Was Ortho Evra's Manufacturer Aware of Health Risks?
In November 2005, the Food and Drug Administration (FDA) reported that the Ortho Evra birth control patch would carry a new label warning users they will be exposed to 60% more estrogen than users of the typical birth control pill. This announcement came four months after the Associated Press reported that the risk of dying or suffering a survivable blood clot was three times higher for birth control patch users than pill users.
The announcement that the birth control patch delivers more than twice as much estrogen as the pill probably came as a surprise to many patch users, since early reports talked about the similarities between the patch and the pill but did not mention this significant difference. The FDA approved the Ortho Evra patch, touted as a more convenient way to get the same birth control effect as with the pill, in 2001. At that time, it was stated that Ortho Evra was as safe as the pill and carried only the same risks as the pill.
There is some evidence that when Ortho Evra entered the market the manufacturer, Ortho McNeil, a Johnson & Johnson subsidiary, was aware of the increased risks posed by the patch. The FDA was aware that there was an increased risk of non-fatal blood clotting, but there may have been disagreement about the risk of death. According to the Associated Press, during FDA trials, two women suffered potentially fatal pulmonary embolus, but Ortho McNeil did not want to count one of the women because she had undergone surgery, a contributing factor for some blood clots. One FDA reviewer disagreed with Ortho McNeilÂs wishes to exclude the woman from the statistics. The reviewer urged that the label on Ortho Evra patches should reflect his concern about a potential increased risk, and suggested that it would be important to study users after the patch came on the market.
Until recently, no follow-up studies were ordered for the Ortho Evra patch. Along with its announcement about the new warning label, the FDA reported that Ortho McNeil is conducting additional studies to compare the risk of developing serious blood clots in women using Ortho Evra to the risk of women using typical birth control pills. Documents released in the course of litigation related to Ortho Evra reveal that Ortho McNeil previously considered such a study, but declined to fund it over concerns that there was too high a chance that the study may not produce positive results for Ortho Evra. Other documents released for litigation showed that Ortho McNeil was monitoring the death and injury reports of the birth control pill as compared to the birth control patch, and charting the differences.
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