Protopic Eczema Medication
Protopic (tacrolimus) is used to treat moderate to severe atopic dermatitis, a type of eczema. The ointment, which is manufactured by Astellas Pharmaceuticals (formerly known as Fujisawa Healthcare), was originally approved by the FDA in 2000 for use by adults and children 2 years and older. However, the FDA recently requested a label change for Protopic following a public health advisory to healthcare professionals warning of the potential risk of cancer.
On January 19, 2006, the FDA announced that it will require a “black box” warning for the label of Protopic, in an effort to alert patients of the risk of cancer. The new label will also clarify that Protopic should only be prescribed after other medications have been tried (unsuccessfully) by patients. A black box warning is the most severe warning that the FDA can issue to the public.
Protopic ointment is applied to the skin to control eczema and other skin disorders. It works by suppressing the immune system (immunosuppressants), which is possibly one of the cancer-causing factors.
The FDA released the following statement regarding major potential risks and side effects for those who have taken Protopic Therapy:
Do not use Protopic as the first prescription treatment for your atopic dermatitis since there are risks of some serious side effects.
- Possible risk of lymph node or skin cancer: As noted in the FDA Alert, a public health advisory has been issued to inform healthcare professionals about a potential cancer risk from the use of Protopic. This concern is based on information from animal studies, case reports and knowledge of how drugs in this class work.
- Skin Irritation: Protopic’s most common side effects are stinging, soreness, burning sensation, and itchy skin.
- Viral Infections: Protopic use may increase the chance of getting chicken pox, shingles or other viral infections.
- Other Side Effects: include headache, skin redness and flu-like symptoms.
If you are suffering from one of the following Protopic side effects, contact us immediately:
- Skin cancer
- Lymphoma
- Additional Protopic side effects:
- Swollen/infected hair follicles
- Skin burning and pruritus
- Muscle pain
- Herpes Zoster
If you or a loved one have experienced any side effects from Protopic such as skin cancer (lymphoma), please call us at 1.800.966.4999 or fill out our online contact form for a free case evaluation.
