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Safety of Phenylpropanolamine

Safety of Phenylpropanolamine Abstract Sir.—I would like to respond to several statements contained in the article by Bale and colleagues1 describing the case of a 13-year-old girl who exhibited hypertension, severe headache, and grand mal seizures three hours after ingestion of one pill of an over-the-counter (OTC) diet preparation containing phenylpropanolamine (50 mg) and caffeine (200 mg) along with "two glasses of wine." Although the potential toxicity of multiple-drug ingestion by patients in a nontherapeutic milieu is a valid concern, the authors' statement that "The pathogenesis of serious CNS [central nervous system] complications, in particular headache and intracranial hemorrhage, appears to be related to the sympathomimetic effects of phenylpropanolamine on systemic BP [blood pressure]" is not substantiated. In their table entitled "Phenylpropanolamine-Associated CNS Complications in the Pediatric Age Group" the authors cite five additional cases of CNS complications. In three of the six cases listed, the blood pressure was either normal or References 1. Bale JF, Fountain MT, Shaddy R: Phenylpropanolamine-associated CNS complications in children and adolescents . AJDC 1984;138:683-685. 2. Bernstein E, Diskant BM: Phenylpropanolamine: A potentially dangerous drug . Ann Emerg Med 1982;11:311-315.Crossref 3. King J: Hypertension and cerebral hemorrhage after Trimolets ingestion . Med J Aust 1979;2:258. 4. Elliott CF, Whyte JC: Phenylpropanolamine and hypertension . Med J Aust 1981;1:715. 5. Horowitz JD, Howes LG, Christophidsis M, et al: Hypertensive responses induced by decongestant preparations . Lancet 1980;1:60-61.Crossref 6. Noble RE: Phenylpropanolamine and blood pressure . Lancet 1982;1:1419.Crossref 7. Silverman HI, Kreger BE, Lewis GP, et al: Lack of side effects from orally administered phenylpropanolamine and phenylpropanolamine with caffeine: A controlled three-phase study . Curr Ther Res 1980;28:185-194. 8. Unger DL, Unger L, Temple DE: Effect of an anti-asthmatic compound on blood pressure of hypertensive asthmatic patients . Ann Allergy 1967;25:260-261. 9. Renvall U: A double-blind clinical study with Monohydrin tablets in patients with nonallergic chronic rhinitis . J Int Med Res 1979;7: 235. 10. Mitchell CA: Possible cardiovascular effect of phenylpropanolamine and belladonna alkaloids . Ther Res 1968;10:47-55. 11. Randall JE, Hendley JO: A decongestant–antihistamine mixture in the prevention of otitis media in children with colds . Pediatrics 1979;63:483-485. 12. Kjellman NM, Harder H, Lindwall L, et al: Long-term treatment with brompheniramine and phenylpropanolamine in recurrent otitis media: A double-blind study . J Otolaryngol 1978;7:257-261. 13. Saunte C, Johansson S: Clinical trial with Lunerin mixture and Lunerin mite in children with secretory otitis media . J Int Med Res 1978; 6:50-55. 14. Altschuler S, Conte A, Sebok M, et al: Three controlled trials of weight loss with phenylpropanolamine . Int J Obes 1982;6:549-556. 15. Hoebel BG, Krauss IK, Cooper J, et al: Body weight decreased in humans by phenylpropanolamine taken before meals . Obes/Bariatric Med 1975;4:200-206. 16. Appelt GD: Weight control products , in: Handbook of Nonprescription Drugs , ed 7. Washington, DC, American Pharmaceutical Association, 1982. 17. Appelt GD: The safety of phenylpropanolamine . J Clin Psychopharmacol 1983;3:332-333.Crossref 18. Hayes AH: New drug status of OTC combination products containing caffeine, phenylpropanolamine, and ephedrine . Federal Register 1982;47:35344-35346. 19. FDA takes action on diet aids . Pharmacy Weekly 1983;22:187. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png American Journal of Diseases of Children American Medical Association

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References (22)

Publisher
American Medical Association
Copyright
Copyright © 1985 American Medical Association. All Rights Reserved.
ISSN
0002-922X
DOI
10.1001/archpedi.1985.02140090013009
Publisher site
See Article on Publisher Site

Abstract

Abstract Sir.—I would like to respond to several statements contained in the article by Bale and colleagues1 describing the case of a 13-year-old girl who exhibited hypertension, severe headache, and grand mal seizures three hours after ingestion of one pill of an over-the-counter (OTC) diet preparation containing phenylpropanolamine (50 mg) and caffeine (200 mg) along with "two glasses of wine." Although the potential toxicity of multiple-drug ingestion by patients in a nontherapeutic milieu is a valid concern, the authors' statement that "The pathogenesis of serious CNS [central nervous system] complications, in particular headache and intracranial hemorrhage, appears to be related to the sympathomimetic effects of phenylpropanolamine on systemic BP [blood pressure]" is not substantiated. In their table entitled "Phenylpropanolamine-Associated CNS Complications in the Pediatric Age Group" the authors cite five additional cases of CNS complications. In three of the six cases listed, the blood pressure was either normal or References 1. Bale JF, Fountain MT, Shaddy R: Phenylpropanolamine-associated CNS complications in children and adolescents . AJDC 1984;138:683-685. 2. Bernstein E, Diskant BM: Phenylpropanolamine: A potentially dangerous drug . Ann Emerg Med 1982;11:311-315.Crossref 3. King J: Hypertension and cerebral hemorrhage after Trimolets ingestion . Med J Aust 1979;2:258. 4. Elliott CF, Whyte JC: Phenylpropanolamine and hypertension . Med J Aust 1981;1:715. 5. Horowitz JD, Howes LG, Christophidsis M, et al: Hypertensive responses induced by decongestant preparations . Lancet 1980;1:60-61.Crossref 6. Noble RE: Phenylpropanolamine and blood pressure . Lancet 1982;1:1419.Crossref 7. Silverman HI, Kreger BE, Lewis GP, et al: Lack of side effects from orally administered phenylpropanolamine and phenylpropanolamine with caffeine: A controlled three-phase study . Curr Ther Res 1980;28:185-194. 8. Unger DL, Unger L, Temple DE: Effect of an anti-asthmatic compound on blood pressure of hypertensive asthmatic patients . Ann Allergy 1967;25:260-261. 9. Renvall U: A double-blind clinical study with Monohydrin tablets in patients with nonallergic chronic rhinitis . J Int Med Res 1979;7: 235. 10. Mitchell CA: Possible cardiovascular effect of phenylpropanolamine and belladonna alkaloids . Ther Res 1968;10:47-55. 11. Randall JE, Hendley JO: A decongestant–antihistamine mixture in the prevention of otitis media in children with colds . Pediatrics 1979;63:483-485. 12. Kjellman NM, Harder H, Lindwall L, et al: Long-term treatment with brompheniramine and phenylpropanolamine in recurrent otitis media: A double-blind study . J Otolaryngol 1978;7:257-261. 13. Saunte C, Johansson S: Clinical trial with Lunerin mixture and Lunerin mite in children with secretory otitis media . J Int Med Res 1978; 6:50-55. 14. Altschuler S, Conte A, Sebok M, et al: Three controlled trials of weight loss with phenylpropanolamine . Int J Obes 1982;6:549-556. 15. Hoebel BG, Krauss IK, Cooper J, et al: Body weight decreased in humans by phenylpropanolamine taken before meals . Obes/Bariatric Med 1975;4:200-206. 16. Appelt GD: Weight control products , in: Handbook of Nonprescription Drugs , ed 7. Washington, DC, American Pharmaceutical Association, 1982. 17. Appelt GD: The safety of phenylpropanolamine . J Clin Psychopharmacol 1983;3:332-333.Crossref 18. Hayes AH: New drug status of OTC combination products containing caffeine, phenylpropanolamine, and ephedrine . Federal Register 1982;47:35344-35346. 19. FDA takes action on diet aids . Pharmacy Weekly 1983;22:187.

Journal

American Journal of Diseases of ChildrenAmerican Medical Association

Published: Jul 1, 1985

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