FDA tells companies to halt sales of 2 unapproved drugs
WASHINGTON - The Food and Drug Administration told companies to stop selling two unapproved drugs used to irrigate eyes during surgery and to treat lesions such as diabetic ulcers, saying dangerous side effects were associated with the products.
The FDA warned it may act against companies that continue to sell ophthalmic balanced salt solution for the eyes and topical drugs containing papain, drawn from papayas, without regulatory approval.
Companies selling unapproved versions of the eye drug and lesion treatment "have bypassed the requirement of the law and put consumers at risk," said Deborah M. Autor, director of FDA's drug compliance office.
Unapproved versions of the eye drugs are sold by Baxter International Inc., Hospira Inc., and B. Braun, Autor said. About a dozen companies sell the papain drugs, she said, but didn't name them. Unapproved medications may not be safe and effective and may be improperly labeled, she said.
Baxter stopped producing the eye treatment this year, though some may remain on the market, said spokeswoman Erin Gardiner.
Hospira plans to stop making the drug, said spokeswoman Tareta Adams. B. Braun also plans to stop selling the drug, which the company says has been on the market legally, according to spokeswoman Susan Denby.