A prominent consumer advocacy group says Ortho Evra, Johnson & Johnson’s controversial birth control patch, is too dangerous to be on the market.  Public Citizen is asking federal regulators to ban Ortho Evra because it poses a higher risk of potentially fatal blood clots than other hormone-based contraceptives.

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 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. (more…)

Johnson & Johnson, the maker of the Ortho Evra birth control patch, is looking to the courts to protect it from lawsuits stemming from the defective device.  Johnson & Johnson is asserting that Ortho Evra lawsuits should not be allowed to go forward because the contraceptive patch was approved by the Food & Drug Administration (FDA) - even though it is becoming increasingly clear that Johnson & Johnson withheld vital Ortho Evra safety information from the agency for years.

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 related to oral contraceptives. But in 2005, the FDA warned that women using Ortho Evra were exposed to approximately 60% more estrogen than those who used oral contraceptive pills. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries. As of November 2005, the FDA had received twenty-one reports of life-threatening blood clots and other ailments associated with the use of Ortho Evra. Then a study was published that showed women using Ortho Evra were twice as likely to suffer blood clots 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. (more…)

Ortho Evra, Johnson & Johnson’s defective contraceptive patch will now include yet another new warning on blood clots.  Information received from a second study that revealed a higher risk of blood clots compared with birth-control pills will be included in the patch’s packaging, according to a statement from U.S Food & Drug Administration (FDA).

In 2006, the prescribing instructions for the Ortho Evra patch were revised to include information about a study warning that women could face a doubling of blood clot risks when using the patch.  Previous to that study, Johnson & Johnson had touted a study that inidcated that Ortho Evra’s blood clot risks were equal whether one took the Pill or wore the contraceptive patch.   (more…)

The Ortho Evra Birth Control Patch is still being called a “safe and effective” contraceptive by the Food & Drug Administration (FDA), even though two separate studies have now shown that Ortho Evra users are at a higher risk of developing potentially fatal blood clots than women who use oral birth control pills. This weekend, even as the FDA announced it was adding a second blood clot warning to the Ortho Evra label, patch users were not advised to seek other forms of birth control. Instead, users of the Ortho Evra were told by the FDA to “thoroughly discuss with their health care providers the risks and benefits involved. ”

Johnson & Johnson received FDA approval to market the Ortho Evra Birth Control patch in 2001. When it went on the market in 2002, the company touted Ortho Evra as a more convenient alternative to once-daily birth control pills. Johnson & Johnson maintained that Ortho Evra carried side effects similar to the Pill, and exposed users to similar amounts of estrogen.

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A second Ortho Evra Birth Control Patch study has found that the contraceptive puts users at a higher risk of blood clots than estrogen-containing birth control pills, prompting the Food & Drug Administration (FDA) to announce another round of label modifications for the Johnson & Johnson birth control patch. This is the second time since 2006 that the Ortho Evra label has been changed over blood clot concerns.

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 FDA warned that women using Ortho Evra were exposed to approximately 60 percent more estrogen than those who use oral contraceptive pills. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries.

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A former Ortho Evra Birth Control Patch user who suffered a series of potentially-fatal blood clots while using the defective drug will not be able to receive more than $250,000 in punitive damages should she win her lawsuit against patch maker Johnson & Johnson, an Ohio court has ruled.  The Ohio Supreme Court’s 5-2 decision to uphold a state law capping punitive damages is unfortunate not just for patients injured by Ortho Evra, but for anyone in that state injured by a defective drug or medical devices.

When Ortho Evra was introduced in 2002, Johnson and 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 related to oral contraceptives. But in 2005, the Food & Drug Administration warned that women using Ortho Evra were exposed to approximately 60 percent more estrogen than those who used oral contraceptive pills. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries. As of November 2005, the FDA had received twenty-one reports of life-threatening blood clots and other ailments associated with the use of Ortho Evra. Then in 2006, a study was published that showed women using Ortho Evra were twice as likely to suffer blood clots 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.

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Ortho Evra Birth Control Patch studies that proved the contraceptive patch exposed women to dangerously high levels of estrogen where either altered or withheld by Johnson & Johnson before the medication was approved by the Food & Drug Administration (FDA), according to court papers file by lawyers for women suing the patch maker in Ohio.   Johnson & Johnson is being sued by 2,400 women nationwide who claim the defective Ortho Evra Birth Control Patch caused them to suffer strokes, heart attacks, and blood clots in the legs and lungs.

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 related to oral contraceptives. But in 2005, the FDA warned that women using Ortho Evra were exposed to approximately 60% more estrogen than those who used oral contraceptive pills. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries. As of November 2005, the FDA had received twenty-one reports of life-threatening blood clots and other ailments associated with the use of Ortho Evra. Then a study was published that showed women using Ortho Evra were twice as likely to suffer blood clots 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.

(more…)