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FDA approval of hair loss medications

Does FDA approval matter?

FDA approval does matter. It directs us to consider that considerable review has been done to evaluate that safety of a given medication. However, readers must keep in mind that 99 % of the medications that a hair dermatologist uses are not FDA approved for that particular hair loss condition!! When a medication that is not FDA approved for hair loss is used, we say that this is a so called 'off label' use. 

When I use minoxidil for alopecia areata, I'm using the medication in an 'off label' manner. Minoxidil is not FDA approved for alopecia but but sure can help many patients.  In fact - there is not a single medication on the planet that is FDA approved for alopecia areata. Steroid injections, DPCP, methotrexate, Tofacitinib - these are not FDA approved - yet we use them.

When I use Plaquenil for lichen planopilaris, I'm using the medication in an 'off label' manner. Plaquenil is not FDA approved for lichen planopilaris but but sure can help many patients.  In fact - there is not a single medication on the planet that is FDA approved for lichen planopilaris. Steroid injections, topical steroid, tacrolimus - these are not FDA approved - yet we use them.

When I use clindamycin for folliculitis decalvans, I'm using the medication in an 'off label' manner. Clindamycin is not FDA approved for folliculitis decalvans but but sure can help many patients.   In fact - there is not a single medication on the planet that is FDA approved for folliculitis decalvans.

When I use minoxidil and steroid injections for traction alopecia, I'm using these medications in an 'off label' manner. Minoxidil and steroid injections are not FDA approved for traction alopecia but but sure can help many patients. In fact - there is not a single medication on the planet that is FDA approved for traction alopecia.

 

Conclusion

Approval by a governing body does not mean a drug is completely safe. It simply means that the safety has been carefully evaluated. That's a big difference compared to a medication that has never been evaluated.  

FDA approval matters. It does not mean that I agree to use the drug.   Heath Canada approval matters. Approval by the French National Agency for Medicines and Health Products Safety matters.  If a drug is FDA approved in North America - but another country bans the drug - I take notice!  Similarly if a drug is FDA approved in one country, but another country refuses to approve the drug - I take notice! It can be a confusing world out there. 

 

 


Dr. Jeff Donovan is a Canadian and US board certified dermatologist specializing exclusively in hair loss. To schedule a consultation, please call the Vancouver office at 604.283.9299



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