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Published on Jun 10, 2005 by Edgar Snyder

Over-the-Counter Drugs Often Lack Up-to-Date Medical Warnings

Over-the-Counter Drugs

Trying to save a few dollars by picking up a generic over-the-counter drug as opposed to its more expensive counterpart? Beware—that purchase might not have the same drug information on the box, leaving you and your family at risk.

That’s because the ability of the Food and Drug Administration (FDA) to make generic manufacturers update their labels is murky and not often strictly enforced. When the FDA approves a generic drug, it is supposed to have the same label as its brand-name competitors. When a brand-name drug changes its drug labels to reflect new information or warnings, it can take months for generic drugs to follow suit, as new labels are printed and old packages sell out.

But a new FDA initiative might light a fire under generic drug manufacturers. The agency wants non-steroidal anti-inflammatory drugs, or NSAIDs, to include more information about heart, stomach and skin risks. Popular pain relievers included in the non-prescription NSAID family are ibuprofen, naproxen and ketoprofen. Motrin and Advil are brand-name ibuprofen drugs; Aleve is a branded naproxen.

This request to change the label information is in response to the belief that the drug class might present more risk than previously thought. Current concern centers on prescription strength NSAIDs such as Celebrex, Vioxx and Bextra, the latter two drugs already pulled from the shelves because of damaging effects to patients.

Currently the drug information for Motrin and Advil warn the patient to consult with a doctor before taking the drugs if you suffer from high blood pressure, heart or kidney disease. Some generic versions of the drugs have yet to include this updated information.

The FDA also wants drugmakers to remind patients about dosage limits and how often they can take the drugs. A 2003 National Consumers League study showed that 44% of American adults who took over-the-counter medications for pain exceeded the recommended dosage. More worrisome, only 16% read the product label entirely and 80% did not discuss the drugs’ key risks with medical professionals.

Please note: All of our lawyers are licensed to practice in the state of Pennsylvania. We also have lawyers licensed to practice in Ohio, and West Virginia and we associate with experienced attorneys in other states. In addition, all drug-related litigation involves co-counsel.

Source: “Updating generic-drug labels can take months.” By Julie Schmit. USA Today. May 17, 2005.
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