Safety of diclofenac use during early pregnancy: A prospective observational cohort study
| Autor: | Reinhard Meister, Katarina Dathe, Stephanie Padberg, Christof Schaefer, Stefanie Hultzsch, Katja Meixner, Verena Linsenmeier, Tatjana Tissen-Diabaté |
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| Rok vydání: | 2018 |
| Předmět: |
Male
medicine.medical_specialty Diclofenac Analgesic Early pregnancy factor Abortion Toxicology Congenital Abnormalities Pharmacovigilance 03 medical and health sciences 0302 clinical medicine Pregnancy Germany medicine Humans Prospective Studies Maternal-Fetal Exchange 030219 obstetrics & reproductive medicine biology Obstetrics business.industry Anti-Inflammatory Agents Non-Steroidal Infant Newborn Pregnancy Outcome medicine.disease Pregnancy Trimester First stomatognathic diseases biology.protein Female Teratogenic risk business 030217 neurology & neurosurgery medicine.drug Cohort study |
| Zdroj: | Reproductive Toxicology. 77:122-129 |
| ISSN: | 0890-6238 |
| Popis: | Diclofenac is a widely used analgesic so that exposure during pregnancy may frequently occur. Most publications have evaluated the safety of NSAIDs on pregnancy outcome as a group of substances. Specific data on diclofenac are rare. This observational cohort study used the German Embryotox pharmacovigilance database to assess the risk of major birth defects and spontaneous abortion after first trimester exposure to diclofenac. A group of 260 women who took diclofenac during first trimester was compared to 778 non-exposed pregnancies. In the diclofenac exposed cohort 4 major birth defects were observed among 220 live-born infants and 25 spontaneous abortions occurred. Neither the rate of major birth defects (1.8% vs. 3.1%; OR adjusted 0.59; 95% CI 0.17-2.08) nor the risk of spontaneous abortion (HR adjusted 0.90; 95% CI 0.56-1.46) was increased. The study results do not indicate that diclofenac exposure during first trimester is associated with a teratogenic risk. |
| Databáze: | OpenAIRE |
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