WARNING FROM FDA ON PRESCRIPTION EAR DROPS FOR EAR PAIN

July 8, 2015

Here is an important alert for patients using prescription ear drops for ear pain and swelling.

On July 1, 2015, the Food and Drug Administration (FDA) issued a consumer update announcing that the agency will be requiring drug manufacturers to stop selling 16 types of prescription ear drops.[1] These drugs have been marketed for years but have never been approved as safe and effective by the FDA.[2] The drugs have remained on the market so long due to historical regulatory loopholes that are now slowly being addressed by the FDA.[3]

The prescription ear drops covered in the FDA warning are labeled for relief of ear pain, infection, and inflammation. The FDA noted that these drugs often are given to young children with ear infections and other conditions that cause ear pain and swelling.[4]

Ear drops containing the following combinations of active ingredients are not FDA-approved:

• benzocaine.
• benzocaine and antipyrine.
• benzocaine, antipyrine, and zinc acetate.
• benzocaine, chloroxylenol, and hydrocortisone.
• chloroxylenol and pramoxine.
• chloroxylenol, pramoxine, and hydrocortisone.

The FDA directed companies to stop manufacturing these products or face criminal and civil legal action, such as seizure of the drugs.[5] The agency has received at least five reports of allergic reactions to drugs containing these ingredients, including rapid swelling of the ear, eye, face, neck, and/or mouth. Benzocaine, one of the active ingredients in some of the ear drops, causes a rare but potentially fatal blood reaction known as methemoglobinemia. The FDA reported that it is aware of at least one case in which an infant developed methemoglobinemia after receiving ear drops containing benzocaine, and this infant died as a result.

What you can do

If you or a loved one is using an ear product that contains the active ingredients listed above, call your doctor and discuss FDA-approved alternatives.[6] There are many FDA-approved drugs for middle and outer ear infections, plus other over-the-counter products that are effective for prevention of swimmer’s ear and earwax buildup.[7] These products are better alternatives for consumers, as FDA approval helps ensure that the ear drops have been tested for safety, effectiveness, and quality control.[8]

To see the FDA safety communication, visit the following link: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm453087.htm.

References

[1] Food and Drug Administration. FDA: Use Only Approved Prescription Ear Drops . July 1, 2015. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm453087.htm.

[2] Ibid.

[3] Food and Drug Administration. Guidance for FDA Staff and Industry: Marketed Unapproved Drugs – Compliance Policy Guide. September 19, 2011. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070290.pdf.

[4] Food and Drug Administration. Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality. July 1, 2015. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm453430.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.

[5] Ibid.

[6] Food and Drug Administration. FDA: Use Only Approved Prescription Ear Drops . July 1, 2015. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm453087.htm

[7] Ibid.

[8] Ibid.