New Info For Ortho Evra Label in CanadaMar 20, 2009 | Parker Waichman LLP
Canadian health regulators have announced a label update for the Ortho Evra birth control patch. Ortho Evra - sold as Evra in Canada - has been linked to dangerous blood clots. According to Health Canada, the new Canadian label will include information on the average daily release rates of contraceptive hormones from the Ortho Evra patch.
Earlier this month, we reported that Johnson & Johnson subsidiary Janssen-Ortho had agreed to settle a class-action lawsuit started by Canadian women who claimed they were injured by Ortho Evra. The plaintiffs in the lawsuit had charged that Janssen-Ortho failed to adequately warn them and their doctors about the patch’s association with an increased risk of developing blood clots, pulmonary embolisms, strokes, heart attacks and deep vein thrombosis.
Since it was approved in Canada in 2002, Health Canada has received at least 16 reports of blood clots and one heart attack among Ortho Evra users. Two patients died, including a 16-year-old girl,
In a Health Canada announcement released yesterday, consumers were informed of the following:
- The EVRA product monograph now includes new information on the average daily release rates of the contraceptive hormones norelgestromin (200 micrograms every 24 hours) and ethinyl estradiol (35 micrograms every 24 hours). This information replaces the previously labeled daily delivery rate of norelgestromin (150 micrograms every 24 hours) and ethinyl estradiol (20 micrograms every 24 hours).
- The new information on the average daily release rate was determined by measuring hormone content that remained in the EVRA patches worn by women for 7 days. The previously labeled delivery rate information was estimated using a different method. The term "release rate" has replaced the previously labeled term "delivery rate" as a more descriptive term regarding release of hormones from the patch.
- There has been no change to the way the EVRA patch is made. The estimates of actual exposure to the hormones from the EVRA patch (amount of contraceptive hormones actually measured in the blood stream) have not changed. There is no known impact on the safety and effectiveness of the EVRA patch as a result of the new information on the average daily release rate.
When Ortho Evra was introduced in 2002, Johnson & Johnson touted the once-weekly patch as a convenient alternative to daily oral contraceptive pills. The drug’s original safety label stated that the patch’s health risks were similar to those of oral contraceptives.
But in 2005, the U.S. Food & Drug Administration (FDA) warned that women using Ortho Evra were exposed to approximately 60 percent more estrogen than those who use oral contraceptive pills.
It is believed that the difference in exposure is related to the delivery mechanism of the birth control patch. Hormones in birth control pills are partially diluted by the digestive system. However, hormones in Ortho Evra are absorbed directly into the blood stream, which causes a higher concentration of the medication to enter a patient’s body. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries.
In 2006, a study was published that showed women using Ortho Evra were twice as likely to suffer a type of blood clot called venous thromboembolisms (VTEs) — a clot that can travel to the lungs and cause a fatal pulmonary embolism - as those taking oral birth control pills. That study prompted the FDA to request a change on the Ortho Evra label to include a stronger safety warning. Then in January 2008, the FDA asked that the Ortho Evra label be changed again to include information on yet another study that indicated the patch doubles the risk of developing VTEs compared to the Pill.