FDA News Digest September 15, 2003 ______________________________________________________________ FDA Takes Action Against Two Companies Importing Unapproved Drugs FDA has taken action against Rx Depot Inc. and Rx Canada to stop them from importing drugs that pose a serious threat to the public health. The agency uncovered a disturbing pattern of actions by these companies resulting in potentially hazardous errors. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00939.html ______________________________________________________________ First in New Class of Antibiotics Approved for Treating Skin Infections FDA has approved the injected drug Cubicin (daptomycin), a new type of antibiotic for treating complicated skin and skin structure infections that usually occur in hospitalized patients. Cubicin is intended to treat "staph" and several types of "strep" infections, which can progress to life-threatening conditions. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01252.html ______________________________________________________________ FDA Warns Companies About Selling Unapproved Version of Accutane FDA has sent letters to several companies warning them to stop illegal Internet sales of unapproved, mislabeled versions of the acne drug Accutane (isotretinoin). FDA believes that these products, which include a topical (skin-applied) gel version of the drug, could pose serious health risks to consumers. For example, Accutane can cause birth defects if taken by pregnant women. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00940.html ______________________________________________________________ Milk Processors Warned to Remove 'Hormone Free' From Labels FDA has sent warning letters to four processors of whole milk, reduced-fat milk, and ice cream, informing them that their products are misbranded because the labels contain the false statements "no hormones" or "hormone free." FDA explains that all milk contains naturally occurring hormones, and milk cannot be processed in a way that renders it hormone free. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00943.html ______________________________________________________________ Campaign to Inform Women About Risks, Benefits of Hormone Therapy FDA has joined with two members of Congress to launch a nationwide campaign aimed at raising awareness about recent findings on risks and benefits of menopausal hormone therapy. Included in the campaign are a menopause and hormone therapy fact sheet, along with a "purse guide" that provides questions for discussion with a healthcare professional, both available online or in printed form. Press release: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00938.html More information: http://www.fda.gov/womens/menopause/ ______________________________________________________________ Consumers Advised Not to Drink Teas Brewed From Star Anise Herb Following reports linking brewed teas made with the herb star anise to illnesses affecting about 40 persons, 15 of them infants, FDA is advising consumers to avoid drinking those teas. Though the agency has not identified the specific type of star anise involved in the illnesses, it issued the advisory as an interim measure while gathering more information. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00941.html ______________________________________________________________ FDA Urges Developing Two Drugs That Can Treat Radiation Exposure As part of its efforts to provide the public with treatments in the event of a terrorist attack, FDA is calling for manufacturers to submit applications for approval of two drugs that, under certain conditions, can be safe and effective for treating internal contamination with the radioactive elements plutonium, americium, or curium. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00944.html ______________________________________________________________ McClellan Praises House Committee Passage of Animal Drug User Fee Bill FDA Commissioner Mark B. McClellan, M.D., has issued a statement praising members of the House Energy and Commerce Committee for their passage of the Animal Drug User Fee Act of 2003. As passed by the committee, the legislation authorizes collection of fees totaling $43 million over five years to accelerate and improve the review of new animal drugs. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00942.html ______________________________________________________________ RECALLS The following product is being recalled for the reason shown. Go to the linked page for more information. Mandalay Trading Corp. Macapuno Strings (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/mandalay09_03.html ______________________________________________________________ Thanks for subscribing to FDA News Digest. Our next posting will be September 22. To leave this list at any time, send an e-mail to LISTSERV@xxxxxxxxxxxx In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
