The FDA, Regulation, and the Risk of Stroke
Abstract
When Jane Henney, commissioner of the Food and Drug Administration (FDA), announced on October 10, 2000, the agency's intention to have products containing phenylpropanolamine withdrawn from the market, another chapter — perhaps the final one — for this over-the-counter drug was opened. The FDA acted even before the results of the work on which the decision is based could be published. In this issue of the Journal, Kernan et al. report the results of an exemplary epidemiologic effort, the Hemorrhagic Stroke Project.1 This project was designed in response to the FDA's concern about the safety of phenylpropanolamine, which began in . . .
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The association of sympathomimetic amines with dose-related increases in blood pressure has been well established.
“The association of sympathomimetic amines with dose-related increases in BP has been well established.214,215”
From Resistant Hypertension: Detection, Evaluation, and Management: A Scientific Statement From the American Heart Association (2018) · cites this paper as [214]
Cites
Haller, C. A., & Benowitz, N. L. (2000) · New England Journal of Medicine · doi:10.1056/nejm200012213432502 · Cited by 956 · see citing works
Phenylpropanolamine and the Risk of Hemorrhagic Stroke
Kernan, W. N., Viscoli, C. M., Brass, L. M., Broderick, J. P., Brott, T. G., Feldmann, E. G., Morgenstern, L. B., Wilterdink, J. L., & Horwitz, R. I. (2000) · New England Journal of Medicine · doi:10.1056/nejm200012213432501 · Cited by 746 · see citing works
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Carey, R. M., Calhoun, D. A., Bakris, G. L., Brook, R. D., Daugherty, S. L., Dennison-Himmelfarb, C. R., Egan, B. M., Flack, J. M., Gidding, S. S., Judd, E., et al. (2018) · Hypertension · doi:10.1161/hyp.0000000000000084 · Cited by 1,153 · see citing works
ISSN exercise & sport nutrition review: research & recommendations
Kreider, R. B., Wilborn, C. D., Taylor, L., Campbell, B., Almada, A. L., Collins, R., Cooke, M., Earnest, C. P., Greenwood, M., Kalman, D. S., et al. (2010) · Journal of the International Society of Sports Nutrition · doi:10.1186/1550-2783-7-7 · Cited by 428 · see citing works
Jones, D. W., Ferdinand, K. C., Taler, S. J., Johnson, H. M., Shimbo, D., Abdalla, M., Altieri, M. M., Bansal, N., Bello, N. A., Bress, A. P., et al. (2025) · JACC · doi:10.1016/j.jacc.2025.05.007 · Cited by 280 · see citing works
Herbal ephedra/caffeine for weight loss: a 6-month randomized safety and efficacy trial
Boozer, C., Daly, P., Homel, P., Solomon, J., Blanchard, D., Nasser, J., Strauss, R., & Meredith, T. (2002) · International Journal of Obesity · doi:10.1038/sj.ijo.0802023 · Cited by 203 · see citing works
Creatine use among young athletes
Metzl, J. D., Small, E., Levine, S. R., & Gershel, J. C. (2001) · PEDIATRICS · doi:10.1542/peds.108.2.421 · Cited by 188 · see citing works
Nutritional supplements and doping
Pipe, A., & Ayotte, C. (2002) · Clinical Journal of Sport Medicine · doi:10.1097/00042752-200207000-00008 · Cited by 128 · see citing works
ISSN Exercise & Sport Nutrition Review: Research & Recommendations
Kreider, R. B., Almada, A. L., Antonio, J., Broeder, C., Earnest, C., Greenwood, M., Incledon, T., Kalman, D. S., Kleiner, S. M., Leutholtz, B., et al. (2004) · Journal of the International Society of Sports Nutrition · doi:10.1186/1550-2783-1-1-1 · Cited by 38 · see citing works
- Authors
- Fleming, G. A.
- Corresponding author
- Fleming, G. Alexander
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2000-12-21
- Volume
- 343
- Issue
- 25
- Pages
- 1886-1887
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2028472700
- Cited by
- 63
- References
- 2
- Citations by year
- 2026: 1 · 2025: 3 · 2021: 1 · 2020: 1 · 2019: 1 · 2018: 2 · 2017: 3 · 2015: 1 · 2014: 1 · 2012: 1
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Health Sciences › Medicine › Epidemiology › Acute Ischemic Stroke Management
- Keywords
- phenylpropanolamine, hemorrhagic stroke, drug safety, FDA regulation, drug withdrawal, over-the-counter drugs, adverse drug reactions, regulatory decision-making
- MeSH terms
- Appetite Depressants, Drugs, Chinese Herbal, Ephedrine, Female, Humans, Phenylpropanolamine, Product Surveillance, Postmarketing, United States, United States Food and Drug Administration, Nasal Decongestants, Drug Approval, Dietary Supplements, Intracranial Hemorrhages, Plant Preparations, Ephedra, Ephedra sinica
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