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azelaic acid FDA Alerts

The FDA Alert(s) below may be specifically about azelaic acid or relate to a group or class of drugs which include azelaic acid.

MedWatch Safety Alerts are distributed by the FDA and published by Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for azelaic acid

Perfect Image Solutions Topical Hair Regrowth Products: Recall - Unapproved Drugs, Risk of Health Hazards

Jan 20, 2012

Audience: Consumer

  • 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

ISSUE: Perfect Image Solutions recalled all lots of these topical hair regrowth products because they are deemed “unapproved new drugs” under FDA regulations, and may present potential health hazards.

Use of these topical products containing 15% and 10% Minoxidil have not been shown to be safe, and could pose a risk to the general public due to the possibility of systemic absorption. Skin abrasions or irritations, such as psoriasis or sunburn, could increase the systemic absorption of topically administered Minoxidil. Minoxidil 15% and 10% could cause low blood pressure, heart 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.

BACKGROUND: These products are used to slow or stop hair loss and promote hair regrowth and are packaged in glass-dropper containers or plastic shampoo bottles, and are sold in single units. They are used by men and women generally in middle to late adulthood. The product can be identified by the name Perfect Image Solutions on the container. Product was distributed nationwide or worldwide via the internet.

RECOMMENDATION: Consumers that have product which is being recalled should discard it.


[01/20/2012 - Press Release - Perfect Image Solutions]

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