If Schering-Plough wants to know what the future possibly holds for its Nuvaring contraceptive -- accused in lawsuits of killing a woman via a thromboembolism -- it might want to look at what happened with Johnson & Johnson's Ortho Evra birth control patch. Mother Jones reports:
Since 2001, when the FDA green-lighted NuvaRing, the agency has received reports of at least 300 serious adverse events, including strokes, nonfatal blood clots, and fatalities, says Scott. (The company says it doesn't keep a tally, but forwards all such reports to the fda.) More than 100 pending lawsuits attribute injuries to the device.Those numbers are small, but the fact-pattern within them is remarkably similar to those alleged against Ortho Evra. On that brand, more than 1,500 suits were brought after more than 40 women died from blood clots and strokes.
The problem with the patch and Nuvaring (a hormone-infused ring worn inside the vagine) is the same: They both 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 is in the patient's blood, it declines until the next pill is taken. Thus the body of a pill-taker gets a "rest" from the drug were the patch/ring-wearer does not.
J&J no longer actively promotes Ortho Evra, raising the question of why this more-dangerous-than-pills brand is still on the market. And it's not just birth control. J&J has taken flack over its Duragesic painkiller patch, too.
The Nuvaring story has an interesting twist that the Ortho Evra one does not: Before the brand was acquired by Schering, it was promoted by product placement on the TV shows Scrubs and Gray's Anatomy. There's an interesting debate to be had over where a mere brand appearance counts as a legit "reminder" ad (where no efficacy claims are made) or illegitimate promotion that lacks fair balance. But that will be for a jury to decide.
- See previous coverage of patches:
- Duragesic Recall Causes More Patch Woes for J&J
- J&J Settles Fatal Patch Cases, So Why Is This Thing Still on the Market?