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:: HEALTH MENU |
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:: HEALTH REALTED SITES |
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| :: HEALTH FEATURES |
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:: Eczema Drug Warning ::
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The Food and Drug Administration (FDA) issued a public health advisory March 10 about two popular eczema treatments, citing a possible link to cancer. The move has particularly worried the parents of many children who use the drugs Elidel (pimecrolimus) and Protopic (tacrolimus) for relief from this chronic skin condition.
The advisory was guided by the recommendations of the FDA Pediatric Advisory Committee. According to Jonca Bull, MD, of the FDA's Office of Drug Evaluation and Research, the committee based their decision on a "growing and troubling body of information from animal trials," reports of cancer in a small number of people, and concerns based on the way these drugs work in the body.
According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, eczema occurs in at least 20 percent of all infants and children in the United States and in about 2.5 percent of adults. Eczema causes red, itchy patches on the skin. Oozing and crusting can also occur, leaving the skin vulnerable to infection.
While stating that it would take at least 10 years of study to establish whether Elidel and Protopic were linked to cancer, the FDA advisory explained that studies looking at high doses of the drugs in mice, rats and monkeys suggest a link to lymphoma and skin cancer. And since December 2004, the FDA has received 10 reports of cancer in people using the Elidel and 19 cancer cases in people using Protopic.
The FDA also pointed out that another form of tacrolimus (marketed as Prograf), which is given orally or via IV at high doses to prevent liver or kidney transplant rejection, is known to cause lymphoma and skin cancer.
Elidel cream and Protopic ointment are the only two drugs in a class called topical immunomodulators. While it's not fully understood how these medications work, they appear to suppress the immune reactions that can trigger symptoms; it's theorized that this activity may somehow increase cancer risk.
In the advisory, the agency announced that it will add a black box warning for health professionals about the cancer risk to the labels of the drugs. The FDA recommended that health professionals only prescribe these drugs to patients when other eczema treatments, such as corticosteroids, have failed to provide relief from eczema symptoms. The agency also recommended that doctors avoid using the drugs in children younger than two years old. The drugs were never approved for children under two, but the committee noted that the drugs were increasingly being prescribed off-label to very young children. The concern with such young children, Dr. Bull said, is that "we don't know what the implications are in children whose immune systems are still developing."
The FDA also recommended that people with eczema in other age groups only use the drugs for short periods of time and take the minimum amount needed. Additionally, children and adults with weakened immune systems should not use either drug, the FDA said.
But the FDA's advisory has not been greeted as a necessary safety measure by all corners of the dermatology community.
"We were very disappointed in the FDA," said Clay J. Cockerell, MD, president of the American Academy of Dermatology. "I know that the FDA has been under a lot of pressure after Vioxx and Celebrex to make sure that they are not making a mistake, but we feel like targeting these drugs was not the way to go…They are diluting the value of a black box warning."
Dr. Cockerell argued that very little of these medications, both of which are rubbed on the skin, is absorbed into the body, where it could cause cancer.
"I would tell parents to calm down," he said. "These are theoretical cases, and if your kid needs these drugs, then you should not worry about [the cancer risk]. We feel confident that little of these drugs are absorbed through the skin, and that the risk/benefit ratio is low."
The FDA's Dr. Bull, on the other hand, suggested that parents and patients follow up with their physicians to make sure that the drugs are being use appropriately for their particular case of eczema.
"We don't think that these drugs should be used without a significant amount of deliberation," she said. |
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:: ADVERTS |
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