Consumers of Yaz and Yasmin birth control pills should be warned of the serious risk of dangerous blood clots linked to the drugs, said FDA scientists in a written report.
In documents released Tuesday, in advance of a Thursday panel hearing, the Food and Drug Administration (FDA) said information about the risk of dangerous blood clots should appear in labeling used by doctors and patients.
“We believe that, because of the consistency in recent reports for an increased risk, product labeling should reflect that very real possibility,” state the briefing documents from FDA scientists.
Even though Yasmin and Yaz were marketed by Bayer as safer alternatives to older birth control drugs, the reality has turned out to be the opposite, with analyses of 800,000 women showing higher risk of blood clots than seen with other contraceptives.