FDA News Digest September 2, 2003 ______________________________________________________________ Drug OK'd for Reducing Risk of Heterosexual Transmission of Genital Herpes FDA has approved the oral drug Valtrex (valacyclovir hydrochloride) to reduce the risk of heterosexual transmission of genital herpes when used with safe sex practices in susceptible partners with healthy immune systems. A common sexually transmitted infection, genital herpes can be transmitted even when no symptoms are present in infected people. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01250.html ______________________________________________________________ FDA Explains Proposed Changes to Safety Reporting Requirements FDA has posted an updated list of 10 questions and answers to help explain a rule the agency has proposed that would revise current safety reporting regulations for drug and biological products. The proposal is aimed at strengthening FDA's role in managing the risks of medical product use, both during clinical trials and when products are on the market. The updated list also is intended to help clarify FDA's current thinking about standardized medical terminology for postmarketing safety reporting. http://www.fda.gov/oc/initiatives/barcode-sadr/qa-sadr.html ______________________________________________________________ Doctor, Pharmacists Indicted for Illegally Dispensing Prescription Drugs A doctor, two pharmacists, and an office manager have been indicted in Indiana for dispensing prescription drugs outside the scope of professional practice and for illegitimate medical purposes. Among the drugs allegedly involved were Vicodin, Xanax, Darvocet, and Halcion. The scheme allegedly took place between September 2000 and July 2002. http://www.fda.gov/bbs/topics/NEWS/2003/doj082603.pdf ______________________________________________________________ RECALLS The following products are being recalled for the reasons shown. Go to the linked page for more information. Roxy Trading Inc. Dried Guava Slices (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/roxy08_03.html HDCC International Dried Guava Slices (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/HCDD08_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 _____________________________________________________________ Thanks for subscribing to FDA News Digest. Our next posting will be September 8. 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
