The FDA issued this caution in March and announced that the drug should carry a black box warning because of reports of cancer. Black box warnings are literally printed black boxes enclosing the warnings.
The advisory followed a recommendation by the FDA'S Paediatric Advisory Committee during its mid-February meeting when research material contained reports of cancers in children and adults treated with Elidel.
However Dr Michael Fitz-Henley, president of the Caribbean Dermatology Association, told the SUNDAY SUN on Friday that "medically speaking" there was no overwhelming evidence to show the strong link between cancer and the drug.
"The strength of the advisory is a little harsh based on evidence presented but I agree that the appropriate advice must be given and patients must be aware," he cautioned.
Fitz-Henley, speaking from his office in Jamaica, also said the amount of Elidel used to treat eczema in patients was too small to cause problems.
He, however, said it was "reasonable" to give the warning especially as it relates to treatment of children who have a bad case of the skin condition and therefore needed to use more of the drug.
"The levels of Elidel that are absorbed in the body are too small to cause problems," he assured. He said it should also be noted that the dosage known to cause problems was highest when the drug was taken orally (tablet) and not topical (cream).
Doctors, he added, still feel comfortable and confident using Elidel. Information on the black labelling for the drug has already been circulated to doctors across the region.
Novartis, the manufacturers of Elidel, said clinical studies in 1996 involving more than 19 000 patients (including 2 600 infants and 7 300 children) showed Elidel to have a favourable safety profile and not to be associated with an increased risk
of malignancy, stated a release from the company.
A check with local doctors and pharmacies revealed that Elidel was still on the shelf and one source said there was no plan to remove the product.
Fitz-Henney said it was still important for patients to be aware of the side effects of any drug, especially given the unlimited information which can be found on the Internet.
Elidel is a relatively new drug marketed in the Caribbean over the last three years, with its use increasing during that time.
Through an official statement, Norvartis registered its concern about the recent health advisory and the label change. It also underscored patient safety as its paramount concern.
"Novartis believes that a recommendation to add a boxed warning to the Elidel label in the US is unwarranted and unsubstantiated by the evidence from clinical studies and experience in more than five million patients worldwide.
"Novartis remains confident in the safety . . . . We are committed to working with the FDA and other health authorities to ensure that information about the appropriate use of Elidel for the tratment of mild to moderate eczema is communicated properly to patients who desire a safe and effective alternative to topical steriods," added the statement.