The U.S. Food and Drug Administration Addresses Unapproved Prescription Ear Drop Products
The U.S. Food and Drug Administration notified manufacturers asking them to stop manufacturing unapproved prescription ear (otic) drugs, otherwise strict repercussions including seizure, injunction, and or criminal proceedings may be enforced. Although these products have not been evaluated by the FDA for safety, effectiveness and quality, they are indicated to treat otitis media (middle ear infections), swimmer’s ear, and other ear conditions. They contain active ingredients like benzocaine and hydrocortisones, which help to manage inflammation and pain. With approval of these otic products still pending, the FDA noted that several OTC and approved prescription options are currently available for said conditions.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability. All trademarks are the property of their respective owners.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.