FDA Sends Warning Letter to Makers of Yaz – Yasmin

yazAs if the makers of Yasmin / Yaz didn’t have enough to worry about with pending lawsuits related to major side-effects, now they’ve been served a warning letter from the FDA for quality control problems at a plant in Germany that manufactures one of the ingredients in the drug. FDA inspectors discovered the problems during an inspection in March, 2009, and informed Bayer. Bayer claims that the quality of the drug was not affected.

Unacceptable Testing Method
According to the FDA warning letter, Bayer used a testing method that averaged the test results rather than reporting the test results for individual batches. The average was within specified parameters, but individual batches were out-of-specification (OOS), and according to the FDA letter should not have been released. At least eight batches that were tested with this method were shipped to the U.S.

After the March inspection, Bayer reviewed the batches it had shipped to the U.S. between 2007 and 2009. They responded to the FDA in April, 2009, claiming that there was no problem with the quality and an explanation of why it believes this. This recent letter from the FDA states that Bayer’s “response does not adequately address some of the deficiencies.”

Bayer is now required to give the FDA a list of all the batches shipped to the U.S. that may have been tested with the unacceptable method. The FDA may also delay imports from the plant.

Yasmin / Yaz Plagued with Problems
This is just the latest problem Bayer has faced with Yaz / Yasmin birth control medications. Life threatening side effects have already prompted multiple lawsuits against the drug maker. Yasmin is a birth control pill that uses a combination of the hormones drospirenone and ethinyl estradiol to prevent pregnancy. Drospirenone can cause elevated potassium levels leading to heart problems and other health problems.

Yaz/Yasmin side effects may include deep vein thrombosis (DVT), pulmonary embolism (PE), heart attack, stroke, cardiac arhythmias, gallbladder disease, and sudden death. The generic version of Yasmin is called Ocella, and carries the same risks.

One of the biggest reported risks of Yaz/Yasmin is the development of blood clots, leading to stroke or heart attack in women who were healthy before taking the drug and were not at risk for either life threatening event. DVT is blood clot in the legs. PE is blood clot in the lungs. In young, healthy women these blood clots are often overlooked or misdiagnosed, leaving them in grave danger.

Even when the clots are discovered and treated the effects can be long-term and can mean a lifetime of taking medications to prevent more clots from forming.

If you have already experienced these adverse health effects while taking Yasmin, Yaz, Ocella or Beyaz Click Here to speak to an attorney.

There are 31 comments. Add yours.

  1. robert king

    Guess I’m not as lucky as all you as in March 30,2009 after 96 days of my then 18 year old daughter taking yaz she died of P.E. i would pray that all would get off this product as it is a killer and Beyer will not even do one hour for killing other with their product

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  2. Lisa

    I was on the generic form of Yaz for about 2 years and went off it because of a bad panic attack and just like the other women who have suffered have mentioned, my life has changed because of the phobias that have come from having panic attacks. I wouldn’t wish panic on my worst enemy and if Yaz is really what caused my panic attacks (and it probably is) then no one should ever take it.

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  3. Mom of 2

    My very healthy, athletic, well adjusted & happy 18 year old daughter has been on Yaz for 2 years. Good things: cleared up skin & effective birth control.

    She never had or has PMS or bad cramps so no experience there with improvement or worsening. Never been depressed or anything either.

    However. For the past 3-4 months she has been very lightheaded. She has actually passed out & hit the floor 3 times. She has been working out with a personal trainer lately and while there they tracked her heartbeat to make sure it was in the “range”. It was 200 BPM (with moderate exertion!). The trainer was concerned & had her sit down & stretch for a a little while & her heart rate did not go do. She’s pale a lot, very tired, and she is out of breath just going up the stairs – heart jumps to 125.

    She has an appointment with a cardiologist on Tuesday.

    I’m convinced this is YAZ related. I just hope it’s not permanent.

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  4. Concerned Dad

    My daughter has been taking Yaz for two years. She has developed high anxiety and depression since taking this medication. I don’t know if this is from the drug or not. Her doctor recommended Prozac. However, I think it may be linked to Yaz.

    Message to Mary Davis, MD — I understand that in most cases these drugs appear to work as they are marketed. However, I do not agree with your analogy of crossing the street or driving a car. Taking medication affects your personal well being 24/7. Driving a car or crossing the street are single occurrences. The risks of taking drugs are not always apparent whereas humans are well adapted to gauge such risks as crossing the street or driving a car both of which involve instinct and skill. There is no skill involved in taking a pill and it is very difficult for that person to assess the risk — especially when the research was performed by the company selling the product.

    Additionally, many doctors accept free samples (which they resell) from drug companies and receive compensation for prescriptions. This can create a conflict of interest and temptation to direct patients to drugs that pay the highest kickbacks. I’m not suggesting this is true in your case but it happens all too often.

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  5. Eileen

    I have recently been put on Yaz for perimenopausal symptom that are making my life miserable. Imagine having PMS for 30 days out of the month. My periods are very erratic. I am 49 years old and have not been on the pill since my early 20s. I had complications after a pregnancy and could not have any more children. Didn’t need to worry about BC. Has anyone out there tried this drug for perimenopausal symptoms? How were your results. I am nervous with all this talk about Yaz. My Dr. assure me that it is ok.

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  6. Megan

    Yaz is not poison. It is very beneficial for many women. There are risks with every birth control as is printed in the pamphlets in every script. Yaz has been a miracle for me.

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  7. Grace

    I have been on Yaz for a little under 2 years. I have developed clots in my brain and now I need to have my heart and lungs checked. This week alone, I have been in the hospital twice. I loose balance, don’t have energy and my body is so heavy and feels like I’m going to faint. Anyone, who is on Yaz get off of it. Its poison!

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  8. Katie

    I’ve been on Yaz for almost 5 years now. No Problems. People need to tell the doctor if they can’t handle the hormone strengths, I’ve been on many birth control pills & yaz has always worked the best. I kinda think this is why doctors want you to tell them if you feel different or funny on new drug medications. That’s how you learn what your body can handle. EVERYONE is different. I dunno, people just like to blame things instead of working around it.

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  9. Kristi Frank

    I am 33 years old and just discovered that I have 2 blood clots in my brain. I have been taking Yasmin for years now and the doctors have discovered that there is no other reason for me to of developed these but from the Yasmin birth control pills. So women if you are taking these pills please stop at once! The side effects are not worth your health. I am in pain and seeing many doctors right now and have no idea of what the outcome will be. This is all for real and should be taken seriously.

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  10. 20something

    I was on Yaz for about a year. It was horrible. I was depressed, had terrible mood swings, to the point that my family asked me to stop taking the pill because I was extremely emotional. Around the time I stopped Yaz, I also noticed some varicose veins behind my knee, and some vein swelling with exercise. It was DVT, all throughout my right leg – no smoking, under 100 lbs, active 27 yr old, all genetic clotting factors ok. Thanks to Yaz, I was in the ER twice in a week, had to take blood thinners for 3 months, and now have to wear compressions stockings all the time. Luckily, lungs were clear. I would not advice anyone to take this horrible little pill – the risks are too great, and there are many other safer pills to choose from.

    Reply
  11. 30something

    Seeing all the people who have had strokes from this is incredibly scary. I have been taking it for 3 years and have had only good side affects like weight loss and clear skin and less moodiness at periods.

    Reply
  12. Heather

    I have been taking Yaz for a year now and never once had a problem with it. The exact opposite actually, all side effects were beneficial. My doctor switched me to Loestrin last month after this news was released and it was a terrible move! I have never had more problems, cramping, sporadic bleeding.. I’m asking my doctor tomorrow to go back on Yaz. But I want to have my research done first.. I’ve been looking into the FDA study that was done.. has this pill actually been recalled? Is the FDA advising women to go off the pill? And realistically, Yaz has been reported to have all these problems before. Has anything changed drastically in the last several months outside of the FDA’s report?

    Reply
  13. Mary Davis, MD

    I am an Endocrinologist who has prescribed over 500 prescriptions for Yaz and Yasmin as well as other birth control pills. The risk is the same for all of these birth control pills, and they are in the grand majority very rare. I have never had a patient of mine develop a serious complication, and in general all of my colleagues agree. There are risks with any drug and the benefit needs to be recognized as well. These websites describing the “dangers of Yaz” are sent out by Lawyers. Please dont be mislead by such poor information on the internet. It is sad how misinformed patients become from the internet. Please also dont be mislead by histrionic, anxiety driven women, with neurosis that post their personal experiences. These are not the norm. If you are worried about getting a blood clot or other serious side effect from a BCP, then dont drive a car, take tylenol, or cross the street because these also pose fatal risks. Dr. Davis.

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  14. Kara

    I do not want to diminish the tragedy that some people have faced with negative side effects, but this is an optional medication, and all medications have risks.

    I have been on Yasmin/Ocella for 9 years now. I have briefly tried 2 low ortho tri cyclins about 4 years into using the pill, and found that I was uncomfortable, moody, melancholy, and gaining a lot of weight. Additionally, almost all of my friends in college and post college have been on BC pills, and we all have different experiences with the same pill. All BC pills have side effects, and individuals respond differently to each.

    When I first went on yasmin, in 2001, I was counseled by my gyno who explained all BC has a 1% chance of blood clots, made worse by smoking, and yasmin has a 2% chance. I also familiarized myself with the fine print (even at age 16). I am aware that I am responsible for putting this in my body, nobody else.

    I am sorry for anyone who has fallen into the 2% or have suffered from this, but please discuss BC with your doctor, please educate yourself before you take a medication, and please take responsibility for your own decisions.

    Reply
  15. Dawnmarie

    I was on Yasmin a few years back. I stopped taking it because I was having bad mood swings. A few days later, I developed EXTREME panic attacks for months after. I was put on Zoloft (and Ativan initially) and later changed to Lexapro to fix the problem. Not realizing what happened, I went back on Yasmin and then off a few months later and began the same nasty panic attacks again. I realized it was the Yasmin and contacted my doctor. She said it was possible but rare and not likely. I KNOW it was the Yasmin that caused it and to this day, I still have side effects of all those medications. I can’t even explain the fears and phobias that those panic attacks cause and that I still deal with.

    Reply
  16. Jenise

    Emily-
    I also was diagnosed with gallbladder disease at age 27 and the doctors couldn’t understand why because they never even found gall stones. They decided to remove my gallbladder anyway and I have horrible scars, as well. This all was done after I was diagnosed with Pancreatitis and admitted to the hospital for a week. This was a few months prior to the gallbladder surgery back in 2007. Every doctor that treated me had absolutely no explaination or could explain anything that may have caused any of this. My family and I are finally able to start understanding what may have caused all of this. I had been on Yaz and Yasmin since it was put out on the market (5-6 yrs or so I believe).

    Reply
  17. Emily

    I have been taking Yasmin (Ocella) for the past 3 years. I was diagnosed with gallbladder disease in June of this year and had it removed in July, leaving me with scarring and food sensitivity. I also had elevated Lipase levels, which is a hormone found in the pancreas, and the doctors couldn’t explain why. I was only 28 when diagnosed with gallstones. I don’t know if it was due to the fact that I was taking Yasmin, but I am now switching my pills. Is there any brand considered safe with minimal side effects?

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  18. Karen

    My Dr put me on Yaz a few weeks ago for my hormones and it has helped alot. I asked different Dr’s about Yaz and they explained that it carries the same risks that all other Birth Control Pills do. All I know is that I feel alot better taking this Medication.

    Reply
  19. Gabrielle

    I was diagnosed with a deep vein thrombosis this year after taking Minesse (Wyeth-Pfizer) about 10 years. Three weeks before my thrombosis, I had a long-distance flight. The thrombosis may have been provoked by the pressure from the ski boots when I was skiing.

    Reply
  20. Rachael

    I am on Ocella (generic yasmin) are there side effects in that too? The blood clots/stroke so on?

    Reply
  21. Nadia

    My daughter is on Birth control for three years till now, Recently I noticed that she has a pain in her heart and hand and increase the rate of her heart pulse, I asked her profession doctor about my concerns and side effect of Yasmin pills of high level of Potassium, she replied that nothing to worry about and keep in taking the dose monthly.
    If she doesn’t in need for this medicine to compensate her lost period I would rather to stop taking this medicine

    Reply
  22. Rhonda

    Are anxiety/panic attacks or other emotional problems side effects from taking Yaz? I have not been able to find the information anywhere. I noticed that Becky mentioned it above.

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  23. Lanni

    Can YAZ do something to your glucose levels because I had a mycolonic siezure (not sure if I spelled that correctly) a couple of weeks after I started taking YAZ. However, it got better after I ate something, especially the potatoes in my soup that I had. I can’t just suddenly have diabetes. It would have happened again and it has been over 2 months since then. So, can it.

    Reply
  24. Becky Burroughs

    My daughter has been taking Yaz for acne for 10 months. We are very concerned and are wondering how long it will take to get this out of her system now that she has stopped taking it? She has had no obvious side effects but we can have no idea of damage done. As of now she has only had the problem of anxiety attacks but we attributed this to higher stress levels in college.

    Reply
  25. Catherine

    I have been on it for years and just turned 40 in July. I could not take the breast pain any longer and just quit taking it this month. Thank God!!

    Reply
  26. E. Sizemore

    Kelly,

    There is not currently a recall for Yaz / Yasim. Most women tolerate this form of birth control very well. However, in rare cases, there have been serious side effects, which the FDA wants to make the public aware of so they can discuss the risks and benefits with their doctor.

    Reply
  27. Kelly

    I need to know has yaz been recalled or not. My doctor put me on it a month ago.

    Reply

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