FDA NEWS DIGEST -- APRIL 15, 2002 BOTOX NOW OK'D FOR TREATING FROWN LINES -- FDA has approved Botulinum Toxin Type A (Botox Cosmetic) to temporarily improve the appearance of moderate-to-severe frown lines between the eyebrows. The FDA action allows the product's manufacturer, Allergan Inc., to market Botox for this new indication. The drug previously was approved to treat two eye muscle disorders and a neurological movement disorder. http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01147.html
HEALTH PROFESSIONALS WARNED ABOUT POSSIBLE INFECTIONS FROM POWDERED FORMULA -- FDA has alerted health care professionals about the risk of Enterobacter sakazakii infections in hospitalized newborn infants fed powdered infant formulas. The alert focuses on premature infants or other infants with weakened immunity and does not extend to use of liquid infant formulas. Enterobacter sakazakii is a foodborne pathogen that can cause meningitis and other disorders. http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01146.html NEW INDICATION, LABEL REVISIONS APPROVED FOR ARTHRITIS DRUG VIOXX -- FDA has approved a supplemental application for the use of Vioxx (rofecoxib) to treat rheumatoid arthritis. FDA had previously approved the drug for osteoarthritis and pain. Labeling for the drug also will be revised to indicate updated information about gastrointestinal and cardiovascular effects. http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01145.html NICOTINE LOLLIPOPS, LIP BALM CALLED ILLEGAL; MAY POSE HEALTH RISKS -- FDA has warned three pharmacies selling nicotine lollipops and nicotine lip balm over the Internet that these products are illegal. The products, promoted to help stop smoking or to treat nicotine addiction, pose health hazards, including a risk of accidental use by children. http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01144.html PENNSYLVANIA COMPANY RECALLS MUSHROOM PRODUCT -- Phillips Mushroom Farms is recalling its 3-oz. packages of Dried Wild Pasta Blend Mushrooms, Containing Sun-Dried Tomatoes because the tomatoes contain high levels of sulfite, which could cause a serious allergic reaction in people sensitive to sulfites. http://www.fda.gov/oc/po/firmrecalls/phillips04_02.html _________________________________________________________________ Thanks for subscribing to the FDA News Digest. The next posting will be sent April 22. To leave this list at any time, send an e-mail to [EMAIL PROTECTED] In the body of the message, write "SIGNOFF FDA-NEWSDIGEST-L"
