x Alerts [numbered 1-x] were compiled between 12/24/98 and 1/27/99

Copies of the full-text original sources for Safety-Related Drug Alerts! are available on request from the Drug Information Center (druginfo@u.washington.edu; 598-6347) and electronically via the UW computer network (through FDRx), and via the World Wide Web at the URL listed at the end of each alert. In addition, Safety-Related Drug Alerts! are compiled on the PRN website at http://weber.u.washington.edu/~druginfo/Alerts/dralerts.html

--------------------------------------------------------------- ---------------------------------------------------------------

TABLE OF CONTENTS FOR 1/27/99 SAFETY-RELATED DRUG ALERTS! 1. Levocarnitine [Carnitor] 2. Extensive labeling changes a. Trimethoprim/sulfamethoxazole (Bactrim) b. Disopyramide (Norpace/Norpace CR) c. Albuterol (Proventil) d. Tolcapone (Tasmar) e. Cefpodoxime (Vantin) f. Sildenafil (Viagra) ------------------------------------------------------------------------------- ------------------------------------------------------------------------------- 1. LEVOCARNITINE (CARNITOR) Dated 1/13/99 The adverse reaction section of the levocarnitine package insert has been revised to include information regarding the occurrance of seizures in patients receiving either IV or oral levocarnitine (Carnitor). Seizures have been reported to occur in patients without pre-existing seizure activity and an increase in seizure frequency and/or severity has been reported in patients with pre-existing seizure activity. http://www.fda.gov/medwatch/safety/1998/carnit.htm 2. VARIOUS DRUGS: SAFETY-RELATED LABELING CHANGES Dated 1/21/99 a. A total of 18 products had safety-related drug labeling changes during the month of November. http://www.fda.gov/medwatch/safety/1998/nov98.htm b. The following 6 UW formulary drug products underwent extensive safety-related labeling revisions during the months. As the package insert available from the pharmacy may not be current, prescribers of these products are urged to review the changes on-line at the URL indicated. *BACTRIM (trimethoprim/sulfamethoxazole) http://www.fda.gov/medwatch/safety/1998/nov98.htm#bactri *NORPACE/NORPACE CR (disopyramde) http://www.fda.gov/medwatch/safety/1998/nov98.htm#norpac *PROVENTIL (albuterol) revisions not available on-line; contact the company (Schering) for a copy of the new package insert *TASMAR (tolcapone) revisions not available on-line; contact the company (Hoffman-La Roche) for a copy of the new package insert *VANTIN (cefpodoxime) revisions (to provide for the treatment of acute otitis media in pediatric patients at a dose of 5mg/kg q 12h and for the treatment of acute maxillary sinusitis) not available on-line; contact the company (Pharmacia & Upjohn) for a copy of the new package insert *VIAGRA (sildenafil) http://www.fda.gov/cder/consumerinfo/viagra/viagralabel2.pdf ------------------------------------------------------------------------------- About Safety-related Drug Alerts! -------------------------------------------------------------------------------- In response to practitioner demand, the Drug Information Center has joined together with the Medical Director's office to assist in the timely dissemination of safety-related drug alerts. Once every two weeks, brief summaries of the drug alerts judged to be most relevant to the care of UWMC and HMC patients are forwarded via email to the UWMC, HMC, and UWPN Medical Directors for further dissemination to clinical practitioners. "Safety-Related Drug Alerts!" encompass formulary and non-formulary prescription and non-prescription drugs, products regulated as food supplements, and medical devices that may be prescribed by UWMC/HMC/UWPN practitioners or used by UWMC/HMC/UWPN patients. "Safety-Related Drug Alerts!" may originate from the FDA, pharmaceutical manufacturers, or other sources deemed reliable. Your assistance in helping to achieve dissemination of this information to all levels of UWMC, HMC, and UWPN health care providers, including physicians, nurse practitioners, physician's assistants, and other allied health professionals, is appreciated. Questions about Safety-related Drug Alerts should be addressed to the Drug Information Center (548-6347; druginfo@u.washington.edu). -------------------------------------------------------------------------------