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Protopic Class Action Lawsuits Information
The FDA has ordered a "black box" warning be placed on a
popular skin cream called Protopic used to treat the skin condition eczema
because of a possible cancer risk.
Protopic is usually applied topically through a cream, but authorities warn if
absorbed it can cause cancer. The drug agency issued a Protopic public health
advisory based on information from animal studies.
Fujisawa Pharmaceuticals, the maker of Protopic, said its research indicated no
increase in the rates of lymphoma or skin cancer in users of the of the drug,
but the FDA has received reports of lymphoma and skin cancer in children and
adults treated with Protopic since its December 2000 approval.
The FDA said the manufacturer has agreed to do more tests to determine the
actual cancer risks in Protopic users, but until then, the FDA has recommended
use of Protopic in children younger than two years of age be avoided and that it
be used only as a second-line agent for short-term and intermittent treatment in
adult patients that have been unresponsive or intolerant to other treatments.
Protopic Side Effects
Evidence based on animal studies indicated Protopic side
effects might include cancer, such as lymphoma and skin cancer. FDA said
research had shown the cancer Protopic side effects risk might occur when it is
absorbed into the body. Protopic is usually applied topically through a cream.
The drug agency said it could take human studies of ten years or longer to
determine if use of the eczema cream is linked to cancer, and until then, the
Protopic side effects risks are uncertain at this time. The FDA has ordered a
"black box" warning be placed on the drug's labeling, warning of the potentially
dangerous Protopic side effects. A black box warning is the FDA's most severe
drug warning.
The agency has also recommended that because of the risk of potentially serious
Protopic side effects, the drug should only be used for patients who have failed
treatment with other therapies first. Children under the ages of two should not
be treated with the cream at all because the agency said there is not enough
information on Protopic side effects among infants and children with developing
immune systems.
In February, members of an FDA advisory panel said they were concerned with
companies, such as Protopic manufacturer Fujisawa Pharmaceuticals, aggressively
advertising eczema creams to treat infants and others with skin problems the
creams were not approved to treat. Based on the FDA Pediatric Advisory
Committee's advice, the FDA will require labeling changes will be made, warning
of potentially serious Protopic side effects like cancer.
More Protopic Information
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