Generic alternatives to brand-name drugs may endanger consumers

posted on:
April 26, 2010


Just read the community boards for people living with Epilepsy. There is much talk these days among a group of concerned citizens who rely on medication to control their seizure disorders. Some have found that switching to a generic version of a medication that had been controlling their seizures has resulted in side effects from severe headaches to an increase in the re-occurrence of their seizures. While these disabling symptoms can be dangerous and life threatening, they can also result in economic losses from having their driving privileges revoked to the inability to work or attend school.

The drug in question is Keppra and its generic alternative Levetiracetam. The generic version is made by a number of different manufacturers. The Food and Drug Administration (FDA) tests generic drugs to ensure the active ingredients match those of the brand name. But in many cases these generics have inactive ingredients that may result in allergic reactions or sensitivities that can make switching from the brand name drug to a generic alternative dangerous.

Edward F. Blizzard, a blogger for Huffington Post, says the FDA’s current method of testing generic alternatives to brand-name drugs is “badly flawed.”

When prescription drugs are approved by the FDA, they receive a patent that stalls competition for a certain number of years in order for the company to recoup expenses incurred while developing the drug. During this time of free reign, the drug company must track and report adverse events and data to the FDA. Once the patent expires, competing manufacturers can market generic alternatives to the brand-name medication. These generic drug makers are required to report any adverse events or data to the FDA; however, many fail to do so. In the end, it is the consumer who suffers.

“The Food & Drug Administration’s well-known shortcomings in protecting consumers from dangerous prescription drugs have been illustrated in high-profile examples, like the recent scandal surrounding GlaxoSmithKline’s drug, Avandia, as well as Merck’s drug, Vioxx,” Blizzard says. “These failures often stem from the relative weakness of the FDA as a regulatory body: overextended and underfunded, the FDA must largely rely on drug companies to police themselves.”

And that, Blizzard says, can be dangerous to consumers. “For too long, generic manufacturers have marketed potentially deadly products without regard for the long-term safety of their products. With the increased popularity of generics and the billions in additional profits that their manufacturers stand to make, this free ride must come to an end.”

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