The U.S. Food & Drug Administration (FDA) has ordered several U.S. pharmaceutical companies to stop marketing unapproved ophthalmic balanced salt solutions (BSS), used to irrigate the eye during surgery on the eye, and unapproved topical drug products containing papain, used in treating skin ulcers, or risk enforcement action.

Different play, same actors

While several companies may be involved, the FDA has pointed its finger at three in particular. Two of the three pharmaceutical companies who have been marketing these products for unapproved FDA uses are B. Braun and Baxter International – who were also part of the heparin controversy less than a year ago. The third company is Hospira, Inc.

According to Janet Woodcock, M.D., director for the Center for Drug Evaluation and Research, "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. 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."

Information on unapproved products

• BSS products. Users of … unapproved products have reported to FDA injuries including eye inflammation, cloudy vision, and permanent loss of visual acuity. Inspection of these products revealed contaminants and other product defects. [The] FDA urges doctors and others who use these products to switch to approved versions of BSS made by Alcon and Akorn.
• Topical Papain Products. Trade names for these products include Accuzyme, Allanfil, Allanzyme, Ethezyme, Gladase, Kovia, Panafil, Pap Urea, and Ziox. Other products are marketed under the names of the active ingredients, for instance, papain-urea ointment.

For additional information from the FDA, go to: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01890.html/

Why do companies market unapproved products?

According to industry experts, the answer to that question is simple – money. In fact, these unapproved products are estimated to produce over $50 million per year in income. Unfortunately, many pharmaceutical companies realize that the FDA is overworked and under funded and are taking advantage of the situation. However, the consequences can be serious. The FDA has already received over 300 reports of serious reactions from unapproved BSS and approximately 40 from unapproved topical products containing papain.

If you’ve been injured due to a product in which the pharmaceutical company avoided seeking FDA approval, contact an attorney to discuss your situation. Consultations are free, without obligation and are strictly confidential. To speak with an experienced attorney, please click here.