Drug Induced Alopecia Areata : A Closer Look at the FAERS Database

Introduction

Medications have the potential to trigger many diseases. This includes hair loss. It’s always important to pay close attention to drugs that cause or trigger a specific disease because this provides important clues to the underlying mechanisms governing the disease pathogenesis.

The FDA Adverse Events Reporting System (FAERS): A Powerful Tool to Track Post-Marketing Side Effects

The Food and Drug Administration (FDA) launched a publicly available database that allows individual patients, healthcare professionals, and manufacturers to report adverse events caused by medications.

This data is essential to better understanding “real-world” side effects. By real-world, I mean side effects outside a well-controlled, highly monitored clinical trial.

There are now over 26 million side effects reported on the FDA database.

Ravipati A et al, 2024

The authors of a new study set out to review the FAERS database to understand better medications associated with alopecia areata.

The authors found 1,331 AA cases reported on FAERS since 1997. Reports are increasing over time. Approximately 75.6% of AA reports were in females, whereas 24.4% were in males. Most cases were in patients ages 18-64, but there are pediatric patients in the database and patients over 65.

Top 10 Medications Associated with AA in FAERS

The following are the ten medications:

1. 29.2% of AA cases were seen with docetaxel (a taxane chemotherapy drug)

2. 8.3% were with adalimumab (a tumour necrosis factor (TNF) inhibitor)

3. 4.7% with trastuzumab (monoclonal antibody; HER2 inhibitor cancer therapy)

4. 4.4% with cyclophosphamide (alkylating agent- used in cancer treatment and autoimmune dz)

5. 4.3% with infliximab (a tumour necrosis factor (TNF) inhibitor)

6. 4.1% with carboplatin (alkylating agent- used in cancer treatment

7. 3.4% with dupilumab (monoclonal antibody, blocks IL4 and IL13)

8. 2.7% with levonorgestrel (progestin)

9. 2.6% with etanercept (a tumour necrosis factor (TNF) inhibitor)

10. 2.6% with from pertuzumab (monoclonal antibody; HER2 inhibitor cancer therapy)

A Closer Look at the Top 10

Monoclonal antibodies accounted for 6 out of the top 10 drugs. 3 of the top 10 medications were chemotherapeutic agents, including two HER2 receptor inhibitors and carboplatin.

Among the monoclonal antibodies, males were more likely to report AA when taking adalimumab (OR: 1.79, P = 0.04) and dupilumab (OR: 2.56, P = 0.03).

Other less common reported causes in the FAERS (rank order 11-30)

11. methotrexate (antimetabolite used in cancer therapy and autoimmune disease)

12. levocetirizine (antihistamine)

13. secukinumab (interleukin-17A (IL-17A) receptor inhibitor)

14. montelukast (leukotriene receptor antagonist - used in allergy treatment)

15. Olopatadine (selective histamine H1 antagonist and mast cell stabilizer)

16. prednisolone (corticosteroid)

17. tacrolimus (calcineurin inhibitor immunosuppressant)

18. doxorubicin (anthracycline chemotherapeutic drug)

19. fexofenadine (antihistamine)

20. tofacitinib (JAK 1/3 inhibitor)

21. levothyroxine (thyroid medication)

22. azathioprine (antiproliferative and immunosuppressive agent)

23. ustekinumab (monoclonal antibody, anti IL-12/23 inhibitor)

24. sertraline (selective serotonin reuptake inhibitor (SSRI)

25. simvastatin (cholesterol medication)

26. leflunomide (disease-modifying anti-rheumatic drug)

27. paclitaxel (taxane chemotherapeutic)

28. dexamethasone (corticosteroid)

29. certolizumab (a tumour necrosis factor (TNF) inhibitor)

30. Ribavirin (nucleoside analogue, used in hepatitis C treatment)

Comment

This is an interesting paper that highlights the new world of drug-induced AA. Monoclonal antibodies will increasingly be a part of our therapeutic toolbox for many diseases, so it will be important to understand how this changes over time. Of the 26 million side effects in FAERS, just 1400 are related to AA. It could be that this is underreported. However, drug-induced AA is still likely a minor contributor to AA.

REFERENCE

Ravipati A et al. A cross-sectional analysis of medications used by patients reporting alopecia areata on the FDA adverse events reporting system. Int J Dermatol. 2024 Apr;63(4):497-502. doi: 10.1111/ijd.17014. Epub 2024 Jan 12.