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According to Benjamin, one woman involved in a clinical trial became pregnant, and the company urged her to have an abortion. Phenytoin: Isotretinoin capsules have not been shown to alter the pharmacokinetics of phenytoin in a study in seven healthy volunteers. . Phenytoin is known to cause osteomalacia. No formal clinical studies have been conducted to assess if there is an interactive effect on bone loss between phenytoin and isotretinoin.. Is buying Accutane online safe.Isotretinoin became Accutane, and in clinical trials researchers carefully avoided exposing pregnant women to the drug. In an affidavit, David Benjamin who monitored the clinical trials in 1977 and 1978 explained, I felt that the risk of giving birth to a deformed was so great as to make it ethically improper and scientifically foolish to give Accutane to women who were not using an effective form of contraception. Therefore, caution should be exercised when using these drugs together. 21 Most test centers excluded women. Those researchers who did include women in trials required a negative pregnancy test and contraceptive use. 22 When Roche submitted Accutane for FDA approval in July of 1981, the company reported that no human babies had been exposed to the drug.The internal debate alleged in the case comes to light after a Food and Drug Administration researcher last month told a Senate panel Accutane was one of five drugs that should be studied for possible withdrawal from the market. The FDA has since moved to tighten safeguards against the major side effect: birth defects in children whose mothers took Accutane while pregnant. Hoffmann-La Roche had conducted animal studies, and offspring of subjects showed facial deformities much like the ones that have subsequently been seen in Accutane babies. These results are consistent with the in vitro finding that neither isotretinoin nor its metabolites induce or inhibit the activity of the CYP 2C9 human hepatic P450 enzyme.

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