In July 2015, the U.S. Food and Drug Administration announced that it will be taking enforcement action against manufacturers of unapproved, prescription ear drop products that are labeled to relieve ear pain, infections and inflammation.
The drugs, which have been prescribed and used for many years to relieve ear pain and swelling have not been evaluated by the FDA for safety, quality and effectiveness, according to the FDA. The agency is telling the drug makers to stop marketing the ear drops after receiving reports of allergic reactions in the ear, eyes, face, neck and mouth.
Ear (Otis) products with the following ingredients should be avoided
Products that contain the following ingredients are covered by this safety warning:
- benzocaine and antipyrine;
- benzocaine, antipyrine, and zinc acetate;
- benzocaine, chloroxylenol, and hydrocortisone;
- chloroxylenol and pramoxine; and,
- chloroxylenol, pramoxine, and hydrocortisone.
The FDA did not mention any specific brands in its safety warning. The packaging for these drugs does not disclose that they are not FDA approved, they have not been tested in children and they have not been proven to be effective in anyone, so there is no proof that they actually work, according to Dr. Charles Lee of the FDA.
Why the FDA is getting involved
The FDA’s role is to protect public health by ensuring the safety, efficacy and security of drugs for people and animals, biological products medical devices, our food supply, cosmetics and products that emit radiation.
The FDA regulates the development of new drugs and it has established rules regarding clinical trials that must be conducted on all drugs. Clinical trials have three phases, which the FDA monitors to make sure the drug is safe and effective. Once the tests and trials are completed, the drug manufacturer must send the data from the tests and the proposed labeling for review. If the review establishes that the benefits of the drug outweighs its risks, then the drug is approved for sale. If an unexpected health risk arises once an approved drug is on the market, a Drug Safety Communication may be published. Approved drugs may be withdrawn from the market if the safety risks outweigh any benefits it might provide.
There are several FDA approved products on the market that relieve ear infections and help get rid of excess ear wax. The FDA recommends that if you think your doctor has prescribed a medication that is not FDA approved, to ask them to suggest something else.