Elidel and the FDA ‘Black Box’ Warning
Elidel use has recently been linked with the possible development of lymphoma and/or skin cancer. While a causative link between Elidel and cancer remains inconclusive at this point, initial data is such that it has led the FDA to issue a new safety warning with regards to use of the immunomodulating agent.
The FDA began to take notice of the possible relationship between skin cancer, lymphoma and Elidel use in 2005. Efforts made by the FDA to institute significant warning label changes were met with resistance by Novartis, the manufacturers of the drug. However, in January of 2006, the FDA required that Elidel be labeled with a “black box” warning advising patients and doctors of the serious nature of Elidel side effects.
Elidel is the brand name for pimecrolimus, a type of prescription-only immunomodulating agent that is most often used as a topical ointment for the treatment of atopic eczema. Elidel is manufactured and marketed by Novartis, a multinational pharmaceutical company.
The immunosuppressant nature of Elidel can weaken a patient’s immune system to such an extent that they become increasingly susceptible to the development of a variety of diseases and cancers.
Elidel is similar in nature to another type of topical immunosuppressant that has recently come under FDA fire because of its possible link with cancer; Protopic (tacrolimus). Both drugs are used to treat atopic eczema and both have recently been required to include “black box” warnings on their labels to make patients and doctors fully aware of the possible side effects associated with use.
Elidel is the most common form of treatment for atopic eczema, a type of allergic inflammation of the skin that causes itching, reddening, scaling and blistering. Elidel is prescribed for twice-a-day application to control the symptoms of mild-to-moderate eczema.
Patients are advised to spread a thin layer of Elidel ointment on the affected area two times a day until symptoms of atopic eczema subside. It can take several weeks of treatment with Elidel to produce an effect; however, if the symptoms have not cleared after six weeks, treatment should be halted and a medical professional should be consulted.
Elidel should not be used by anyone who is predisposed to the development of skin cancer or lymphoma. Additionally, the topical immunosuppressant should not be used by children under the age of two.
Elidel Side Effects
There are a number of side effects that have been associated with the use of Elidel in the treatment of atopic eczema, some of which include:
- Warm / burning sensation on area of Elidel application
- Cold-like symptoms
- Sore throat
- Viral skin infection
Drug manufacturers are responsible for ensuring the safety and efficacy of their products before marketing them for public consumption. Failure to do so is considered negligent and grounds for personal injury litigation. The Pensacola personal injury attorneys of Aylstock, Witkin Kreis & Overholtz handle national litigation across the United States for victims injured by defective pharmaceuticals and medical devices. They have successfully represented and obtained substantial compensation for a number of patients who have been harmed by drugs. Contact AWKO law today at (844) 794-7402 to get more information about your rights as an Elidel injury victim. AWKO Law also has highly skilled Pensacola wrongful death lawyers and has represented persons harmed by defective medical products and other defective drugs.