Ortho Evra News &
Announcements
07/02/2007 - Accident Raises Safety Concerns About Chinese Tires
Wall Street Journal reports that more than 450,000 Chinese-made tires may lack an important safety feature.
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Ortho Evra, the first birth control developed as a skin patch and the first weekly form of birth control, was approved by the U.S. Food & Drug Administration (FDA) in 2001. Manufactured by Ortho-McNeil (a Johnson & Johnson company), Ortho Evra has been linked to an increased exposure to estrogen as well as the possibility that its users are at twice the risk for developing blood clots than women who use a birth control pill.
The wafer-thin Ortho Evra patch, like some birth control pills, is a combination hormonal contraceptive. The two hormones contained in the patch are a form of estrogen called ethinyl estradiol (EE) and a form of progestin known as norelgestromin (NGMN). The adhesive patch is applied once a week to the upper outer arm, upper torso, abdomen or buttock. It is detached and replaced with another patch each week for three weeks every month.
Although many pill forms of birth control contain the same type and dose of hormones as Ortho Evra, the hormones are absorbed into the bloodstream very differently. Conventional birth control pills are metabolized through the digestive system. A portion of the dose of hormones is excreted in the feces and urine, while what remains of the dose is further metabolized in the liver where it then enters the bloodstream. On the other hand, the hormones administered by the Ortho Evra patch directly enter the bloodstream after being absorbed through the skin.
In 2001 when Ortho-McNeil applied to the FDA requesting approval of Ortho Evra, the FDA's medical reviewer raised a concern over "the possible increased risk of venous thromboembolism and/or pulmonary embolism associated with the transdermal delivery" of the hormones after two participants in the study reportedly developed potentially fatal blood clots. The medical reviewer also recommended that the final label for Ortho Evra address the possible increased risk of blood clots associated with the patch.
It was not until November 2005, however, that the FDA issued a public warning that users of the Ortho Evra patch may be exposed to 60% more estrogen than they would be exposed to by taking a birth control pill containing norgestimate and 35 micrograms of estrogen. The FDA also requested that Ortho-McNeil amend Ortho Evra's product label to include the warning.
The 2005 warning came after the interim report of an unpublished study found that users of the contraceptive patch may have a two-fold increased risk for developing blood clots compared with women who take a combination hormonal contraceptive pill. After further review of the report, the FDA announced on September 20, 2006 that Ortho-McNeil must update the Ortho Evra label once again. The FDA, has also requested that the pharmaceutical company provide a longer follow-up on the risks of developing blood clots associated with use of Ortho Evra.
The latest label for Ortho Evra must now include the results of the study which reflect an increased risk that users of Ortho Evra may develope blood clots, as well as include the results of a similar study which concluded that the risk of developing blood clots is no higher for users of Ortho Evra than for users of a similar birth control pill. Both studies were sponsored by Johnson & Johnson and were conducted using electronic health insurance claims. Information regarding the studies was publicly provided by Johnson & Johnson in a press on February 16, 2006.
More than 4 million women have used the Ortho Evra patch since it received FDA approval, but not without incident. In April 2004, an 18 year-old college student in New York collapsed on a subway platform and died after developing a pulmonary embolism in her lung. According to the coroner, an autopsy revealed the pulmonary embolism formed as a direct result of using the Ortho Evra patch. It is reported that Ortho-McNeil quietly settled with the woman's family out of court. There have since been numerous accounts of women using Ortho Evra suffering hauntingly similar incidents of strokes, miscarriages and other complications involving blood clots.
In August 2006, Ortho-McNeil disclosed that approximately 500 legal claims have been filed against it related to injuries allegedly suffered from the Ortho Evra patch. Families of several women who died while using the patch have also brought wrongful death actions against Ortho-McNeil and Johnson & Johnson.
If you or a relative have suffered severe side effects, such as a blood clot, while using the Ortho Evra birth control patch and would like to speak to a professional regarding your rights, please fill out this short form and a member of Seeger Weiss's experienced legal staff will contact you. Initial attorney consultations are free of charge and do not create a legal relationship. Seeger Weiss LLP has offices located in both New York and New Jersey and its attorneys are available to practice in courts throughout the country.
The wafer-thin Ortho Evra patch, like some birth control pills, is a combination hormonal contraceptive. The two hormones contained in the patch are a form of estrogen called ethinyl estradiol (EE) and a form of progestin known as norelgestromin (NGMN). The adhesive patch is applied once a week to the upper outer arm, upper torso, abdomen or buttock. It is detached and replaced with another patch each week for three weeks every month.
Although many pill forms of birth control contain the same type and dose of hormones as Ortho Evra, the hormones are absorbed into the bloodstream very differently. Conventional birth control pills are metabolized through the digestive system. A portion of the dose of hormones is excreted in the feces and urine, while what remains of the dose is further metabolized in the liver where it then enters the bloodstream. On the other hand, the hormones administered by the Ortho Evra patch directly enter the bloodstream after being absorbed through the skin.
In 2001 when Ortho-McNeil applied to the FDA requesting approval of Ortho Evra, the FDA's medical reviewer raised a concern over "the possible increased risk of venous thromboembolism and/or pulmonary embolism associated with the transdermal delivery" of the hormones after two participants in the study reportedly developed potentially fatal blood clots. The medical reviewer also recommended that the final label for Ortho Evra address the possible increased risk of blood clots associated with the patch.
It was not until November 2005, however, that the FDA issued a public warning that users of the Ortho Evra patch may be exposed to 60% more estrogen than they would be exposed to by taking a birth control pill containing norgestimate and 35 micrograms of estrogen. The FDA also requested that Ortho-McNeil amend Ortho Evra's product label to include the warning.
The 2005 warning came after the interim report of an unpublished study found that users of the contraceptive patch may have a two-fold increased risk for developing blood clots compared with women who take a combination hormonal contraceptive pill. After further review of the report, the FDA announced on September 20, 2006 that Ortho-McNeil must update the Ortho Evra label once again. The FDA, has also requested that the pharmaceutical company provide a longer follow-up on the risks of developing blood clots associated with use of Ortho Evra.
The latest label for Ortho Evra must now include the results of the study which reflect an increased risk that users of Ortho Evra may develope blood clots, as well as include the results of a similar study which concluded that the risk of developing blood clots is no higher for users of Ortho Evra than for users of a similar birth control pill. Both studies were sponsored by Johnson & Johnson and were conducted using electronic health insurance claims. Information regarding the studies was publicly provided by Johnson & Johnson in a press on February 16, 2006.
More than 4 million women have used the Ortho Evra patch since it received FDA approval, but not without incident. In April 2004, an 18 year-old college student in New York collapsed on a subway platform and died after developing a pulmonary embolism in her lung. According to the coroner, an autopsy revealed the pulmonary embolism formed as a direct result of using the Ortho Evra patch. It is reported that Ortho-McNeil quietly settled with the woman's family out of court. There have since been numerous accounts of women using Ortho Evra suffering hauntingly similar incidents of strokes, miscarriages and other complications involving blood clots.
In August 2006, Ortho-McNeil disclosed that approximately 500 legal claims have been filed against it related to injuries allegedly suffered from the Ortho Evra patch. Families of several women who died while using the patch have also brought wrongful death actions against Ortho-McNeil and Johnson & Johnson.
If you or a relative have suffered severe side effects, such as a blood clot, while using the Ortho Evra birth control patch and would like to speak to a professional regarding your rights, please fill out this short form and a member of Seeger Weiss's experienced legal staff will contact you. Initial attorney consultations are free of charge and do not create a legal relationship. Seeger Weiss LLP has offices located in both New York and New Jersey and its attorneys are available to practice in courts throughout the country.