Archive for the 'Yaz' Category

Yaz, Yasmin Judge Asked To Allow Evidence Of FDA Conflicts

The judge overseeing the Yaz and Yasmin multidistrict litigation has been asked to allow evidence concerning a U.S. Food and Drug Administration (FDA) conflict of interest. Women suing Yaz, Yasmin maker, Bayer, for injuries they alleged to have suffered from the controversial birth control pills, have urged U.S. District Judge, David Herndon, to review evidence pointing to conflicts of interest at the agency, wrote The Madison Record.

The Plaintiffs’ Steering Committee has opposed a January 17 motion by the defense to exclude former FDA commissioner, David Kessler’s, opinions about the current FDA. Kessler, an expert witness for the plaintiffs, noted panel conflicts in an expert opinion in which he stated, after reviewing internal Bayer documents, that Bayer wrongfully withheld safety information from the agency, said Pharmalot. (more…)

Yaz, Yasmin Need Stronger Blood Clot Info, FDA Advisors Say

Yaz, Yasmin and similar birth control pills need stronger blood clot information, according to the U.S. Food & Drug Administration (FDA).

Advisers to the health agency issued a recommendation that labels for the popular, newer generation oral contraceptives, including Yaz and Yasmin, indicate that the drugs may put women at increased risks for dangerous blood clots. Yaz and Yasmin contain drospirenone, a controversial progestin that lawsuits allege has led to serious side effects, including deep vein thrombosis and pulmonary embolism, as well as heart attack, stroke, and gall bladder disease. (more…)

Yaz, Yasmin Could Soon Have Stronger Blood Clot Warnings

As health regulators consider reported side effects from new generation birth control pills, Yaz and Yasmin could soon be mandated to contain stronger blood clot warnings. The U.S. Food & Drug Administration (FDA) is currently conducting a review of Yaz and Yasmin safety.

The FDA has scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee for this Thursday to discuss Yaz, Yasmin, and similar, new generation birth control pills. Evidence indicates that these pills may be putting women at increased risks for dangerous blood clots, including deep vein thrombosis and pulmonary embolism, as well as heart attack, stroke, and gall bladder disease. (more…)