FDA
The U.S. Food and Drug Administration (FDA) today announced that companies
marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved
topical drug products containing papain must stop manufacturing and marketing
these products or risk enforcement action. FDA is taking these actions because
it has received reports of serious adverse events associated with their uses.
Companies must stop manufacturing unapproved BSS products on or before Nov. 24, 2008, and must stop shipping such unapproved products on or before Jan. 21, 2009. After these dates, all unapproved BSS products must have FDA approval to be manufactured or shipped in interstate commerce. Companies that continue to market unapproved BSS products after these dates may be subject to immediate FDA enforcement action, such as seizure and/or injunction against the company.
Today's action does not affect approved ophthalmic BSS products.
Companies marketing any unapproved topical drug products containing papain
must stop manufacturing them on or before November 24, 2008. Companies or others
engaged in shipping these products must stop shipping these products on or
before Jan. 21, 2009. After these dates, all topical products containing
papain must have FDA approval to be manufactured or shipped in interstate commerce.
Companies that continue to market unapproved topical papain products after
these dates may be subject to immediate FDA enforcement action, such as seizure
and/or injunction against the company.
No topical drug product containing papain has been approved by the FDA.
Companies that do not comply with the designated timelines may face further
FDA action, including enforcement action. If FDA takes enforcement action against
a company that continues to market an unapproved product after the stated timeframes,
the FDA may simultaneously take additional action regarding any other violative
products that the company may be marketing, including any other unapproved
drugs.
"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."
About Unapproved Ophthalmic Balanced Salt Solutions (BSS):
Ophthalmic balanced salt solutions are used to irrigate the eye during
surgery on the eye, including cataract and other ocular procedures. FDA has
received reports of serious injuries to the eye from unapproved ophthalmic
BSS. Users of these 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. Thus, FDA
urges doctors and others who use these products to switch to approved versions
of BSS made by Alcon and Akorn. FDA oversight of the manufacturing of ophthalmic
BSS products helps to ensure that they are properly made and to reduce the
risk of contamination and associated injuries.
About Unapproved Topical Papain Products:
Topical drug ointments containing papain are used to remove dead or contaminated
tissue in acute and chronic lesions, such as diabetic ulcers, pressure ulcers,
varicose ulcers, and traumatic infected wounds. 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.
The FDA is taking action today against these products because it has received
reports of serious adverse events in patients using products containing papain.
Reports include hypersensitivity (allergic) reactions that lead to hypotension
(low blood pressure) and tachycardia (rapid heart rate). In addition, patients
who are allergic to latex can also be allergic to papaya, the source of papain.
Therefore, patients with latex sensitivity may be at increased risk of suffering
an adverse reaction to a topical papain drug product.
FDA urges consumers who are using topical drug products containing papain,
and who have questions or concerns, to contact their health care provider about
discontinuing treatment with these products. There are a number of FDA-approved
topical products that have been found safe and effective as wound healing agents
and that do not contain papain.
"Removing unapproved topical drug products containing papain and unapproved
ophthalmic balanced salt solutions is yet another step forward for patient
safety," said Deborah M. Autor, director, Office of Compliance for CDER,
FDA.
These actions are part of FDA’s unapproved drugs initiative. That initiative
seeks to ensure that all drug products marketed in the United States are shown,
through the drug approval process, to be safe and effective and to meet appropriate
standards for manufacturing and labeling. This represents the eighth and ninth
actions taken by the agency against a class of unapproved drugs since issuing
a compliance policy guide (CPG) on marketed unapproved drugs in June 2006.
The CPG describes FDA’s risk-based enforcement approach to marketed unapproved
drugs.
To read FDA’s Compliance Policy Guide (CPG): http://www.fda.gov/cder/Guidance/6911fnl.htm.
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