–November 21, 2005
The parents of now-deceased 14-year-old Alycia Brown are filing a lawsuit against Ortho McNeil, the makers of the Ortho Evra birth control patch. After concern over unwanted pregnancies, Alycia and her parents decided she should use a contraceptive. Just eight weeks after beginning the Ortho Evra patch, she died of blood clots in her lower pelvic area. The county medical examiner has discovered that Ortho Evra was a likely cause of her untimely death. While many young and healthy women have suffered injuries and death from Ortho Evra use, Alycia Brown is the youngest known victim of fatal Ortho Evra side effects.
Ortho Evra was approved by the FDA in 2001 and aggressively marketed to women as a safe and effective contraceptive patch. In July 2005, the Associated Press published the results about an alarmingly high risk of Ortho Evra side effects. According to FDA side effect reports, women using Ortho Evra were three times more likely to develop blood clots, suffer stroke, or die compared to women using an oral contraceptive. According to AP findings, at least 23 women died of possible Ortho Evra side effects, including blood clots and stroke. Most were young and healthy. Ortho McNeil denied these findings, stating that Ortho Evra was as safe as other contraceptives.
Two weeks ago, CBS news did a story on a lawsuit filed on behalf of a young mother severely paralyzed by stroke only 12 days after starting the Ortho Evra patch. During this lawsuit, Ortho McNeil internal documents were produced, indicating the company received over 500 reports of significant Ortho Evra side effects between April 2002 and December 2004. By comparison, only 61 side effect reports were received with respect to oral contraceptives. Of these reports, women using the Ortho Evra patch suffered four times as many strokes as those taking oral contraceptives. The risk of blood clots appeared to be fourteen times greater for women using the birth control patch.
The Associated Press ran a follow-up study, stating the company refused to sponsor an Ortho Evra study in 2003 comparing the effects of Ortho Evra and Ortho-Cyclen, a popular oral contraceptive. According to a company memo, Ortho McNeil refused the study because there was, “too high a chance that study may not produce a positive result for Evra…There is too high a risk that Ortho Evra may be the same or worse than Ortho-Cyclen.”
Even before Ortho Evra was approved by the FDA, evidence suggests Ortho McNeil was aware of the serious risks associated with their product. During pre-marketing clinical trials, two women developed blood clots while using Ortho Evra. The company denied the connection between the patch and the blood clots. An FDA reviewer, however, strongly disagreed with the company’s conclusion. He also voiced concern about other Ortho Evra side effects. For example, nearly eight percent of all women in the clinical trials gained at least ten pounds. The effectiveness of Ortho Evra in patients over 198 pounds was significantly reduced.
Only last week did Ortho McNeil finally acknowledge these serious Ortho Evra side effects. The company now admits that women using Ortho Evra are exposed to 60 percent more estrogen than women taking another form of hormonal contraception. This exposure drastically increases one’s risk of blood clots, stroke, and death.
Though a ‘black box’ warning has been added to all Ortho Evra labeling, this dangerous drug still remains on the market, threatening the lives of young and healthy women. According to Public Citizen, a consumer watchdog group, “There is no medical reason for women to use the more dangerous Ortho Evra, rather than one of the older, better understood, and equally effective oral contraceptives.”
