Elidel Side Effects Lawsuit

              Elidel, a pimecrolimus cream, is used as the second-line therapy, in non- immunocompromised adults and children 2 years of age and older, for short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in patients who have failed to respond adequately to other topical prescription treatments or when other topical prescription treatments are not advisable.

              Elidel is available in a 30 gram tube, a 60 gram tube, and a 100 gram tube and the cream contains the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin called pimecrolimus. 10mg of pimecrolimus is contained in each gram of Elidel Cream 1%. The pimecrolimus is contained in a whitish cream base of cetyl alcohol, benzyl alcohol, citric acid, oleyl alcohol, propylene glycol, sodium cetostearyl sulphate, mono-glycerides, di-glycerides, sodium hydroxide, stearyl alcohol, triglycerides, and water. The cream should be stored at 77°F and the excursions are permitted to 59°F-86°F. The cream is not to be frozen.

              The compound pimecrolimus is a fine crystalline, white to off-white powder that is soluble in methanol and ethanol but is not soluble in water. It has a molecular weight of 810.47 and is chemically (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-2-{(1R,3R,4S)-4-chloro- 3-methoxycyclohexyl}-1-methylvinyl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy- 13,19,21,27-tetramethyl-11,28-dioxa-4-aza-tricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16- tetraone. The empirical formula for the compound is C43H68CINO11.

Elidel Side Effects Lawsuit

            Elidel should be administered to the affected skin in a thin layer twice a day by the patient or care giver. Use of Elidel should stop when the signs and symptoms resolve and the patient or care giver should request instructions on what actions to take if symptoms return. The patien should be re-examined by their health care provider if symptoms persist past 6 weeks to confirm the diagnosis of atopic dermatitis. The patient should avoid continuous, long term use of Elidel Cream and the application of the cream should be limited to only the areas that involve atopic dermatitis.  Elidel Side Effects Lawsuit

              Individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream should not use Elidel. Pimecrolimus binds with high affinity to macrophilin-12 (FKBP-12) and inhibits the calcium-dependent phosphatase, calcineurin. It inhibits T cell activation by blocking the transcription of early cytokines as a result of this. Pimecrolimus inhibits at nanomolar concentrations Interleukin-2, interferon gamma (Th1-type), Interleukin-4 and Interleukin-10 (Th2-type) cytokine synthesis in human T cells. Pimecrolimus stops the release of inflammatory cytokines and mediators from mast cells after stimulation by antigen/IgE.

              The Medicine Guide provided should be read every time Elidel Cream is obtained because there may be new information. The medicine guide does not replace talking with a doctor about the medical condition or treatment. If there are any questions about Elidel Cream they should be proposed to a doctor or pharmacist. 

It is not yet known how safe using Elidel for long periods of time is. A small amount of people who have used Elidel Cream have cancer but a link between the cancer and Elidel has not been proven. Some important things to know about Elidel Cream are that Elidel Cream should not be used continuously for a long period of time, the cream should only be used on the area of the skin where eczema is present, and the cream should not be used on children younger than age 2.

Some side effects associated with the use of Elidel include:

·       impetigo

·       skin infection

·       superinfection (infected atopic dermatitis)

·       rhinitis

·       Urticaria

·       Back Pain

·       Arthralgias

·       Earache

·       Headache

In 2006 the FDA approved a new black box warning about the possible cancer risk.