Challenges for Thyroid Drug Maker Mylan

Cleared by the FDA

thyroid medication, generic, levothyroxine, hypothyroidism
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If you are researching generic levothyroxine and liothyronine drugs to treat your hypothyroidism, you may hear about a U.S. Food and Drug Administration (FDA) investigation into Mylan. Mylan is the world's third-largest generic drug maker, and manufacturer of generic levothyroxine and liothyronine, a generic version of the drug Cytomel. Both drugs are thyroid hormone replacement medications used to resolve hypothyroidism.

In the summer of 2009, the FDA opened an investigation, but within several weeks, the investigation was closed, and there was no evidence that the quality of the Mylan-made drugs, including levothyroxine, were affected. 

Here is the information you need to know to make an informed decision about these medications.

The Background

In 2009, West Virginia-based Mylan was the subject of a federal investigation into production problems at their plant. The Pittsburgh Post Gazette broke 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."

At the time, the FDA alleged that Mylan was involved in falsifying information and altering products, possibly for as long as two years or more. After FDA the opened an investigation into Mylan, the company issued a statement suggesting that the FDA investigation was routine. The FDA, however, took the unusual step of issuing a statement to refute and rebut Mylan's efforts to downplay the severity of the investigation.

At the time the investigation was launched, the Pittsburgh Post-Gazette provided in-depth coverage of the Mylan situation, including the following articles:

After several weeks during which Mylan's stock prices tumbled, and Mylan and FDA conducted a public war of words in the press. Mylan also sued the Pittsburgh Post Gazette reporters who broke the story for defamation.

The FDA ultimately cleared Mylan, making an announcement on August 13, 2009. According to the FDA, Mylan had conducted an adequate investigation, agency spokeswoman, and the FDA closed the investigation.

The Mylan lawsuit against the newspaper was settled in 2012, and Mylan and the Post-Gazette released a statement that said, in part:

"The litigation has been resolved to the satisfaction of both parties. The Post-Gazette did not find and did not intend to report that Mylan had manufactured or distributed any defective drugs."

A Word From Verywell

The upside of this situation for thyroid patients was that there was no evidence that the quality of drugs manufactured by Mylan, including the levothyroxine and liothyronine drugs taken by many people with hypothyroidism, was affected in any way.

At the same time, people with hypothyroidism taking the thyroid hormone replacement drug levothyroxine need to be aware that many doctors do not recommend that thyroid patients take any generic levothyroxine from any manufacturer. The reason is that all levothyroxine drugs, including the generic and brand name drugs, are legally allowed to vary in potency from 95 to 105 percent of the stated dosage. When taking a generic levothyroxine, refills can come from any manufacturer, which means that each refill of a stated dosage can fall anywhere within that potency range.

Even slight variations in potency can interfere with the effectiveness of your thyroid hormone replacement. Stable thyroid hormone replacement is also especially important for thyroid cancer survivors, who may require consistently suppressed thyroid stimulating hormone (TSH) levels as part of their treatment, and to prevent recurrence of thyroid cancer.

If you are taking generic levothyroxine from any manufacturer, it's helpful to discuss your specific situation with your health care provider, to determine if a brand name drug would be a better option for your treatment.

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