FDA Warns Drugmakers Over Unapproved Headache Drugs
The U.S. Food and Drug Administration has ordered 20 drug companies to stop marketing unapproved drugs to fight headaches. Eight drug makers were sent warning letters, including Ivax Pharmaceuticals and Novartis AG's Sandoz unit. While the unapproved headache drugs in question contain the active ingredient ergotamine tartrate, which is the same active ingredient found in other approved drugs for headaches, these drugs have been produced and distributed without the FDA's approval.
"Doctors and patients often do not realize that not all drugs that are available on the market are backed by FDA approval. Drugs that skirt the approval process may be unsafe, may not work, and in our experience, often have inadequate labeling," said Deborah Autor, from the FDA, adding that fewer than 2 percent of medications are unapproved.
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