FDA Goes After Unapproved Eye Washes, Skin Ointments
TUESDAY Sept. 23, 2008 -- The U.S. Food and Drug Administration has warned companies making unapproved eye wash solutions and a widely used but unapproved skin cream to stop making and marketing the products or face enforcement actions.
The agency took this action Tuesday because of reports of serious adverse events linked to these prescription products.
"Those manufacturers and distributors who do not comply with today's notices after Nov. 24, 2008, will be subject to enforcement action such as seizure or injunction," Deborah M. Autor, director of the FDA's Office of Compliance in the Center for Drug Evaluation and Research, said during a morning teleconference.
Ophthalmic balanced salt solutions are used to irrigate the eye during procedures such as cataract and other eye operations. Reports of adverse effects include eye inflammation, cloudy vision, and even blindness. These same consequences can occur with approved versions of these products, Autor said.
Two companies, Alcon Surgical and Akorn Inc., sell approved balanced salt solution products, which are not subject to this FDA action, Autor said. The companies making unapproved eye wash products are B. Braun in Bethlehem, Pa., Baxter Healthcare in Deerfield, Ill., and Hospira Inc. of Lake Forest, Ill., she said.
Skin creams containing papain are prescribed to treat conditions such as diabetic ulcers, pressure ulcers, varicose ulcers, and traumatic infected wounds. These products remove dead or contaminated tissue from the wounds. "Firms marketing these products have not shown them to be safe and effective," Autor said.
No topical drug products containing papain have been approved by the FDA, officials said.
Adverse reactions associated with these ointments include allergic reactions that can lead to low blood pressure and rapid heart rate. In addition, people who are allergic to latex may also be allergic to papaya, the source of papain, and be at increased risk for adverse reactions to papain drug products.
Trade names for these products include Accuzyme, Allanfil, Allanzyme, Ethezyme, Gladase, Kovia, Panafil, Pap Urea, and Ziox. There are a number of products that are safe and effective for wound healing that do not contain papain, the FDA said.
Posted: September 2008