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PROTOPIC CANCER SIDE EFFECTS- FDA HEALTH ALERT
Alert
for Healthcare Professionals
Tacrolimus (marketed as Protopic)
FDA
Alert [03/2005]:
The
FDA has issued a public health advisory to inform healthcare professionals and
patients about a potential cancer risk from use of Protopic (tacrolimus). 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 Protopic is linked
to cancer. In the meantime, this risk is uncertain, and FDA advises Protopic
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
Protopic, 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 Protopic, or who are considering prescribing the
drug, should consider the following:
- Use
Protopic only as a
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 Protopic in children younger than 2 years of age. The effect of Protopic
on the developing immune system in infants and children is not known.
- Use
Protopic only for short periods of time, not continuously. The long term
safety of Protopic is unknown.
- Children
and adults with a weakened or compromised immune system should not use Protopic.
- Use
the minimum amount of Protopic needed to control the patient’s symptoms.
In animals, increasing the dose resulted in higher rates of cancer.
Data
Summary
Although tacrolimus is not genotoxic and does not interact directly with DNA, it
may have a potential to impair local immunosurveillance. Carcinogenicity studies
conducted with topical application of tacrolimus in mice demonstrated a
dose-dependent development of lymphoma. The systemic administration of
tacrolimus in kidney and liver transplant patients has been associated with
increased susceptibility to infection and development of lymphoma and skin
malignancies.
As of
December 2004, the FDA had received 19 cases of postmarketing reports linking
Protopic with cancer-related adverse events. Three cases occurred in children up
to 16 years of age, and 16 cases occurred in adults. Two deaths in adults were
reported related to complications of the cancers, and 8 hospitalizations were
reported, including 2 in pediatric patients.
The 19 postmarketing cases included 9 lymphomas, 10 cutaneous tumors, of which 7
occurred at the site of Protopic application, as well as cases of squamous cell
carcinoma, cutaneous sarcoma, malignant melanoma and other tumor types. The
median time until diagnosis after initiation of treatment with Protopic was 150
days, with a range between 21 days and 790 days. Six cases also reported
lymphadenopathy. Two cases reported pre-existing serious conditions, and 4 cases
reported a recurrence or aggravation of a pre-existing malignancy. Three
additional cases were confounded by other possible risk factors, including
environmental exposure, or pre-existing conditions that may have been
pre-malignant.
The systemic form of tacrolimus (Prograf) is known to cause both skin cancers
and lymphoma in humans by suppressing the body’s normal immune defenses
against cancer. The cancer risk increases with higher doses and longer treatment
courses of Prograf. Protopic is sometimes absorbed through the skin, though
usually at very low amounts. Occasionally, children who have been treated with
Protopic have had measurable blood levels of the drug, in the range of patients
treated with Prograf. The potential for systemic immunosuppression is unknown
and the role of Protopic 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/ProtopicPIS.pdf
Report
serious adverse events to FDA's MedWatch at 1-800-FDA-1088; or
http://www.fda.gov/medwatch/report/hcp.htm
Questions?
Call Drug Information, 1-888-INFO-FDA (automated) or 301-827-4570
Druginfo@cder.fda.gov
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 If
you or a loved one have used Elidel or Protopic and have
been diagnosed with a cancer, tumor,lymphoma, lymph node
disorder or immune systems disorders, then call us for
a Free Initial Consultation. Talk to a Board Certified
Personal Injury Trial Lawyer in Texas with over 20 years
of experience.The Willis Firm is currently representing
several individuals and families with possible complications
from the use of Elidel. Call us now to learn what can be
done to protect your rights and recover the monetary damages
for any injuries that you or your loved one has sustained.
E-Mail
Us
Call 1 800 883 9858
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 Mr.
Willis is a Board Certified Personal
Injury Trial Lawyer, certified by the
Texas Board of Legal Specialization
since 1988. Certification by the Texas
Board of Legal Specialization identifies
an attorney who has been recognized
as having extensive knowledge and actual
experience trying a prescribed number
of personal injury cases to a jury
verdict. In order to be Board Certified,
Mr. Willis had to pass strict testing
and qualification requirements to demonstrate
his knowledge of the law of evidence,
procedure and other areas of substantive
law in the trial of civil cases. Less
than 2% of all Texas attorneys have
earned this important certification.
Toll Free Call
1 800 883 9858
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IMPORTANT NOTICES
There
has been no Elidel Recall or Protopic Recall by the FDA.
Please visit www.fda.gov for more Elidel warnings and Elidel
alerts and Protopic warnings. Elidel & Protopic
are still being prescribed by doctors in the United States.
Elidel is a manufactured by Novartis. If you are having any
problems or side effects while taking Elidel or Protopic,
then please inform you doctor or health care provider of
your symptoms and problems.This website is for informational
purposes only. No information should be relied on as legal
or medical advice or medical research. We encourage all people
to talk with their doctors. It is important that you keep
your doctor informed of your symptoms and follow their advise
about prescription drug and over the counter drug usage,
mixing of different drugs, exercise, health choices, change
of diet, routine drug monitoring and follow-up exams. The Willis Firm is a law firm in Houston,Texas, and will
not give medical advise concerning your usage of this or
any other medication.
The Food and Drug Administration (FDA) has advised health care professionals that Elidel cream (pimecrolimus) and Protopic cream (tacrolimus) have failed to work and that because of a potential Elidel cancer risk associated with their use, that a black box warning for Elidel is forthcoming. Likewise a similar Black Box Warning is forthcoming for Protopic as well. The two eczema creams Elidel and Protopic, must carry a strong warning of cancer risk. The Food and Drug Administration in March 2005, that medical research and studies show that these creams are absorbed into the body and can cause skin cancer and lymphoma. Elidel cream will carry an Elidel “black box” warning, which is the strongest warning carried on drugs and medicines. Likewise, Protopic cream will also carry a Protopic “black box” warning.The FDA Elidel warning contained on the FDA website (www.fda.gov) outlines additional information about Elidel cancer risks and other Elidel side effects and Elidel Warnings not contained on this site.
This law firm strongly urges each parent, guardian of a child / infant or and individual that has used Elidel cream or Protopic cream to talk to their doctor and get medical advice as to whether they are at an increased risk of cancer from Elidel or Protopic usage or whether any additional medical or cancer testing is needed. Studies have shown that with the use of Elidel, lymphoma, skin cancer, tumors and other cancers are increased. Studies have shown the use of Protopic, lymphoma, skin cancer, tumors and other cancers are increased with usage. Please consult your doctor concerning any Elidel infant usage as in a recent FDA Elidel warning, the FDA issued strong concerns against continued usage without consulting your doctor. Our law firm sincerely hopes that any increased risk of Elidel cancer or Protopic cancer or other complications are extremely low and that any person or infant affected can be properly treated and that any residual effect can be medically cured and eliminated from one's body.If you have any medical questions, call you medical doctor. If you have any legal questions, please call the lawyer of your choice or call us for a Free Confidential Consultation at 1-800-883-9858.
Call Toll Free
1-800-883-9858
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Nationwide
Assistance for Victims of Elidel & Protopic Related Injuries 
