Every 3 months, FDA updates its New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System listings (here) to include newly identified potential serious risks that FDA is investigating. The FDA wants to emphasize that “[T]he appearance of a drug or biological product on a quarterly report does not mean that FDA has concluded that the drug or biological product has the listed risk or that FDA has identified a causal relationship between the drug or biological product and the listed risk at the time the report is posted.” However, it does indicate that the FDA is reviewing and investigating the reported events and will determine what action, if any, needs to be taken.
The listing is required by legislation in order to alert healthcare providers and patients by making this information available at the earliest time possible.
The most current quarterly listing can be found here. Most of the ADE reports are for FDA approved products; however, one of the items on the current list that caught my attention was adverse events reported for a compounded topical product of finasteride to promote hair growth. Finasteride is not approved for topical administration but there are two FDA approved NDA tablet versions of the product (and multiple approved generic tableted products for both reference listed drugs). Proscar tablets are for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate and Propecia which is approved for treatment of male pattern hair loss. Propecia is not indicated for use in women.
Both FDA approved products contain the specific warning that “women should not handle crushed or broken finasteride tablets when they are pregnant or may potentially be pregnant due to potential risk to a male fetus”. In addition, the FDA says the “absorption of finasteride through the skin into the bloodstream is expected, and the [ADE] reports describe adverse events that are consistent with those reported in association with the approved oral finasteride products, such as erectile dysfunction, anxiety, suicidal ideation, brain fog, depression, fatigue, insomnia, decreased libido and testicular pain following the use of compounded topical products with finasteride alone or in combination with other active ingredients.” Given the topical use in males, there is also the concern about the unintended transference to females during contact with a male partner. This is one example of how a seemingly simple dosage form change from tablet to topical solution can cause a problem based on the lack of incomplete label warning or miscommunication from the compounder when there is no required patient package insert for the product to warn of such potential adverse drug reactions.
Reviewing the quarterly published potential risk list would be instructive for not only health care providers, but also for both 503A compounding pharmacies and 503B outsourcing facilities to catch a potentially significant risk that should be communicated to the consumers/patients.
