US FDA orders two unapproved drugs off the market

U.S. health officials warned companies on Tuesday to stop selling unapproved versions of an eye-surgery solution and a prescription wound cream that have been linked to serious health problems.

The products are ophthalmic balanced salt solutions (BSS) used to irrigate the eye during cataract and other surgeries, and skin ointments made with the ingredient papain.

Baxter Healthcare Inc and Hospira are among the makers of unapproved versions of the eye solution, Food and Drug Administration officials said.

Companies selling either product “have bypassed the requirements of the law and put consumers at risk,” Deborah Autor, director of compliance in the FDA’s drugs center, told reporters.

The FDA has received more than 300 reports of problems, including permanent vision loss and eye inflammation, in patients treated with the eye solution since 1969, agency officials said. Inspections found contaminants and other product defects in some cases.

Alcon Inc and Akorn Inc sell approved versions of the eye solution. Those will remain on the market.

About 3.2 million units of the solution were sold in 2007, with an estimated 1 percent being unapproved, Autor said.

A Baxter spokeswoman had no immediate comment. A Hospira spokeswoman could not immediately be reached.

There are no approved topical papain products, which are used to remove dead or contaminated tissue in diabetic ulcers, pressure ulcers, varicose ulcers and infected wounds. Papain is an enzyme derived from the papaya fruit and other plants.

The agency has received 37 reports of serious health problems in patients who used papain products, including four cases of a life-threatening allergic reaction. There is no evidence the papain products work, FDA officials said.

About a dozen companies make papain products and annual sales reach about $50 million a year, Autor said.

The FDA ordered makers to stop manufacturing unapproved versions of either product by Nov. 24, and to stop shipping them by Jan. 21.

The action is part of an ongoing FDA effort to remove unapproved medicines from the market. About 2 percent of prescriptions in the United States are filled with unapproved drugs, the FDA said.

By Lisa Richwine
WASHINGTON (Reuters)