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Sunday, January 22, 2012

FDA recalls Minoxidil a commonly used drug for hair loss

Minoxidil a commonly used topical hair regrowth drug has been recalled by FDA due to safety concerns.
What is Minoxidil?
Minoxidil is a vasodilator commonly used for alopecia or hair loss. First developed as an oral anti hypertensive agent, an interesting side effect of increased hair growth was noted, anda 2% topical solution for women and 5% topical solution for men have been introduced.
It is to be appliedtwice daily and may have to be used continuously to support hair follicles.

How does Minoxidil work?
It essentially has a nitric oxide moiety which has a vasodilator action thus incresing the blood supply and in turn oxygen and nutrients for hair follicles. Also it is a potassium channel opener. These two functions add up to bring about the decrease in hairfall and promote the regrowth of hair. however it is largely implicated only in central(vertex) hair loss.

What are the side effects?
Irritation of eyes,
Itchingredness and irritation of treated area
Unwanted hair growth in other parts of body
Allergic reactions
Dandruff due to alcohol content of solution
Paradoxical hair loss

Trade names available:
Rogaine/Regaine, Vanarex, Mintop

What are the preparations that are recalled?

  • Men's Minoxidil 15% Azelaic 5% Hair regrowth topical, 60ml

  • Men's Minoxidil 10% Azelaic 5% Hair regrowth topical, 60mL

  • Men's Minoxidil 5% Azelaic 5% Hair regrowth topical, 60mL

  • Women's Minoxidil 3% Azelaic 5% Hair regrowth topical, 60mL

  • Hair regrowth shampoo enhanced with Ketoconazole and salicylic acid, 180mL

  • Why are these not safe?
    Use of these topical products containing 15% and 10% Minoxidil have not been shown to be safe, and could pose a risk due to the possibility of systemic absorption. Skin abrasions or irritations could increase the systemic absorption of topically administered Minoxidil causing low blood pressure, palpitations and associated cardiac symptoms. Azelaic acid contained in the topical products could make the skin where it is applied more sensitive to sunburn. Ketoconazole contained in the shampoo product could cause hair discoloration and abnormal hair texture, removal of the curl from permanently waved hair, itching, rash, skin irritation and dry skin. Salicylic acid contained in the shampoo could cause mild, temporary burning, itching, irritation, or stinging.