Summary

Original source:
http://www.cnn.com/medpage/ProductAlert/Prescriptions/tb1/2523

Details

• The FDA said black box warnings about the possible risks of skin cancer and lymphoma have been added to the labels of Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus), two popular eczema drugs.
• Although no causal link between cancer and the two drugs has been established, the FDA said it has received reports of 78 cases of cancer among patients using the drugs.
• A year ago, the FDA's Pediatric Drugs Advisory Committee recommended that the drugs' labeling be updated with a boxed warning and a medication guide about the possible cancer risk for these drugs.
• A month later the FDA issued a Public Health Advisory advising physicians about the possible cancer risk.
• It recommended that the drugs be considered second-line therapy, used for short-term treatment in patients who have not responded to other treatments.
• "We are taking steps to ensure that healthcare providers and patients are aware of the possible long-term risks of these products so that they will be used appropriately," said Steven Galson, M.D., director of FDA's Center for Drug Evaluation and Research.
• "Today's actions are aimed at making sure that health care providers and consumers understand the new warnings and that it is important that these products be used as recommended in the label."
• Elidel is made by Novartis Pharmaceuticals and Protopic is made by Astellas Pharma Inc. "Although studies are being conducted by the manufacturers of both drugs to try to answer questions about cancer risk, it could be many years before the research is concluded," the FDA said.
• A statement issued by Novartis said the company is confident that Elidel is safe.
• A statement issued by Astellas said Protopic is safe and effective when used "in a manner consistent with its label."

Related Articles

Popular Topics: Cancer, Eczema, The FDA, Diabetes, Breast cancer, Prostate cancer, Heart disease, Depression, High cholesterol, Osteoporosis, Vaccines, Autism, ADHD, Infertility, Weight loss, Cancer, Alzheimer's, Trans fats, Acrylamides, Fluoride, Mercury	Take Action: Support NaturalNews.com Email this article to a friend Share this article on: NewsVine | digg | del.icio.us Permalink to this article: http://www.NaturalNews.com/018735.html Reprinting this article: Non-commercial OK, cite NaturalNews.com with clickable link. <a href = "http://www.NaturalNews.com/018735.html">FDA adds black box to eczema drug labels to warn public about cancer risks</a>
Receive our Natural Health Newsletter for FREE Subscribe now (it's free!) to win. We randomly choose a subscriber each month to send $100 in eco-home products or a RealGoods.com gift certificate (our choice). Plus, you'll receive FREE news, articles and action alerts from NaturalNews.com editors and join over 800,000 monthly readers who report extraordinary health improvements after becoming a subscriber! Receive breaking news alerts on natural health solutions, renewable energy, the environment, global warming and more. Receive a free instant download of our $29 Secret Sources guide that reveals top sources for little-known health and diet solutions.	Your Email Address: Free Subscription Code: Enter the numbers you see: 100% free of charge. Unsubscribe anytime. Absolutely no spam. We respect your email privacy.
Recommended Special Report: Seven Words that can Change the World by Joseph R. Simonetta Read this special report now... "Seven Words That Can Change the World reveals the astonishing, simple truths that have the power to forever transform our world for the better while freeing our minds from the enslavement of limiting beliefs. This is not a text for the simple-minded; it is a guiding philosophy for the mindful, intelligent few who are wise enough to seek out -- and recognize -- the higher simplicities of truly purposeful living." - Mike Adams, the Health Ranger, editor of NaturalNews.com	More on NaturalNews.com: • Streaming Health Ranger Videos • CounterThink Cartoons • FREE Special Reports • Podcasts