Novartis manufactures and markets Elidel to treat eczema, an allergic reaction that causes skin inflammation. The Food and Drug Administration (“FDA”) approved Elidel in December 2001. Unfortunately, Elidel is linked to severe and fatal side effects, including skin cancer and lymphoma.

Elidel Linked to Cancerous Side Effects

On March 10, 2005, the FDA issued a Public Health Advisory announcing that animal studies link Elidel use to serious side effects, including skin cancer and lymphoma. The animal studies have shown that three different animal species developed cancer after exposure to Elidel, including mice, rats, and monkeys. The animal studies also concluded that the cancer side effect risk increased with higher doses and longer Elidel use.

The FDA further announced that a few patients have reported developing

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cancer after Elidel use. In October 2005, Dr. Stanka Kukich, the acting director of the FDA’s Dermatologic and Dental Drug Products Division, announced that the FDA received 78 reports of skin cancer or lymphoma from Elidel users. The FDA urges caution when using Elidel until additional human studies can determine if Elidel use causes these cancerous side effects.

Elidel Side Effects: Skin Cancer

Skin cancer is a serious side effect of Elidel. Skin Cancer is a severe and progressively worsening growth on the skin. Typically, skin cancer develops on the skin’s outermost layer, so the tumor is clearly visible. Therefore, skin cancer is usually detected in the early stages and non-fatal. Skin cancer side effects include:

  • A small lump that is shiny, waxy, pale, and smooth
  • A red lump that is firm
  • A bleeding or crusty sore
  • Rough patches on the skin

Elidel Side Effects: Lymphoma

Lymphoma is a cancer that originates in the lymphocytes, a type of white blood cell. Lymphoma cancer is medically classified as a hematological malignancy, meaning it arises from the blood. Lymphoma’s most common symptom is enlarged, swelling of the lymph nodes in the neck, underarm, or groin. Other Lymphoma cancer side effects may include:

  • Unexplained fever, weight loss, or poor appetite
  • Constant fatigue
  • Itchy skin
  • Reddened, thick, or dark patches on the skin

FDA Elidel Side Effects Warning

In January 2006, the FDA ordered Novartis to add a black box warning to Elidel’s label notifying healthcare providers and patients about the increased risk of cancerous side effects. The black box warning provides:

  • That Elidel should only be used if all other therapy fails
  • To avoid Elidel use in children under two years-old
  • To use Elidel for only short time periods (not continuously)
  • To use only a minimum dose of Elidel to control the patient’s symptoms

Injured by Elidel Cancerous Side Effects?

If you or a loved one developed skin cancer, lymphoma or other serious side effects after prolonged Elidel use, you may wish to consult with our attorneys about your legal rights.

Published November 17, 2011 by