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Findings from studies completed by the British Medical Journal and the U.S. Food and Drug Administration (FDA) add to evidence linking oral contraceptives to a higher risk of blood clots, strokes, and pulmonary embolisms in women.
These contraceptives—which include Yaz® and Yasmin®, America’s highest selling birth control since 2006—contain a synthetic hormone drospirenone, which has been discovered to marginally increase the risk of blood clots in its users. The increased risk suggested by the studies is about two to three times more than those from older contraceptives.
Studies show that drospirenone, which is similar in chemical makeup to any popular diuretic, can cause significantly increased potassium levels due to its interference with normal kidney functions. When the kidney function is stalled, potassium builds in the bloodstream. Too much potassium, called hyperkalemia, can lead to cardiac arrest, death, and the formulation of blood clots.
While the report recognizes all birth control contraceptives contain risk for blood clots, the use of drospirenone in drugs such as Yaz and Yasmin has further increased the risk of blood clots forming in a deep vein in the body, a potentially fatal condition known as deep vein thrombosis (DVT).
DVT, a rare birth control pill side effect, could block blood flow and increase the risk of a pulmonary embolism, which has potential for deadly consequences. A pulmonary embolism is often caused by a blood clot in the leg breaking loose, traveling to the lungs. Each year, more than 300,000 people develop DVT or pulmonary embolisms.
Yaz also is linked to heart attacks. Not only does the blood clotting risk increase the chances of heart attacks from Yaz, but also the drug’s link to dangerously high potassium is an extreme emergency because it can cause the heart to stop suddenly. The symptoms are fairly nonspecific, including muscle weakness, malaise, and heart palpitations. Because of these risks, Yaz should not be taken if you have kidney failure, one kidney, liver disease, adrenal disease, or a history of blood clots. Some drugs—such as ibuprofen, high blood pressure medicine, and certain diuretics—can have serious interactions with Yaz and cause hyperkalemia.
An additional report published by the FDA further supports the BMJ findings, revealing that of 800,000 women analyzed, there is a 75 percent increased risk of blood clots in Yaz users when compared to other oral contraceptives. In response to these findings, Bayer—manufactures of Yaz and Yasmin—began updating packaging labels to properly warn consumers of the health risks associated with the drug. Reflecting this body of evidence, the new labels now state:
A prospective cohort study (EURAS1), conducted in Europe, showed the risk of thromboembolism (particularly venous thromboembolism) and death in Yasmin users to be comparable to that of oral contraceptive preparations, including those containing levonorgestrel.
Another prospective cohort study (Ingenix2), conducted in the USA, also showed a comparable risk of thromboembolism in Yasmin users compared to users of other COCs, including those containing levonorgestrel. In this study, COC comparator groups were selected based on having similar characteristics to those being prescribed Yasmin.
Prior to the release of amended warning labels, lawsuits had been filed against Bayer for unlawfully promoting the drug by concealing side effects, including blood clots, heart attacks, and pulmonary embolisms in Yaz users.
So far, the FDA has received hundreds of reports of injury or death among women taking Yaz or Yasmin. The Institute for Safe Medicine Practices also reported that Yaz and Yasmin ranked second in 2011 for the number of complications reported to the FDA.
The Consumer Product Safety Commission (CPSC) released a statement on Thursday announcing a voluntary recall on American Signature, Inc.’s Hayward Push Back Reclining Arm Chairs. According to a press release, the recall is being conducted due to a fall hazard with the potential to cause serious injuries.
The affected chairs stand 38-inches high and contain a double needle stich pattern that crosses the center of a brown or black faux leather backing. The recalled chairs were sold at Value City and American Signature Furniture Stores between June 2012 and Aug. 2012 for approximately $150. The chairs also have an item number of HGB-805-1 or HGB-805-2.
Problems with the chairs began when the CPSC began to receive reports of the chairs tipping backwards when in the fully reclined position, which can present a serious safety hazard to someone sitting in the chair.
Those who own an affected chair are being instructed to stop using the piece of furniture immediately. They should contact the manufacturer and the retailer where the item was purchased in order to receive store credit towards the purchase of a replacement item.
The Tennessee Personal Injury Lawyers with Hughes and Coleman Injury Lawyers recognize how dangerous a defective product can be, and they suggest speaking to an experienced product liability lawyer if you have been harmed by a defective or unsafe product.
Hughes & Coleman Injury Lawyers files seven lawsuits against DePuy® Orthopedics, Inc. in the Multi-District Ligation in Ohio.August 22, 2012
In 2010, Johnson & Johnson’s artificial joint replacement company, DePuy Orthopedics, Inc. issued a recall on two of their metal on metal hip replacement devices; ASR Hip Resurfacing System and ASR XL Acetabular System. The ASR Hip Resurfacing had been on the market since 2003 and the ASR XL since 2004. The FDA is currently reviewing problems associated with metal on metal hip replacement devices.
Lee Coleman, partner of Hughes & Coleman, speaks out about the lawsuits filed, "It is our job as attorneys to fight for those who are not able to fight for themselves. These clients deserve justice for the pain and suffering DePuy Orthopedics, Inc. caused and that is exactly what we are working for. Compensation will not erase the harm done by DePuy Orthopedics, but it will help our clients move forward with their lives." Read more.
Johnson & Johnson has notified the court that they will be pulling four of their transvaginal mesh lines from the market. In addition, Johnson & Johnson will be making changes to the warning labels and instructions on those transvaginal mesh lines that will remain on the market. This is good news to many, as the surgeries have severe complications. These complications include: mesh erosion through the vaginal wall and internal organs, infection, extreme pain, urinary problems, prolapse recurrence, bladder- bowel-vessel perforation, scarring, pain during sexual intercourse, and other injuries that significantly decrease the quality of life.
Woman suffering from any of the complications above should know, you are not alone. In 2010, more than 75,000 women had transvagtinal mesh surgery to repair pelvic organ prolapse. Many woman have started their own local support groups for those dealing with transvaginal mesh surgeries and complications. These groups give woman the opportunity to share and speak with woman having similar experiences with this condition.
June 22, 2011
News Channel 2 reported on a study conducted by a Nationwide Children’s Hospital doctor, who used data complied by the US Consumer Product Safety Commission to determine that a child drowns every five days in a portable “kiddie” pool during the summer months.
Statistics showed that:
- 209 children below the age of 12-years-old died in portable pools from 2001 to 2009
- 94% of the accidents involved children younger than 5-years-old
- 81% of the events took place in the summer
- Boys accounted for 56% of the accidents
Sarah Haverstick of the Safe Children Program at the Children's Hospital at Vanderbilt Medical Center says that a child can drown in less than an inch of water.
Several suggestions were given in order to keep children safe around the pool this summer, such as:
- adult supervision
- fencing and gating
- after use, portable pools should always be drained to empty and stored upside down
The article stated Vanderbilt Medical Center saw five times more drowning’s in 2010 than in 2009.
The Tennessee Personal Injury Attorneys at Hughes and Coleman care about the safety of children and have even put on an annual Children’s Safety Day since 1995. Founding attorney, J. Marshall Hughes, discussed the event in a recent news report.