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Saturday, November 15, 2014

FDA makes Drug Safety Labeling Changes

In September 2014, FDA required safety labeling changes to be made to 55 drug products, including a chronic hepatitis C medicine, an arthritis tablet and a nicotine addiction treatment.
The changed labeling of the hepatitis C medicine, Pegasys, added warnings that include possible birth defects, fetal death and behavioral reactions. A warning added to the arthritis medicine, Arthrotec, states using Arthrotec with other non-steroidal anti-inflammatory drugs, such as aspirin, should be avoided. A warning for the nicotine addiction medication, Chantix, states that there have been reports of seizures and increased intoxicating effect while taking the drug.

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