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Ortho Evra Class Action Lawsuits Information
The Ortho Evra birth control patch has become a popular birth
control option for American women after receiving FDA approval in November 2001.
Containing a combination of estrogen and progesterone that is slowly absorbed
when applied to the skin, the patch allows the combined hormones to prevent
ovulation and pregnancy. In less than three years on the market, Ortho Evra was
tried by more than five million women in the United States, which made the July
2005 Associated Press report that a dozen deaths during 2004 could be linked to
the device's use so concerning.
According to the AP, about a dozen women, most of them in their late teens and
early 20's, died from blood clots in 2004 that were using the Ortho Evra patch.
The AP filed a Freedom of Information Act to request to obtain reports of
adverse events from the FDA, which they said revealed the risk of death with the
patch could be about three times greater than with the pill. Ortho Evra's maker,
Ortho-McNeil, refuted the AP's claims, saying the report exaggerated the risk by
using too low a number of patch users in 2004.
The AP said there were 12 clot-related deaths among the approximately 800,000
Ortho Evra users in 2004, but Ortho-McNeil said industry data showed two million
women used Ortho Evra in 2004. While the AP's review did not establish a casual
link between the deaths and the patch, Amy Allina of the Washington-based
National Women's Health Collective sent a letter to the FDA supporting the idea
that the data provides a strong argument for a requirement by the FDA that the
manufacturer of any new drug that is know to have serious side effects conduct a
substantial post release study of its safety.
In the letter, Allina said that even if such a study did not establish causality
between the deaths and Ortho Evra use, women would have a clearer idea about the
rate at which problems were occurring associated to the use of the patch. This
information would allow women to make more informed choices about the use of
hormonal contraceptives. The AP said an FDA medical reviewer recommended a post
release study at the time Ortho Evra was approved, but the FDA did not mandate
the study.
Though some experts cautioned about overreaction to the AP report, others
believed the adverse reports could be indicative of greater problems. Because
Ortho Evra is a new delivery system, the belief that the hormone dosage delivery
is the same as those found in oral contraceptives could be inaccurate. Should a
quicker dose deliver from Ortho Evra be present, it could be making the drug
more potent, thus increasing the risks for suffering adverse events.
Blood clots are a known risk of all hormonal contraception, but it is considered
a rare event, especially among women under 35 years of age. The recent news
stories regarding the risks of blood clots and strokes in women using Ortho Evra
have increased concerns. Ortho-McNeil has cautioned Ortho Evra should not be
used by women who have the typical risk factors for cardiovascular disease, such
as smoking, a history of heart attack, stroke or clotting disorders.
Ortho Evra Side Effects
The Associated Press report concerning Ortho Evra side
effects suggests that the birth control patch is riskier than an oral
contraceptive. Using FDA data obtained under the Freedom of Information Act, the
report indicates that in 2004 – when 800,000 women were on the patch—the risk of
dying or suffering a survivable blood clot while using the device was about
three times higher than while using birth control pills. Raw data indicated that
about a dozen young women who used Ortho Evra in 2004 died from blood clots, and
the FDA data showed that dozens of other young women survived strokes and other
clot conditions after using the patch.
The women who suffered lethal Ortho Evra side effects were mostly in their teens
and early 20's and apparently at low risk for blood clots. A women who is
younger than 35 is very unlikely to get a blood clot, with her risk being
between two and five in 100,000. While some doctors reviewing the FDA reports at
the request of the AP were shocked with the results, other doctors said the
Ortho Evra side effects are warranted considering the high use rate of the
devices.
Ortho McNeil, the maker of Ortho Evra, said none of the deaths could be directly
attributed to Ortho Evra. Women concerned with reports of Ortho Evra side
effects risks were told not to overreact without first talking to their
individual doctors, but other safety experts believed the Ortho Evra side
effects were a consequence of the FDA approving drugs after trials with only a
few thousand users and failing to require post approval studies to ensure
safety.
The AP said an FDA medical reviewer recommended a post release study of Ortho
Evra's safety at the time of its approval in November 2001, but the FDA did not
mandate one. If there are serious Ortho Evra side effects, it should not be
surprising that they are surfacing now, according to critics. Because the patch
is a new delivery system, any potential Ortho Evra side effects will not emerge
until the drug reaches the general market.
The FDA's reporting system is voluntary and has other deficiencies, so drawing
reliable conclusions about Ortho Evra side effects risks is difficult. Ortho
McNeil called the data quoted in the AP report as “misleading” because they are
based on spontaneous reports that are called in voluntarily. The National
Women's Health Network wrote to the FDA following news about possible increased
Ortho Evra side effects risks, urging the agency to conduct a study to look at
the risk of blood clots associated with the use of the birth control patch. Even
if it failed to establish causality between side effects and the patch, the
group believed the risk of blood clots associated with the use of Ortho Evra
should be further investigated.
Ortho Evra has enjoyed booming sales ever since its arrival to the U.S. market,
and is currently used by tens of thousands of American women. The Ortho Evra
side effects concerns are the latest example of the FDA needing safety reforms
to give greater authority, independence and resources to the agency's
post-market safety monitoring system. The fact that an FDA medical reviewer
recommended a study to better determine Ortho Evra side effects risks at the
time of its approval but that this study was not required by the agency is,
according to some critics, further evidence of pervasive deficiencies in drug
safety.
More Ortho Evra Information
Ortho Evra defects have prompted serious concern since the
publication of studies linking the contraceptive to fatal blood clots and
cardiovascular complications. The Ortho Evra birth control patch is the first
contraceptive of its kind to gain FDA approval. Since its 2001 approval, Ortho
Evra has been aggressively marketed by its maker, Ortho McNeil. Recent reports
of serious Ortho Evra defects have prompted serious concern and scrutiny of the
drug's maker.
It is alleged that Ortho McNeil learned of dangerous Ortho Evra defects before
this medication was approved and that, once approved, the company failed to warn
consumers about the risks associated with their product. In a pre-marketing
Ortho Evra trial involving over 3,000 participants, Ortho McNeil discovered two
cases of women who developed blood clots that traveled to their lungs, a
life-threatening condition called pulmonary embolism. Some medical experts
believed these injuries might have been related to Ortho Evra defects, yet the
medication was still approved for consumer use.
Despite these pre-market findings, Ortho McNeil has taken no steps to further
investigate the possibility of Ortho Evra defects that may pose a serious threat
to consumers. In 2005, the Associated Press conducted an analysis of the FDA's
database of Ortho Evra adverse drug reports. The organization discovered nearly
ten thousand reports of adverse reactions to the birth control patch. In just
one year, the FDA received 44 reports of death or serious injury linked to Ortho
Evra defects.
Based on their findings, the Associated Press concluded that using the birth
control patch tripled a woman's risk of developing a blood clot and related
complications. Ortho McNeil states that this report is over-exaggerated.
According to AP calculations, an Ortho Evra user has a three in 200,000 chance
of developing a blood clot as a result of this medication. For comparison, oral
contraceptives carry one in 200,000 risk of developing blood clot related
complications.
At least 23 deaths have been linked to Ortho Evra, 17 of which were caused by
blood clot complications. Most of the women who have died were young, healthy,
and had no history of cardiovascular conditions. Ortho Evra defects have been
linked to the deaths of women as young as 18 years old. Ortho McNeil announced
they are investigating the possibility of Ortho Evra defects that may lead to
serious patient injury or death.
While the exact link between Ortho Evra and serious cardiovascular complications
remains unknown, some medical experts have expressed their professional opinion
about Ortho Evra defects. They believe the increased risk of serious health
problems may be related to the Ortho Evra delivery system. Oral contraceptives
are first processed through the digestive system before hormones enter the blood
stream. With the Ortho Evra patch, similar hormones are delivered directly into
the blood stream. This may result in a surge of harmful hormones flooding a
patient's system thereby causing deleterious effects. If you would like to learn
more about Ortho Evra defects, please contact us to speak with a qualified
attorney.
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