Posts Tagged ‘Lancaster’
Yaz has been shown to cause pulmonary embolism, Blood clots and Stroke in young women. Yaz lawyers Filing yaz Blood clot lawsuits.
FDA advisory panel recommends stronger warning for drospirenone-containing birth control
Publish date: Dec 16, 2011
An FDA advisory panel has recommended that some oral contraceptives may need stronger warning labels, according to recent reports.
The day-long joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of FDA was to involve discussion on the risks and benefits of drospirenone-containing birth control pills because of emerging safety concerns over the potentially higher risk of venous thromboembolism associated with these drugs compared with levonorgestrel-containing drugs, according to FDA meeting materials.
The committee heard testimony on research results from Bayer HealthCare Pharmaceuticals, the manufacturer of a family of drospirenone-containing birth control pills, including Yaz and Yasmin. Research results presented by Bayer demonstrated no increased risk of blood clots, which conflicted with other studies that found evidence that drospirenone was associated with higher risk of blood clot formation.
Although 15 of FDA's 26 expert advisors voted that the benefits of these birth control pills outweighed the risk of blood clots, 21 of the 26 panelists voted that the current labels for Bayer's drospirenone-containing combination oral contraceptives do not adequately reflect the products’ risk benefit profile and should be revised to include additional information from available studies, said a statement from Bayer.
In September, FDA released a statement informing the public that it remained concerned about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills. The agency scheduled the meeting after several studies demonstrated conflicting results.
Bayer HealthCare Pharmaceuticals Vice President and Head of US Medical Affairs Pamela A. Cyrus, MD, said, "We thank the Committee members for their efforts and participation in the discussion on the benefit-risk profile for drospirenone-containing combination oral contraceptives.” The company added that it will continue to work with FDA and other regulatory authorities to make label updates as appropriate.
Yaz Lawyers Pennsylvania and Yaz lawyers Philadelphia Allentown, Erie, Harrisburg, Lancaster, Meadville, Pitttsburgh, Pocanos, Reading, Scranton, Williamsport, and thru-out Pennsylvania. are filing Yaz lawsuits for blood Clots, Pulmonary embolism, Stroke and heart Attacks from Yaz.
Philadelphia Yaz News
May 12th, 2010. By Kristine B
As Bayer adds new warnings to its birth control pills in the wake of Philadelphia , Pennsylvania Lawsuits for Yaz, we thought it would be a good idea to break Yasmin and Yaz down by the numbers.
2001: The year Yasmin came on the market
2006: The year Yaz came on the market
2008: The year Bayer (maker of Yasmin and Yaz) received a warning from the FDA about overstating the pills’ effectiveness while minimizing their risks
2008: The year Ocella receives FDA approval; Ocella is the generic version of Yaz that is manufactured by Barr, which is owned by Teva
2009: The year Bayer launches new $20 million ad campaign to address the FDA’s warning
2009: The year the FDA issued a recall on certain lots of Yaz and Ocella for “Out of Specification analytical value for chemical assays of drospirenone and ethinyl estradiol was averaged with another analytical value to provide a reported result that was within specification.”
2010: The year Bayer added new warnings about the risks of blood clots linked to Yasmin and Yaz
1,100: Approximate number of lawsuits filed against Bayer regarding Yasmin and Yaz
$1.64 billion: Approximate profit Bayer reportedly made from Yasmin and Yaz during 2009
993: Number of reports the FDA received by November, 2009, of cases of pulmonary embolism linked to Yaz or Yasmin
487: Number of reports the FDA received of deep vein thrombosis
229: Number of reports the FDA received of other blood clots
800: Number of Canadians who have joined class-action lawsuits against Bayer
50: Number of women who reportedly died after taking Yaz, as of July, 2009
6.3: The number of times the risk of developing a blood clot is increased in women who take Yasmin or Yaz, according to a study in the British Medical Journal.
If you have a daughter who has blood clots from yaz or yasmin Call the yaz Birth control Pills helpline Today.
Note: Bayer has defended the birth control pills, saying they are safe and effective.
All stats taken from the FDA.gov, The New York Times, Los Angeles Times, Calgary Herald, BusinessWeek, The Bulletin (Philadelphia) and WISH tv, in addition to the British Medical Journal.