FDA Warns Companies to Stop Marketing Two Unapproved DrugsSep 24, 2008 | Parker Waichman LLP
In response to reports of serious adverse events associated with them, the U.S. Food & Drug Administration (FDA) just announced that companies which market unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing and marketing these products. If these companies do not stop making these unapproved drugs, they risk enforcement action. BBS products are used to irrigate eyes during surgery and papain products are used to treat lesions.
Manufacturing of unapproved BSS products and unapproved drug products containing papain must stop by November 24, 2008, and shipping such unapproved products must stop by January 21, 2009. After these dates, all such unapproved products must have FDA approval to be manufactured or shipped in interstate commerce. Any companies that continues to market unapproved BSS products after these dates are subject to immediate FDA enforcement action, including seizure and/or injunction against the company. No topical drug product containing papain has FDA approval.
Noncompliant companies may face other action, including enforcement and action on other violative products and unapproved drugs that such companies may be marketing. "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, M.D., 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."
The FDA has received reports of serious eye injuries from unapproved ophthalmic BSSs, including eye inflammation, cloudy vision, and permanent loss of visual acuity. Inspection of unapproved products revealed contaminants and other defects and the FDA is now urging doctors and others to switch to approved BSS products made by Alcon and Akorn. Topical drug ointments containing papain are used to remove dead or contaminated tissue in acute and chronic lesions, such as diabetic, pressure, and varicose ulcers, and traumatic infected wounds and include the trade names Accuzyme, Allanfil, Allanzyme, Ethezyme, Gladase, Kovia, Panafil, Pap Urea, and Ziox. Serious adverse event reports include hypersensitivity (allergic) reactions that lead to hypotension (low blood pressure) and tachycardia (rapid heart rate); patients with latex allergies may also be allergic to papaya, papain’s source and may be at increased risk of suffering an adverse reaction to a topical papain drug product.
Companies selling unapproved versions of these drugs "have bypassed the requirement of the law and put consumers at risk," said Deborah M. Autor, director of FDA's drug compliance office. Unapproved BSS are sold by Baxter International Inc., Hospira Inc., and B. Braun and about a dozen companies sell the papain drugs, she said. Unapproved drugs may not be safe and effective and may be improperly labeled, she added. 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, according to spokeswoman Susan Denby.