Words by: Mandy Moe Pwint Tu
Earlier this year, twenty-eight year old Perth woman Petra Zele died of complications arising from a blood clot in her lungs. She had been admitted into the emergency department at Fremantle Hospital three weeks earlier, complaining about chest pains, but was sent home with painkillers when Dr Susan Hinsley informed her that the pain was caused by muscle soreness.
The coronial report into Petra Zele’s death stated that Zele had been on the oral contraceptive pill known as Yasmin, a drug notorious for the increase of blood clots, and that she had had a genetic mutation that further increased her risk.
What else has happened since then? Surely it can’t have been a lone accident?
Recently, more than a thousand Australian women have rallied together to take action against Bayer Healthcare Pharmaceuticals, one of the world’s largest contraception manufacturers. Law firm Tindall Gask Bentley has been actively seeking out the approximately 200,000 women who use the pills, which contain the hormone Drospirenone. The firm has stated that the contraceptives have been connected to an increased risk of stroke, heart attack, blood clots, deep vein thrombosis, and pulmonary embolisms. They seek to establish that Bayer had misrepresented the pills and their side effects, however this is not the first time that Bayer Pharmaceuticals have made headlines.
The Yaz and Yasmin contraceptive pills have long been under fire and have been the subject of more than 8,250 lawsuits in the United States alone. The main reason for this is that their use has been associated with dangerous side effects such as blood clots (as aforementioned), stroke, as well as heart and blood disorders. This, in turn, has understandably led to more than 10,000 US patients filing lawsuits against Bayer Healthcare Pharmaceuticals. In fact, the surge in lawsuits has so risen that multidistrict legislation (MDL) is now in place to handle the claims.
How did all this start?
The drugs first hit the market in 2006. In addition to preventing pregnancy Yaz was marketed as a treatment for acne and premenstrual syndrome, which in turn led to the popularity of similar drugs such as Yasmin and Ocella. In December 2008, the US Food and Drug Administration (‘FDA’) panel voted in favour of strengthening warnings on Yaz birth control pill labels. Its most serious label, the black box warning, has since appeared on all the Yaz and Yasmin packaging, warning women who smoke about an increased risk of serious cardiovascular side effects that may occur if they utilize either drug. In addition to this, Bayer Pharmaceuticals have been accused of not conducting enough research on the medications, and failing to issue a recall after reports indicated a risk of life-threatening side-effects.
Affected families have been in alliance with the FDA’s rulings that some of the drugs’ uses had been exaggerated in their marketing and advertising campaigns, while their side effects had been vastly downplayed. Consequently, the Yaz and Yasmin pills have been linked to thousands of injuries and at least a hundred deaths because of these severe side effects. Users of the newer generation pill experienced twice as much blood clot risk than if they had used an older generation pill.
Is there anything that supports the fact that the newer contraceptive pills heighten the risk of blood clots?
A UK study confirms evidence that the newer contraceptive pills pose a greater risk of blood clots. While comparing oral contraceptives containing a synthetic version of the hormone progestogen with earlier versions of the pill, the study discovered that the women using the older pills, i.e. not the third generation pill (introduced in the 1990s) or the fourth generation pill (approved in the last decade), had about two and a half times increased risk of venous thrombo-embolism (VTE), while women using the newer pills had four times the increased risk of VTE.
This class of drug “shouldn’t be on the market because there are so many safer alternatives,” said Diana Zuckerman, president of the National Research Center for Women & Families. “We can debate how unsafe it is and for whom — more research could obviously clarify that — but there’s really no doubt that it’s not as safe as dozens of other birth control pills.”