FDA Warns: PROTOPIC (Tacrolimus) and ELIDEL (Pimecrolimus), Pose Cancer Risk (like skin cancer and lymphomas) for Children and Adults.

Protopic (manufactured by Astellas/Fujisawa) was approved in 2000 and Elidel (manufactured by Novartis) in 2001 by the FDA to treat Eczema.

April 26, 2007 - Could a Skin Cream be Giving you Cancer? (news video from CBS Channel 11 KHOU News in Houston)

In a word, faith is what pulls the Rev. Johnny Henderson through this time of his life. Henderson fans picture after picture of himself across the table. And they are of Henderson, but you might not realize it. “This is when it was at its worst,” he said, looking down. In each picture, his face and body is covered with discolorations and what appear to be growths. He said his doctor called it cancer. Henderson just calls it a living hell. (View Full Article)

February 21, 2007 - Prescription Skin Cream Used by Millions May Cause Cancer (news video from CBS Channel 2 News in Chicago)

Some cancer victims and their families say they would not have used the topical medications were the risk made known to them. Drugs used to treat skin conditions were prescribed to millions of users for years before federal authorities warned that the medicines might cause cancer. CBS 2 Investigator Dave Savini reports on the risks that some say should have been made known from the start. “I would never have put this in my body had I known how toxic and potent this drug was,” says Traci Reilly of Naperville, who believes two widely prescribed medications may be responsible for her breast cancer. (View Full Article)

On January 19, 2006 the FDA required black box labeling for two topical eczema drugs, Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus). The labeling will be updated with a boxed warning about a possible risk of cancer. The FDA action in January 2006 follows an agency advisory committee recommendation in February 2005 that Elidel cream and Protopic ointment carry the cancer risk label warnings.

If you are a current or past user of Protopic or Elidel, contact us to receive a free case evaluation in 24 hours

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In March 2005 the FDA agreed with the pediatric advisory committee recommendations. The two drug companies have been aggressively fighting against this black box labeling.

RESPONSE BY DRUG COMPANIES TO FDA'S JAN 2006 ANNOUNCEMENT

The response by the drug companies involved (Astellas/Fujisawa & Novartis) has been to try and block a series of FDA actions on elidel and protopic over the past few years. Moreover, the drug companies now appear to be backtracking and contradicting earlier claims about the safety of using elidel or protopic. Click here to view a PDF file which shows Astellas (formerly known as Fujisawa) comment on January 23, 2006 on the risks of using their drug protopic. This response sent via fax to pharmacists across the United States contradicts previous company statements about the safety and absence of cancer risks. The Law Offices of Larry M. Roth, P.A. encourages all current and past users of protopic or elidel who have been harmed or may be harmed in the future by the use of these two drugs to submit a free case evaluation form online or to contact us via phone at one of the numbers to the left.

BLACK BOX WARNING - Protopic & Elidel

On March 15, 2005 the FDA advised health care professionals to prescribe Elidel and Protopic, only as directed and only after other drugs have failed to work, due to the risk of cancer (including skin cancer and lymphoma) associated with these drugs, especially in young children.

The FDA in January 2006 required Novartis and Astellas (formerly known as Fujisawa) to put a “Black Box Warning” regarding the use of Protopic and Elidel on the products. A “Black Box Warning” is the most severe warning that the FDA can issue to the public. The FDA’s actions were taken after recommendations from the FDA’s Pediatric Advisory Committee during its February 15, 2005 meeting, and only after strong protests from the manufacturers who fought the FDA's concern for children's safety, in particular, every step of the way.

FDA'S PUBLIC HEALTH ADVISORY

Elidel and Protopic are approved only for short-term and intermittent treatment of atopic dermatitis (eczema) in patients unresponsive to, or intolerant of more conventional and safety-proven treatments, as in cortico-steroids. Do not allow the use of these drugs on you unless safety-proven conventional treatment will not work.

Elidel and Protopic are not approved for use in children younger than 2 years old. The long-term effect of Elidel and Protopic on the developing immune system in infants and children is not known. In clinical trials, infants and children younger than 2 years of age exposed to Elidel had a higher rate of upper respiratory infections than those treated with placebo cream. Also, with Protopic there was absortion systemically.

Elidel and Protopic should be used only for short periods of time, not continuously. The long term safety of these products is unknown.

Children and adults with a weakened or already compromised immune system should not use Elidel or Protopic.

Use the minimum amount of Elidel and Protopic needed to control the patients' symptoms. Both animal data and human experience suggest that the risk of cancer increases with increased exposure to Elidel or Protopic.

WHAT TO DO IF YOU OR YOUR CHILD HAS USED PROTOPIC OR ELIDEL

If you have a child who was prescribed these drugs under the age of two years old, contact your doctor for medical guidance. Quite possibly, your physician was unaware of the serious adverse events and cancer risks that these drugs present. These drugs were not approved by the FDA for use in children under the age of two. Seek immediate medical treatment if your child has been experiencing any harmful consequences or unexpected side effects since they started using these drugs. Even if your child appears to be healthy, obtain a thorough medical examination and talk to your physician about the cancer risks associated with the use of these two drugs. Educate yourself on the signs and symptoms of Cancers such as T-Cell Lymphoma, Squamous Cell Carcinoma, Non-Hodgkin's Lymphoma, and Hodgkin's Lymphoma. Your child may develop symptoms in the months or years to come and you should monitor his or her condition closely in the event that he or she develops cancer. Blood tests are important. Look for concentrations in the blood of tacrolimus or pimecrolimus and in reduction of lymphocites. Ask for specific blood profiles which will measure this.

If you or your child, or another family member has already experienced harmful or fatal consequences from the use of these drugs, you should report your experience to the Food and Drug Administration (FDA) adverse event reporting system. You can contact them via the website. You should then contact an attorney who specializes in filing lawsuits against Pharmaceutical Companies who manufacture defective and dangerous drugs to evaluate if there is merit to your potential claim. Our firm is currently evaluating cases for all children and adults who have used either Protopic and/or Elidel and who have experienced an adverse event. We have chosen to concentrate on these two potentially dangerous drugs and are devoting the necessary time and resources to evaluate claims and to help prosecute lawsuits against the makers of these two drugs, Astellas (formerly known as Fujisawa) and Novartis.

Drug Companies that manufacture and negligently market drugs which are defective or dangerous may be liable for any damages you have experienced, including responsibility for paying compensation for death and injury as a result of using their drugs. If you feel you have been harmed by the use of one of these drugs, please contact us.

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