Black box warnings in prescription drug labeling: Results of a survey of 206 drugs

Food and Drug Law Journal

Volumn 53, Issue 3, 1998, Pages 403-411

  Beach, Judith E ^a   Faich, Gerald A ^b   Bormel, F Gail ^c   Sasinowski, Frank J ^a  

^a Hyman Phelps & McNamara PC   (United States)

^b Pharmaceutical Safety A   (United States)

^c UNITED STATES PHARMACOPEIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BENAZEPRIL; CAPTOPRIL; ENALAPRIL MALEATE; FOSINOPRIL; KETOROLAC; LISINOPRIL; MOEXIPRIL; QUINAPRIL; RAMIPRIL; TERFENADINE; VALPROIC ACID;

ARTICLE; DRUG INFORMATION; DRUG LABELING; DRUG MARKETING; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; GOOD LABORATORY PRACTICE; HUMAN; PRACTICE GUIDELINE; PRESCRIPTION; RISK ASSESSMENT; TREATMENT INDICATION;

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; DRUG INFORMATION SERVICES; DRUG LABELING; DRUG THERAPY; HUMANS; LEGISLATION, DRUG; LIABILITY, LEGAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VALPROIC ACID;

EID: 0031709689     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (41)

1. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended 21 U.S.C §§ 301 et seq. (1994)).
2. 21 U.S.C. § 352(f)(1) (FDCA § 502(f)(1)).
3. 40 Fed. Reg. 15,392 (Apr. 7, 1975).
4. 21 U.S.C. § 353(b)(2) (FDCA § 503(b)(2)).
5. 21 C.F.R. § 201.100 (1997).
6. United States v. Vital Health Prod., Ltd., 786 F. Supp. 761, 786 (E.D. Wis. 1992).
7. United States v. Evers, 643 F.2d 1043, 1052 (5th Cir. 1981).
8. 21 U.S.C. § 352(a) (FDCA § 502(a)).
9. 21 U.S.C. § 321(n) (FDCA § 201 (n)).
10. 39 Fed. Reg. 33,229 (Sept. 16, 1974).
11. 21 C.F.R. §§ 201.56, 201.57 (1997).
12. McFadden v. Haritatos, 448 N.Y.S.2d 79, 81 (N.Y. App. Div. 1982).
13. 44 Fed. Reg. 37,434 (June 26, 1979); 21 C.F.R. § 201.57(d)-(g).
14. 21 C.F.R. § 201.57(e).
15. Lars Noah, The Imperative To Warn: Disentangling the "Right To Know" From the "Need To Know" About Consumer Product Hazards, 11 YALE J. ON REG. 293 (1994).
16. 21 C.F.R. § 201.57(e). See also 44 Fed. Reg. at 37,447; 40 Fed. Reg. at 15,397.
17. 21 C.F.R. § 201.57(e).
18. Preamble to New Drug, Antibiotic, and Biological Drug Product Regulations; Accelerated Approval, 57 Fed. Reg. 58,942 (Dec. 11, 1992).
19. FOOD AND DRUG ADMIN., POLICY & GUIDANCE HANDBOOK FOR FDA ADVISORY COMMITTEES, ch. XI, Center-Specific Guidance, CDER: Specific Guidance for Topics to Be Presented Before Advisory Committees (1994) ("Consideration of special labeling features, such as boxed warnings, special limitations on use, monitoring requirements, or patient package inserts.")
20. 44 Fed. Reg. at 37,434.
21. K. Gilpin, Company News: Panel Backs Tagamet Use In Treatment of Heartburn, N. Y. TIMES, Mar. 28, 1995, at D4.
22. PHYSICIANS' DESK REFERENCE 414 (49th ed. 1995).
23. 21 C.F.R. § 201.57(e).
24. ACE Inhibitors Will Be Required to Carry "Boxed Warning," Food and Drug Admin, Press Release P92-08 (Mar. 13, 1992).
25. Dangers of ACE Inhibitors During Second and Third Trimesters of Pregnancy, 22 FDA MED. BULL. 2 (1992); Katie Rodgers, Michael C. Vinson & W. Marvin Davis, Breakthroughs: New Drug Approvals of 1995 - Part 1, 140 DRUG TOPICS 84 (Feb. 5, 1996).
26. Dangers of ACE Inhibitors During Second and Third Trimesters of Pregnancy, 22 FDA MED. BULL. 2 (1992); Katie Rodgers, Michael C. Vinson & W. Marvin Davis, Breakthroughs: New Drug Approvals of 1995 - Part 1, 140 DRUG TOPICS 84 (Feb. 5, 1996).
27. Without clarification, FDA states only that it may require a boxed warning for "[s]pecial problems, particularly those that may lead to death or serious injury . . . ." 21 C.F.R. § 201.67(e). See also 44 Fed. Reg. at 37,447-48; 40 Fed. Reg. at 15,397. The agency has issued no guidance relevant to when and why it requires boxed warnings.
28. PHYSICIANS' DESK REFERENCE, supra note 22.
29. 21 C.F.R. § 201.57(e).
30. Thomas Scarlett, The Relationship Among Adverse Drug Reaction Reporting Drug Labeling, Product Liability, and Federal Preemption, 46 FOOD DRUG COSM. L.J. 31, 33 (1991).
31. 44 Fed. Reg. at 37,434.
32. S.C. Kaufman, T.P. Gross & D.L. Kennedy, Thyroid Hormone Use: Trends in the United States From 1960 Through 1988, 1 THYROID 285 (1991).
33. FDA Request Marion Merrell Dow to Warn Doctors, FDA Press Release P92-22 (July 7, 1992); Thompson and G. Oster, Use of Terfenadine and Contraindicated Drugs, 275 JAMA 1339 (1996).
34. FDA Request Marion Merrell Dow to Warn Doctors, FDA Press Release P92-22 (July 7, 1992); Thompson and G. Oster, Use of Terfenadine and Contraindicated Drugs, 275 JAMA 1339 (1996).
35. Jennifer Mann Fuller, Drug Stung by Rivals, New Label; Competitors Moved in as Warning Was Added to Seldane, KAN. CITY STAR, May 30, 1996, at B1.
36. Ivan Barofsky, Potential Effects on the Health Care System - 1, Joint Symposium on Drug Information for Patients: The Patient Package Insert, 11 DRUG INFO. J. 71S, 73S (Jan. 1977) ("We can never have the situation where we improve our ability to recognize dysfunction . . . without also increasing the chances of a false alarm."). Also, "evidence indicates that listing possible side effects of drugs increases the probability that patients will report them, even when they are in fact taking placebos." Richard Dorsey, The Patient Package Insert: Is It Safe and Effective?, 238 JAMA 1936, 1938 (1977) (citing K. Rickels and R.W. Downing, Side Reactions in Neurotics: II. Can Patients Judge Which Symptoms Are Caused by Their Medication?, 10 CLIN. PHARMACOL. 298 (1970)).
37. Ivan Barofsky, Potential Effects on the Health Care System - 1, Joint Symposium on Drug Information for Patients: The Patient Package Insert, 11 DRUG INFO. J. 71S, 73S (Jan. 1977) ("We can never have the situation where we improve our ability to recognize dysfunction . . . without also increasing the chances of a false alarm."). Also, "evidence indicates that listing possible side effects of drugs increases the probability that patients will report them, even when they are in fact taking placebos." Richard Dorsey, The Patient Package Insert: Is It Safe and Effective?, 238 JAMA 1936, 1938 (1977) (citing K. Rickels and R.W. Downing, Side Reactions in Neurotics: II. Can Patients Judge Which Symptoms Are Caused by Their Medication?, 10 CLIN. PHARMACOL. 298 (1970)).
38. Ivan Barofsky, Potential Effects on the Health Care System - 1, Joint Symposium on Drug Information for Patients: The Patient Package Insert, 11 DRUG INFO. J. 71S, 73S (Jan. 1977) ("We can never have the situation where we improve our ability to recognize dysfunction . . . without also increasing the chances of a false alarm."). Also, "evidence indicates that listing possible side effects of drugs increases the probability that patients will report them, even when they are in fact taking placebos." Richard Dorsey, The Patient Package Insert: Is It Safe and Effective?, 238 JAMA 1936, 1938 (1977) (citing K. Rickels and R.W. Downing, Side Reactions in Neurotics: II. Can Patients Judge Which Symptoms Are Caused by Their Medication?, 10 CLIN. PHARMACOL. 298 (1970)).
39. See B. Blackwell, Drug Therapy: Patient Compliance, 289 N. ENG. J. MED. 249 (1973).
40. Hammock v. Hoffmann-LaRoche, Inc., N.J. Super. Ct. A-124 Sept. Term 1994, DDS No. 52-1-6305 (decided Aug. 2, 1995) (determining that Hoffmann-LaRoche's black box warning sufficiently informed physicians prescribing Accutane® of the drug's potential to cause birth defects); Margaret Gilhooley, Learned Intermediaries, Prescription Drugs, and Patient Information, 30 ST. LOUIS U. L.J. 633 (1986).
41. 21 C.F.R. § 201.57(e)