep in the bathtub? Could a generic version of her medications have caused her to react differently than usual from the drugs she was taking? Only the autopsy report can shed light onto those questions.
It makes logical sense to check the safety labels of any medications you are taking for possible side effects, especially ones that can put you in harm’s way. However, according to a recent decision by the Supreme Court, makers of generic drugs are not required to warn patients if they receive reports of new side effects from their drugs. (The ruling protects generic drug makers from being sued under state liability laws for failing to warn patients of these new dangers.)
Comparatively, makers of brand-name drugs are required to report any adverse events associated with their medications to the FDA. These possible side effects are ultimately included in an FDA-approved safety label that tells doctors and patients of potential problems associated with the medication.
So the question remains – are generic drugs the same as brand-name medications?