T prescriptions see significant drop after FDA advisory

Monthly prescriptions for testosterone decreased significantly following a safety advisory issued by the FDA in March 2015.

The decline occurred despite a consistent number of monthly clinical encounters with a primary diagnosis of hypogonadism, said Valary Raup, MD, of Brigham and Women’s Hospital, Harvard Medical School, Boston.

The finding “shows the significant impact that an FDA safety advisory can have on the practice patterns of our colleagues, both urologists and overall,” she said.

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On March 3, 2015, the FDA released a safety advisory and prescription labeling change that warned about a possible increased risk of heart attack and stroke in patients taking testosterone. In addition, the FDA noted that the benefit and safety of testosterone had not been established for the treatment of low testosterone levels due to aging, and that “health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests.”

The decrease was “precipitous, right at the time of the advisory, and it continued over the course of the next 6 months,” noted Dr. Raup, who reported the study findings at the AUA annual meeting.

Since the advisory was issued, new guidance by the AUA, published in April 2018, states that, “At this time, it cannot be stated definitively whether testosterone therapy increases or decreases the risk of cardiovascular events (eg, myocardial infarction, stroke, cardiovascular-related death, all-cause mortality).” This recommendation carried an evidence level of grade B. Further, the AUA guideline asserted that a large percentage of men in need of testosterone therapy fail to receive it due to clinician concerns, mainly surrounding prostate cancer development and cardiovascular events.

If the cardiovascular risk is not significant but clinicians are reluctant to prescribe testosterone replacement anyway, “then you’re missing an opportunity to help a lot of people,” said Dr. Raup, who worked on the study with Martin Kathrins, MD, and colleagues.

Dr. Raup and her co-authors used the Research Patient Data Registry, which is a clinical patient data repository pertaining to eight hospitals in the Boston metro area within the Partners Healthcare network, to examine the effect of the FDA warning on testosterone prescribing patterns. The database was queried for men 45 to 84 years of age who were prescribed transdermal or injectable forms of testosterone (by any prescriber) from March 2013 until August 2016. Monthly visits for hypogonadism were also assessed.

The estimates of effect and the relative effects were calculated for 1, 3, 6, 9, 12, 15, and 16 months following the safety advisory.

Next: Total number of transdermal T prescriptions written declined from about 800 per month in March 2013 to fewer than 100 per month by July 2016The total number of transdermal testosterone prescriptions written declined from about 800 per month in March 2013 to fewer than 100 per month by July 2016, and the total number of injectable prescriptions dropped from about 200 per month to fewer than 100 per month over the same time frame. Shortly before the FDA advisory, the total number of monthly prescriptions for each was about 600 and 200 per month, respectively, which fell to approximately 400 and 200 per month, respectively, 6 months after the advisory was issued.

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The difference in slope coefficients between pre- and post-safety advisory was –26.5 (p=.000) for transdermal formulations and –7.5 (p=.003) for injectable formulations of testosterone. During the same time, the difference in coefficients for clinical encounters was –3.0, which was not significant (p=.260).

“A lot of the time, a testosterone prescription is not provided at the level of a urologist; it’s by a primary care physician, and so it will be interesting to see if the guidelines that are targeted toward urologists will have any impact on the trend,” Dr. Raup said.

According to the recent AUA guidance, testosterone therapy “should not be commenced for a period of 3 to 6 months in patients with a history of a cardiovascular events.”

“This is something to keep in mind but should not preclude you from prescribing testosterone to men who might benefit,” she said.

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