Navigation Links
FDA Issues Safety Communication Regarding Increased Risk of Blood Clots with Certain Birth Control Pills

PHILADELPHIA, Sept. 27, 2011 /PRNewswire-USNewswire/ -- On Monday, the United States Food and Drug Administration ("FDA") said its primary results of an agency funded study suggest a 1.5 fold increase risk of blood clots for women who use drospirenone-containing birth control products, such as Yaz and Yasmin.

The safety of Yaz and Yasmin is the subject of approximately 2,000 lawsuits filed in Pennsylvania before Philadelphia Court of Common Pleas Judge Sandra Mazer Moss, Coordinating Judge of the Complex Litigation Center.  Another 7,110 lawsuits are pending in federal court before the Honorable Judge David R. Herndon, who oversees the federal multidistrict litigation (MDL).  

The lawsuits allege that Yaz and Yasmin have risks beyond those of traditional birth control pills and that Bayer over-promoted the drug without disclosing the higher risks. Bayer was warned by the Food and Drug Administration (FDA), in the fall of 2008, that its television advertisements were misleading and did not disclose the additional risks.  

The FDA announced through its website that, "initial data from an FDA-funded epidemiologic study exploring the association of blood clots with several different hormonal contraceptive products, including levonorgestrel-containing contraceptives, appear consistent with results from the 2009 and 2011 published studies. Although FDA's review is ongoing, the preliminary data from the FDA-funded study are consistent with an approximately 1.5-fold increase in the risk of blood clots for users of drospirenone-containing contraceptives compared to users of other hormonal contraceptives."

Judge Moss appointed three Pennsylvania lawyers as Liaison Counsel for the plaintiffs, including Michael M. Weinkowitz of Levin, Fishbein, Sedran & Berman, Philadelphia; Daniel N. Gallucci of RodaNast, P.C., Lancaster, and Rosemary Pinto of Feldman & Pinto, Philadelphia.  Dianne M. Nast, RodaNast, P.C. was appointed Pennsylvania Federal-State Liaison Counsel by the Honorable David R. Herndon.

SOURCE RodaNast, P.C.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. The First Annual Cervical Cancer/HPV Conference Tackles Controversial Vaccine Issues and Encourages Advocacy
2. European Unions CHMP Issues Positive Opinion on PEGINTRON(TM) Combination Therapy for Retreating Hepatitis C Patients Who Failed Previous Therapy
3. European CHMP Issues Positive Opinion for ATRIPLA(R) (efavirenz 600 mg/ emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)
4. Bayer Issues Additional Guidance to Physicians on Trasylol(R)
5. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on CEL-SCI Corporation
6. QIAGEN and Center for Molecular Medicine Create Research Collaboration for Molecular Diagnostic Markers for Breast Cancer, Other Womens Health Issues
7. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on Bioniche Life Sciences Inc.
8. Lupus Under the Spotlight: U.S. Congress Shows Support for Womens Health Issues
9. European Unions CHMP Issues Positive Opinion on Sugammadex
10. Newly Published Study Shows OPKOs siRNA Bevasiranib Is Taken Up by Target Tissues in the Eye
11. Ending Cervical Cancer Featured at Summit; QIAGEN CEO Issues a Call to Global Women Leaders
Post Your Comments:
(Date:6/24/2016)...  Collagen Matrix, Inc., ("Collagen Matrix") the driving ... collagen and mineral based medical devices for tissue ... Messer has joined the company as Vice ... growing portfolio of oral surgery, neurosurgery, orthopaedic and ... the Collagen Matrix executive team as an accomplished ...
(Date:6/24/2016)... , June 24, 2016   Bay ... Rehabilitation Network,s Dean Center for Tick Borne ... Medicine and Rehabilitation, MIT Hacking Medicine, University of ... Innovation, today announced the five finalists of ... Lyme disease.  More than 100 scientists, clinicians, researchers, ...
(Date:6/24/2016)... , June 24, 2016 ... of the "Structural Electronics 2015-2025: Applications, Technologies, ... In-Mold Electronics, Smart Skin, ... Photovoltaics Structural electronics involves electronic ... load-bearing, protective structures, replacing dumb structures such as ...
Breaking Medicine Technology:
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... On June ... sponsor of the 2016 Cereal Festival and World’s Longest Breakfast Table in Battle Creek, ... of the city’s history as home to some of the world’s leading providers of ...
(Date:6/26/2016)... ... ... blind and certified personal trainer is helping to develop a weight loss fitness plan that ... the two major problems leading the fitness industry today:, , All ... They don’t eliminate all the reasons people quit their exercise program , ...
(Date:6/25/2016)... , ... June 25, 2016 , ... Austin residents seeking ... American College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical ... effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by ...
(Date:6/25/2016)... ... 25, 2016 , ... First Choice Emergency Room , the largest network ... the Medical Director of its new Mesquite-Samuell Farm facility. , “We are pleased ... location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. ...
(Date:6/25/2016)... ... , ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department ... in recognition of their exemplary accomplishments in worksite health promotion. , The Wellness at ... Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was one of 42 ...
Breaking Medicine News(10 mins):