Did A Generic Version Of A Name-Brand Drug Cause A Man’s Death?

Generic versions of name-brand prescription drugs are supposed to be “just as good” and just as effective as the name-brand drugs for which they are substituted. Generic drugs (“generics”) are often preferred by health insurance companies and by many patients because they tend to cost much less than their name-brand counterparts. Many generics look different than the name-brand drugs but are usually taken in the same manner. Most people cannot tell any difference between generics and the name-brand drugs that they take.

But the safety of generics are sometimes questioned. For example, an epilepsy patient in Michigan was given a generic version of his epilepsy medication. Two days later, the patient died from a seizure. According to the Epilepsy Foundation, deaths due to seizures after being switched to a generic version of an epilepsy medication are not unique.

The Epilepsy Foundation had conducted a survey from 2006 to 2009 that found that more than half of 1,085 patients had reported adverse consequences from a switch in their medication to a generic version (59% reported worsening seizures, 49% reported more serious side effects from their medication, and some families reported deaths of patients).

To investigate the issue, a two-year research study conducted by the University of Maryland School of Pharmacy that is funded by the U.S. Food and Drug Administration (FDA) and scheduled to be concluded in 2013 is testing 32 epilepsy patients with histories of seizures to determine if the name-brand and generic version of the epilepsy medication lamotrigine (for which there are 16 generic versions) give patients the same blood levels of the medication. At present, the study has entered clinical trials in which patients are being monitored for two and a half months during their 14 visits to the clinic.

The FDA approval process for generics requires bioequivalence studies in healthy humans who are given single doses of drugs to assure that the generics provide the same therapeutic and safety profiles as the brand-name drugs. If they do and the FDA approves the generic versions, the generics are considered interchangeable with the brand-name drugs.

The potential issue with epilepsy generics may involve the narrow range of effectiveness of epilepsy medications that only work if properly administered. Because the FDA approval process is not done in a clinical setting, the bioequivalence is not the same and the FDA guidelines may not be sufficiently accurate. If the University of Maryland School of Pharmacy study finds a difference when the study is completed, additional studies would be justified.

Source: University of Maryland Maryland Magazine, 2012 Research & Scholarship

If your pharmacy is intending to fill your prescribed brand-name medication with a generic version of the medication, you should discuss the substitution with your prescribing medical provider to insure that you are receiving the medication that is intended. Don’t assume that your prescribing doctor is OK with a generic version — some doctors will specifically instruct pharmacies to provide the brand-name medication and not fill the prescription with a generic version. When in doubt, discuss the issue with the prescribing doctor before accepting and taking the generic version.

If you have had a bad reaction or serious side effect from a prescribed or over-the-counter medication, you may wish to discuss your legal rights with a medical malpractice attorney.

Visit our website  or telephone us toll free at 800-295-3959 to be connected with medical malpractice lawyers in your local area who may be willing and able to assist you in investigating your potential claim for compensation for your injuries and losses.

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This entry was posted on Monday, February 13th, 2012 at 11:10 am. Both comments and pings are currently closed.

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