Thyroid Drug Maker Mylan Under Investigation by FDA

Mylan, the West Virginia-based drug company that makes a generic levothyroxine medication, and recently received FDA approval recently for its generic version of Cytomel is now the target of a federal investigation. The Pittsburgh Post Gazette has broken the story of workers at the Mylan's West Virginia plant, who were, according to internal documents obtained by the Post-Gazette, "routinely overriding computer-generated warnings about potential problems with the medications they were producing."

Mylan is the world's third largest generic drug company and makes a number of generic medications. Allegedly, Mylan was involved in falsifying information and altering products, possibly for as long as two years or more. It's not clear if the quality of their products -- which include various generic thyroid medications, among other generic drugs -- was affected.

The U.S. Food and Drug Administration has said that it is now investigating Mylan. Mylan issued a statement suggesting that the FDA investigation was routine, but the FDA took the unusual step of issuing a statement to refute and rebut Mylan's efforts to downplay the severity of the investigation.

The Pittsburgh Post-Gazette is ground zero for investigation and coverage of the Mylan scandal, as you'll see from these links to the coverage.

Mylan is, of course, in full spin control mode, pumping out press releases saying that they're not to blame, and so on, as they've watched their stock prices tumble more than 10% since the news came out on Sunday.

What Should Thyroid Patients Do?

We've always known that many doctors do NOT recommend that thyroid patients take generic levothyroxine from any maker, including Mylan.

No one knows whether there are quality or consistency issues with Mylan's generic T3 at this point. But there is not a great cost differential between brand name Cytomel and the generic liothyronine from Mylan. So, at this point, patients may consider waiting a while to see how this Mylan scandal shakes out before being willing to change over to their generic T3 medication.


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