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| 12 March 2014 | By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) has issued a new Untitled Letter to a pharmaceutical company for allegedly misbranding its hypothyroidism drug on Facebook.
Untitled Letters are essentially unofficial warnings from FDA that a practice-Untitled Letters are most often reserved for alleged marketing violations-runs afoul of federal advertising regulations. Unlike a Warning Letter, Untitled Letters do not threaten subsequent enforcement action by FDA.
In its latest Untitled Letter, FDA's Office of Prescription Drug Promotion (OPDP) alleges that Institut Biochimique SA and its US agent, Akrimax Pharmaceuticals, improperly used Facebook to market its drug Tirosint (levothyroxine sodium).
The drug is approved as a replacement or supplemental therapy for most types of hypothyroidism with the exception of transient hypothyroidism during the recovery phase of subacute thyroiditis. The drug, FDA notes, "is associated with a number of serious risks."
"The Package Insert (PI) for Tirosint includes a Boxed Warning indicating that Tirosint should not be used for the treatment of obesity or for weight loss," FDA recounted. The drug is also contraindicated for patients, and especially children, who might be unable to swallow a capsule or who have acute myocardial infarction.
Unlike FDA's February 2013 Warning Letter to AMARC Enterprises, in which it censured the company for having "Liked" an unapproved claim on its Facebook page, FDA's Untitled Letter is simply concerned with a more common concern: The omission of risk information.
Institut Biochimique reportedly failed to make any mention of the drug's contraindication for patients with transient hypothyroidism during the recovery phase of subacute thyroiditis.
The Facebook page also failed to make any mention of the risks associated with the use of the drug, an omission FDA called "particularly concerning" due to its Black Box warning. Such "Boxed" warnings typically convey risks that are especially prominent or serious to the welfare of patients taking the drug.
"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," FDA wrote.
An attached image of the Facebook page shows it simply stating: "If you have just been diagnosed with hypothyroidism or are having difficulty controlling your levothyroxine blood levels, talk to your doctor about prescription Tirosint, a unique liquid gel cap form of levothyroxine."
The claim, absent risk information and contraindications, caused the drug to be misbranded, FDA said. The company was asked to remove the page and respond to FDA by 10 March 2014.
The Facebook page appears to already have been deleted by the company.
Untitled Letter to Institut Biochimique
Tags: Ommission of Risk, Misbranding, Tirosint, Facebook, Untitled Letter, Latest News