Food and Drug Administration (FDA) has ordered the manufacturers of certain prescription ear drops to stop making and distributing the products because they are not FDA-approved. The product labels do not disclose that they lack FDA approval and health care providers may not be aware of the unapproved status, notes FDA. The agency took action against unapproved prescription otic drug products containing these ingredients:
- benzocaine and antipyrine;
- benzocaine, antipyrine, and zinc acetate;
- benzocaine, chloroxylenol, and hydrocortisone;
- chloroxylenol and pramoxine; and
- chloroxylenol, pramoxine, and hydrocortisone.
These drugs are frequently given to relieve ear swelling and pain in young children, and FDA took this action to protect patients from the risks of taking unapproved drugs with no proven safety or effectiveness information. Further, such drugs may be contaminated or manufactured incorrectly, notes the agency in a press release. Health care providers are encouraged to report any adverse effects to FDA’s MedWatch Adverse Event Reporting Program.
Source; NABP e-News