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NuvaRing Alleged In Woman's Death

Posted by Chrissie Cole
Tuesday, May 05, 2009 12:36 PM EST
Category: Major Medical
Tags: FDA and Prescription Drugs, Protecting Your Family, NuvaRing, Birth Control, Medical Devices, VTE, Ortha Evra



Is NuvaRing to blame for Jackie Bozicev’s death? Her husband believes so.

Jackie died in December 2007. An autopsy showed she died of a blood clot that traveled from her pelvic area to her lungs. Her husband Rob was baffled. Up until that dreaded day, Jackie was seemingly healthy. She didn’t have a history of clots, nor did she smoke.

When doctors had no answers as to what caused the blood clot that led to his wifes death, Rob turned to Google and found what he believes is the culprit: NuvaRing, a birth control device inserted into the vagina monthly and removed after 3 weeks. A new ring must be inserted no more than 7 days later, according to NuvaRing's Web site.

The device, made by Organon Pharmaceuticals (now owned by Schering-Plough) is touted as the first-of-its kind contraceptive with magazine ads proclaiming, “Let Freedom Ring.”

More than one million women use NuvaRing. Jackie started using the ring in May 2007, a month after giving birth to her second child.

“Jackie had no indication NuvaRing was any more dangerous than any other contraceptive,” says Carmen Scott, a lawyer representing the family in a civil lawsuit against the drugmaker.

All hormone-based contraceptives raise the risk of blood clots (which can lead to stroke and heart attack) but it is more common with some than others. The riskiest use third-generation hormones, like desogestrel (a similar compound is used in the ring).

Developed in the 1980s, the pills were intended to lessen non-serious side effects of the pill including acne and facial hair. Although largely ineffective in doing so and no better as birth control - which is acknowledged by the FDA – the pills remain on the market, says Mother Jones.

Research has consistently shown that these newer pills nearly double the risk of life-threatening blood clots compared to older forms of birth control pills. In 2007, Public Citizen, a watchdog group, petitioned the FDA to ban third-generation birth control pills. But the agency has yet to take action.

Blood clots can be particularly dangerous because they can travel through the veins and block blood flow at another location, causing a condition known as venous thromboembolism (VTE). Blood clots that travel to the lungs can cause pulmonary embolism, which is often fatal.

The FDA has received reports of 300 or more adverse events including stroke, heart attack, nonfatal blood clots and death, since NuvaRing’s approval in 2001, says Scott. More than 100 pending lawsuits attribute injuries to NuvaRing.

While those numbers may seem low, the pattern within them is relatively similar to those alleged against Johnson & Johnson’s - Ortho Evra, a skin patch approved for birth control. On that brand, 1,500 lawsuits were brought after more than 40 women died from blood clots and stroke.

The problem with both the patch and NuvaRing is one in the same: they deliver a constant stream of the active drug. By contrast, birth control pills enter the body through the digestive tract where much of the chemical is destroyed. Once the drug enters the patient’s blood, it lessens until the next pill is taken. Thus the body gets a rest from the drug whereas the patch/ring-wearer does not. #

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