Protopic Side Effects Injury Lawsuits. Protopic(Generic:Tacrolimus) is a cream approved for the treatment of eczema and is commonly prescribed off-label for psoriasis and dermatitis seborrhea. Protopic is manufactured by Astellas Pharmaceuticals, formerly Fujisawa Healthcare, and was approved by the FDA in 2000.
The FDA required a warning for Protopic and Elidel after reviewing numerous animal studies that did indicate a risk, including one monkey study that showed an increasing risk of developing tumors as doses increased. The FDA added that the cancer risks of Elidel and Protopic are biologically plausible. Protopic and Elidel are medications that suppress the immune system, and this may be a precipitating factor in the development of cancer. Research has also linked Elidel and Protopic to about 25 cases of cancer in adults and children who used the drugs. Protopic and Elidel have become widely prescribed as an alternative to steroid creams, which have long term side effects.
On January 20, 2005 the FDA declared that Protopic will have to bear a “black box” warning indicating possible cancer risks. The new labeling also will clarify that the drug be recommended for use only after other prescription topical medicines have been tried by patients. The agency is also issuing a guide updating patients about these risks and concerns. A black box warning is the most serious type of warning in prescription drug labeling. The warning will be located lower on the labels of the two drugs than is typical, although a statement higher on the labels will refer to the risk. As of October 2004, the FDA had received reports of 78 cases of cancers, including skin and lymphoma, in patients treated with both Protopic or Elidel, said Dr. Stanka Kukich, the acting director of the FDA’s dermatologic and dental drug products division.