Elidel and Protopic warnings

The “black box” warning placed on Elidel and Protopic BACK IN 2005 scared patients off using these drugs unnecessarily or so the American Academy of Dermatology (AAD) believe.

Elidel and Protopic are non-steroidal eczema drugs that became available by prescription in 2000 and 2001.  They were heralded as the new miracle treatments for eczema, making steroids a thing of the past.

Recent months have seen much controversy over the use of these drugs as they have been linked to skin cancer and lymphoma.  The Food and Drug Association (FDA) has ruled that both drugs must carry the “black box”, which is the strongest of all safety warnings.

The AAD believes that this warning is unnecessary and will only serve to scare patients and their doctors off using the drugs even when it is their best option of treatment.

AAD spokesperson, Abby Van Voorhees says “The AAD is very disappointed with this ruling by the FDA.  We don’t think the science supports this harsh labeling.   The link to cancer is not proven, and the data shows these medications are quite safe.”

Novartis, the manufacturer of Elidel has been publicly critical of the FDA decision.  Novartis spokesperson, Megan Humphrey stated “We want to make it very, very clear that this action is not substantiated by scientific or clinical evidence…. Based on 21 000 patients in clinical trials, and based on postmarketing use of Elidel in more than 6 million patients, there is no evidence of a causal relationship between Elidel and cancer.”

The FDA has defended their decision stating that there was a real concern for how many scripts for Elidel and Protopic were being written as a first line treatment and for children under 2 years.

The drugs have only ever been approved for adults and children over 2 years and only as a last resort when other treatments have proven unsuccessful.

Norman Fost from the FDA advisory panel said, “A “black box” warning may be excessive, may be overshoot, may be unduly inhibiting (to patients who need the drugs) but it may be that’s the only tool left to stop millions of prescriptions that are inappropriate … that may be the only way to do it.”

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