FDA News Digest March 29, 2004 ______________________________________________________________ THIS WEEK'S NEWS -- FDA Cautions About Use of Antidepressants in Adults and Children -- Safeguards Boosted for Those Sensitive to Certain OTC Ingredients -- FDA Releases Final Action Plan for Food Byproduct Acrylamide -- FDA Seeks to Maximize Benefits of Pain Drug While Curbing Abuse -- First Oral Fluid-Based Rapid Test Kit Approved for Screening HIV -- FDA, NIH Aim to Improve Adverse Events Reporting in Gene Trials -- Recalls/Market Withdrawals -- FDA Congressional Testimony -- Public Meetings ______________________________________________________________ FDA Cautions About Use of Antidepressants in Adults and Children FDA is cautioning doctors, patients, families, and caregivers about the continuing need to monitor adults and children who take antidepressants for worsening depression and suicidal thoughts and actions. This is important especially at the beginning of treatment or when doses are increased or decreased. The agency's action was prompted by studies suggesting an increased risk of suicidal tendencies. FDA also is asking the makers of 10 antidepressants to include stronger warnings about suicidal tendencies in their product labeling. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01283.html Safeguards Boosted for Those Sensitive to Certain OTC Ingredients FDA has published a rule that requires new information in the labeling of over-the-counter drugs containing levels of calcium, magnesium, sodium or potassium that might be harmful to people with certain medical conditions. FDA emphasizes that these ingredients generally can be used safely, but the agency wants those at risk of side effects to be alerted to their presence. http://www.fda.gov/bbs/topics/news/2004/NEW01041.html FDA Releases Final Action Plan for Food Byproduct Acrylamide FDA has released a final action plan to evaluate the risks associated with the food byproduct acrylamide and examine ways to reduce its levels in foods. The agency also has published data on acrylamide levels in more than 750 food samples. First reported in foods in 2002, acrylamide is created in certain carbohydrate-rich foods when they are exposed to high heat. Health officials have not determined if the chemical has any effects in humans. http://www.fda.gov/bbs/topics/news/2004/NEW01040.html FDA Seeks to Maximize Benefits of Pain Drug While Curbing Abuse FDA has released a statement on managing the benefits and risks of oxycodone hydrochloride extended-release products, which include Oxycontin and two recently approved generics. While the products are important options for managing moderate-to-severe pain, they also have the potential for abuse. To curb such abuse, the two generic manufacturers have agreed to put in place risk management plans consistent with that of the brand name product. http://www.fda.gov/bbs/topics/news/2004/NEW01039.html First Oral Fluid-Based Rapid Test Kit Approved for Screening HIV FDA has approved a new type of diagnostic test kit that uses oral fluid samples to screen for HIV-1. The device offers more than 99 percent accuracy and can return results in as little as 20 minutes. Positive results from the new test must be confirmed with an additional, more specific test. http://www.fda.gov/bbs/topics/news/2004/NEW01042.html FDA, NIH Aim to Improve Adverse Events Reporting in Gene Trials FDA and the National Institutes of Health have launched the Genetic Modification Clinical Research Information System, a Web-accessible database that will help monitor adverse events in gene therapy research. http://www.nih.gov/news/pr/mar2004/od-26.htm ______________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reasons shown. Go to the linked page for more information. Solutions IE Ageless Formula II (dietary supplement); Lot #s P2207, P2221; 180-capsule bottles (excess vitamin D) http://www.fda.gov/bbs/topics/news/2004/NEW01043.html Major Twice-a-Day 12-Hour Nasal Spray; 1/2 oz. bottle, Lot #K4496, Exp. 10/06 (contaminated with Burkholderia cepacia bacteria) http://www.fda.gov/oc/po/firmrecalls/propharma03_04.html Sheer Blonde Curvaceous Blonde hair styling spray; 6.7 oz. pump spray (possible contamination with Pseudomonas bacteria) http://www.fda.gov/oc/po/firmrecalls/johnfrieda03_04.html Chaca Chaca, a candy imported from Mexico (may contain excessive lead levels) http://www.fda.gov/oc/po/firmrecalls/chacachaca03_04.html E. Wedel, Delicje Soft Biscuits Topped with Fine Chocolate and Delicious Filling (undeclared milk) http://www.fda.gov/oc/po/firmrecalls/grandprix03_04.html For a listing of recalls, market withdrawals, and safety alerts from the last 60 days, go to http://www.fda.gov/opacom/7alerts.html ______________________________________________________________ FDA CONGRESSIONAL TESTIMONY FDA Center for Food Safety and Applied Nutrition Director Robert E. Brackett, Ph.D.: before the House Subcommittee on Human Rights and Wellness; subject: "Ten Years After the Implementation of DSHEA: The Status of Dietary Supplements in the United States" (March 24) http://www.fda.gov/ola/2004/dietarysupplements0324.html To view the text of past FDA testimony, go to http://www.fda.gov/ola/listing.html ______________________________________________________________ PUBLIC MEETINGS April 14 -- Meeting to allow the public to present information related to how prescription drugs could be imported safely and what the consequences would be for American patients. http://www.fda.gov/OHRMS/DOCKETS/98fr/04-6145.htm For a list of upcoming FDA meetings, seminars, and other public events, go to http://www.fda.gov/opacom/hpmeetings.html. ______________________________________________________________ Thanks for subscribing to FDA News Digest. Our next posting will be April 5. 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