For the first time, FDA has issued a letter notifying a company that representations made on a drug's Facebook page violate the Federal Food, Drug & Cosmetic Act. The company, Institut Bochimique SA (IBSA), was cited by FDA for maintaining a Facebook page for the drug Tirosint (levothyroxine sodium) that is false or misleading in that it makes representations about the efficacy of Tirosint, but fails to communicate any information about the drugs risks as required by FDA regulations.
Tirosint is approved as a replacement or supplemental therapy for hypothyroidism. While the Facebook page makes suggestions regarding the use of Tirosint for patients with hypothyroidism, it fails to convey that Tirosin is not indicated for transient hypothyroidism during the recovery phase of subacute thyroiditis.
FDA requests that IBSA immediately discontinue the use of the misleading material on the Facebook page and respond to the FDA in writing on or before March 10, 2014.
[1] FDA NDA #021924 TIROSINT (levothyroxine sodium) capsules, for oral use MA #42, Reference ID: 3461139 (2/24/2014).
Tirosint is approved as a replacement or supplemental therapy for hypothyroidism. While the Facebook page makes suggestions regarding the use of Tirosint for patients with hypothyroidism, it fails to convey that Tirosin is not indicated for transient hypothyroidism during the recovery phase of subacute thyroiditis.
FDA requests that IBSA immediately discontinue the use of the misleading material on the Facebook page and respond to the FDA in writing on or before March 10, 2014.
[1] FDA NDA #021924 TIROSINT (levothyroxine sodium) capsules, for oral use MA #42, Reference ID: 3461139 (2/24/2014).
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