FDA Turns the Heat on two Unapproved Drugs

Taking a ‘concerted and concentrated approach’, the Food and Drug Administration (FDA) officials, in a bid to accelerate the removal of unapproved drugs, ordered some of the companies to stop selling ophthalmic salt solution (BSS) and a skin ointment with an active ingredient papain.

The focus was particularly the companies Baxter Healthcare Inc and Hospira, the sellers of the contaminated products. The usage of the defective product, used to irrigate eyes after surgery, showed ill effects, resulting in eye damage, inflammation and loss of vision.

The unapproved drugs have bypassed the agency’s screening process through which the FDA ensures marketed goods as safe, effective, properly manufactured and accurately labeled. Deborah Autor, director of FDA drug center, said by marketing the two products they have violated the requirements of law and put the consumers at risk.

All marketed drugs require FDA approval. Alcon Inc and Akron Inc provide the approved versions of the medication that can be safely marketed.

There is no documented evidence that papain, an enzyme from the papaya fruit, removes dead skin in diabetic ulcers, pressure ulcers, varicose ulcers and infected wounds. On the contrary, the agency received 37 reports of serious health problems with four very severe and life threatening allergic reactions.

The spokesperson for both Basxter and Hospira were unavailable for comments. About a dozen companies make papain products with a yearly sale touching $50 million. The FDA has ordered the makers to stop manufacturing of unapproved versions of both products by November 24th and stop the shipment by 21st January.