8 Pharma companies receive FDA Warning Letters

The FDA issued Warning Letters to eight (8) pharmaceutical companies regarding the unapproved use of drugs containing ergotamine tartrate for headache relief. From the ScientificAmerican.com article:

Like other approved products for migraine and other headaches, the drugs contain the active ingredient ergotamine tartrate. But they have been manufactured and distributed without undergoing review by the FDA, the agency said.

"Doctors and patients often do not realize that not all drugs that are available on the market are backed by FDA approval," said FDA's Deborah Autor, who oversees compliance issues. She added that fewer than 2 percent of prescription medications are unapproved.

"Drugs that skirt the approval process may be unsafe, may not work, and in our experience, often have inadequate labeling," she said in a statement.

The unapproved ergotamine tartrate drugs do not carry necessary cautions against their use in patients also taking the metabolic enzyme inhibitor CYP 3A4 found on labels for similar approved headache drugs, the FDA said.

Such inhibitors can include certain antibiotics, antifungal treatments and protease inhibitors.

Click here to read the article. Click here to access the FDA Warning Letters.