FDA News Digest August 18, 2003 ______________________________________________________________ Novel Wheelchair Allows Climbing Stairs, Reaching Shelves FDA has approved the Independence iBot 3000 Mobility System, a new type of battery-powered wheelchair that uses a computerized system of sensors, gyroscopes and motors to allow wheelchair-bound people to climb stairs, reach shelves, and hold eye-level conversations. The wheelchair is available only by prescription, and health care professionals must undergo special training to prescribe it. People using the wheelchair can weigh no more than 250 pounds and must have the use of at least one arm. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00933.html ______________________________________________________________ New Statin Drug Crestor Approved for Lowering Cholesterol FDA has approved Crestor (rosuvastatin), a new statin drug for lowering blood cholesterol levels, a key factor in reducing the risk of heart disease. Like other statin drugs, Crestor works by partially blocking the formation of cholesterol in the liver, leading to increased removal of cholesterol from the blood. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01247.html ______________________________________________________________ Asthma Drugs Serevent and Advair to Carry New Warning FDA is adding new safety information and warnings to the labeling of drug products that contain salmeterol, a bronchodilator used to treat asthma and chronic obstructive pulmonary disease. The new labeling will warn about a small increased risk of life-threatening asthma episodes or asthma-related deaths seen in a recent study. Affected products are Serevent Inhalation Aerosol, Serevent Diskus, and Advair Diskus. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01248.html ______________________________________________________________ FDA Offers Tips for Giving Nonprescription Medicine to Children When giving over-the-counter medicines to children, read the drug's label carefully to make sure you are giving the right amount of the right medicine, FDA urges. The agency has a new website that lists 10 tips to help ensure that there's no guesswork when administering medicine to kids. The site, which also includes a recommended childhood immunization schedule, is available in text form or as an online brochure in PDF format. Text version: http://www.fda.gov/cder/consumerinfo/sickkids.htm PDF version: http://www.fda.gov/cder/consumerinfo/sickkids.pdf ______________________________________________________________ FDA Commissioner McClellan Joins Second Health Benefits Tour FDA Commissioner Mark B. McClellan, M.D., recently joined three other top Department of Health and Human Services officials for a five-state Better Benefits Tour. The tour is an effort to promote the need to strengthen Medicare with better benefits and more choices, including prescription drug and preventive care coverage. The four officials took a similar tour in June. http://www.hhs.gov/news/press/2003pres/20030813.html ______________________________________________________________ RECALLS The following products are being recalled for the reasons shown. Go to the linked page for more information. MLO Products Chocolate Soy Nuts, 8-oz. and 20-gram bags (undeclared peanuts) http://www.fda.gov/oc/po/firmrecalls/mlo08_03.html Kerber Dairy Chocolate Chip Cookie Dough and Chocolate Brownie Fudge ice cream, 1/2-gal. containers (undeclared egg or wheat ingredients) http://www.fda.gov/oc/po/firmrecalls/kerber08_03.html Anthony's Inc. Cheese Products (undeclared allergens) http://www.fda.gov/oc/po/firmrecalls/anthony08_03.html To view a list of recalls and safety alerts from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html ________________________________________________ RECENT SPEECHES FDA Commissioner Mark B. McClellan, M.D., at the National Press Club (Aug. 8) http://www.fda.gov/oc/speeches/2003/nationalpress0808.html To view past speeches by FDA officials, go to http://www.fda.gov/speeches/speechli.htm ______________________________________________________________ Thanks for subscribing to FDA News Digest. Our next posting will be August 25. 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
