FDA Tightens Screws on Unapproved Ear Drops
The FDA is cracking down on companies that manufacture or distribute unapproved prescription ear drops labeled to relieve pain, infection and inflammation, warning they will be subject to seizures, injunctions and criminal proceedings.
The unapproved ear drops contain active ingredients including benzocaine and hydrocortisone and have not been evaluated by the agency. Additionally, product labels don’t disclose the unapproved status, so healthcare professionals may not be aware, the FDA says in a safety alert.
Healthcare providers have prescribed and pharmacies have sold these drug products for years, the agency says, noting other active ingredients include antipyrine, zinc acetate and chloroxylenol.
The FDA is concerned because the eardrops are most often used with young children — the group most susceptible to ear infections and other painful ear conditions. The products may be poorly manufactured or contaminated, which could result in a wrong dosage, even when administered according to labeled directions, the agency says.
FDA-approved prescription and OTC ear drops are not subject to the action, the agency said.
To read the safety alert, go to www.fdanews.com/07-06-15-EarDrops.pdf. — Kellen Owings