Yasmin and Yaz
Update: Drospirenone-Containing Birth Control May Increase Risk for Blood Clots
Some combination oral contraceptives (COC) such as Yaz and Yasmin may triple the risk of getting blood clots when compared to other products, according to the U.S. Food and Drug Administration (FDA). The synthetic hormone drospirenone, which is a progestin, may increase the users’ risks of getting blood clots when these drugs are compared to other progestin-containing pills.
The information was published April 10 in a drug safety announcement from the FDA. The agency had finished its observational (epidemiologic) review of studies about the use of drospirenone in women taking drospirenone-containing COCs.
The results of the epidemiological review were inconclusive for various reasons:
- The studies did not supply consistent estimates of the comparative risk of blood clots between oral contraceptives containing drospirenone and those that did not.
- The studies did not take into account important patient individualities that may influence prescribing
For these reasons, it is not known if the increased risk seen in some of the studies actually is due to the drospirenone.
The FDA communication said that one way to understand the risk of taking the drospirenone-containing pills is that “The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum (after the birth of the baby) period.”
The federal agency said it is adding information from the new review to the labels of drospirenone-containing contraceptives.
The FDA advised women to talk with their healthcare professional about the risk of blood clots before deciding which birth control pill to take.
Yasmin and Yaz Lawsuits Filed Amid Reports of Heart Attack and Stroke
The Food and Drug Administration (FDA) has issued a third warning to Bayer HealthCare Pharmaceuticals, Inc. regarding what it termed as “misleading” advertising. This most recent warning was issued following reports linking the manufacturer’s popular oral contraceptives with life-threatening injuries, including deep vein thrombosis (DVT), stroke, heart attack, pulmonary embolism, kidney failure and even death.
FDA warning letters indicated that Yaz ads made exaggerated claims about the drug’s benefits and failed to mention important side effects. As a result of increased FDA pressure, Bayer has agreed to spend $20 million on a corrective advertising campaign, but maintains that the pills do not pose any additional health risks than other oral contraceptives.
Yasmin and Yaz Side Effects
Yasmin and Yaz are low estrogen oral contraceptives. Yasmin was approved in the U.S. in 2001, while Yaz, which contains even less estrogen, was approved in 2006. Together, the pills generated approximately $1.8 billion for Bayer HealthCare last year alone.
Yaz contains a synthetic type of progestin called drospirenone. This ingredient, not used in any other birth control pill approved in the United States, has been linked to hyperkalemia, a condition caused by excessive amounts of potassium in the blood, which may lead to serious heart problems, as well as other medical conditions.
Former FDA head says Bayer hid reports of potentially fatal blood clots
Dec. 5, 2011 – 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 Kessler from testifying at trial about Bayer’s deceptions, in civil lawsuits brought by women who suffered blood clots after taking Yasmin or Yaz.
Kessler is expected to testify that Bayer failed to properly warn of the risk that women taking the drug would develop dangerous blood clots called venous thromboembolisms, or VTEs. VTEs are believed to significantly increase the risk of strokes and death.
The newly released documents indicate that Kessler may also testify that Bayer promoted Yaz and Yasmin for uses not approved by the FDA, a violation of federal regulations.
A Dec. 5 report from Reuters states:
Kessler’s report, according to court documents unsealed on Monday in U.S. federal court in Illinois, states that, prior to the approval of Yasmin in May 2001, Bayer failed to inform the FDA or the public of adverse VTE events, including those in a study showing a much higher than expected incidence of VTEs.
It also states that, in 2003 Bayer, refused to change its warning of VTE risk when FDA experts calculated a higher reporting rate for Yasmin than for other oral contraceptives.
Kessler is also expected to testify that Bayer received reports of higher blood clot risks from a pair of independent studies, but failed to report them to the FDA or public until the studies were officially published more than a year later.
The Kessler report also says Bayer engaged in extensive off-label promotion of Yasmin and Yaz for premenstrual syndrome (PMS), despite a lack of FDA approval for the condition.
Bayer is facing thousands of personal injury lawsuits from users of Yasmin and Yaz with trials scheduled to begin next month in Illinois and Pennsylvania.
An FDA panel will convene Dec. 8 to consider what action to take in reaction to the latest information about the dangers of Yasmin and Yaz and Bayer’s failure to fully disclose information.
Attorneys for some of the injured women asked the FDA panel to consider the unsealed court documents, but were told by the FDA that the documents were released too late to be taken into consideration by the panel, due to panel procedures setting deadlines for submissions.
New Studies Reveal Yaz/Yasmin Danger of Potentially Fatal Blood Clots
Two new studies indicate that Yaz birth control pills double or triple the threat of dangerous blood clots.
The results of the two studies, released April 21, 2011, show that the Yaz/Yasmin birth control pills increase the risk of a woman developing life-threatening blood clots in a condition known as thromboembolism or deep vein thrombosis (DVT) — a blood clot in the veins that can become dislodged, causing fatal clogging in arteries of the lungs.
One of the studies was based on U.S. medical claims data, while the other was based on data from the British General Practice Research Database.
The specific cause of the increased risk is the hormone drospirenone, one of the hormones used in Yasmin, which had a two to threefold higher risk of venous thromboembolism than the older synthetic hormone levonorgestrel, which is used in other birth control pills.
Yasmin and Yaz Lawsuits
Lawsuits against Bayer may soon number in the thousands. All of the suits filed contain similar allegations that the warning labels are inadequate because they fail to indicate that the use of drospirenone increases health risks.
If you or your loved one has suffered a debilitating injury while using Yaz, Yasmine or any other defective drug, you may be entitled to receive damages. The lawyers of Aylstock, Witkin, Kreis and Overholtz are among the most experienced defective drug attorneys in Florida who can inform you of your legal rights. Contact the AWKO team at (888) 255 – 2956 to learn more.