Oral Contraceptives Petition Seeking Ban On Third-Generation Products Denied By FDA
This article was originally published in The Pink Sheet Daily
Public Citizen losses again as the agency says current product labeling for desogestrel-containing oral contraceptives adequately describes the risk of venous thromboembolism; FDA notes the difficulty in comparing the magnitude of risks between combination OCs.
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EMA says there is currently no cause for concern, amid increasing claims in Europe’s media that combined contraceptives can cause blood clots.
Bayer updates labeling for its drospirenone-containing contraceptives to reflect potentially higher risks compared to other birth control pills as FDA seeks ways to get more definitive information.
Some patients in an FDA-funded study had less risk for blood clots than others and finding the reason is a subject for future studies, several members of an advisory panel told FDA Dec. 9. The Reproductive Health Drugs and Drug Safety and Risk Management Committees concluded in a 19-5 vote that the drug’s benefits outweigh its risks.