剛在另一個topic內看到有關非類固醇藥Elidel 及Protopic
的最新資料, 據報導美國食品及藥物管理局的專家委員會今天建議，食品及藥物管理局應該對兩種抗溼疹藥物可能引起皮膚癌提出警告。
現茲列有關英文報章給大家參考:(抱歉暫時未能找到中文的資料)
FDA panel recommends 'black box' warnings for eczema creams
By Donna Leinwand, USA TODAY
Two popular medicines used to treat eczema should carry a warning about a potential risk for cancer and infection, a Food and Drug Administration (news - web sites) advisory panel recommended Tuesday.
The medicines, Elidel and Protopic, were approved originally as second-line treatments for eczema, a skin disorder, to be used when traditional treatment with steroid creams did not work or caused a reaction. But both creams have become popular with parents who believe they are safer than steroid creams.
One of the creams, Elidel, is advertised often on television and in women's magazines as a safe alternative to steroid creams.
FDA (news - web sites) officials said at a hearing Tuesday that they were highly concerned that several animals, including primates, developed cancer in studies of the drugs.
An advisory panel of pediatricians, dermatologists, consumer advocates and other scientists concluded Tuesday that the drug labels should include "black box" warnings about the potential cancer risk and the danger of prescribing the creams for children younger than 2.
"Black boxes" - literally printed black boxes enclosing the warnings - are considered the strongest possible labeling. The FDA usually heeds the advice of its professional panels.
"There are animal models that make us concerned that these products could contribute to an increase in cancer," said Dianne Murphy, director of the Office of Pediatric Therapeutics for the FDA. "We have no human proof, but the monkey data was very concerning."
Murphy calls the potential for cancer "biologically plausible."
"We don't want to scare people," Murphy said. "We just want to make people more informed."
Novartis, the manufacturer of Elidel, said in a statement issued after the hearing that the black box warning was "unwarranted and not substantiated by clinical evidence." About 5 million people worldwide are using the drug, Novartis said.
The FDA raised the issue of a potential cancer risk at a hearing in 2003 when early animal studies showed some signs of cancer.
Several members of the panel said then that they were alarmed by the study and wanted more direct warnings on the label. But the panel stopped short of voting for a black-box warning.
Use of the medicines has increased more than fourfold over the past four years, FDA documents show.
Physicians wrote almost 2 million prescriptions for children between June 2003 and May 2004, the FDA said. Doctors also prescribed the creams for about 500,000 children younger than 2. The creams are not recommended for infants.
Skin creams may warn of cancer risk
FDA raises concerns about Elidel, Protopic
By ROB STEIN
Washington Post
WASHINGTON - Government scientists, concerned that two prescription creams used widely for a common skin condition may increase the risk of certain cancers, especially among children, will propose adding strong new warnings to the product labels.
A handful of cases of cancer have been reported among adults and children using the creams, sold under brand names Elidel and Protopic, and animal and laboratory studies suggest the drugs could be to blame, according to a Food and Drug Administration analysis.
"The evidence raises serious safety concerns in children regarding the potential for carcinogenicity in humans treated with these agents," wrote Jean Temeck of the FDA's division of pediatric drug development in a recommendation posted Friday on the agency's Web site.
The document was one of several posted in preparation for a meeting of an expert panel next week to assess the safety of the creams and recommend action the agency should take.
Protopic and Elidel were approved in 2000 and 2001, respectively, to treat eczema, a common, chronic skin condition that causes redness and itching.
Before the new creams, the only treatment had been steroid creams and ointments, which can be used only for short periods and can have a variety of side effects.
The new creams, which were seen as effective and much safer, immediately became popular. At least 5 million prescriptions have been written.
The creams were approved for short-term or intermittent use by adults and children age 2 and older, but Novartis Pharmaceuticals Corp. has marketed Elidel aggressively.
"These products are being widely used to treat ... a non-life-threatening disease, and heavily advertised for use in young children without appreciation ... regarding the potential for carcinogenic risk," Temeck wrote.
Both Novartis and Fujisawa Healthcare, which makes Protopic, defended the safety of their products to the FDA.
"Elidel is an effective, steroid-free treatment for mild to moderate eczema and has a well-established safety profile," Novartis spokesman Tom Jones added in an e-mail.
Because the drugs work by suppressing the immune system, scientists had been concerned that they could increase the risk of cancer. As a result, when the FDA approved the creams the agency required both companies to monitor whether any cancers were reported among users.
有關濕疹資料可參考以下:-
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