Reglan Gets A Blackbox Warning
On February 26, 2009, the FDA required the manufacturers of metoclopramide-containing drugs such as Reglan to include a black-boxed warning (the strongest warning available) to their drug labels about the risk of the long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken. Manufacturers will be required to include a medication guide with their products that discusses this risk.
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A Sanford, Florida jury awarded $13.3 million to the family of 34-year-old Susan Susan Hodgemire, who died from the
The FDA has warned Bayer numerous times about its marketing efforts and claims for these products. Because the FDA does not scrutinize supplements, Bayer pulled a fast one by combining aspirin with supplements and promoting health benefits through television and other advertising venues. The two products are “
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