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.
Ruling Aids in Protection of Elidel Victims' Rights
In October of 2006, a U.S District Judge ruled in favor of States' rights to administer justice with regards to a Novartis claim that certain Elidel lawsuits were preempted by FDA approval of the topical immunosuppressant's label. FDA regulations permit the addition of supplemental labels based on newly discovered risks and warnings. As such, the court ruled that state suits filed against Novartis for injuries caused as a result of using the drug did not conflict with FDA regulations. This ruling is viewed as an important victory for Elidel victims' currently engaged in litigation against Novartis for injuries incurred as a result of using the drug.
About Elidel
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 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
- Cough
- Sore throat
- Congestion
- Headache
- Viral skin infection
- Cancer
Elidel Lawsuits
Elidel lawsuits are aimed at compensating those who have been injured as a result of using the immunomodulating agent prior to being adequately informed of its serious side effects. If you or a loved one has been injured as a result of using Elidel, it is highly recommended that you contact the FDA to report your case in addition to contacting a personal injury lawyer who specializes in litigation surrounding drug injuries.
The Law Offices of Justice Lawyers have a great deal of experience in litigating personal injury cases resulting from drug side effects. The lawyers and staff representing Justice Lawyers are some of the finest personal injury attorneys Pensacola, Florida has to offer. Contact the Law Offices of Justice Lawyers today at 877 810 4808 to get more information regarding Elidel injury victims' rights.
The attorneys of the Law Office of Justice Lawyers are personal injury lawyers in Pensacola who protect victims of auto accidents, personal injury, wrongful death, defective drugs, consumer fraud, insurance fraud, product defects and defective medical devices, such as Guidant and Medtronic Pacemakers, and potentially harmful drugs, such as Ortho Evra. When you think of the top personal injury lawyers or car accident lawyers in Pensacola, think of Justice Lawyers.