In an effort to cut prescription drug costs, there is constant pressure to switch from brand name medications to their generic equivalents.
But in this special report from MedPage Today, there may be some variability between generic medications that can lead to clinical symptoms. However, most of the data is anecdotal, and at best, based on retrospective data.
For instance, when it comes to anti-seizure medications, some neurologists are cautioning about switching to generic drugs, as “for antiepileptic drugs, the window is narrower and the short-term consequences of changes in drug blood levels are greater.”
Generic drugs gain FDA approval by showing they are bioequivalent to the branded original. But, “although the generic’s mean maximal concentration and area under the concentration-time curve are typically within a few percentage points of the original’s — typically about 4% — the 90% confidence interval for those means can be 20% below or 25% above the branded drug’s mean.”
Although that may be acceptable for some classes of drugs, like antibiotics, for instance, some are arguing that this may be too loose a definition for drugs that require a specific blood level, like blood thinners or anti-seizure drugs.
Generic medications are a clear source of cost savings, which is why both the government and private insurers are making a hard push to convince both doctors and patients to switch. I continue to support the use of generic drugs, but there is growing sentiment that more rigorous study is needed to ensure that there will be minimal adverse effects when switching.
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- Paying doctors off to use generic medications
- "Pay to delay": How Big Pharma is paying off generic drug companies
- Seniors, generics and brand name medications
- Insurance companies ripping patients off for generic drugs?
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Old news. When I was in residency (late 1980’s) the concerns were for generic synthroid, digoxin, and anticonvulsants. In the ensuing almost 20 years, despite persistent calls from neurologists for “further study”, I have failed to notice an epidemic of breakthrough seizures and other clinical manifestations implied by these dire warnings.
I have had patients sensitive to a particular levothyroxine generic. After documenting the fluctuations in TSH, I write “brand necessary”, but only for those patients.
I have also had multiple patients complain of efficacy issues with fluoxetine (generic Prozac). I therefore tend to select other SSRIs, as the limited advantages of Prozac specifically are not worth the hassle to avoid the generic.
Make patients more aware of the FDA Orange Book, so they could look up to see if there is a manufacturer that makes both the brand and the generic of the medication in question. I suspect issues would be minimized, assuming there is such a manufacturer for the medication, and one can find a pharmacy that stocks that manufacturer’s generic product.
This might only be anecdotal but it is real. My wife takes several brand name drugs for her migraine headaches. She has tried the generic equivalents and they just do not work. Her doctor, if we understood correctly, suggested that the binding material in the generics, which would be different than the brands, might have made a difference.
I have taken Omeprazole for acid reflux for many years now. I recently tried generic Omeprazole versus the brand name (i.e. Prilosec), however the generic did not work for 24 hrs like Prilosec does for me. A generic should never be assumed to behave in exactly the same manner as the brand name.
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