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drug_recall protopicThe FDA’s public health advisory announcement about Protopic causing cancer came in March 2005 after researchers discovered that patients using this prescription ointment are at an increased risk of developing lymph node and skin cancer. As a result of Protopic causing cancer, the FDA has warned doctors and patients of these risks and advised them to only use Protopic when alternative treatments have failed or cannot be tolerated.
Protopic is a topical tacrolimus ointment that was first approved by the FDA in 2000. This prescription medication is used to treat patients older than two years of age who have moderate to severe atopic dermatitis, a form of eczema. There are two strengths of Protopic though only one is approved for pediatric use. Patients who must take this medication should use it on a short term basis and no longer than necessary in light of protopic causing cancer.
In addition to concerns about protopic causing cancer, there are certain patient populations for whom Protopic use is contraindicated. Women who are pregnant or breastfeeding should not use Protopic. Patients whose atopic dermatitis is infected should also not use this product. Patients with Netherton’s syndrome, a genetic condition marked by significant skin irritation, should also not use this topical ointment.
Information about protopic causing cancer was collected from animal studies, human case studies, and scientific knowledge about how this medication works. In animal studies, researchers found that those treated with protopic developed lymph node and skin cancer tumors at a faster rate than those not given protopic. Human case studies show protopic causing cancer in human subjects as well. The FDA has stated that it will take at least ten years of human clinical trials to determine the extent of protopic causing cancer risks.
In addition to protopic causing cancer, use of this prescription medication also carries other risks. Patients using protopic may experience common skin irritations including stinging, burning, itching, redness and soreness, headaches, and influenza-like symptoms. Protopic users are at an increased risk of developing some viral infections including chicken pox and shingles. Exposure to sunlight or tanning beds can also increase the chances of protopic causing cancer.
If you or a loved one has used protopic tacrolimus ointment, you may wish to speak with your health care professional about the risks of protopic causing cancer. Patients should only use this product exactly as directed by a doctor for the shortest duration of treatment possible. A doctor will inform you of the way to use the ointment in order to mitigate the risk of protopic causing cancer.
If you or a loved one has developed cancer while using protopic ointment, you may wish to explore your legal rights and options with regards to seeking compensation for your losses. A highly trained and experienced attorney can help to protect and maximize your legal interests in a case involving protopic causing cancer.