Cerivastatin and the Dissemination of Adverse Event Information

Dear Health Care Professional Letter: market withdrawal of Baycol (cerivastatin). [cited 2001 October 8]. Available from: URL: http://www.fda.gov/medwatch/safety/2001/Baycol2.htm.

Thompson CA . News. Am J Health Syst Pharm 2001;58: 458–62.

Recommendations from the International Conference on Harmonisation (ICH) described in the report “Managing the Risks from Medical Product Use.” US Department of Health and Human Services, Food and Drug Administration, May 1999.

Physicians' desk reference. 52nd ed. Montvale, NJ: Medical Economics, 1998.

Bayer Corporation. Gemfibrozil contraindication with Baycol. West Haven, CT: Bayer Corp., 1999.

Physicians' desk reference. 54th ed. Montvale, NJ: Medical Economics, 2000.

Physicians' desk reference. 55th ed. Montvale, NJ: Medical Economics, 2001.

What is MedWatch? [cited 2001 October 8]. Available from: URL: http://www.fda.gov/medwatch/what.htm.

Kessler DA . Introducing MedWatch: A new approach to reporting medication and device adverse effects and product problems. JAMA 1993;269: 2765–8.

Code of Federal Regulations. 21 CFR 314.80 and 21 CFR 600.80.

Chen RT Rastogi SC Mullen JR Hayes SW Cochi SL Donlon JA The Vaccine Adverse Event Reporting System (VAERS). Vaccine 1994;12: 542–50.

Rawlins MD . Pharmacovigilance: Paradise lost, regained or postponed? The William Withering Lecture 1994. J R Coll Phys Lond 1995;29: 41–9.

Strom BL Tugwell P . Pharmacoepidemiology: Current status, prospects, and problems. Ann Intern Med 1990;113: 179–81.

Scott HD Rosenbaum SE Waters WJ Colt AM Andrews LG Juergens JP Rhode Island physicians' recognition and reporting of adverse drug reactions. R I Med J 1987;70: 311–6.

Code of Federal Regulations. 21 CFR 201.57.

Smalley W Shatin D Wysowski DK Gurwitz J Andrade SE Goodman M Contraindicated use of cisapride: Impact of Food and Drug Administration regulatory action. JAMA 2000;284: 3036–9.

Cohen JS Insel PA . The Physicians' Desk Reference: Problems and possible improvements. Arch Intern Med 1996;156: 1375–80.

Cohen JS . Dose discrepancies between the Physicians' Desk Reference and the medical literature, and their possible role in the high incidence of dose-related adverse drug events. Arch Intern Med 2001;161: 957–64.

Summary of the Second Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). JAMA 1993;269: 3015–23.

Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA 2001;285: 2486–97.

Managing the risks from medical product use: creating a risk management framework. Washington, DC: US Department of Health and Human Services, Food and Drug Administration, 1999.

Physicians' Desk Reference. 50th ed. Montvale, NJ: Medical Economics, 1996.

Physicians' Desk Reference. 55th ed. Montvale, NJ: Medical Economics, 2001.

Petition to require a box warning on all HMG-CoA reductase inhibitors (“Statins”) August 20, 2001. [cited 2001 October 8]. Public citizen. Available from: URL: http://www.citizen.org/publications/release.cfm?ID=7051.