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The usage of Isotretinoin may perhaps cause severe birth defect

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Updated on: 2025-07-26

New research found that Isotretinoin a drug which is being used to care for severe acne is the main reason of reducing the sebum secretion. Researchers have practiced on the consequence of the drug in pregnant women discloses with the purpose of it can cause birth defects. Taking into consideration of the potential risks, the U.S. Food and Drug Administration and the drug manufacturers developed a voluntary pregnancy prevention program (PPP) in 1988 to try and avoid conception in women taking the drug. 

It was almost immediately placed by the SMART program (System to Manage Accutane Related Teratogenicity) with the intention of placed more importance on pregnancy testing and contraception. On the other hand the FDA launched an innovative plan called the iPLEDGE with stricter requirements that required patients and doctors to maintain register in an electronic database earlier than the drug can be dispensed. However it also includes the earlier stated requirements on the subject of pregnancy tests and birth control.

An investigation was performed surrounded by 34 women who became pregnant at the same time as taking isotretinoin. These women had got in touch with the intention of a birth defect information service looking for information on the effects of isotretinoin. As the main motive of the assessment was to appraise how the drug was distributed in women who consequently became pregnant and to recognize potential reasons for failure in preventing conception.  Interestingly the consequences amid 1989 and 1993, 177,216 permitted women registered in the inspection.

In a discussion with 24,503 women within one month of enrollment exposed that 99 percent had been told to keep away from pregnancy. Next to that time, roughly 54 percent were not sexually active (of whom 37 percent used contraception) and 42 percent were sexually active (of whom 99 percent used contraception); 4 percent were unproductive. In the middle of 124,216 women with completed telephone or mail follow-up results, there were 402 pregnancies during therapy (3.4 per 1000 courses of isotretinoin); 72 percent of the pregnant women had elective abortions, 16 percent spontaneous abortions, 3 percent ectopic pregnancies, and 8 percent live births.



 
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