Elidel Side Effects Attorneys

Elidel (pimecrolimus) is a topical cream used to treat atopic dermatitis, a type of eczema. Atopic dermatitis is a non-contagious, chronically relapsing, inflammatory, and pruritic (with an itching sensation) skin disease.

Elidel, which is made by Novartis, is considered an immunomodulating agent because it affects the immune system. More specifically, it works by inhibiting cytokines (signaling molecules used in cellular communication) from T-cells and prevents the release of inflammatory cytokines and mediators from mast cells.

In February 2005, the Pediatric Advisory Committee of the US Food and Drug Administration (FDA) recommended that the drugs labeling be changed to include a boxed warning about the possible risk for cancer. The FDA followed up by issuing a Public Health Advisory in March 2005 cautioning healthcare professionals about the potential risk.

In January 2006, the FDA then announced the approval of updated labeling for Elidel that included a stronger black box warning concerning the possible risk of cancer. The FDA also announced that the medication would include a Medication Guide to help make patients aware of the potential risk.

The FDA has since released a Postmarket Drug Safety Information for Patients and Providers for pimecrolimus (Elidel) that, as of this writing, was last updated on April 30, 2009. Recommendations include:

• Elidel should only be used for a short time, and only if other prescription treatments are ineffective or inappropriate.
• Elidel is approved for those over two years of age with normal immune systems.
• Do not use Elidel if you have any skin infection including herpes or chicken pox, if you have Nethertons Syndrome, if you are allergic to Elidel or any of its ingredients, or if you are pregnant or breastfeeding, unless otherwise directed by your doctor.

In addition to the potential risk for cancer (such as skin and lymphoma), Elidel may increase the risk for chicken pox, skin warts, shingles, and other viral infections. A common side effect is a sensation of warmth or burning in the area where the cream is applied. A doctor should be consulted if the reaction is severe or lasts longer than one week.

If you suspect that you or a loved one has been injured by taking Elidel, you may be entitled to compensation. Contact a qualified pharmaceutical injury attorney for an evaluation of your case.

See also:
Protopic Side Effects