About My Health Careers Internship MedBlogs Contact us
Medindia LOGIN REGISTER
Advertisement

FDA Orders to Halt Marketing of Eye Solution, Ointment

by VR Sreeraman on September 24, 2008 at 12:14 PM
Font : A-A+

 FDA Orders to Halt Marketing of Eye Solution, Ointment

The US Food and Drug Administration on Tuesday warned pharmaceutical laboratories to stop marketing two unapproved products that have been linked to serious health problems.

The first is an eye solution used to irrigate the eyes during and following cataract surgery, and the second is an ointment to treat sores and ulcers containing papain, which is not FDA approved.

Advertisement

"These unapproved products have put consumers health in jeopardy, from reports of permanent vision loss with unapproved balanced salt solutions to a serious drop in blood pressure and increased heart rate from the topical papain products," said Janet Woodcock, the FDA's director for the Center for Drug Evaluation and Research.

"Consumers need to be assured that all drug products are manufactured according to the high quality standards required for FDA approval and that they are safe and effective."
Advertisement

The FDA asked doctors to prescribe only ophthalmic balanced salt solutions (BSS) which are FDA-approved and produced by Alcon or Akorn.

Out of the some 3.2 million bottles of BSS solution sold in the United States since 2007, just one percent were approved by the FDA.

The FDA recommended that doctors refrain from prescribing any topical drug ointments containing the enzyme papain.

The agency also warned that companies must stop manufacturing and marketing these products by November 24, or face penalty such as injunction or seizure.

Source: AFP
SRM
Advertisement

Advertisement
News A-Z
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Advertisement
News Category
What's New on Medindia
January is the Thyroid Awareness Month in 2022
Menstrual Disorders
Coffee May Help You Fight Endometrial Cancer
View all

Medindia Newsletters Subscribe to our Free Newsletters!
Terms & Conditions and Privacy Policy.

More News on:
Eye Vision LASIK Surgery Facts Allergy Eye Drops Routine Eye Examination Quiz On Eye Donation Floppy Iris Syndrome Eyelid Bump 

Recommended Reading
Cataract in Detail
Encyclopedia section of medindia gives general info about Cataract...
Cataract Surgery - Animation
An Illustration of the Cataract surgery that is performed to restore the sight for the patients ......
Conjunctivitis
Conjunctivitis or Pink Eye causes redness and soreness of the conjunctiva and is responsible for 1% ...
Allergy Eye Drops
Eye allergies are treated with different types of eye drops such as lubricants, antihistamines, NSAI...
Eyelid Bump
Our eyelids protect our eyes and keep them moist. Swelling of the eyelid may be localized due to cha...
Floppy Iris Syndrome
Floppy iris syndrome is associated with a high risk of complications following cataract surgery....
Routine Eye Examination
A comprehensive eye exam can take an hour or more, depending on the doctor and the number and comple...

Disclaimer - All information and content on this site are for information and educational purposes only. The information should not be used for either diagnosis or treatment or both for any health related problem or disease. Always seek the advice of a qualified physician for medical diagnosis and treatment. Full Disclaimer

© All Rights Reserved 1997 - 2022

This site uses cookies to deliver our services. By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use
open close
CONSULT A DOCTOR
I have read and I do accept terms of use - Telemedicine

Advantage Medindia: FREE subscription for 'Personalised Health & Wellness website with consultation' (Value Rs.300/-)