Protopic and the FDA ‘Black Box’ Warning

Protopic use has recently been linked with the possible development of lymphoma and/or skin cancer. While a causative link between Protopic and cancer remains inconclusive, initial data is such that it has led the FDA to issue a new safety warning with regards to use of the immunosuppressive drug.

The FDA began to take notice of the possible relationship between skin cancer, lymphoma and Protopic use in 2005. Efforts made by the FDA to institute significant warning label changes were met with resistance by Astellas, the manufacturers of the drug. However, in January of 2006, the FDA required that Protopic be labeled with a “black box” warning advising patients and doctors with regards to the serious nature of Protopic side effects.

About Protopic

Protopic is the brand name for tacrolimus (FK-506 / Fujimycin), an immunosuppressive drug approved by the FDA in 2000. Developed by Fujisama Healthcare Inc. (Astellas), Protopic has recently garnered a great deal of negative publicity with regards to its potential link with cancer.

Immunosuppressives are used to diminish immune system response when such a response is believed capable of eliciting a negative effect. For example, immunosuppressives like Protopic are used after allogenic organ transplantation (donor transplantation) to prevent the immune system from attacking the newly transplanted foreign cells; such an attack could result in organ rejection.

The immunosuppressant nature of Protopic 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.

Protopic is similar in nature to another type of topical immunosuppressant that has recently come under FDA fire because of its possible link with cancer; Elidel (pimecrolimus). 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.

Protopic Ointment

Protopic is commonly used in a topical preparation designed to treat severe cases of atopic dermatitis / atopic eczema, an allergic inflammation of the skin. Protopic treats atopic dermatitis in a similar manner to steroids in that it suppresses inflammation; however, Protopic is significantly weaker than steroids. Unlike steroids, the weaker Protopic Ointment does not cause a thinning of the skin (skin atrophy) and can therefore be used on areas of the body where the skin is already thin (like the face). Protopic has therefore become an increasingly popular topical immunosuppressant.

People using Protopic are at risk of developing a number of side effects. As such, the immunosuppressive is indicated for use as a “second-line” therapy for short-term treatment of atopic dermatitis. I.E, it is only recommended for use after other therapies have proven unsuccessful.

Protopic Side Effects

There are a number of side effects that have been associated with the use of Protopic Ointment in the treatment of atopic dermatitis, some of which include:

  • Burning skin sensation
  • Headache
  • Flu-like symptoms
  • Severe itching of the skin (pruritus)
  • Cancer
  • Protopic Lawsuits

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 pharmaceutical 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 a Protopic injury victim.