When a Uniquely Effective Drug is Teratogenic
Abstract
Isotretinoin is a uniquely effective oral agent for the treatment of severe cystic acne.1 Typically a patient uses the medicine for 20 weeks, and in most cases enters a prolonged remission. First marketed in the United States in 1982, isotretinoin had been used by more than 800,000 people by the end of 1987. About 40 percent of these were women.2 , 3 The substantial teratogenic effect of retinoic acid in animals has been known for many years. As a result, the package insert for isotretinoin included from the beginning a warning against its use during pregnancy. In spite of this precaution, within . . .
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RA induces undesirable side effects (congenital malformations as well as mucocutaneous dryness, headache, and hypertriglyceridemia) when administered at high concentrations.
“Moreover, it induces undesirable side effects (congenital malformations40 as well as mucocutaneous dryness, headache, and hypertriglyceridemia41) when administered at high concentrations.”
From Advances and challenges in retinoid delivery systems in regenerative and therapeutic medicine (2020) · cites this paper as [40]
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References 14 · Cited by 86
- Authors
- Stern, R. S.
- Affiliations
- Beth Israel Deaconess Medical Center (US)
- Corresponding author
- Stern, Robert S.
- ORCID
- Stern, Robert S.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 1989-04-13
- Volume
- 320
- Issue
- 15
- Pages
- 1007-1009
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2061170014
- Cited by
- 86
- References
- 14
- Citations by year
- 2025: 1 · 2024: 1 · 2023: 1 · 2020: 2 · 2019: 3 · 2018: 1 · 2017: 5 · 2016: 4 · 2014: 2 · 2013: 1 · 2012: 4
- FWCI
- 8.19
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
- Health Sciences › Medicine › Dermatology › Acne and Rosacea Treatments and Effects
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Keywords
- isotretinoin, teratogenicity, retinoic acid, cystic acne, pregnancy, drug safety, adverse drug reactions
- MeSH terms
- Abnormalities, Drug-Induced, Abortion, Spontaneous, Acne Vulgaris, Drug Labeling, Female, Humans, Pregnancy, Drug Prescriptions, Isotretinoin
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