Pharmaceutical Drug Litigation Updates

Birth Control That Uses Combined Hormones Raises Heart Risk: Study

Quoted from http://health.msn.com/womens-health/birth-control-that-uses-combined-hormones-raises-heart-risk-study

Birth Control That Uses Combined Hormones Raises Heart Risk: Study

Overall odds of heart attack and stroke, however, are still low

By Maureen Salamon
HealthDay Reporter

WEDNESDAY, June 13 (HealthDay News) -- Sweeping new research comparing various forms of hormonal contraception -- including birth control pills, vaginal rings and skin patches -- suggests that the risk for heart attacks and strokes is twice as high among users of combined estrogen-progestin versions.

These include brands such as Yasmin and Yaz pills, the NuvaRing vaginal ring and Ortho Evra patches. The overall odds of suffering such debilitating effects, however, are still quite low.

Analyzing 15 years of observational data from more than 1.6 million women aged 15 to 49, Danish scientists found that those taking low-dose estrogen birth control pills combined with various progestins suffered heart attacks and strokes between 1.5 and 2 times more often than women not using hormonal contraception. The risks were between 2.5 and 3 times higher among users of vaginal rings and transdermal patches compared to non-users.

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Blood Clot Risk Linked to Some Non-Pill Contraceptives

Quoted from http://health.msn.com/womens-health/blood-clot-risk-linked-to-some-non-pill-contraceptives

Blood Clot Risk Linked to Some Non-Pill Contraceptives

Women using hormone-releasing skin patches, implants, vaginal rings were more likely to develop clots, study finds

By Steven Reinberg, HealthDay Reporter

THURSDAY, May 10 (HealthDay News) -- Some women using hormonal contraceptives other than birth control pills may have an increased risk for serious blood clots, Danish researchers report.

These alternate hormone-releasing birth control methods include skin patches, implants and vaginal rings. To reduce the risk, women who use these should consider switching to the pill, the researchers said.

Deep vein thrombosis is a kind of clot that typically originates in the legs and can travel to the lungs, where it becomes an often deadly pulmonary embolism. Both types of clots combined are called venous thrombosis, according to the study. Symptoms include leg pain, chest pain or sudden shortness of breath.

"The transdermal patch and vaginal ring confer at least a sixfold increased risk of venous thrombosis as combined pills with desogestrel or drospirenone, a risk which is about twice the risk among women using second-generation pills with levonorgestrel," said lead researcher Dr. Ojvind Lidegaard, a professor of obstetrics and gynecology at the University of Copenhagen.

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FDA advisers: Ortho Evra patch needs clearer label

Quoted from http://www.reuters.com/article/2011/12/09/us-fda-birthcontrol-patch-idUSTRE7B827N20111209

FDA advisers: Ortho Evra patch needs clearer label

By Alina Selyukh

ADELPHI, Maryland | Fri Dec 9, 2011 6:13pm EST

ADELPHI, Maryland (Reuters) - U.S. drug advisers recommended that the label for Johnson and Johnson's Ortho Evra birth control patch be simplified to better explain the risk of blood clots.

In a 20 to 3 vote with one abstention, advisers to the Food and Drug Administration found that the current label for Ortho Evra inadequately reflects the risks women face by using it. It is the only contraceptive patch sold in the United States.

The panel voted 19 to 5 that the patch's risks were outweighed by its benefits, such as pregnancy prevention through a once-weekly application.

"I'm satisfied generally with what the content is for this label, it's the understandability and presentation that needs some work," said Jacqueline Gardner, panel member and a University of Washington professor.

All commonly used birth control pills increase women's chances of getting blood clots. The patch, approved in 2001, has been linked to an even higher risk as it contains a much greater amount of the hormone estrogen than a pill.

The current label, which has undergone numerous revisions over the past decade, has a boxed warning of a higher risk compared to older birth control pills. But a new FDA study earlier this year again showed that women using the patch were about 60 percent more likely to experience venous thrombotic events (VTEs).

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BC Government Sues Contraceptive Patch Manufacturer

Quoted from http://www.lifesitenews.com/ldn/2010/oct/10100710.html

BC Government Sues Contraceptive Patch Manufacturer

Thursday October 7, 2010

By Thaddeus M. Baklinski

VANCOUVER, October 7, 2010 (LifeSiteNews.com) - The British Columbia government has filed a lawsuit against pharmaceutical giant Johnson & Johnson Inc., claiming the maker of the "Ortho Evra" contraception patch “aggressively marketed the contraceptive without disclosing the safety hazards associated with Evra.”

The lawsuit claims that women using the patch “did not receive any warnings about the increased risk of developing blood clots, pulmonary emboli, strokes, heart attacks or deep vein thrombosis associated with Evra.”

The BC government is seeking to recover past and future health care costs associated with caring for women who develop serious and sometimes fatal illness as a result of using the dangerous hormonal contraceptive.

The patch delivers the hormones estrogen and progestin directly into the bloodstream through the skin, whereas oral contraceptives, which contain a similar amount of the drugs, must pass through the digestive system before being absorbed.

Health Canada approved the contraceptive in 2002, following approval by the US Food and Drug Administration in 2001.

The lawsuit claims that, although doctors reviewing the clinical trials of Evra before its approval recognized the potential for serious health problems from the use of the patch, Johnson & Johnson was negligent in providing adequate label warnings, failed to conduct long-term use risk studies, and failed to provide Health Canada with complete and accurate risk information.

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Did Johnson & Johnson Bury Data on Ortho-Evra’s Health Risks?

Quoted from http://healthland.time.com/2010/09/24/did-johnson-johnson-bury-data-on-ortho-evras-health-risks/

Did Johnson & Johnson Bury Data on Ortho-Evra's Health Risks?

By Meredith Melnick

Friday, September 24, 2010

It's should be common knowledge that the Johnson & Johnson (J&J) Ortho-Evra birth-control patch has more risks than the birth control pill (it's on the label) — because it exposes women to higher levels of hormone, it carries a higher risk of blood clots and stroke. And now an NBC report alleges that the company knew about the increased health risks before the patch ever reached market.

Since it's introduction in 2002, the patch has been prescribed 40 million times.Many public health experts have praised the device because it does not require women to remember to take a daily pill, which is one of the major barriers to perfect birth-control use among many women worldwide.In fact, TIME Magazine named the Ortho-Evra patch one of the best inventions of 2002.

But the patch is associated with higher risks of pulmonary embolism — a type of blood clot — as well as stroke and heart attack. These are all rare side effects of any birth control medication that contains synthetic forms of estrogen. The problem is, the patch pumps 60% more estrogen into your bloodstream than the Pill does. While the oral Pill is quickly digested and broken down in the body, the patch provides a constant stream of estrogen for three weeks of each month.

An NBC report, broadcast during Thursday's broadcast of the Today show, said that according to leaked patient reports from J&J, the company knew that users of the patch were 12 times more likely to suffer stroke and 18 times more likely to have blood clots than Pill takers. Further, NBC revealed, a vice president of research at J&J, Dr. Patrick Caubel, had quit over frustration that the company ignored his data showing elevated levels of complications and mortality associated with the patch.

According to NBC, 24 deaths have been attributed to blood clots induced by the patch, and more than 2,400 women currently have personal injury lawsuits filed against Johnson & Johnson.

The FDA is currently reviewing the safety of the patch and a clinical trial is ongoing to determine the relative risks of blood clot, stroke and heart attack in patch users versus women who take oral birth control pills. In the meantime, doctors are still prescribing the patch regularly, citing the fact that it is FDA approved and that despite its increased risks, it is safe for women overall.

'She almost died'

Quoted from http://www.saultstar.com/ArticleDisplay.aspx?e=2519359

'She almost died'

HEALTH: Woman, 24, hospitalized with blood clots after being prescribed birth control patch

Posted By FRANK DOBROVNIK, THE SAULT STAR

Posted 7 hours ago

A Sault Ste. Marie woman wants to warn others of the risks of using a controversial birth control patch, a warning she says her doctor failed to give her.

Alisha Gutcher, 24, spent the previous week at Sault Area Hospital recovering from a potentially fatal blood clot in her leg and two in her lungs. The clots were discovered a month after she began using the Ortho Evra contraceptive, which delivers hormones through the skin.

"We are so traumatized by this," said mother Wendy Gutcher. "I wake up in the middle of the night crying, because I don't know if my daughter's going to wake up."

It was only after Alisha was hospitalized with severe chest pains on March 22, and she was diagnosed with a pulmonary embolism -- a blockage of the main artery of the lung -- and deep vein thrombosis in her leg that they realized the risks of the patch.

As of Jan. 31, 2009, Health Canada reports that four women have died after having an "adverse reaction" while on Evra since the product was introduced in this country in 2004. Health Canada received 154 reports of adverse reactions, including blood clots and heart attacks.

The public health agency first issued a warning in 2006 that using Ortho Evra may increase a woman's risk of developing blood clots in their legs and lungs. The warning was based on research that showed a United States formulation of drug maker Janssen-Ortho Inc.'s patch contraceptive may be associated with a higher risk of blood clots than oral birth control pills, because of estrogen levels some 60 per cent higher.

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Estrogen patch suspected in student death

Quoted from http://www.upi.com/Health_News/2009/10/21/Estrogen-patch-suspected-in-student-death/UPI-43151256149584

Estrogen patch suspected in student death

BOSTON, Oct. 21 (UPI) -- A Boston woman whose teenage daughter died of a pulmonary embolism says she doesn't understand why the contraceptive patch Ortho Evra is still on the market.

Leslie Niedner says she believes the Sept. 28 death of her daughter Adrianna was linked to the 17-year-old's use of the contraceptive patch, The Boston Globe reported Wednesday.

Niedner says an online search revealed thousands of lawsuits have been filed against the makers of Ortho Evra by women who had heart attacks, strokes or blood clots after using the patch.

Though sales of the drug have plummeted about 75 percent, it is still FDA-approved.

"It's needlessly dangerous," said Sidney Wolfe, director of the Health Research Group at Public Citizen, a consumer advocacy organization in Washington.

Wolfe cites research showing the patch delivers far more estrogen than birth control pills. Higher estrogen levels can double a woman's risk of blood clots, he says.

Thrombosis Risk with OCs Depends on Progestogen

Quoted from http://www.medpagetoday.com/OBGYN/GeneralOBGYN/15525

Thrombosis Risk with OCs Depends on Progestogen

By Kristina Fiore, Staff Writer, MedPage Today Published: August 13, 2009 ReviewedbyZalman S. Agus, MD; Emeritus Professor University of Pennsylvania School of Medicine.

The risk of venous thrombosis from oral contraceptives is associated with both the estrogen dose and the type of progestogen used, two new studies show. Both found that levonorgestrel carried the lowest risk of thrombosis among all the progestogens. "Our results clearly show that the safest option with regard to the risk of venous thrombosis is an oral contraceptive containing levonorgestrel combined with a low dose of estrogen," wrote Astrid van Hylckama Vlieg, MD, of Leiden University Medical Center, and colleagues on the Dutch study. The study was published online in BMJ along with another by Ojvind Lidegaard, MD, of the Gynecological Clinic in Rigshospitalet in Copenhagen, that produced similar findings. Action Points Explain that two studies in BMJ found that risk of venous thrombosis was associated with both estrogen dose and type of progestogen used in oral contraceptives. Note that levonorgestrel was associated with the lowest risk of venous thrombosis among all the progestogens in both studies. Several large studies have already confirmed a two- to six-fold increased risk of venous thrombosis associated with oral contraceptive use. Estrogen doses have since been lowered, but it is still unclear which oral contraceptive is safest in this regard. [Article continues at original source]