Other safety alerts
|
| |
| The United States: Unapproved prescription ear drop (otic) products: Not FDA evaluated for safety, effectiveness and quality |
| |
FDA announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear pain, infection, and inflammation. The unapproved prescription ear drops contain active ingredients such as benzocaine and hydrocortisone, and have not been evaluated by the FDA for safety, effectiveness and quality. The labels on these products do not disclose that they lack FDA approval, and health care professionals may not be aware of their unapproved status.
Unapproved prescription otic drug products are frequently given to young children suffering from ear infections and other conditions that cause ear pain and swelling. Patients taking unapproved drugs may be at greater risk because there is no proven safety or effectiveness information. These products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use. Unapproved prescription otic drug products containing the following ingredients are covered by this action include benzocaine; benzocaine and antipyrine; benzocaine, antipyrine, and zinc acetate; benzocaine, chloroxylenol, and hydrocortisone; chloroxylenol and pramoxine; and chloroxylenol, pramoxine, and hydrocortisone.
Consumers who believe they are using unapproved prescription ear drops should contact their health care provider to discuss alternatives.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm453430.htm
In Hong Kong, all pharmaceutical products containing benzocaine and/or hydrocortisone need to be registered with the Pharmacy and Poisons Board before they can be sold, offered for sale, distributed or possessed for the purposes of sales, distribution or other use in Hong Kong. The Hong Kong registration number for a registered pharmaceutical product can be found on the sales pack in the form of "HK-xxxxx" ("x" denotes a number). Registered product can be found by searching the Drug Database (http://www.drugoffice.gov.hk/eps/do/../search_drug_database.html ) at Drug Office website. Members of the public are strongly advised not to buy or consume any products of unknown or doubtful composition, or consume products from unknown sources including through internet. The public should consult healthcare professionals before using any medication.
Ends/ Thursday, July 02, 2015
Issued at HKT 16:30
|
| |
