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14th March 2005


Eczema cream cancer scare

The US Food and Drug Administration have ruled two eczema creams should carry warnings that they may increase the risk of cancer.

The FDA have issued the statement following research that showed Elidel and Protopic may pose a cancer risk when absorbed into the body. They have also said that the two creams should not be used on babies at all.

Both creams work by suppressing the immune system, an activity which is known to potentially contribute to cancer.

The view is strongly disputed by the manufacturers, Novartis, which makes Elidel, and Fujisawa Pharmaceutical, which makes Protopic.

However, in a statement the FDA said animal studies had shown a potential link with cancer. There were also reports of seven cases of lymphoma and six of skin cancer among children and adults treated with Elidel or Protopic.

A spokesperson for the UK's Medicines and Healthcare products Regulatory Agency said it was closely monitoring the safety of the creams although they already come with a strong warning in this country.

A spokesperson said, "Any patient or parent of a patient who has concerns about their treatment or their child's treatment should speak to their doctor."

Novartis dismissed claims Elidel could increase the risk of cancer, and said it planned no immediate change in its product label.

Fujisawa Pharmaceutical said it had not found any data to clearly link Protopic to cancer, and believes it has provided sufficient information to ensure the drug is used safely.

The American Academy of Dermatology (AAD) has also questioned the FDA move, arguing that virtually none of the creams would get inside the body.

Dr Clay Cockerell, ADD president, said, "These are valuable medications, and if used properly they significantly reduce the debilitating impact of eczema and allow millions of our patients to live normal lives."

In February, members of an FDA advisory panel said they were concerned the companies were aggressively advertising the medicines to treat infants and others with skin problems that the creams are not approved to treat.

 

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