FDA Warns Drugmakers to Quit Selling Unapproved Rx Otic Drops

Agency Also to Examine Children's Use of Cough, Cold Medications With Codeine

July 07, 2015 03:44 pm News Staff

On July 1, FDA officials moved to shut down the manufacture and sale of 16 unapproved prescription otic products used to relieve ear pain, inflammation and infection. Specifically, the agency notified(www.fda.gov) companies that produce and/or distribute these products that it will take enforcement action against them if they continue to make and market the ear drops.

[FDA-Approved stamp]

In separate action, the agency said it also plans to scrutinize safety data pertaining to the use of codeine-containing products used to treat cough or colds in children younger than 18 years.

Prescription Ear Drops

Otic drops are frequently given to young children suffering from ear infections and other ailments that cause ear pain and swelling. A number of FDA-approved prescription otic products are available to manage these symptoms, as are legally marketed OTC ear drops. Those products are not affected by the agency's action.

Products that have not been evaluated by the FDA for safety, quality and efficacy, on the other hand, increase patients' risk for adverse effects, such as those due to contamination or varying dosage levels that stem from improper manufacturing practices. The unapproved products covered by this action contain the following ingredients:

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

Patients who are using these unapproved products (or their parents) are advised to consult with their physician regarding other treatment options.

Codeine-containing Cough-and-Cold Products

In a Drug Safety Communication(www.fda.gov) issued July 1, FDA officials announced that the agency is investigating the safety of using cough-and-cold medications that contain codeine in children younger than 18 years. The agency cited concerns about the potential for severe side effects associated with use of these products, including slowed or difficult breathing.

Children with existing respiratory problems, such as asthma or other breathing disorders, may be particularly susceptible to these adverse effects.

The FDA's action comes on the heels of an April announcement(www.ema.europa.eu) from the European Medicines Agency (EMA), which declared that the use of codeine-containing cough-and-cold medications was contraindicated in children younger than 12 years because of the risk of side effects. The agency also noted at the time that use of these products was not recommended in children ages 12-18 who have breathing problems.

Furthermore, EMA officials warned, patients of any age who are considered "ultra-rapid metabolizers" of the drug, which is converted into morphine in the body, must not use codeine to treat cough or colds.

The FDA announcement states that the agency will continue to evaluate the safety of using codeine products to treat cough or colds in children and young teens -- including reviewing the EMA's action and the evidence on which it was based -- and will release final conclusions when that investigation is completed.

In the meantime, agency officials recommend caution when prescribing these medications for young patients, and they urge both physicians and patients to report adverse effects(www.accessdata.fda.gov) linked to use of the drugs via MedWatch, the FDA's Safety Information and Adverse Event reporting Program.