Are You Willing To Risk Death For Your Birth Control?

If you're lucky enough to live in America, television commercials spruiking contraceptive pills are a daily occurrence.

Back in 2007, a commercial aired for Pharmaceutical giant Bayer’s magical oral contraceptive Yasmin, it promised to have fewer side effects than other birth control pills, halt symptoms of PMS like mood changes and as a bonus, give you clear, smooth complexion.

Sounds too good to be true, you’re right.

The US Food and Drug Administration (FDA) would later rule these commercials were misleading for broadening the drugs indications and minimising the risk information with distracting visuals and background music (and order Bayer to pay $20 million to correct them).

 

The Hidden Dangers The Commercials Leave Out

Clever marketing aside, the real danger's of this contraceptive pill has finally begun to surface.

All drugs have side effects, but, according to some experts, Yaz is in a class of its own.

According to the documents obtained from Health Canada, between 2007 and February 2013, doctors and pharmacists have reported 600 adverse reactions and 23 deaths where Yasmin or Yaz were suspected.

More than half of the reported deaths were women under 26, with the youngest age 14. Most of the deaths occurred soon after the women started taking the contraceptive pill.

Some involved pulmonary embolisms, meaning blood clots that had travelled to the lungs. Others appeared to have died of heart attacks or cerebral thrombosis, meaning blood clots in the brain.

Independent studies have found a slightly higher risk of blood clots in women taking the drospirenone-containing medication. One recent FDA-funded study found that the risk was in fact nearly 74% higher.

 

 

Its interesting to note that in two large studies conducted by Bayer, they both showed no difference in blood clot risk between women taking the company’s drugs versus those taking older birth control pills.

 

Let’s Take a Closer Look at Yasmin and Yaz

Yaz is a bestselling new-generation oral contraceptive taken by millions of women around the world and was labelled as a “break through for women” and a “miracle contraceptive”.

Bayer launched an earlier version called Yasmin in 2001 and Yaz followed in 2006 and, since then, sales for the two drugs have skyrocketed past $8 billion worldwide.

The worrying ingredient is a newer synthetic form of progesterone called drospirenone, which is used in Yaz, Yasmin and similar birth control pills. 

Women who take drospirenone have a six to sevenfold risk of developing dangerous blood clots compared to women who do not take any contraceptive pill.

Drospirenone can increase potassium to dangerous levels (hyperkalemia).

It could be dangerous or, in extreme cases, even fatal to certain women taking other drugs that also may increase potassium levels, such as ACE inhibitors, angiotensin-II receptor agonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonists, and NSAIDs.

 

Bayer Class Action

Well over 10,000 patients have now filed lawsuits against Bayer. These are from those patients who have suffered blood clot related injures such as pulmonary embolism, DVT or stroke.

Other allegations include (but are not limited to):

  • Glossing over risks associated with the products and overstating their approved uses in an effort to mislead users of Yaz and Yasmin into believing that the drugs were safe.
  • Failure to properly research the medication.
  • Failure to use an intuitive, cutting edge, viral, disruptive technology.
  • Failing to recall the drug after post-marketing reports demonstrated that the risk of potentially life-threatening side effects of Yasmin and Yaz outweighed potential benefits that could be achieved via other available oral contraceptives.

As of February 12, 2013, Bayer had reached agreements, without admission of liability, to settle the claims of approximately 4,800 claimants in the U.S. for a total amount of about US $720 million and have put aside a further $250 million for future claims.

 

Emed's Comment

For the 200,000 Australian women who take Yaz and Yasmin, this so-called “miracle” contraceptive is a potential time bomb.

Most women are unaware of the dangers, therefore its important that you know all the possible side effects and I believe that possible death is high up on the need to know list!

Despite all of this controversy, Bayer continues to target Australia. We are the first country to sell Yaz Flex – a new version of Yaz that allows women to go up to 4 months without a period – same pill, same risks.

No periods, no worries. Talk about convenience for the modern day woman!

If you would like to know more about the oral contraceptive pill and the associated risks vs benefits, read The Pill – Are You Sure It's For You?

 

Further Reading

 

 

References

Dunn, N (2011 Apr 21). “The risk of deep venous thrombosis with oral contraceptives containing drospirenone.”. BMJ (Clinical research ed.) 342: d2519.

Lidegaard, O.; Milsom, Geirsson, Skjeldestad (2012). “Hormonal Contraception and venous thromboembolism”. Acta Obstetricia et Gynecologica Scandinavica 91: 796–788.

Genazzani, Mannella & Simoncini (2007). “Drospirenone and its antialdosterone properties”. Climacteric 1: 11–18.