Eczema is a form of dermatitis (skin irritation) characterized by red, flaky skin, that may crack or blister. It is usually treated topically, with creams or ointments. The word is of Greek origin, meaning “boiling over.” Eczema almost always begins early in childhood, and usually presents itself during infancy. It can continue into adulthood, but often does not. Eczema and its associated symptoms can vary widely in intensity, from mild to extremely severe. While there is no known cure, there are medications available to treat the frustrating and debilitating symptoms of eczema.
One such treatment, Elidel, which is produced by the Switzerland-based pharmaceutical manufacturer Novartis, was approved by the Food and Drug Administration (FDA) in December 2001 in order to treat eczema. Elidel is commonly used “off-label” for psoriasis and dermatitis seborrhea. Like many medications, Elidel has been seen to cause side effects in patients. Symptoms indicating that you should call your doctor include, but are not limited to the following:
- worsening skin symptoms;
- signs of a skin infection (redness, swelling, itching, oozing);
- swollen glands; and/or
- fevers and chills, body aches or flu symptoms.
Mild side effects, which appear to be more common among patients, include:
- burning, stinging, tingling, or soreness of treated skin (especially during the first few days of treatment);
- swollen hair follicles;
- zits or warts;
- an upset stomach;
- muscle soreness or pain;
- a runny or stuffy nose;
- feeling especially sensitive to hot and cold temperatures
More serious side effects have, however, been observed over time. Following several trials and reports, the FDA is now aware of 78 cases of cancers, including skin and lymphoma, in patients treated with Elidel, according to Dr. Stanka Kukich, the acting director of the FDA’s dermatological and dental drug products division. On January 20th, 2005, the FDA declared that Elidel must bear “black box” notifications warning of possible cancer risks to patients. It is believed that the immunosuppressant properties of Elidel weaken the patient’s immune system to the level that he or she becomes increasingly susceptible to the contraction of a variety of diseases and cancers.
The new labeling was also ordered to recommend that Elidel be prescribed for use only after other prescription topical medicines have been tried by patients. The FDA is also issuing a guide that updates patients of concerns, including the risk of cancer, as the result of exposure to Elidel. A black box warning is the most serious and high level warning in prescription drug labeling. The warning will be located lower on the labels of the two drugs than is typical, although a statement higher on the labels will refer to the risk.
In 2006, Elidel Cream (scientifically known as pimecrolimus) complied with the order for label changes. The FDA has recommended that Elidel and Protopic be used only if other medications have failed to relieve symptoms or are not recommended by a doctor. They should only be used for short treatment periods. Treatment may be repeated if necessary, so long as there are break periods when the patient is not using the medication. Patients should be given the smallest dose that will treat the condition properly. Also, this medication should not be given to children younger than 2 years of age. As is the case with every medical decision, consult a doctor for the treatment of your eczema.
At Sheff Law, we have the resources, experience, and national reputation to pursue your potential rights and remedies against major medical manufacturers. If you or a loved one has been injured as a result of the use of Elidel, please fill out the free consultation form or contact an attorney at Sheff law today by calling (888)423-4477 or (617) 227-7000.
February 23rd, 2016 | Posted in Blog