FDA Demands Halt to Drug Products Designed to Treat
Common Senior Citizen Problems
Warns companies to stop marketing unapproved
ophthalmic balanced salt solution products and topical drug ointments
containing papain after serious adverse events
Sept.
24, 2008 – Unapproved drug products designed to treat conditions faced
by many seniors citizens – ointments containing papain and ophthalmic
balanced salt solutions – must stop manufacturing and marketing these
products or face enforcement action by the Food and Drug Administration.
The FDA announced yesterday it is taking these
actions because it has received reports of serious adverse events
associated with their uses.
Topical ointments containing papain are used to
remove dead or contaminated tissue in acute and chronic lesions, such as
diabetic ulcers. Ophthalmic balanced salt solutions are used to
irrigate the eye during surgery on the eye, including cataract
operations.
Today's action does not affect approved ophthalmic
BSS products.
Companies must stop manufacturing these unapproved
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.
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 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.
Additional Information
Questions and Answers about FDA's Enforcement Action Regarding
Unapproved Topical Drug Products Containing Papain
Questions and Answers about FDA’s Enforcement Action Against Unapproved
Ophthalmic Balanced Salt Solution Products
