US warning on eczema drugs “lacks evidence base”
Prescribing advisers in the UK should be guided by their own evidence-based risk/benefit assessment of topical calcineurin inhibitors (TCIs) rather than the US Food and Drug Administration’s theoretical concerns about the drugs’ cancer risks, dermatology leaders recommended this week.
Speaking at the 8th Congress of the European Society for Pediatric Dermatology
held in Budapest last week, Johannes Ring, president of the European
Academy of Dermatology and Venereology, and Ramon Grimalt, general secretary
of the ESPD, criticised the FDA’s recent announcement that it was
to put black box warnings on the labels for pimecrolimus cream (Elidel)
and tacrolimus ointment (Protopic) used as alternatives to topical corticosteroids
to treat atopic dermatitis.
“
There is no clinical evidence whatsoever to support this warning. We
think it is disproportionate and unjustified,” said Professor Ring. “We
are upset because we don’t want this to limit access to TCIs or
cause unnecessary anxiety to patients and caregivers.” The move
has prompted the European Medicines Agency to start conducting its own
comprehensive review of the drugs.
The FDA’s concerns stem from the drugs’ immune-suppressing
action. Oral immunosuppressant drugs such as oral steroids and oral calcineurin
inhibitors used in transplant patients have been associated with an increased
risk of lymphoma.
Susan Lewis-Jones, consultant paediatric dermatologist at Ninewells Hospital,
Dundee, defended the safety record of topical TCIs. Pimecrolimus cream
has been used by over five million patients, half of them children aged
under 10 years, and tacrolimus ointment by 2.5 million. Clinical trial
data are available on tens of thousands of patients. “The few cancers
observed, including lymphomas, had been evaluated by independent experts
and found unrelated to drug treatment,” she noted. |
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