Posts Tagged ‘ blood clots ’

Why are there NuvaRing Lawsuits? Here’s NuvaRing by the Numbers…

May 25th, 2012. By AbiK

As NuvaRing lawsuits continue to wind their way through litigation, it’s interesting to look at some of the numbers on the contraceptive—as numbers tend to tell a story.

NuvaRing was also in the news recently for another reason: in a newly published study, apparently longer-term reversible contraception was found to be more effective in preventing pregnancy than shorter-term methods. Longer-term contraception would include IUDs and implants; shorter-term would be birth control pills, patches and rings. The study, published in the New England Journal of Medicine (5/24/12), found longer-term contraception to be 20 times more effective in preventing pregnancy (of course, one of the reasons cited for this was human error–such as forgetting to take the pill).

So here we go…

NuvaRing by the Numbers

2001: Year in which NuvaRing received FDA approval

950+: Number of NuvaRing lawsuits pending, as reported in Merck’s 10-K earnings report, fiscal year 2011

56%: Percent by which FDA study found NuvaRing raised risk of blood clots vs. older birth control pills.

6: Types of serious NuvaRing adverse events alleged in lawsuits (blood clots, pulmonary embolism, deep vein thrombosis, heart attack, stroke, sudden death)

6.5x: Times higher risk for NuvaRing blood clots compared to non-users of hormonal contraception, according to British Medical Journal study (5/10/12)

5,493: Total number of adverse events reported at the FDA AERS database for NuvaRing, 1Q’04-2Q’11*

30: Average age of women who have had a NuvaRing adverse event reported to the FDA*

1,953: Number of NuvaRing adverse events categorized under “Pulmonary Vascular”, 1Q’04-2Q’11*

1,921: Number of NuvaRing adverse events categorized under “Embolism & Thrombosis”, 1Q’04-2Q’11*

1,648: Number of NuvaRing pulmonary embolism adverse events reported, 1Q’04-2Q’11*

1,274: Number of NuvaRing deep vein thrombosis adverse events reported, 1Q’04-2Q’11

*Source: FDA NuvaRing AERS reports via drugcite.com

Tags: Adverse Events, AERS, BJM, blood clots, DVT, FDA, NEJM, NuvaRing, NuvaRing lawsuit, PE
Posted in Drugs/Medical, Emerging Issues, Personal Injury | No Comments »

Midway Point for Heart Drug Plavix Statute of Limitations

May 20th, 2011. By AbiK

Plavix has started to appear in the news again. Word about Plavix lawsuits—as happens with many pharma tort cases—had died downed within a few weeks of the FDA’s announcement that it would place a black box warning on Plavix (clopidogrel bisulfate). That black box label change happened back in March, 2010—so for many, the statute of limitations for filing a Plavix lawsuit will be up as we approach April 2012—and that’s not as far away as it might seem.

Plavix, which is prescribed for patients at higher risk for heart attack or stroke, is an anti-platelet drug that works by helping to prevent blood from forming clots.

The issue with Plavix—and the reason for the black box warning—is that some patients are not able to metabolize the drug effectively once it’s in their system. The result is that the drug’s effectiveness is reduced. Which, for a person who may be prone to heart attack or stroke, could perhaps be life-threatening.

The patients identified as those at risk for lower metabolization of Plavix are those with an abnormal CYP2C19 genotype—those known as “poor metabolizers”; CYP2C19 is the drug-metabolizing enzyme that serves as the body’s catalyst to convert Plavix to its active (and effective) form.

Reports have indicated that potentially 2 to 14 percent of the population are “poor metabolizers”. Read the rest of this entry »

Tags: antiplatelet, black box warning, blood clots, blood thinner, clopidogrel bisulfate, CYP2C19, FDA, heart attack, Plavix, plavix_heart_attack_stroke, stroke
Posted in Drugs/Medical, Emerging Issues | 2 Comments »

International Women’s Day should Single Out Ortho Evra Makers

March 11th, 2009. By janem

It was International Women’s Day this past Monday and that got me thinking about how the event causes much joy and celebration in most western countries, but likely goes unnoticed in parts of the world that still allow female circumcision. Of all the personal injury lawsuits needed to be filed to protect women, female genital mutilation should surely get top billing. Hillary Clinton said, “Laws are still on the books denying women the right to own property, access credit, or make their own choices within their marriage. And honor killings, maiming, female genital mutilation, and other violent and degrading practices that target women are tolerated in too many places today.” But what about closer to home? Read the rest of this entry »

Tags: blood clots, international womens day, ortho evra, the patch
Posted in Personal Injury | 9 Comments »