The Generic Version of the ADHD Drug Concerta is Not “Therapeutically Equivalent” to the Name-Brand

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Generic drugs not as effective as brand-name counterparts.
Generic drugs not as effective as brand-name counterparts.
Generic drugs not as effective as brand-name counterparts.
Generic drugs not as effective as brand-name counterparts.

 

Generic drugs may not be as effective as their brand-name counterparts. For people living with attention-deficit hyperactivity disorder (ADHD), the difference in quality can make life immensely frustrating.

Last November, the U.S. Food and Drug Administration (FDA) announced two generics of the ADHD drug Concerta may not be “therapeutically equivalent” to the name-brand. Student Emily Hingle, 17, had already figured that out by the time the announcement was made. The teen had been taking a generic form of the drug, along with the long-acting version of Ritalin to help her focus. After she began taking the generic Concerta, her grades began to drop and Emily grew so restless that one teacher told her she had “senioritis” and was slacking. Now that she is on a new medication, her performance has improved and she is feeling much better, according to WCAX.

While the generic versions in question have no serious safety issues and can still be prescribed, the FDA no longer recommends them as an automatic substitute for Concerta. The agency has given the makers of the generics six months to prove their products are effective or voluntarily recall the drugs. The FDA says patients with questions about who manufactures their medication should contact the pharmacy where the prescription was filled, WCAX reported.

The generics were approved through the FDA’s abbreviated drug application (ANDA) process. The agency looks primarily at data showing the generic drug is bioequivalent to the name-brand version. “Bioequivalence” refers to the “absence of a significant difference” between the extent and rate of absorption of two pharmaceutical drug equivalents over the course of a period of time, at the same dose and under the same conditions, Regulatory Affairs Professionals Society (RAPS) explains.

Equivalency problems may still emerge after a generic drug is approved. Problems may arise from the manner in which the drug underwent bioequivalence testing, for example. The FDA may approve a generic for a higher dose than the drug was tested at, according to RAPS.

Generic drugs have ratings that indicate their bioequivalency, as well. If the generic is an exact equivalent to the name-brand drug, it receives an A rating. If the generic does not have the exact bioavailability profile – meaning the drug is absorbed at a faster or slower rate in the bloodstream – then it will receive a B rating. The generic version of Concerta was originally A-rated, but the FDA changed its rating to B last November. Doctors probably will not know a generic’s rating, but a pharmacist will, Fox News reported.

Read more at: http://www.yourlawyer.com/practice-areas/defective_drugs