FDA Issues Health Warning on Popular Hair Loss Treatment
The U.S. Food and Drug Administration (FDA) has raised serious alarms regarding the use of compounded topical finasteride, a compound frequently used in hair-loss creams and serums. Concerns relate to a range of serious side effects, including cognitive issues, mood disturbances, and sexual dysfunction.
Adverse Effects Reported
Since 2019, the FDA has documented 32 instances of adverse events linked to compounded topical finasteride. These instances encompass cases where finasteride was applied either alone or in conjunction with minoxidil, another well-known hair-loss treatment. The side effects are notably troubling and mirror those reported with the approved oral forms of finasteride, such as Proscar and Propecia.
- Erectile dysfunction
- Brain fog
- Depression and anxiety
- Suicidal thoughts
- Fatigue
- Insomnia
- Decreased libido
- Testicular pain
Regulatory Status of Finasteride
It is important to note that currently, the FDA has only approved oral formulations of finasteride for specific medical conditions such as benign prostatic hyperplasia and male pattern baldness. There are no FDA-approved topical versions of this medication available in the market.
Long-Term Effects and Provider Guidance
A particularly alarming aspect of the reported adverse effects is that some patients experienced symptoms persisting even after discontinuation of the product. Many users expressed a lack of awareness regarding the potential risks associated with topical finasteride when they began treatment, often due to assurances from their healthcare providers about the safety of topical application.
The FDA urges consumers to engage in thorough discussions with healthcare professionals prior to starting any treatment involving compounded topical finasteride, emphasizing the need for awareness regarding associated health risks.
Local Reactions and Gender Considerations
Topical finasteride can also lead to localized skin reactions, including:
- Redness
- Irritation
- Dryness
- Burning sensations
Additionally, because the medication is applied directly to the scalp, there is a risk of unintentional exposure to others, particularly females. The FDA advises against the use of finasteride products during pregnancy due to their potential to cause birth defects in male fetuses.
Reporting Adverse Events
The FDA calls on consumers, healthcare practitioners, and compounding pharmacists to report any adverse events or quality concerns associated with compounded finasteride through the MedWatch Adverse Event Reporting program.
For any health-related queries or concerns, it is critical to seek professional medical advice.