 |
Alert for Healthcare
Professionals
Pimecrolimus (marketed as Elidel)
6/2006:
The issues described in this alert have been addressed in product
labeling.
FDA ALERT [3/2005]:
The FDA has issued a public health advisory
to inform healthcare professionals and patients about a potential
cancer risk from use of Elidel (pimecrolimus). This concern is
based on information from animal studies, case reports in a small
number of patients, and knowledge of how drugs in this class work.
It may take human studies of ten years or longer to determine if use
of Elidel is linked to cancer. In the meantime, this risk is
uncertain, and FDA advises Elidel should be used only as labeled,
for patients after other prescription treatments have failed to work
or cannot be tolerated.
This information reflects FDA’s preliminary
analysis of data concerning this drug. FDA is considering, but has
not reached a final conclusion about, this information. FDA intends
to update this sheet when additional information or analyses become
available.
To report any unexpected adverse or serious events
associated with the use of Elidel, please contact the FDA MedWatch
program at 1-800-FDA-1088 or
http://www.fda.gov/medwatch/report/hcp.htm
Recommendations
Physicians with patients using Elidel, or who are considering
prescribing the drug, should consider the following:
-
Use Elidel only as second-line agent for
short-term and intermittent treatment of atopic dermatitis,
a form of eczema,
in patients unresponsive to, or intolerant of other treatments.
-
Avoid use of Elidel in children younger than 2 years
of age. The effect of Elidel 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 those treated with placebo
cream.
-
Use Elidel only for short periods of time, not
continuously. The long term safety of Elidel is unknown.
-
Children and adults with a weakened or compromised
immune system should not use Elidel.
-
Use the minimum amount of Elidel needed to control
the patient’s symptoms. In animals, increasing the dose resulted in
higher rates of cancer.
Data Summary
Although pimecrolimus is not genotoxic and does not interact
directly with DNA, it may have a potential to impair local
immunosurveillance. Repeat dose studies conducted with topical
application of pimecrolimus in mice demonstrated a dose and
treatment dependent development of lymphoma. Carcinogenicity studies
conducted with oral administration of pimecrolimus in mice
demonstrated a dose dependent development of lymphoma and benign
thymoma. Carcinogenicity studies conducted with topical
administration of pimecrolimus in rats demonstrated development of
follicular cell adenoma of the thyroid. Data from a recently
conducted oral nine-month monkey study showed a dose-related
increase in virus-associated lymphoma following administration of
pimecrolimus.
As of December 2004, the FDA had received 10 cases of postmarketing
reports linking Elidel with cancer-related adverse events. Four
cases occurred in children, 3 of these in children less than 6 years
of age. The other 6 cases occurred in adults.
Of the 10 postmarketing cases reporting cancer, 6 described
cutaneous tumors, 1 described a lymph node/cutaneous tumor related
event, and the locations of 3 others were unreported. Four cases
described lymphomas; 5 cases described a variety of tumors,
including basal cell carcinoma and squamous cell carcinoma; and 1
case described granulomatous lymphadenitis. The median time until
diagnosis after initiation of treatment with Elidel was 90 days,
with a range between 1 week and 300 days. Two cases also reported a
lymphadenopathy. Two cases were confounded, 1 with the presence of
nodules prior to the diagnosis of basal cell carcinoma; and another
with a pre-existing condition associated with an increased risk for
malignant transformation.
Elidel is sometimes absorbed through the skin, though usually at
very low amounts. Occasionally, children who have been treated with
Elidel have had measurable blood levels of the drug. The potential
for systemic immunosuppression is unknown and the role of Elidel in
the development of the cancer-related events in the individual
postmarketing cases is also uncertain.
FDA Patient Information Sheet
http://www.fda.gov/cder/drug/InfoSheets/patient/ElidelPIS.pdf
Questions? Call Drug Information, 1-888-INFO-FDA
(automated) or 301-827-4570
druginfo@fda.hhs.gov
 Back
to Top 
Back to Elidel
Date created: February 14, 2005, updated June 15, 2006 |
|
