NEW YORK, Sept. 26, 2005 (PRIMEZONE) -- Parker & Waichman, LLP (http://www.yourlawyer.com), a leading pharmaceutical liability law firm representing victims who have suffered side effects associated with the Ortho Evra Birth Control Patch, believes that a recent medical study, published in the journal Contraception, clearly illustrates the increased risks of Ortho Evra when compared with other forms of birth control. The study compares ethinylestradiol (EE) pharmacokinetics in three types of hormonal contraceptives: the transdermal patch, the vaginal ring, and an oral contraceptive. The study confirms that, "Of the three contraceptive methods, exposure to EE was highest for the patch group." It is believed that prolonged exposure to high levels of estrogen may be associated with increased risk of adverse effects, including blood clots, pulmonary emboli, and strokes. Ortho Evra is an adhesive, transdermal birth control patch manufactured by Ortho-McNeil, a division of Johnson & Johnson (NYSE: JNJ). For more information on Ortho Evra please visit www.orthopatchlawsuit.com or www.yourlawyer.com/practice/overview.htm?topic=Ortho%20Evra%20Patch.
The study demonstrated that, while Ortho Evra delivers only slightly more EE daily than the vaginal ring or oral contraceptives, subjects using the patch had significantly higher exposure to EE. For example, although Ortho Evra delivers only 33% more EE daily than the vaginal ring, the exposure to EE in the Ortho Evra group was 250% greater than in the vaginal ring group. Ortho Evra subjects also reported more than twice the number adverse events than vaginal ring and oral contraceptive subjects combined. Of the 105 adverse events reported during the trial, 73 were reported among subjects using Ortho Evra.
Ortho McNeil instructs physicians and patients that Ortho Evra can be safely used when worn on the torso, arm, buttock or abdomen, suggesting that all four sites are "therapeutically equivalent". However, the Contraception study found that the application site selected for the patch considerably influenced the EE levels in Ortho Evra patients. Interestingly, the placement of the patch on the abdomen resulted in 20% less EE absorption than placement on the arm, buttock or torso, which were all equivalent.
The unintended detachment of birth control patches was noted in clinical trials of Ortho Evra. The replacement of detached patches is consistent with the manufacturer's packaged instructions. However, the Contraception study implied that exposure to EE in users of Ortho Evra may be higher if the user experiences adhesion problems and has to replace the patch. At least two subjects in the Contraception study experienced adhesion problems and, as a result, were excluded from the study's pharmacokinetic evaluation "because of detached patches that had to be replaced, resulting in additional exposure to study medication and higher serum EE levels."
The study concluded that, while the "transdermal patch is designed to deliver a low daily dose of EE, this does not appear to result in low exposure."
Ortho Evra has been reported to be associated with an increased rate of heart attacks, blood clots, strokes and pulmonary embolism. It is alleged in lawsuits that Ortho-McNeil was aware of the increased medical risks associated with Ortho Evra before the drug was approved and that, once approved, the company failed to adequately warn patients about these risks. This study demonstrates that using the Ortho Evra birth control patch results in increased exposure to estrogen when compared with the vaginal ring or an oral contraceptive. Evidence also shows a correlation with increased exposure to estrogen and an increased risk of blood clots, heart attack and stroke. The incidence of embolisms and thrombotic injuries in Phase III trials of Ortho Evra was reportedly significantly greater than the incidence of such events in oral contraceptives using the hormone levonorgestral. The FDA logged 9,116 reports of adverse reactions to the patch in a 17 month period, whereas Ortho Tri-Cyclen, a birth control pill, only generated 1,237 adverse reports in a six year period. During a 12 month period, 44 serious injuries or deaths have been associated with Ortho Evra, whereas only 17 such reports were linked to the birth control pill during a similar time period. The pattern is further magnified when usage rates are considered: it is reported that Ortho Tri-Cyclen has six times the number of users as Ortho Evra.
Unlike the birth control pill, which is ingested and metabolized by the body's digestive system, the medication in the Ortho Evra patch is released directly into the bloodstream. This may result in dangerously higher concentrations of the medication in the body, leading to adverse effects.
Ortho Evra is an adhesive, transdermal birth control patch that is intended to release 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream per 24 hours. It is replaced once a week for three weeks, and no patch is worn during the fourth week during menstruation. The regimen is then repeated. Ortho Evra was approved by the FDA on November 20, 2001. Over 4 million women have used Ortho Evra since its approval. Ortho Evra continues to be marketed aggressively to both consumers and physicians.
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