As Bayer adds new warnings to its birth control pills in the wake of lawsuits regarding Yaz and Yasmin, we thought it would be a good idea to break Yasmin and Yaz down by the numbers.
2001: The year Yasmin came on the market
2006: The year Yaz came on the market
2008: The year Bayer (maker of Yasmin and Yaz) received a warning from the FDA about overstating the pills’ effectiveness while minimizing their risks
2008: The year Ocella receives FDA approval; Ocella is the generic version of Yaz that is manufactured by Barr, which is owned by Teva
2009: The year Bayer launches new $20 million ad campaign to address the FDA’s warning
2009: The year the FDA issued a recall on certain lots of Yaz and Ocella for “Out of Specification analytical value for chemical assays of drospirenone and ethinyl estradiol was averaged with another analytical value to provide a reported result that was within specification.”
2010: The year Bayer added new warnings about the risks of blood clots linked to Yasmin and Yaz
1,100: Approximate number of lawsuits filed against Bayer regarding Yasmin and Yaz
$1.64 billion: Approximate profit Bayer reportedly made from Yasmin and Yaz during 2009
993: Number of reports the FDA received by November, 2009, of cases of pulmonary embolism linked to Yaz or Yasmin
487: Number of reports the FDA received of deep vein thrombosis
229: Number of reports the FDA received of other blood clots
800: Number of Canadians who have joined class-action lawsuits against Bayer
50: Number of women who reportedly died after taking Yaz, as of July, 2009
6.3: The number of times the risk of developing a blood clot is increased in women who take Yasmin or Yaz, according to a study in the British Medical Journal.
Note: Bayer has defended the birth control pills, saying they are safe and effective.
All stats taken from the FDA.gov, The New York Times, Los Angeles Times, Calgary Herald, BusinessWeek, The Bulletin (Philadelphia) and WISH tv, in addition to the British Medical Journal.
This week marks the 50th anniversary of the birth control pill. We’ve come a long way baby! But some things haven’t changed: Even 35 years ago women were complaining about side effects, including blood clots. Back in 1960, the pill was marketed as 100 percent safe, it would liberate women and it would even prevent divorce. Well, Bayer is still lying about its birth control pills Yasmin and Yaz, saying it is as safe as other oral contraceptives.
A few events regarding the pill have been announced this past month. On April 9, 2010 Bayer HealthCare Pharmaceuticals announced it would update its Yaz and Yasmin labels with a stronger warning, which has already happened in Europe. And Bayer has a dirty little secret: Did you know that 32,856 boxes of Yaz, at three packs per box, and 122,208 boxes of Ocella, an identical product was recalled? You won’t find that recall on its website and you have to dig deep to find it on the FDA recall list.
TIME magazine featured an article on the pill this month. Here is an excerpt:
“In 1954, John Rock, the doctor who was leading the research on the pill, expressed the breathless excitement shared by many of his colleagues: An oral contraceptive, he said, “would be the greatest aid ever discovered to the happiness and security of individual families – indeed, to mankind” because “the greatest menace to world peace and decent standards of life today is not atomic energy but sexual energy.”
Regarding pregnancy, the article says that ” 63 percent say they know little or nothing about Read the rest of this entry »
No matter how frequently or strongly Bayer Healthcare Corp declares their oral contraceptives Yaz and Yasmin to be safe and effective—as long as they’re used according to the product labeling—it’s not preventing women from filing lawsuits against the pharmaceutical giant.
I read a news report recently that stated some 50 women in Indianapolis have filed Yaz/Yasmin lawsuits alleging their use of the contraceptive resulted in their experiencing blood clots and pulmonary embolisms in their lungs and legs, and apparently several of the women required surgery to remove their gallbladders. How did that happen, you ask? Because Yas/Yasmin—among its lengthy list of ‘side effects’ which include pancreatitis, liver and kidney failure, rapid heartbeat and arrhythmias—can also cause gall bladder disease.
What I want to know is how you avoid these serious adverse events—let’s call a spade a spade—if you take the pill according to the product labeling? How does that work? Your doctor prescribes the contraceptive presumably in the knowledge that you are a suitable candidate to take it—meaning you don’t have one of the many conditions that would preclude you from taking it including a history of heart, liver or kidney disease, and you’re not a pack-a-day gal, but you still end up in the hospital having suffered a stroke or embolism. How could you have avoided that?
Also, and this may be a fine point, if the contraceptive is known to be associated with serious adverse events—just what exactly can you do to avoid developing them?
It sounds like a game of Russian Roulette to me. Maybe you’ll develop a blood clot—maybe you won’t—no way to tell really—but take a chance anyway. Worst case scenario, there are treatments, if you don’t die—right?
In a recent newspaper report, Kimberly A. Johnson developed numerous blood clots in both her lungs, which has resulted in her taking blood thinners, which are no picnic, for the last two years. She is a 37-old mother of two. The only sign she had that something was wrong, apparently, was a severe shortness of breath—which was worse at night. She told the Indystar.com in an interview that she felt like she was having a heart attack when she lay down at night. Kimberly had only been taking the contraceptive for three months. “I thought I was going to die,” she said in her interview. I’m betting if she knew how to avoid that situation she would have.
To add insult to injury Yas/Yasmin were marketed as providing health benefits. (If it sounds like snake oil…) In 2008, the FDA actually ordered Bayer to run ads correcting an earlier advertising campaign that claimed (a bit too far) that Yas/Yasmin provided health benefits. That cost them $20 million. Although the spate of Yas/Yasmin lawsuits will likely cost Bayer a good deal more, it will not be as much as it’s already cost women like Kimberly.
Watching the events unfold in Iran over the past week has proven a startling reminder of the power of shared information, especially as it applies to the Internet. The beauty of the Web is that people can share their experiences in their own voice, regardless of whether that experience is about an election gone terribly wrong, the death of a Pop legend such as Michael Jackson, or a woman’s own story about a terrible event in her life. That sharing of information not only helps keep people informed, but in some cases galvanizes them into action. Angela Beck is counting on both. Read the rest of this entry »