Primary androgen-deprivation therapy (ADT) is widely used to treat localized prostate cancer in patients who have opted not to have surgery or radiation therapy.  However, a study published last week in the American Society of Clinical Oncology found that primary ADT did not provide any prostate cancer survival benefit to patients.  Although the study showed a small clinical benefit for a subgroup of high-risk cases, researchers concluded that primary ADT is not an effective therapy for most men.
[1] Potosky, A., "Effectiveness of Primary Androgen-Deprivation Therapy for Clinically Localized Prostate Cancer," American Society of Clinical Oncology, doi:10.1200/JCO.2013.52.5782 (March 17, 2014).
[2] Bankhead, C., "ADT: No Help as Primary Tx for Prostate Cancer,"  medpage TODAY (March 17, 2014). 

After rejecting it three times, FDA has now approved AVEED, a new testosterone and castor oil therapy manufactured by Endo International to treat male hypogonadism.  Male hypogonadism is characterized by low production of testosterone which is responsible for maintaining muscle bulk, bone growth and sexual function.   The FDA had been concerned about the risk of the castor oil causing blockages in blood vessels in the lungs and complications linked to post-injection reactions.  However, FDA determined that the benefits of testosterone therapy outweighed these risks.  Following the approval, AVEED is expected to be available later in March.
[1] Reuters, "FDA approves Endo International's testosterone drug" (March 6, 2014).
[2] FDA Approved Drug Products, AVEED (March 5, 2014).

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).