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Group Urges FDA to Take Ortho Evra Off Market  |
| The New York Times | May 9, 2008 |
A consumer advocacy group petitioned the government Thursday to pull the birth control patch off the market, calling it far riskier than the pill.
"Ortho Evra is a poor choice for women," Dr. Sidney Wolfe of the group, Public Citizen, wrote the Food and Drug Administration.
Warnings about the Ortho Evra weekly patch have escalated since a 2005 investigation by The Associated Press found that patch users had higher rates of life-threatening blood clots than did women who took birth control pills. |
Johnson & Johnson Altered Birth Control Patch Data to Hide Risks  |
| Bloomberg | November 29, 2007 |
Johnson & Johnson misled doctors and regulators for years by altering and withholding medical data about the health risks of its Ortho Evra birth control patch, lawyers for women suing the company claim in court papers.
J&J, the world's largest maker of health care products, faces lawsuits by 2,400 women who claim the patch releases high levels of estrogen that cause strokes, heart attacks and blood clots in the legs and lungs. Internal documents and pre-trial interviews with J&J scientists show the company learned the risk in 1999 and misled the Food and Drug Administration when seeking approval in 2001 to market the device, the filings state. |
Johnson & Johnson Exec Claims He Was Fired for Raising Safety Concerns  |
| Law.com | December 20, 2006 |
| A former vice president at two Johnson & Johnson subsidiaries claims in a lawsuit he was fired for seeking recalls of numerous faulty products, including the Ortho Evra birth control patch, itself the subject of at least 1,000 product liability suits. |
Johnson & Johnson Issues Patch Warning  |
| NBC5i.com | November 29, 2006 |
|
A health alert is being issued for women who use a popular form of birth control patch.
Johnson & Johnson is adding new warnings to its labels after the Canadian manufacturer of Ortho
Evra revealed new dangers associated with the drug.
The company is now warning women who use the patch
to not expose it to sources of heat. Health officials said the added heat may cause an unintentional
increase in estrogen exposure that could lead to blood clots. |
Women Sue Over Ortho Evra Birth Control Patch  |
| MSNBC | November 2, 2006 |
|
More than 40 women sued the makers of a popular birth-control patch Wednesday,
claiming the contraceptive caused serious illnesses and at least one death.
One lawsuit alleges that
43 women suffered from blood clots and other health ailments after taking Ortho Evra, one of the
fastest-growing forms of contraception in the U.S. |
J&J Settles Suits Over Ortho
Evra Contraceptives  |
| Los Angeles Times | May 13, 2006 |
| Johnson & Johnson has settled lawsuits with about 30 women who claim they developed
blood clots after using the company's Ortho Evra birth control patch, said a lawyer who negotiated
the confidential agreements. |
Drug-Patch Safety Triggers an FDA Probe  |
| The Philadelphia Inquirer | March 5, 2006 |
|
In July, the Food and Drug Administration announced an investigation into 120 deaths caused by fentanyl
patches, used for chronic pain.
In November, the agency issued a warning about birth-control patches after studies showed that women
using them had 60 percent more estrogen in their blood than those on the pill, giving them a higher
risk of potentially fatal side effects. |
Birth Control Patch Users Risk Blood Clots  |
| Houston Chronicle | February 16, 2006 |
| Women who use the Ortho Evra birth-control patch face twice the risk of developing blood
clots than those who take the pill, the patch's manufacturer said late Thursday, citing recent company-funded
research. |
Lawsuit Grows Over Ortho Evra Birth Control Patch  |
| CBS 13 | January 12, 2006 |
| Ortho Evra is the first and only birth control patch on the market. It's marketed to be
as effective and an equal to the birth control pill, but in the lawsuits, many women say there are
serious health concerns that its parent company, Johnson & Johnson knew of but purposely never
disclosed. |
FDA Issues Warning for Contraceptive Patch  |
| Los Angeles Times | November 11, 2005 |
| Users of the Ortho Evra contraceptive patch are exposed to more estrogen than from birth
control pills and therefore are at a higher risk of blood clots and other side effects, the Food and
Drug Administration has warned. |
Warning Issued for Birth Control Patch  |
| ABC News | November 11, 2005 |
| The Food and Drug Administration warned users of the popular Ortho Evra birth control patch
that they are being exposed to more hormones, and are therefore at higher risk of blood clots and other
serious side effects, than previously disclosed. |
Lawsuit: Birth Control to Blame for Brain Clot  |
| The Kansas City Star | September 2, 2005 |
|
Not long after Amanda Bianchi began using a birth-control patch, she started getting incapacitating
headaches, numbness in her hands and ringing in her ears.
An MRI revealed a 6- to 8-inch blood clot in her brain. |
Lawsuit Alleges Strokes, Blood Clots Linked to Ortho Evra  |
| CNN | July 25, 2005 |
| Ten women filed a lawsuit Monday against the maker of a birth control patch, claiming the
device caused them to suffer strokes and blood clots, their attorney told CNN. |