A recent article in the New York Times highlighted the legal impact of a 2011 Supreme Court ruling on the liability of generic drug makers for damage done to patients by their products. The ruling concluded that generic drug makers are not liable for damage resulting from their failure to warn patients of specific dangers of their generic products. Instead, they may simply copy the warnings associated with the brand name “equivalent” drug.
At first glance it seems that a generic drug should have identical side effects to its parent drug. This is often, but not always, true with systemic drugs, like the sad stories told in the Times.
In eye care, of course, we deal mostly with topical medications, and differences between generics and branded medications are much more common, and their side effects much more important locally. In eye care, we place the drug directly on the target organ. The active ingredient goes directly where it’s needed, but the inactive “excipient” ingredients (including preservatives, buffers, vehicles and contaminants) are also applied to the delicate target organ. Because generic drugs can have widely varying inactive ingredients, this means ocular toxicity can be a real concern.
It is no surprise that a growing number of complications from generic nonsteroidal anti-inflammatory drugs are being discovered, and similar cases are arising with the generic glaucoma medications, which may be more concerning because of their chronic use and chronic exposure to varying inactive ingredients.
I applaud the New York Times for bringing to light the concern about substitution of generic drugs and the potential dangers to patients in doing so. We as physicians have to be fiscally responsible in the drugs we prescribe while at the same time protecting patients from dangers that they may not even know about.
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