US doctors oppose black box warning for eczema drugs
pharmafile | March 17, 2005 | News story | Sales and Marketing |
US dermatologists have voiced their disapproval of new FDA restrictions on two eczema drugs because of potential cancer risks.
The US regulator had advised that Elidel (pimecrolimus) and Protopic (tacrolimus) carry black box warnings, to emphasise the safety risks, and stressed that they only be used once other eczema treatments had failed.
It has also advised physicians to consider a raft of guidelines before prescribing the drugs and taken the step of developing a Medication Guide for patients, outlining the dangers of the drugs.
"The American Academy of Dermatology is disappointed that the FDA has taken this action, despite the fact that there is no data that proves proper topical use of pimecrolimus and tacrolimus is dangerous in people. We are concerned that these warnings will confuse and unnecessarily worry our patients," said dermatologist Clay J Cockerell, academy president.
The FDA's advice follows recommendations made by its Paediatric Advisory Committee, which reviewed data including a small number of reports of cancer in children and adults treated with the drugs. The committee also scrutinised findings of cancer in three different animal species, with the data showing cancer risk increased with an increase in dosage.
But the academy says it is outraged by the recommendations and believes the labelling restrictions will not only limit treatment options for patients but will endanger the lives of millions of eczema sufferers.
"Because these medications are applied to the skin, virtually none of it gets inside the body. It's not the same as taking a pill. 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," Cockerell continued.
Both manufacturers, Fujisawa Healthcare (Protopic) and Novartis (Elidel) are undertaking further research to determine whether there is a risk of cancer associated with the drugs.
The FDA believes that it could take more than 10 years to establish whether the use of one of the drugs, Protopic, is linked to cancer, but did not comment on Elidel.
Both drugs were approved in the US in the last five years to treat eczema and are applied to the skin to control eczema by suppressing the immune system.
