Over-The-Counter Topical Muscle and Joint Pain Relievers May Cause Serious Skin Injuries

The US FDA informs healthcare personnel and consumers that certain Over-The-Counter (OTC) Topical Muscle and Joint Pain Relievers may cause serious burns.

Background of Over-The-Counter Topical Muscle and Joint Pain Relievers

Over-The-Counter (OTC) Topical Muscle and Joint Pain Relievers are mainly used for the temporary relief from minor muscle and joint aches and pain.

FDA Alert on Over-The-Counter Topical Muscle and Joint Pain Relievers

The FDA received reports that certain OTC Topical Muscle and Joint Pain Relievers caused serious burns. In some cases of serious complications hospitalization was required.

These OTC Topical Muscle and Joint Pain Relievers contain capsaicin, methyl salicylate or menthol. The brand names include Mentholatum, Icy Hot, Flexall, Capzasin and Bengay. Formulations include patches, ointments, lotions and creams.

Recommendation on Over-The-Counter Topical Muscle and Joint Pain Relievers

 “Consumers using an OTC topical muscle and joint pain reliever who experience signs of skin injury where the product was applied, such as pain, swelling, or blistering of the skin, should stop using the product and seek medical attention immediately. When recommending OTC topical muscle and joint pain relievers to patients, healthcare professionals should counsel patients about how to use the products appropriately and inform them about the risk of serious burns.”

Contacting the FDA to report cases with Over-The-Counter Topical Muscle and Joint Pain Relievers

In case of detection of adverse events or side effects related to the use Over-The-Counter Topical Muscle and Joint Pain Relievers, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

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