Tag Archives: fda
FDA scientists say blood clot risk should be added to Yaz and Yasmin labels
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 … Continue reading
Former FDA Commissioner says Bayer hid blood clot dangers of Yasmin and Yaz birth control pills
A former head of the FDA says Bayer hid reports of dangerous blood clots from the FDA, according to court documents released Monday by a U.S. federal court in Illinois. Bayer attorneys have been trying to prevent former FDA Commissioner David … Continue reading
FDA Panel Urges Additional Studies and Regulations for Pelvic Mesh
A U.S. Food and Drug Administration (FDA) advisory panel on Sept. 8 called for additional clinical studies and tighter regulations of transvaginal mesh to treat pelvic organ prolapse (POP). According to The Wall Street Journal, the FDA panel supports plans … Continue reading
FDA Says Surgical Mesh Makers May Have to Submit More Safety Data
Transvaginal surgical mesh manufacturers may need to conduct more human safety studies according to a U.S. Food and Drug Administration (FDA) staff recommendation released August 31, 2011. According to Bloomberg, an increasing number of women are having serious problems with … Continue reading
Risk of Bladder Cancer Added to Actos (Pioglitazone) Label
The risk of bladder cancer has been added to the label of the diabetes drug, Actos (pioglitazone). The new warning was approved Aug. 5 by the U.S. Food and Drug Administration (FDA) after interim findings from a 10-year study showed … Continue reading
Diflucan May be Linked to Birth Defects, Warns the FDA
The U.S. Food and Drug Administration (FDA) issued a safety alert on Aug. 3 to warn patients and healthcare providers about a potential risk of birth defects when women take high doses of Diflucan (fluconazole) during the first trimester of … Continue reading
Breast Implants Linked to Cancer, Says FDA
The U.S. Food and Drug Administration (FDA) announced that there might be a link between breast implants and cancer. The type of cancer is known as anaplastic large cell lymphoma (ALCL). ALCL is a very rare and aggressive type of … Continue reading
FDA Cautions Insulin Pen Users Not to Share Pens or Needles
After learning that at least 2,000 patients were at risk of getting blood-borne HIV or hepatitis through sharing insulin pens, the Food and Drug Administration (FDA) issued a warning to emphasize that the pens must be used by one person … Continue reading
Insulin Pen Risks Include HIV and Hepatitis Transmission- Warning Issued
The FDA has issued an alert to remind health care professionals that single-patient insulin pens and insulin cartridges should not be used to administer medication to more than one patient because of the potential risk of transmitting blood-borne pathogens such … Continue reading
Wyeth Accused of Racism in its Testing of Rapamune
House Oversight Committee chairman Ed Towns of New York (D) has accused Pfizer newly acquired unit, Wyeth, of targeting African Americans in its testing and sales of the kidney transplant drug Rapamune. Chairman Towns, having reviewed the situation first hand, … Continue reading