The above was posted two (2) years, on September 29, 2009, ago on Facebook - Yasmin & YAZ Claims/Lawsuits as awareness was growing on the risks associated with the #DRSP #drospirenone family of birth control pills. In August 2009, a BMJ study challenged the safety profile of these pills which only included YAZ, Yasmin & Ocella (generic). Today, there are a number of variations of these pills and this week the FDA noted a continued ‘concern’ over their safety and potential for a blood clot risk. Advisory panel meetings are scheduled for December 2011 to discuss conflicts in scientific evidence and interpretations of this risk.
The Wall Street Journal article below explains the FDA’s announcement and scheduled hearings. However, belated efforts by the manufacturer to ‘clear up’ their promotional campaign and risk profile of their pill offers little consolation to nearly 10,000 litigants claiming injuries from the #DRSP #drospirenone family of pills. #DRSP Lawsuits continue to be filed over injuries claimed from the use of drospirenone and are often referred to as DRSP Lawsuits or YAZ Lawsuits.
Gabriel F. Zambrano, P.A., is the sponsor of this blog and commentary. The Facebook Page - Yasmin & YAZ Claims/Lawsuits, as well as @yazattorney on Twitter are also maintained and updated, in a continued effort to raise awareness and the dangers of #DRSP. FREE CASE EVALUATIONS are also offered with regard to potential injuries from these ‘bitter pills’.
The U.S. Food and Drug Administration said Monday it “remains concerned” a certain type of birth-control pill that contains drospirenone could raise the risk of blood clots beyond that of other pills.
In a drug safety communication posted on the agency’s website Monday, the FDA said preliminary results of an agency-funded study involving 800,000 women suggest about a 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth-control pills, compared to users of other hormonal contraceptives.
Drospirenone is used in pills including Yaz and Yasmin, which are marketed by Bayer AG. Drospirenone is a type of female sex hormone called a progestin. Some drospirenone pills are also available in generic versions.
But the FDA said it hasn’t reached a final conclusion that the products raise the risk of blood clots beyond that of other pills, and the agency will convene an outside panel of medical experts on Dec. 8 to discuss the matter.
Most birth-control pills contain two types of hormones, estrogen and progestin. All types of pills increase the risk of blood clots, and product labels warn of such risk.
The FDA said there is conflicting information about the blood-clot risk possibly associated with drospirenone from six other published studies. Some of the studies have reported that the risk of blood clots for women who use birth-control pills containing drospirenone is higher than that for women who use birth-control pills containing levonorgestrel, while other studies haven’t found such a risk. While the risk of blood clots is low among women who take birth-control pills, the FDA said it is higher than the risk among women who aren’t taking the pills.
Blood clots form inside a vein and are known as deep vein thrombosis, or DVT. The clots usually form in the lower leg or thigh, but can break loose and travel to other areas of the body such as the lungs, where they are called a pulmonary embolism, or PE. The FDA said the symptoms of a DVT include the new onset of persistent leg pain, while those of a PE include severe chest pain and sudden shortness of breath.
Bayer has said its analysis of the available scientific evidence shows that the risk of developing a blood clot associated with taking pills containing drospirenone “is comparable” to that of other birth-control pills studied, but it is working with the FDA on the matter. Sales of Bayer’s Yaz product family have been declining, which the company blames on generic competition in the U.S.
In May, the European Medicines Agency said the risk of developing blood clots for oral contraceptives containing drospirenone was higher than that of pills containing levonorgestrel but said the risk for any type of birth-control pill was small. EMA said the product labels of birth-control pills containing drospirenone will be updated.
#ACTOS has been linked to #bladder cancer. The #FDA is evaluating data and alleged link to long term use. In this story ABCNews reports on the potential for 1 in 3 Americans suffering from diabetes and why the numbers continue to rise. ACTOS is used to treat Type 2 Diabetes. A growing body of scientific evidence has linked ACTOS use to bladder cancer and heart problems. ACTOS has been banned in France & Germany by their health authorities. New Zealand is reportedly scheduling a bann as well.
However, the FDA continues to evaluate data on the safety and effectiveness of ACTOS.
Gabriel F. Zambrano, P.A., is the author and sponsor of this blog and commentary. Gabriel F. Zambrano, P.A., is actively investigating cases of bladder cancer in users of #ACTOS for Type 2 diabetes. Previously posted information on ACTOS appears here.
Lawsuits revolving around BAYER’s novel progestin, #DRSP (#drospirenone), combined with #EE (#ethinyl estradiol) continue in the US. There are over 7,000 lawsuits pending with Trials expected in 2012. Allegations surrounding the #YAZ #Yasmin #Ocella family of #DRPS pills include: Death, Stroke, Deep Vein Thrombosis, Pulmonary Emboli, Pancreatitis, Gallbladder removal and complications from injuries. Related information and posts can be found on Facebook at Yasmin & Yaz Claims.
Gabriel F. Zambrano, P.A., is actively representing girls and women that suffered serious personal injuries from #DRSP #drospirenone pills. Gabriel F. Zambrano, P.A., is the sponsor of this blog and commentary.
Over the counter medicines can kill you, it is that plain and simple. In prior posts we have discussed #Acetaminophen, #NSAIDS, #BENZOCAINE, #MOTRIN and related products that continued to draw scrutiny from the #FDA and medical community, as well as consumers and injured victims. How are they victims ? Well, if you were not warned about risks and may have altered your decision making you are potential victim. You cannot make informed decisions about ingesting a product if you are not provided necessary disclosure or information. Unfortunately, the combination of an over the counter (#OTC) product and a prescription product can also prove fatal.
A recent USAToday story, “Read the Drug Labels, Avoid Dangerous Side Effects”, is one of a series of stories on the dangers of the popular Extra Strength Tylenol pills that contain acetaminophen. It also touches upon the dangers of too much #IBUPROFEN (#ADVIL, #MOTRIN) and #NAPROXEN (#ALEVE).
While the past few months have revealed efforts by the FDA, and manufacturers, to change dosing and warnings, how long manufacturers have known of the need to place stronger warnings on their over the counter products remains to be seen. The last year was marked by an unprecedented number of recalls of J&J’s McNeil unit(s) products for both adults and children, Congressional hearings and a recently concluded internal investigation of corporate conduct, one has to wonder if where there is smoke there is fire. Prior posts address these #recalls and related products, but you are always welcome to contact me directly for additional information.
Gabriel F. Zambrano, P.A., is investigating cases of personal injuries, liver failure and death from Acetaminophen, NSAIDs and other drugs. Gabriel F. Zambrano, P.A., is the sponsor of this blog and commentary.
#ATV use continues to rise in recreational activities throughout the US. American Suzuki Motor Corporation #recalled the pictured ATV due to a crash hazard, as announced by the CPSC during March 2011. The #SUZUKI #QuadSport ATV #recall affects about 1,400 ATV’s that were deemed potentially hazardous as a result of a regulator/certifier circuit board that could fail and cause engine failure during operation, thus creating the risk for a crash. According to the CPSC, the subject ATV’s were sold between September 2008 and February 2011 nationwide. Additional information on this recall is available at this link: “American Suzuki Motor Corp. Recalls QuadSport ATVs Due to Crash Hazard”
Gabriel F. Zambrano, P.A., is the sponsor of this blog and commentary. Gabriel F. Zambrano, P.A., is investigating cases involving death, catastrophic injuries, amputations, or serious personal injuries from the use of ATV products. Gabriel F. Zambrano, P.A., is not affiliated with the CPSC, but is posting this in an effort to continue to raise awareness and further promote a public safety message regarding the dangers of ATVs.