On November 24, 2013, The New York Times published an article stating that testosterone prescriptions have increased in recent years for uses unapproved by the United States Food and Drug Administration (FDA). Testosterone-containing drugs are approved as replacement therapy in men diagnosed with testosterone deficiency or absence due to hypogonadism (reduced function of the gonads). The article stated that testosterone medications are being used to treat a condition called low-testosterone (or low T) in men without clinical symptoms of hypogonadism, which may lead to serious adverse effects.
Federal law prohibits the marketing of any drug for indications that are not approved by the FDA. However, it is legal for doctors to prescribe drugs for unapproved uses if the health care professional sees it as a fit treatment option for patients. This has led to an upsurge in prescription rates of testosterone therapies for many men without debilitating symptoms of hypogonadism. Symptoms of this disease in men include decreased growth of body hair, decreased muscle mass, development of breast tissue (gynecomastia), erectile dysfunction, and loss of bone mass (osteoporosis). Testosterone drug labels state that the hormone is indicated to treat hypogonadism caused by birth defects, chemotherapy, or deficiencies caused by pituitary-hypothalamic injury.
AbbVie, the marketer of AndroGel (testosterone gel), created a website (IsItLowT.com) geared towards informing potential patients about low testosterone. The site comes equipped with a self-report test for patients with a header that states, “The Low T quiz can help you find out if you may have low T and if you should talk to your doctor.” This quiz is an exact copy of the self-report test that is shown on the AndroGel website. As the IsItLowT.com website does not specifically state that AndroGel should be used for the treatment of low T, AbbVie is not breaking any marketing laws.
The drug label for AndroGel warns of serious side effects such as prostate cancer, low sperm counts, congestive heart failure, sleep apnea, early onset of puberty in children exposed to testosterone, and impaired liver function. The NYT article stated, “…some public health experts warn that the popularization of testosterone drugs is outpacing research into efficacy and possible harms.” According to a study published this year in JAMA Internal Medicine, almost 25% of male patients prescribed with testosterone therapy received no blood work to diagnose their condition. Considering the safety profile of testosterone therapy, the extent of patient impairment and results of adequate blood tests should be taken into account before this drug is prescribed to patients.
AndroGel (testosterone gel) is an androgen indicated for daily testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone such as primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired). AndroGel is a topical treatment available in two different strengths. AndroGel was approved by the FDA on February 28, 2000.
AdverseEvents uses a proprietary disproportionality analysis tool called RxSignal to track and predict pending FDA safety actions.
Using RxSignal, AdverseEvents’ analysts have identified multiple safety signals for Androgel which have not yet been sufficiently listed in the prescribing information. Adverse events of concern for Androgel include altered mood, skin burning sensation, and musculoskeletal pain. Any of these may trigger further FDA safety reviews.
Using FAERS data (from 11/01/1997 to 12/31/2012), aggregated and standardized by the AdverseEvent RxFilter process, we identified 72 cases of heart failures, 58 cases of prostate cancer or enlarged prostate, 76 cases of accidental exposure or puberty, 16 cases of sleep apnea, 18 cases of hepatic impairment, and 8 cases of decreased sperm count where AndroGel was listed as the primary suspect drug.
Note: In order to calculate the total number of patients experiencing prostate cancer or enlarged prostate, decreased sperm count, congestive heart failure, sleep apnea, early onset of puberty, and impaired liver function, we aggregated reports listing the following adverse events: MedDRA Preferred Terms: Benign prostatic hyperplasia, prostate cancer, prostate cancer metastatic, prostate cancer recurrent, prostate cancer stage 0, prostate cancer stage 1, prostate cancer stage II, prostate cancer stage III, prostate cancer stage IV, aspermia, asthenospermia, azoospermia, hypospermia, sperm concentration abnormal, sperm concentration decreased, sperm concentration zero, sleep apnea, accidental exposure, precocious puberty, puberty ; MedDRA High-Level Group Term: Heart Failures, Hepatic and hepatobiliary disorders.