What is Protopic?
Protopic, which has the generic name Tacrolimus, is an "immunomodulating agent" used in the treatment of dermatitis. It is marketed by Astellas Pharmaceuticals. Protopic comes in the form of a topical cream that is applied to the skin. Recently, the FDA issued a "black box warning" for Protopic after it reviewed numerous animal studies that implied a cancer risk, including one study on monkeys that showed an increasing frequency of tumors with increasing doses. The FDA stated that a cancer risk associated with Protopic is biologically plausible, along with a similar drug, Elidel.
Protopic Side Effects
The most common side effects are stinging and burning. Protopic may also associated with an increased risk of certain skin infections, such as Herpes Simplex Viral infections (HSV). It has also been cited by the FDA as a possible cancer risk, including skin cancers and non-Hodgkins lymphoma.
Protopic Black Box Warning
The FDA has issued an advisory that informs patients and healthcare providers about possible risks of lymph node (lymphoma) and skin cancer as a result of using Protopic. Animal studies, as well as small numbers of case reports, indicate that Protopic may have a cancer risk. They have indicated that it may take human studies of 10 years or longer to confirm these reports. The FDA announced that it was adding a "black box warning" to the labels on Protopic. Black box warnings are considered the strongest possible FDA warning.
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Protopic And Cancer
The FDA advisory follows recommendations made by the FDA's Pediatric Advisory Committee during its mid-February meeting. At that meeting, the committee reviewed research that showed that the risk of cancer in three different species of animals increased along with increases in the doses of Protopic. The research material also included reports of cancers in children and adults treated with Protopic. In February, members of an FDA advisory panel said they were concerned with the aggressive advertisements for eczema creams to treat infants and others with skin problems the creams were not approved to treat.
Protopic suppresses the immune system, which may foster the development of cancer. Research links it and related drug Elidel to 25 cases of cancer in adults and children. Protopic is widely prescribed as an alternative to steroid creams, which also have long term side effects.
Questions and Consultations
If you or a family member has used the prescription drug Protopic and noticed adverse side effects, you should contact a physician immediately. If you would like to discuss your rights, are interested in more information on Protopic litigation, or if you have information about the cases that you would like to share with us, please click here to fill out a short evaluation form, and a member of Seeger Weiss LLP's experienced staff will call you to discuss your potential rights concerning Protopic. Attorney consultations incur no obligation on your part and all initial consultations are free of charge and do not create an attorney-client relationship. Seeger Weiss LLP has office locations in both New York and New Jersey and its attorneys practice in courts throughout the country.
Link To Lawyer Seek's Protopic Content:
<a href='http://www.lawyerseek.com/Practice/Pharmaceutical-Injury-C1/Protopic-P38/'>Protopic: Lawyer Seek</a> |
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