The safety of newly approved medicines: Do recent market removals mean there is a problem?

JAMA

Volumn 281, Issue 18, 1999, Pages 1728-1734

  Friedman, Michael A ^a   Woodcock, Janet ^a   Lumpkin, Murray M ^a   Shuren, Jeffrey E ^a   Hass, Arthur E ^a   Thompson, Larry J ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BENOXAPROFEN; BROMFENAC; DEXFENFLURAMINE; ENCAINIDE; FENFLURAMINE; FLOSEQUINAN; MIBEFRADIL; NOMIFENSINE; SUPROFEN; TEMAFLOXACIN; TERFENADINE; ZOMEPIRAC;

ARTICLE; DRUG APPROVAL; DRUG MARKETING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; PRIORITY JOURNAL;

EID: 0033549087     PISSN: 00987484     EISSN: None     Source Type: Journal    
DOI: 10.1001/jama.281.18.1728     Document Type: Article

References (38)

1. Withdrawals of FDA-approved drugs raise questions. Mayo Clin Health Lett. 1998;16:4.
2. The FDA and drug safety. Del Med J. 1998;70: 405-406.
3. Is the FDA approving drugs too fast? BMJ. 1998; 317:899-900.
4. Rubin R, Policy speeds approvals, but some say it's risky. USA Today. July 10-12, 1998:1-2.
5. Rock A. A dose of trouble. Money. December 1998: 123-128.
6. FDA's drug approval techniques are in question. "CBS Evening News." CBS Television. June 6, 1998.
7. Bachorik L. FDA announces withdrawal of fenfluramine and dexfenfluramine [press release], Rockville, Md: US Dept of Health and Human Services, HHS NEWS; September 15, 1997.
8. Weintraub M. Long-term weight control, [published correction appears in Clin Pharmacol Ther. 1992; 52:323]. Clin Pharmacol Ther. 1992;51:581-646.
9. Connolly HM, Crary JL, McGoon MD, et al. Valvular heart disease associated with fenfluraminephentermine. N Engl J Med. 1997;337:581-588.
10. Mark EJ, Patalas ED, Chang HT, Evans RJ, Kessler SC. Fatal pulmonary hypertension associated with short-term use of fenfluramine and phentermine. N Engl J Med. 1997;337:602-606.
11. Khan MA, Herzog CA, St Peter JV, et al. The prevalence of cardiac valvular insufficiency assessed by transthoracic echocardiography in obese patients treated with appetite-suppressant drugs. N Engl J Med. 1998; 339:713-718.
12. Jick H, Vasilakis C, Weinrauch LA, Meier CR, Jick SS, Derby LE. A population-based study of appetite-suppressant drugs and the risk of cardiac-valve regurgitation. N Engl J Med. 1998;339:719-724.
13. Devereux RB. Appetite suppressants and valvular heart disease. N Engl J Med. 1998;339:765-766.
14. US Food and Drug Administration. Analysis of cardiac valvular dysfunction in patients treated with appetite suppressants. September 17, 1997. Available at http://www.fda.gov/cder/news/slides/index .htm. Accessed March 2, 1999.
15. Honig PK, Woosley RL, Zamani K, Conner DP, Cantilena LR Jr. Changes in the pharmacokinetics and electrocardiographic pharmacodynamics of terfenadine with concomitant administration of erythromycin. Clin Pharmacol Ther. 1992;52:231-238.
16. Honig PK, Wortham DC, Zamani K, Conner DP, Mullin JC, Cantilena LR. Terfenadine-ketoconazole interaction, [published correction appears in JAMA. 1993; 269:2088]. JAMA. 1993;269:1513-1518.
17. Markham A, Wagstaff AJ. In discussion of: fexofenadine. Drugs. 1998;55:269-276.
18. Bronsky EA, Falliers CJ, Kaiser HB, Ahlbrandt R, Mason JM. Effectiveness and safety of fexofenadine, a new nonsedating H1-receptor antagonist in the treatment of fall allergies. Allergy Asthma Proc. 1998;19:135-141.
19. Bernstein Dl, Schoenwetter WF, Nathan RA, et al. Efficacy and safety of fexofenadine hydrochloride for treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 1997;79:443-448.
20. Kupec IF. Seldane and generic terfenadine withdrawn from market, FDA [talk paper] [US Food and Drug Administration Web site]. February 27, 1998. Available at: http://www.fda.gov/bbs/topics/ ANSWERS/ANS00853.html. Accessed March 2, 1999.
21. Roche cites drug interactions in mibefradil withdrawal. Am J Health Syst Pharm. 1998;55:1445.
22. Roche Laboratories announces withdrawal of Posicor from the market [talk paper] [US Food and Drug Administration Web site]. June 8, 1998. Available at: http://www.fda.gov/bbs/topics/ANSWERS /ANS00876.html. Accessed March 2, 1999.
23. Krahenbuhl S, Menafoglio A, Giostra E, Gallino A. Serious interaction between mibefradil and tacrolimus. Transplantation. 1998;66:1113-1115.
24. Mullins ME, Horowitz BZ, Linden DH, Smith GW, Norton RL, Stump J. Life-threatening interaction of mibefradil and β-blockers with dihydropyridine calcium channel blockers. JAMA. 1998;280:157-158.
25. Schmassmann-Suhijar D, Bullingham R, Gasser R, et al. Rhabdomyolysis due to interaction of simvastatin with mibefradil. Lancet. 1998;351:1929-1930.
26. Cruzan SM. Warning labeling changes for new heart drug Posicor [talk paper] [US Food and Drug Administration Web site]. December 19, 1997. Available at: http://www.fda.gov/bbs/topics/ANSWERS/ ANS00841.html. Accessed March 2, 1999.
27. Ellison RH. Roche Laboratories Inc Letter to Doctors. December 1997. Available at: http://www .fda.gov/medwatch/safety/1997/posico.htm. Accessed March 2, 1999.
28. Wyeth-Ayerst Laboratories announces the withdrawal of Duract from the market [talk paper] [US Food and Drug Administration Web site]. June 22, 1998. Available at: http://www.fda.gov/search.html. Accessed March 2, 1999.
29. de Vane PJ. Wyeth-Ayerst Laboratories letter to health care professionals withdrawing bromfenac, June 22, 1998. Available at: http://www.fda.gov /medwatch/safety/1998/duract3.htm. Accessed March 2, 1999.
30. Warning label changes for pain reliever Duract [talk paper] [US Food and Drug Administration Web site]. February 10, 1998. Available at: http://www.fda.gov /bbs/topics/ANSWERS/ANS00849.html. Accessed March 2, 1999.
31. de Vane PJ. Wyeth-Ayerst Laboratories warning letter to health care professionals about bromfenac, February 10, 1998. Available at: http://www.fda.gov /medwatch/safety/1998/duract.htm. Accessed March 2, 1999.
32. FY 1998 performance report to Congress for the Prescription Drug User Fee Act of 1992 as amended by the Food and Drug Administration Modernization Act of 1997. US Food and Drug Administration, Dept of Health and Human Services. Available at: www. fda.gov/ope/pdufa/report98/default.htm.Accessed March 2, 1999.
33. Shimmings A. NAS in 1998: quality not quantity counts. Scrip Magazine. 1999;75:62.
34. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients. JAMA. 1998;279:1200-1205.
35. Johnson JA, Bartman JL. Drug related morbidity and mortality. Arch Intern Med. 1995;155:1949-1956.
36. Guideline for Industry. The extent of population exposure to assess clinical safety: for drugs intended for long-term treatment of non-life-threatening conditions. US Food and Drug Administration. Available at: http://www.fda.gov/cder/guidance/index.htm. Accessed March 2, 1999.
37. Expert Working Group (Efficacy) of the International Conference on Harmonisation of the Technical Requirements for Registration of Pharmaceutical for Human Use (ICH). 60 Federal Register 11270 (1995).
38. New drugs, search for health spur pharmacy sales The Washington Times. August 31, 1998:A8.