Summary

Original source:
http://www.nytimes.com/2005/08/13/health/13fda.html

Details

• The regulations, which apply to generic versions of Accutane as well, require doctors and patients to register in an electronic database before it can be dispensed.
• Female patients of childbearing age must take two pregnancy tests and use two forms of birth control to get the drug.
• The new program is the latest and by far most drastic of more than 40 efforts by the agency in the last 22 years to reduce harm from Accutane, an oral medicine made by Roche Holding, while allowing its continued use.
• Health officials say the new plan is the latest sign the F.D.A. is losing faith that the nation's doctors and pharmacists can adequately safeguard the health of patients.
• Before 1998, the agency largely confined itself to advising physicians and pharmacists about how to prescribe and dispense safely any drugs with potentially dangerous adverse effects, and trusted that its advice would be followed.
• But experts say that time after time over the last decade, medical professionals have ignored the advice, providing drugs to patients at risk of severe complications.
• But such withdrawals have left stranded thousands of patients who contend that they needed those drugs to lead normal lives.
• Among the first was a program created in 1998 to ensure that thalidomide, infamous for causing thousands of birth defects in European babies during the 1960's, could be safely used as a leprosy drug.
• Dr. Wolfe added that drug companies were largely to blame, though, saying their huge marketing efforts often encouraged doctors to prescribe drugs excessively.
• By 2002, the last year before generic versions of the medicine entered the market, sales of Accutane in the United States had risen to $380 million, with doctors writing 170,000 prescriptions a month, half of which went to women.

Related Articles

Popular Topics: Drug, Regulations, 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/011214_drug_regulations_FDA.html Reprinting this article: Non-commercial use OK, cite NaturalNews.com with clickable link. <a href = "http://www.naturalnews.com/011214_drug_regulations_FDA.html">FDA poses stricter regulations for the acne drug Accutane</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