FDA warns
about Elidel an eczema treatment
FDA Public Health Advisory
Elidel (pimecrolimus) Cream and Protopic (tacrolimus)
Ointment
The FDA is issuing a public health advisory to inform
healthcare providers and patients about a potential cancer
risk from use of Elidel (pimecrolimus) and Protopic
(tacrolimus), products that are applied to the skin. This
concern is based on information from animal studies, case
reports in a small number of patients, and how these drugs
work. It may take human studies of ten years or longer to
determine if use of Elidel or Protopic is linked to cancer.
In the meantime, this risk is uncertain and FDA advises that
Elidel and Protopic should be used only as labelled, for
patients who have failed treatment with other therapies.
The FDA recommends that healthcare providers, patients and
caregivers consider the following:
Use Elidel and Protopic only as second-line agents for
short-term and intermittent treatment of atopic dermatitis
(eczema) in patients unresponsive to, or intolerant of other
treatments.
Avoid use of Elidel and Protopic in children younger than 2
years of age. The effect of Elidel and Protopic on the
developing immune system in infants and children is not
known. In clinical studies, infants and children younger
than 2 years old treated with Elidel had a higher rate of
upper respiratory infections than did those treated with
placebo cream.
UUse Elidel and Protopic only for short periods of time, not
continuously. The long term safety of Elidel and Protopic
are unknown.
Children and adults with a weakened or compromised immune
system should not use Elidel or Protopic.
Use the minimum amount of Elidel or Protopic needed to
control the patient s symptoms. In animals, increasing the
dose resulted in higher rates of cancer.
Elidel cream and Protopic ointment are topical
immunosuppressant calcineurin inhibitors that are applied to
the skin and are the only approved drug products in this
class.
Animal studies have shown that three different species of
animals developed cancer following exposure to these drugs
applied topically or given by mouth, including mice, rats
and a recent study of monkeys. These studies were conducted
at doses higher than generally used by patients and the risk
of cancer increased with increasing drug dose and duration.
In addition to an ointment, tacrolimus, also comes as a pill
or by injection, this form is known as (Prograf). Prograf is
approved to prevent liver or kidney transplant rejection. It
is known to cause both skin cancers and lymphoma in humans
by suppressing the body s normal immune defences against
cancer. The cancer risk increases with higher doses and
longer treatment courses of Prograf. Both Elidel and
Protopic are sometimes absorbed through the skin, though
usually at very low amounts. Occasionally, children who have
been treated with Elidel or Protopic have had high blood
levels of these drugs.
Protopic was approved in December 2000 and Elidel in
December 2001. Since their approval, FDA has received
reports of lymphoma and skin cancer in children and adults
treated with Elidel or Protopic; whether the reported
cancers are associated with these products has not been
clearly established.
BBased on the advice of the FDA Pediatric Advisory
Committee, which met on February 15, 2005, to review these
findings, FDA will require labelling changes for Elidel and
Protopic, including the placement of a boxed warning about
the potential cancer risk. In addition, FDA will work with
the commercial sponsors of the drugs to develop and
implement a Medication Guide (MedGuide) to provide this
information and instructions about appropriate use of Elidel
and Protopic to patients, their families, and caregivers.
MedGuides are intended to be distributed by pharmacists with
each prescription or refill of a medication.
Source: FDA web page
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