On March 12th, the FDA published a letter it had sent last month to Switzerland-based drug maker IBSA Institut Biochimique SA regarding the false and misleading nature of a Facebook page for the company’s drug, Tirosint.

Specifically, the FDA’s Office of Prescription Drug Promotion (“OPDP”) found that the Facebook page was false and misleading because it discussed the efficacy of Tirosint but failed to also discuss the full indication for and potential side effects of the drug.

As a result, the FDA stated that the company’s Facebook page misbrands Tirosint under the regulations set forth in the Federal Food, Drug, and Cosmetic Act (“FD&C Act”).The FDA found that the Facebook page for Tirosint stated only that Tirosint could be used for the treatment of hypothyroidism or to control a patient’s levothyroxine blood levels.

However, the indications and usage section for Tirosint’s FDA-approved labeling stated that the package insert for the drug includes a boxed warning.  That warning appears as follows:

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The indications further state common adverse reactions, including irregular heartbeats, shortness of breath, chest pain, headaches, leg cramps, and others.

None of this information was included on the company’s Facebook page.  The FDA stated that by “omitting the most serious and frequently occurring risks associated with Tirosint, the Facebook webpage misleadingly suggests that Tirosint is safer than has been demonstrated.”

The FDA further stated that the Facebook page did not provide enough material information regarding Tirosint’s FDA-approved indication.  Even though the webpage stated that the drug could be used in patients suffering from hyperthyroidism, it did not further state that the drug should not be used in patients with transient hypothyroidism during the recovery phase of subacute thyroiditis.

Publicizing this letter indicates that the FDA is increasingly monitoring social media promotional activities after the agency previously produced social media guidance earlier this year.

To review the letter, click here.

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