FDA Delays Some Updates; Product Warnings for Topical Hair Loss Treatment; Supplements with Hidden Ingredients; Counterfeit Ozempic
Dear Readers,
The next regular issue of Ask a Patient® Health News: Drugs & Treatments is scheduled for Sunday, May 4 (the newsletter was on break Sunday, April 20). Today’s post contains an important notification about recent delays in FDA reporting, which could result in temporary changes to the types of alerts covered in this newsletter.
So far this month (April 2025), the FDA has not updated its database containing drug safety-related label revisions. While delays in reporting have happened before, this is an unprecedented amount of time to go without safety updates. The database is one of the primary sources of information for this newsletter.
The FDA’s REMS data files page has not been updated so far this month (April 2025), which is also unusual. REMS (Risk Evaluation and Mitigation Strategy) is a drug safety program that the US Food and Drug Administration (FDA) can require for certain medicines with serious safety concerns, such as drugs that may cause birth defects or pose extreme risk to a patient if not taken strictly according to instruction. In February, we noted that the repository was missing from the FDA website. It was restored after more than a week.
FDA continues to release important recalls and warnings notices. Here are three recent FDA press releases that warn consumers not to use certain drug products on the market:
Warning About Topical Finasteride for Hair Loss
The FDA warns consumers, health care providers, and compounders about potential risks from topical finasteride-containing treatments for male hair loss. The products are sold as spray formulations through telehealth platforms like Roman, Keeps, and Hims & Hers. The online products are available as a finasteride-only treatments or are compounded into a mixture of finasteride and minoxidil (ingredient used in brand name hair loss treatment Rogaine) and sometimes also include tretinoin (ingredient used in the skin treatment Retin-A).
Users have reported side effects including depression, fatigue, insomnia, dizziness, and low libido. These are side effects similar to those associated with the approved finasteride prescription tablets. The telehealth websites falsely suggest that because the drug is sprayed directly onto the scalp, it will have fewer side effects than oral tablets.
Finasteride is a prescription ingredient approved to treat hair loss in men (Propecia tablets) and to treat symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate (Proscar tablets). No topical versions are FDA-approved.
The FDA notes that the topical formulation, which through skin contact could be transferred to others, could be especially dangerous to pregnant women because of the potential to cause abnormalities of a male fetus.
FDA Press Release on Topical Finasteride
Dietary Supplements Painflex Forte and Artrifan King Contain Hidden Ingredients
The Food and Drug Administration warns consumers not to purchase or use Painflex Forte, or Artrifan King, products promoted and sold as treatments for arthritis or joint pain. These products are sold as supplements on various websites, including Amazon, ibspot.com and possibly in some retail stores.
An FDA laboratory analysis found that Painflex Forte and Artrifan King contain active drug ingredients not identified on the label: dexamethasone (corticosteroid) and diclofenac (non-steroidal anti-inflammatory drug (NSAIDs). In addition, Artrifan King was found to contain methocarbamol (a muscle relaxant). These ingredients can cause severe side effects. Read press releases for complete details and product images:
FDA Press Release on Painflex Forte
FDA Press Release on Artrifan King
FDA List of Pain and Arthritis Products Containing Hidden Ingredients
FDA Warns Consumers and Pharmacies about Counterfeit Ozempic
Consumers and retailers are warned about counterfeit Ozempic, some of which has been taken off the market. Retail pharmacies are advised to purchase authentic Ozempic and other semaglutide-containing medicines only through authorized distributors of Novo Nordisk.
Patients are encouraged to only use authentic Novo Nordisk Ozempic (semaglutide) injection obtained through pharmacies and to check the product for any signs of counterfeiting before using. Seized counterfeit products feature lot number PAR0362 and illegitimate serial numbers beginning with the first eight digits 51746517. Lot number PAR0362 is an authentic lot number. Only when both the lot number is coupled with the eight digits 51746517, it is counterfeit and should not be used. Check press release for more information and product images.
FDA Press Release on Counterfeit Ozempic