Elidel

Elidel was approved by the FDA in 2001 for the treatment of itchy, scaly, inflamed skin conditions such as eczema and atopic dermatitis. Manufactured by Novartis, Elidel was advertised and promoted as a safe non-steroid treatment for children as well as adults.

Elidel (generic name is pimecrolimus) is a topical cream that controls eczema by suppressing the immune system.  Inflammation and eczema is actually a product of the body’s immune response system. Elidel uses what are called calcineurin inhibitors to block the inflammation and thereby reduce the other uncomfortable side effects of eczema and atopic dermatitis.  Calcineurin inhibitors can also be used on sensitive skin such as on eyelids where other treatments cannot be used. It was thought that finally a safe alternative had been discovered to steroid based eczema treatments.  Parents in particular were excited about the new Elidel alternative and although it was never approved for children under the age of two- children and infants were treated with Elidel.

However, as patients began to use Elidel strange incidents of cancer started to appear related to the use of the cream.  The total percentage of cases were small but given the seriousness of skin cancer and the fact that most drug related cancers are severely underreported,  in 2005 the FDA finally acted to protect and warn the public about Elidel.

In 2005 the FDA began to require that two creams, Elidel and Protopic carry the FDA’s strongest “black box” warning. The FDA also limited the prescription of Elidel to children older than 2 and cautioned that Elidel and Protopic should only be used on a short-term basis when other eczema products failed to offer relief. People with immune deficiencies were also warned not to use Elidel.

The scope and damage of Elidel remains unknown in humans but animal research has linked the use of Elidel to an increased risk of skin cancer and non-Hodgkin’s lymphoma. The rate of cancer increased in the animal tests in proportion to the amount of drug used and the duration of usage.

At least 25 human cases linking Elidel and cancer have been documented. When Elidel was in trial, infants and children younger than 2 years of age showed an increased rate of respiratory infection. Moreover, in 2000 when Elidel was up for FDA approval doctors wrote in expressing considerable concern that these drugs that had previously been used to suppress the autoimmune system’s rejection of liver and kidney transplants were now going to be used by a much larger group of non-critical patients under uncontrolled circumstances. Their warnings went unheeded and both Novartis and the makers of Protopic marketed these drugs so successfully that millions of prescriptions have been given out for both Elidel and Protopic. All the while the long-term health effects of Elidel on adults, children and infants remain unknown.

The Elidel Lawsuits brought against Novartis claim that Elidel use caused cancer and injury in their clients. Novartis has argued that patients were preempted against filing lawsuits against the company. However, in 2009 Federal Judge Jerome B. Simandle of the U.S. District Court of New Jersey remanded several Elidel Novartis cases back to the New Jersey Superior Court.

The use of Elidel has been linked to:

• Skin Cancer
• Non-Hodgkin’s lymphoma
• Respiratory infections

Elidel had known side effects:

• Burning and itching that goes away after the first few days of treatment
• Acne
• Headache
• Increased skin sensitivity to hot and cold temperatures
• Flu-like symptoms
• Calcerinerin inhibitors increase the skin’s sensitivity to sunlight and ultraviolet light

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