Yasmin/Yaz Recall Way Overdue
September 22nd, 2009. By janem
What comes first: will Bayer issue a recall of Yasmin/Yaz or will the drug company simply stop making its wildly popular and extremely dangerous birth control pill? For Bayer, the decision likely boils down to cost: can more claims be settled by taking the drug off the market? Poor Bayer has plenty to worry about these days. Not only are Yasmin/Yaz lawsuits related to life-threatening side effects stacking up, it was also served a warning letter from the FDA regarding quality control problems.
If and when Yasmin is taken off the market it will surely affect Bayer’s bottom line: In 2008 Yaz brought in $616 million for the company and Yasmin sales brought in $382. And sales increased from the previous year, mainly due to aggressive marketing campaigns that have since been called “deceptive” and “misleading” by the FDA. Advertising is a powerful tool: according to numerous Yasmin users I have spoken with, they had no knowledge of these side effects nor did they hear of any warnings: after all, if you knew Yasmin was life-threatening, you certainly wouldn’t be taking it!
So what’s taking the FDA so long to issue a recall? The agency must act on the countless reports of thrombosis, heart attack and stroke and even gallbladder disease associated with Yasmin and Yaz.
It wasn’t long ago that several fatalities were directly linked to the Ortho Evra birth control patch and it never did get recalled, even though last May the Public Citizen Health Research Group filed a petition on behalf of 80,000 consumers urging the FDA to recall Ortho Evra within six months. I wonder how many deaths it will take to remove Yasmin and Yaz from the market…
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you are unbelievably misinformed. blood clots are a class effect of any estrogen product. the warning that the progestin is not to be used by certain women is if anything overstated. what is a shame is that there are ambulance chasers like your firm out there misleading people.
were you unable to get into medical school and therefore putting all your suppressed anger into suing medical providers and pharmaceutical companies?
Hi Martha, I am so sorry you feel the need to put your suppressed anger into blog comments–but thanks, we do like to stir up emotion in our readers, and clearly we have succeeded. I’m intrigued by your comments–they sound very “pharmaceutical sales rep” type comments. Things that make you go “hmm”, if you follow. Clearly you haven’t been following the news or the lawsuits already filed against Yaz and Yasmin. Interesting for someone who appears a bit more well-versed on the subject. Though, given the job cuts rippling through pharma right now, if you are in the industry, well, I do understand your angst. In terms of my own ambition, no, I never wanted to attend medical school, though I come from a large family of doctors–most of whom have little regard for pharma companies. I did, however, do a stint in pharma advertising, and when I was asked to drum up promotional hype for a drug (a women’s contraceptive mind you) that I questioned in terms of its effects on young women–causing me to, therefore, question how ethical promoting it was–I drew the line, grabbed my integrity and left the place. So no, no suppressed anger here. I enjoy what I do…but thanks for being concerned about me–it’s heartwarming. Cheers…
Sorry Martha, but i do have to agree with 'admin'. I've been on Yaz for a little over six months and it has not had a possitive effect on my cycle! I've been hearing many rumors of a recall and if a recall is being questioned then i don't want to be on the Birth Control.
Hmm, I'm sorry also for those who have had bad experiences with Yaz, as I, myself, have had a great success with it as 1. I'm not pregnant, 2. my cycles are amazingly predictable, and 3. my skin is clear, and that I believe is what it is supposed to do. I've been on it for um, 2 years now. Of course, like all drugs, some work better for some than others, that's the way it is, and ALL drugs have side effects which are not to be taken lightly, I'm an RN, I should know. Anyhow, boo on the one lady who is against "pharma companies," you're just too cynical for your own good, and Yaz is great for me, it's a low dose estrogen birth control pill that isn't going to contaminate my system for years to come with lots and lots of estrogen. So there.
Hi Sarah, Thank you for your comment. Yes, there are certainly women who have had much success with Yaz–and, to your point, some drugs do work better for some than for others. The issue with Yaz though stems from the number of reported cases/adverse events relative to the population of women who've been prescribed and taking Yaz. I'm glad your experience has not been like theirs.
Seriously? In the commercials, and even in the information booklet that comes with Yasmin (which only takes a few minutes to look through), it's noted that Yasmin can cause a bunch of problems, leading up to death. It's not the company's fault that people choose not to read and research what they're taking. I've been on Yasmin for almost a year now, I'm 17, and I'm still alive. I have no health problems, and my potassium level is the same as it's always been. I think that all of this is due to patient's ignorance when they choose to not ask questions about what their doctor is giving them. If not that, then it's because they don't read. Other birth control pills have made me want to die (bleeding for months on end, adding to my already-present anemia, headaches so bad I couldn't go to school, etc), and this is the only one that has worked for me. A recall isn't necessary, just more education.
Hi Brittany, Thanks for your comment on Yasmin. I'm glad that you've found it to be helpful and that you haven't experienced any adverse reactions while you've been on it. I also don't disagree with you in stating that the consumer bears part of the responsibility in determining the appropriateness of taking a prescription drug. However, the issue with Yaz and Yasmin started with Bayer's misleading advertising, which included–according to FDA regulators–downplaying the drugs' potential negative side effects. So in effect, you had many, many new prescriptions being dispensed for touted side benefits like clearing up pimples and minimizing mood swings–without necessarily adequate awareness of the potential negatives of taking the drugs. A consumer–and a doctor–can only go on the information that is provided to them by the pharmaceutical companies. You indicate a need for "just more education"–education is a 2-way process and involves and "educator" as well as a student. When the educator is remiss, the student cannot assume 100% of the fault for not learning…
I was on Yaz off and on for 7 years…and like many of you, I thought it was great once my body adjusted to it. Funny enough, my horrible digestive problems began shortly after I started college (2001) and after seeing doctor after doctor, they all said I had "IBS" and that I was a perfectly healthy young woman. I was athletic, beautiful, young…not a thing was wrong with me.
Fast forward a to 2009, I finally saw a GI Dr for my worsening digestive issues. They were interfering with my life, relationships, self-confidence, weight, happiness, energy, etc. The first step was a colonoscopy. Everything was fine. The very next day I experienced severe pain in which I thought was related to the procedure I had just had and turns out, after 5 hours in the ER, I was diagnosed with Chronic Gallbladder disease and Acute Pancreatitis. Mind you, I am 28, eat healthy, work out and have no family history of the disease. While gallbladder disease is not life threatening, Pancreatitis is. I was hospialized immediately and was not allowed to eat or drink for 5 days so that my pancreas could heal enough to operate and remove my diseased, sick, gallbladder.
I am glad that I had it removed, but have had to make several life changes including monitoring my lipase levels and the possibility of the Pancreatitis returning…which it did months after surgery. I have new pains everyday and am learning to adjust to my new body.
I did not cause this. If some of you have done your homework, you would know that Yaz contains Drospirenone, which no other BC on the market contain. This is the same ingredient (hormone) that they brag about in their commercials to "have clearer skin, eliminate PMDD symptoms, and basically have a better life!!" It's rediculous! Hormones are bad in general, but a necessary evil in today's world. If I had it to do over again, I would never have stopped taking good ole reliable Ortho Tri-Cyclen. They all prevent pregnancy when used properly. We don't need a miracle drug that does it all.
Just wanted to share my story and give you all something to think about before you just blindly trust the drug companies and even some (easily bribed) healthcare providers. I'm not suing for the money…I'm suing because I read about a 15 year old girl who was on Yaz for a few months and had gallbladder disease. There is NO reason for a child to have a faulty gallbladder at that age.
I lucked out if you consider all the other problems it has caused. It made me think twice about what I put in my body, and I refuse to try ANY new drugs, ever again!
OK, so first i have to say, as a few others have, ALL DRUGS HAVE SIDE EFFECTS! this is a no brainer. i also agree that it is the responsibility of the consumer to educate themselves on what they take before they take it, hence me reviewing this page. you can tell me that people weren't given the proper material all you want, but if you take 5 minutes to dig a little deeper than what the company provides, such as talking to other people who have used the product or asking your doctor about the experience with other patients with the drug.
also you shouldn't go into taking something such as the "pill" lightly. have some common sense about it, you are messing with natural necessary (and yes they are necessary) processes in the female body. seriously, after all the research i have done my decision is to take no birth control. not because of my research on this specific brand, but on all brands. i have realized that it's not just side effects of the "pill" but side effects from interfering with the natural processes of your body. I'm not trying to defer anyone from taking this product or any other, all i'm trying to say is you can put blame on other people for what you put in your body all you want. irregardless of how much or little you have educated yourself you were still told at one point in almost these exact words "there is always a chance of major side effects that can harm you or may even cause death." this is even true for a very low dose pill that you could/would take while breastfeeding.
Hi Tina, Absolutely agree with you on being an educated consumer and doing your homework prior to taking ANY drug. Unfortunately, the issue with Yaz and Yasmin stems from their earlier advertising campaign–which they revamped after being told to do so. Anyone who is about to take a prescription drug should always do some research first and at the very least read the monograph. Sadly, this information is not offered upfront at the time in which the prescription is being handed to the patient–the patient only sees this information for the first time usually when they go to pick up the medication at their pharmacy. And, while with birth control, there is usually time to do some research prior to getting a prescription written, with many other prescription drugs, the patient is in a more urgent-care situation that does not allow such effective in thorough research.
I must say that after being on YAZ for a year I decided to STOP taking it b/c I was an emotional wreck. MY “doc” never mentioned to me the REAL problems being REPORTED. EVery medicince has side effects, we all know that and may even skim through them and think “not me”. HAD the REAL side effects and warnings been CORRECTLY told I would have NOT chanced it. After being off of YAZ for 3 months I started being nauseated,pain in my belly (to the point of not wanting to move, then the passing out started here and there. I just assumed it was something else….after I started vomiting every morning, in the middle of the night and having uncontrolable diahrea I went to the ER. I had 2 liters of fluid drained off my belly and every test imaginable done. After thankfully finding out it was not cancer or anything else my doc was puzzled. I am a healthy 27 year old with a 7 year old. He decided to test my gall bladder and while laying there I could see the fluid they put in it was NOT drainging through it. The next day he told me I had no gall stones but for some reason my gall bladder is not functioning and I need to have it out. Unfortuntley I do not have insurance. After a 2 day stay at the hospital my bill was $21,000.00 Now I am involved in a law suit against them. Some meds work great for some and others are just NOT worth chancing. Had I done my research rather than trusting a PRN at Planned Parenthood I would NOT be where I am today.
Every birth control pill has an increased chance of death over not taking a birth control pill. You know what has an even higher death rate….. pregnancy. The percentage of people that die from pregnancy complications is still higher than that of the death rate of taking any pill and even higher than taking Yaz.
You know what else has a higher morbidity rate than Yaz? Complications and the long therm health effects due to PCOS, the reasons many woman (like myserlf) are taking Yaz and other progesterone containing birth control.
I have been on Yaz for 5 years now and there has always been a warning since I started taking it on the ads, on the box, on the info sheet, on the commercials, and now it is the very first thing you see when you go to their website. Or you could just take a second and actually ask the doctor what they are prescribing you. If a consumer is ignorant of these risks it is their own willful ignorance at avoiding any responsibility pertaining to their own health care.
What I definitely do know is Yaz has been the only Birth control Pill that has kept my ovarian cysts (PCOS) under control so that I am not in constant pain and do not have to go through multiple removal surgeries. It also keeps the wild hormone fluctuations due to PCOS under control so that I can participate in life without always feeling crummy. It keeps my cycles under control which has eliminated the crippling anemia that was heading toward a hospitalization in order to get it under control.
And now I am finding it increasingly difficult to purchase Yaz because of scare tactics from lawsuits and lawyers trying to make a buck from someone elses hard work.
I'm not a pharmacy rep, I will be the first to tell you that I think it is over priced and I am angry that I have to pay nearly $100 a month for a medicine that probably costs pennies to make a pill. I'm angry that the generic isn't nearly as good because I tried that too and my body went right back to the same shenanigans that I have without taking any BC.
But what I am more angry at is a bunch of willfully ignorant people being driven by profit hungry lawyers that are trying to sue Bayer into bankruptcy thus taking away any and all choices that I have to be healthy and happy. If you don't want to take the medicine then by all means do not take it. If the meds make you crazy hormonal then don't take them (All other BC makes my hormones fluctuated wildly). If you choose to smoke and take any BC then you are taking your life in your own hands and should expect to have any number or related health issues. But stop acting like you know what is best for me and my well being.
I am a reasonable adult that has done all the research. I consult my medically trained doctor that has proven to be trustworthy in making hard medical decisions related to my issues. I am the one that has to live in my body every single day and suffer from the consequences of my own choices. More importantly I want to be the one making those choices not a person who doesn't know a thing about my issues.
Who do I get to sue when my PCOS turns to full blown diabetes and when I have a heart attach due to the heart disease that PCOS causes. Who is going to be forced to pay my bills when my anemia gets so bad they have to admit me to the hospital (this has come dangerously close to happening). All because there is a group of people out there that feels overly entitled to make my health care decisions for me.?
If you have a problem with Yaz and the potential side effects then don't take it but stop taking away my choice to a healthier life.