Saturday, March 25, 2006

ELIDEL (Pimecrolimus) - Misleading claims for marketing in India

Elidel (PIMECROLIMUS) hs been launched in India for the first time by Novartis for treating Atopic Dermatitis.
I would like to highlight my concern about the marketing for this. The Medical reps and the product monograph state that this is 'safe' for children from 3 months onwards, and tout this as a major advantage over Tacrolimus.
However the international novartis website for ELIDEL clearly states that Elidel should not be used in children below 2 years of age.
Also FDA has recently (march 2005) instructed novartis to put warning labels on this drug in the US which clearly states that this drug is not to be used in children less than 2 years. Also more disturbingly this goes on to state that the long term safety of this drug has not been established and there maybe a small chance of skin and lymphoreticular malignancies in people using this drug, though a causal relationship has not been established. It also advises that this medicine should be used for short term only
This is in complete contrast to the product monographs (in india) which states (on page 53)that "Elidel has an excellent safety profile and induces no clinically significant adverse effects".
On page 54 the monograph further goes on to state that this drug is indicated for long term management of atopic eczema in infants above 3 months of age.
I think that at the very least these issues should be communicated to the pediatricians and the dermatologists who are going to prescribe the medicine to thier patients in good faith. There is no reason for the medicine to be available for infants in India till the time its safety is not proven, and definitely not if their are any concerns about its long term safety.

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