Finasteride is a 5α-reductase inhibitor used to treat an enlarged prostate (benign prostatic hyperplasia or BPH) or hair loss in men. It is also used to treat excessive hair growth in women and as a part of hormone therapy for transgender women. An independent testing laboratory in the US identified the minoxidil (an antihypertensive drug) at greater levels in Finasteride capsules. On 11th May, The manufacturer of Finasteride, MasterPharm, LLC. announced a nationwide voluntary recall from United States of America due to the presence of an undeclared amount of minoxidil at levels greater than those found in FDA approved products.
Which batch/lot of Finasteride product is affected and recalled?
The product is a compounded drug for hair loss and is packaged in orange prescription bottles containing 30 capsules or blue prescription bottles containing 90 capsules. The affected Finasteride Plus 1.25mg lots include the following 02-27-2020:04@11 and a Beyond Use Date of August 25, 2020. The product can be identified by the patient-specific labelled prescription bottles with product batch labels and a patient-specific prescription label. Finasteride Plus 1.25mg was distributed Nationwide on a patient-specific prescription basis only.
Safety concerns attributed to minoxidil exposure:
The potential adverse reactions associated with minoxidil are hypotension (low blood pressure), rapid heartbeat, and swelling due to salt and water retention. Also, patients would be at higher risk of developing heart failure or other heart damage. Excess fluid between the heart and the sac surrounding the heart has also been reported in association with minoxidil use.
Case Reports:
Manufacturer (MasterPharm, LLC) received 33 case reports containing increased heart rate, retention of water, dizziness, and low blood pressure as safety findings. Manufacturer notifying its customers by telephone, e-mail, and common carrier letters and is arranging for return and replacement of all recalled products and requested consumer to stop using and return the Finasteride Plus 1.25mg.
Voluntary Reporting:
Health care professionals and consumers are advised to report any adverse reactions or quality problems experienced with the use of this product to the FDA by online voluntary reporting facility through MedWatch online reporting. This will facilitates in accumulation of the more evident safety data which could expedite the regulatory actions by FDA.