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Ortho Evra Birth Control linked to Blood Clots, Strokes, Heart AttacksA consumer fraud class action lawsuit is currently being investigated against Ortho-McNeil Pharmaceutical, Inc., the manufacturer of the Ortho Evra birth control patch. The investigation concerns whether Ortho-McNeil has failed to disclose that the risks of adverse health events such as blood clots, stroke or heart attacks are greater for women using the patch than for women using birth control pills.The Allegations Regarding this Potentially Fatal form of Birth Control On Sunday July 17th, 2005 The Associated Press reported that they were aware of at least a dozen women, most in their late teens and twenties who passed away last year due to blood clots that are believed to be related to the use of the Ortho Evra Patch. Dozens more allegedly survived strokes and other clot related health issues according to 16,000 federal drug reports filed with the FDA and obtained through the Freedom of Information Act. In fact, API found 23 different fatalities associated with the patch, but the primary cause of death in each case was not always clear.Heartbreaking Tragedies It appears that these cases are incredibly tragedies for the families involved. In one case, a 25 year old woman had a stroke and was placed in the Intensive Care Unit, where her condition was so fragile that her family was unable to speak or touch her in any way because even the slightest amount of stimulation could create a fatal level of pressure on the brain.Despite this, after days of horrible headaches that the coroner stated were brought on by the use of the hormones in Ortho-Evra, this beloved sister, daughter and wife passed away. They never got to touch their loved one or speak to her again after the stroke, a scenario that’s a nightmare for any family with a cherished member who was allegedly affected so horribly by this medication. One very disconcerting aspect of this alleged issue is the age of the women that are most adversely affected. These are young women who are normally at low risk fro blood clots. For example, and 18 year old Manhattan student collapsed and died in a New York Subway Station last April. A 25 year old mother of two from The Bronx, New York died after being on the patch six weeks in March of 2004. These tragedies may be well be happening on a larger scale where the coroner or doctors involved did not consider the effect of the patch in the fatal or near-fatal event, or they failed to report it to the government which is allegedly not uncommon. Did the FDA fail the public for the financial benefit of a Major Pharmaceutical Manufacturer? Even though the FDA and Ortho-McNeil pharmaceuticals saw warning signs of possible problem the Ortho-Evra patch before it was approved for the general market, both entities maintain that the medication is as safe as any other birth control in pill form.However, according to the information obtained by the Associated Press, it appears to indicate that in 2004, while over 800,000 women were using the patch - the risk of dying or suffering a blood clot while using the patch delivery system was actually about 300% higher than regular birth control pills. The Medical Experts versus Many Typical Doctors The editor-in-chief of the respected medical journal “Fertility and sterility” stated, “I was shocked” when presented with the information obtained via the Freedom of Information Act. Of course, some other doctors think it’s not serious enough to warrant concern since they say four million women have used the patch safely. Obviously, most of them don’t have daughters or relatives who have gone through this experience, and they likely know better than to let their own loved ones use it, although many probably prescribe it for their patients. These statistics are not available, nor do we expect much of the medical profession to be forthcoming about such matters.It’s an unfortunate reality that many doctors are legally paid what is essentially the equivalent of sales commissions or other incentives when they prescribe brand name medications in abundance. By providing a financial incentive to prescribe certain medications, this brings up a plethora of ethical and liability issues. Sadly, it seems some doctors will prescribe some questionable medications for perks as basic as prescription pads, clip boards, or even pens and pen holders. Anyone who visits a doctor is bound to see the many sales incentives doctors receive to promote brand name pharmaceuticals. Ortho-McNeil is no different from other pharmaceutical giants when it comes to promoting its high profit, patented non-generic products – in some cases possibly even if they are clearly unsafe in some cases. The Statistics According to the information obtained, if you are female taking birth control pills and you don’t smoke and are under the age of 35, the chance that you might have a blood clot that doesn’t kill you is between 1 and 3 in 10,000. The risk of dying from a blood clot while on the pill is about 1 in 200,000.In contrast with the patch, the rate of non-fatal blood clots was closer to 12 out of 10,000 users during clinical trials (before the drug was approved) while the death rate appears to be closer to 3 out of 200,000 users. Labeling and Package information Contradictions Finally, the package labeling seems to make to statements that contradict themselves. In one case it says the patch is expected to be associated with similar risks as birth control pills. Further on however, it states whether the risk of blood clots from the patch is higher than that for the pill is unknown.Ortho Evra In the News The warnings over Ortho Evra dangers are causing doctors to abandon the use of the birth control patch and search for other alternatives for their patients. (Nov-23-05) [NEWS INFERNO]Millions of women who use Ortho Evra contraceptive warned of exposure to high amounts of estrogen. (Nov-11-05) [CNN NEWS] Ortho McNeil, the makers of Ortho Evra, a popular birth control patch warned millions of women yesterday that the patch exposes them to significantly higher doses of hormones, and that it may put them at greater risk for blood clots and other serious side effects than previously disclosed. (Nov-11-05) [BOSTON GLOBE] A lawsuit against Johnson & Johnson, maker of Ortho Evra birth control patch alleges women suffered strokes and blood clots. (Jul-25-05) [CNN MONEY] Birth Control Patch Linked to Higher Fatality Rate. (Jul-20-05) [MSNBC NEWS] Deaths Linked to Birth Control Patch Use. (Jul-17-05) [WASHINGTON TIMES] LEGAL NOTICE AND
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