d Clot Warning Added To Birth Control Pills Like Yaz: What To Know
10 days ago by Briana Rognlin | 5 Comments | Share a Tip

birth control blood clot warningsThe Food and Drug Administration announced earlier this week that it would add stronger warning labels to Yaz, Yasmin and other birth control pills containing drospirenone (a synthetic version of the hormone progesterone) about the associated risk of blood clots. But, the FDA emphasized, the risk is still small; smaller, in fact, than the risk of blood clots during pregnancy or the postpartum period, and small enough that women taking the pill shouldn’t worry and should “continue taking their pills as directed unless told otherwise by their healthcare professional.” But headlines like “FDA’s Yasmin and Yaz Blood Clots Warning is a Victory for Consumers” and “The Birth Control Warning You Need To Know About” would make you believe otherwise. So we spoke to Planned Parenthood‘s Vice President of External Medical Affairs, Vanessa Cullins, to find out what we really need to know.

Check out our Q&A with Cullins, who put the risk of popular brands like Yaz, Yasmin, Beyaz, Safyral into perspective for us:

First, can you explain which kinds of birth control are most worrisome?

I want to start out by saying that none of the FDA-approved birth control methods should be considered worrisome. There are risks and benefits to all medications, including prescription birth control. When you look across the board at hormonal-containing birth control pills, whether you’re talking about those that contain drospirenone (like Beyaz, Yasmin or Yaz), or, say, desogestril (like Desogen), all are extremely safe and effective. There are some progestins that carry with them a slightly higher risk of venous thromboembolism—yet venous thromboembulism is still extremely rare and occurs much less often than during pregnancy, childbirth and the postpartum period.

Are there women in particular who are at higher risk?

First of all, if a woman has a history of venous thromoembulism she should not be using hormonal birth control pills that contain estrogen.

But a woman may sit down with her doctor, look at her family history and risk factors in general—for instance perhaps she does a whole lot of plane travel, or has other reasons to be very sedentary, and has never been on a contraceptive formulation in the past—and decide that they want to try a formulation that has a history of a lower risk of venous thromboembulism, such as levonorgestrel. But by the same token, you could have a woman who is on a plane or sedentary a lot, and has been on levonorgestrel formulations in the past and not had a good side effect experience, so she’s willing to accept that increased risk of venal stromboembulism because it’s much more important for her to prevent pregnancy at this point in her life, and she wants to use a pill.

What I’m trying to convey here is that it’s very situational and unique to the circumstances and lifestyle issues of an individual woman. It means taking into account the woman’s individual characteristics as it relates to her medical and family history, and such things as whether or not she’s at an increased risk of venous thromboembulism.

The FDA has said that women should “continue taking their pills as directed unless told otherwise by their healthcare professional.” So why are they requiring the new warning labels?

Because information is a good thing., as long as it is appropriately considered. And by appropriately considered I mean not being alarmed. The information is important in individualizing or tailoring a decision around contraception formulation.

Should women book appointments with their physicians in order to discuss the risks, or just sit back and wait until their next appointment as they normally would?

I would advise women to sit back and wait for their next apointment to discuss this. However if she is extremely worried by all means make a phone call. I think a phone call should be adequate in terms of allowing the physician or health care practitioner to talk about her concerns. If by chance an appointment is needed that can be determined through the phone call.

Is this sort of news damaging for birth control types or brands? Have health warnings on other birth control methods persuaded women to switch?

Unfortunately the reaction generally is one of alarm and both providers and women potentially overreacting and stopping their birth control and this resulting in unintended pregnancy rates going up. This issue is not a new issue: The first time this came about was in 1995 when epidemiological studies in Europe, particularly in Great Britain, showed that pill formulations containing gestodene (which is only available in Europe). And on the basis of the findings being reported in an inappropriate context, you had both providers and women becoming very alarmed and people stopping their preferred birth control formulations and the resulting situation the following year was actually an increase in the abortion rate.

Is there one particular kind of birth control that’s clearly “the safest” or risk free? Is there any sort of dream birth control in that sense?

It depends on what kind of risks you’re looking at. What immediately comes to mind is that when you’re not using anything, then you don’t have any risk associated with mediation or use of that particular thing. So with abstinence you tend to not have medical risks. But you can potentially have some psychological risks…[ed. note: at this point, Cullins and I giggle together over the 'risks' of abstenence] depending on who you are.

I would say that, you know, there are risks associated with anything and everything. Clearly all medications have risk associated with them, and you just have to determine what you’re willing to kind of put up with. Whether you’re talking about side effects or very rare risk.

What do you want to drive home?

I just want to say that decision-making around contraception and women to become pregnant or women to parent is based on risk versus benefits, and what’s important to you and for your family at that particular time in your life. So that risk and benefit balance will change over time. And that’s normal. It’s all about putting things into perspective.

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The post Planned Parenthood Speaks Out on Yaz, Just another Product Harming Women appeared first on Vaginal Mesh Helpline.

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Yaz Payoff Complications, Bayer is paying on,

• blood clot,
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•  pulmonary embolism,
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Safety Announcement
[09-26-2011] The U.S. Food and Drug Administration (FDA) is informing the public that it has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills. FDA has completed its review of the two 2011 studies that evaluated the risk of blood clots for women who use drospirenone-containing birth control pills, previously mentioned in FDA's Drug Safety Communication issued on May 31, 2011. FDA is continuing its review of a separate FDA-funded study that evaluated the risk of blood clots in users of several different hormonal birth control products (contraceptives). Preliminary results of the FDA-funded study suggest an approximately 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.
Given the conflicting nature of the findings from six published studies evaluating this risk, as well as the preliminary data from the FDA-funded study (See Data Summary), FDA has scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011 to discuss the risks and benefits and specifically the risk of blood clots of drospirenone-containing birth control pills.

Patients should talk to their healthcare professional about their risk for blood clots before deciding which birth control pill to use. Known risk factors that increase the risk of a blood clot include smoking, being overweight (obesity), and family history of blood clots, in addition to other factors that contraindicate use of birth control pills.
Women currently taking a drospirenone-containing birth control pill should be informed of the potential risk for blood clots. FDA previously communicated preliminary information about these concerns to the public on May 31, 2011 .
FDA has prepared a list of questions and answers to provide an overview of this potential safety issue. FDA will continue to communicate any new information to the public as it becomes available
Health Canada is currently reviewing the safety of Bayer Pharmaceutical’s birth control pills, Yaz and Yasmin, in an effort to determine if women who use these drugs are at an increased risk of developing life-threatening blood clots over women using different brands of birth control.

Yaz Lawyers of Free Legal Shield are pleased to  announce that contraceptive Manufacturer, Bayer, has agreed to pay out at least $110 million to settle 500 lawsuits involving Yaz blood clots. News of the settlements comes at a time when the Yaz lawsuit total exceeds 11,000, with plaintiffs claiming the birth control pill resulted in dangerous blood clots.

New Warning Labels on Yaz April 2012

In an announcement released April 10, 2012, the FDA stated that new warnings about the risk of blood clots will now be required on the labels of birth control pills that contain the progestin “drospirenone.” Yaz, Yasmin, Beyaz, and Safyral will now carry warnings detailing recent studies that suggest these pills may carry a slightly higher risk of Yaz blood clots.

Many Studies show Yaz linked to Blood Clots

two new studies recently published in the British Medical Journal, which concluded that women ages 15-44 taking birth control pills containing the synthetic progestin, drospirenone, are more likely to develop blood clots deep in the veins of the leg (venous thromboembolism), than women using birth control pills containing the common progestin levonorgestrel. The studies reported that the risk of developing blood clots for women taking the drospirenone-containing pills may be two to three times greater than those who take other pills. Yaz is one of these drugs.

Yaz New Warnings  April 2012

In an announcement released April 10, 2012, the FDA stated that new warnings about the risk of blood clots will now be required on the labels of birth control pills that contain the progestin “drospirenone.” Yaz, Yasmin, Beyaz, and Safyral will now carry warnings detailing recent studies that suggest these pills may carry a slightly higher risk of Yaz blood clots

Yaz side effects include:
• Deep vein thrombosis (DVT)
• Pulmonary embolism (PE)
• Blood clots
• Stroke
• Heart attack
• Gallbladder problems
• Pancreatitis
List of Drugs
Approved Oral Contraceptives containing Drospirenone

    Drospirenone and ethinyl estradiol Drospirenone 3 mg and ethinyl estradiol 0.03 mg
    Ocella Drospirenone 3 mg and ethinyl estradiol 0.03 mg
    Safyral Drospirenone 3 mg, ethinyl estradiol 0.03 mg, and levomefolate calcium 0.451 mg
    Syeda Drospirenone 3 mg and ethinyl estradiol 0.03 mg
    Yasmin Drospirenone 3 mg and ethinyl estradiol 0.03 mg
    Zarah Drospirenone 3 mg and ethinyl estradiol 0.03 mg
    Beyaz Drospirenone 3 mg, ethinyl estradiol 0.02 mg and levomefolate calcium 0.451 mg
    Drospirenone and ethinyl estradiol Drospirenone 3 mg and ethinyl estradiol 0.02 mg
    Gianvi Drospirenone 3 mg and ethinyl estradiol 0.02 mg
    Loryna Drospirenone 3 mg and ethinyl estradiol 0.02 mg
    Yaz Drospirenone 3 mg and ethinyl estradiol 0.02 mg

Recent warnings have linked various birth control drugs and devices to serious injuries and even death:

    Yasmin®
    Yaz®
    Ocella®

Injuries reported:

    Deep Vein Thrombosis
    Pulmonary Embolism
    Stroke
    Heart Attack
    Wrongful Death
    Blood Clot Related Injuries
    Kidney Failure
    Gallbladder Injury/Removal

If you or a loved one has suffered from any of the harmful side effects of Yaz,Yasmin or Ocella such as blood clots, stroke or heart attack you may be entitled to file a Yaz,Yasmin,Ocella lawsuit against the manufacturer. Call us for a yaz lawyer with experience in birth control drug lawsuits toevaluate your claim. Many women around the United States have suffered from life-threatening Yaz,Ocella and Yasmin birth control side effects. The manufacturer can be held liable.
The Woman's Yaz Helpline is here for women suffering from Yasmin and Yaz  and Drospirenone side effects
 

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