Pradaxa (Dabigatran) and the FDA Safety Review

By Independent Staff Writer 

Although only on the market for a relatively short period of time, Pradaxa, the blood-thinning drug manufactured by Boehringer Ingelheim—has already suffered under the weight of threatened recalls, lawsuits and warnings by the FDA. Pradaxa is the first FDA-approved drug of its type since the drug Warfarin was approved in 1954. Both Warfarin and Pradaxa are commonly prescribed as blood thinners to reduce the risk of stroke in patients with heart rhythm irregularities.

Warfarin was used almost exclusively until November of 2005 when Boehringer Ingelheim sponsored a clinical trial to determine the long-term safety and effectiveness of their “new kid on the block,” Pradaxa. The Pradaxa blood-thinning drug trial concluded in March of 2009 to rave reviews. More than 18,000 patients were enrolled in the trial across 44 countries. Boehringer announced that Pradaxa was able to significantly reduce the risk of stroke when compared to the older established drug, Warfarin, and that it had similar or even reduced risks of causing major bleeding in the body—depending on the dosage.

Pradaxa (Dabigatran) Lawsuits

By Independent Staff Writer

March of 2012 saw the first lawsuits filed against Boehringer Ingelheim, the manufacturer of Pradaxa. This drug was the first of its type to be marketed in over half a century, and Boehringer had high hopes that Pradaxa would knock its only competitor, Warfarin, out of the running in short order. Pradaxa works differently from Warfarin; while both drugs are used to prevent stroke in patients with atrial fibrillation, Warfarin works by inhibiting the production of Vitamin K, a clotting agent in the body. Should there be excessive bleeding in a patient who has taken Warfarin, doses of Vitamin K can be administered to slow the bleeding. Pradaxa, on the other hand, works by inhibiting thrombin, an enzyme in the blood which also controls blood clotting. At this time there is no known antidote to Pradaxa in the event it leads to excessive or uncontrollable bleeding.

What is Atrial Fibrillation?

Atrial fibrillation affects more than two million Americans and is characterized by rapid, uncoordinated contractions in the upper chambers of the heart. Patients with atrial fibrillation are at a much higher risk of developing blood clots, and since the 1950’s doctors have been using Warfarin—which is also known as Coumadin—to help lessen the likelihood of stroke. The FDA approved Pradaxa for use in patients with atrial fibrillation in October of 2010, yet less than a year later reports were coming in regarding serious side effects and even death among Pradaxa users. In December of 2011, in the face of hundreds of adverse reports, the FDA issued a safety warning to patients and physicians, stating they would taking a hard look at the prior Pradaxa studies.

The Dangers of Pradaxa (Dabigatran): Part 1 of 3: Side Effects and Complications

By Independent Staff Writer

The newest drug approved for use in the treatment of heart valve problems or atrial fibrillation among patients with an increased risk of stroke is the drug Pradaxa, manufactured by Boehringer Ingelheim. The drug Boehringer is seeking to replace with its newest arrival is Warfarin—a blood-thinning drug which has been used since the early 1950’s. Boehringer claims that Pradaxa is over 30% better in decreasing the risk of a serious stroke than Warfarin. The FDA initially agreed with Boehringer, granting FDA approval of Pradaxa in October of 2010.

What is Atrial Fibrillation and How Does Pradaxa Help?

Atrial fibrillation affects over two million Americans and involves excessively rapid, uncoordinated contractions of the upper two chambers of the heart. Those with atrial fibrillation are at a much higher risk of developing blood clots which in turn can lead to a disabling stroke should the clot travel to the brain. Pradaxa works by inhibiting thrombin, an enzyme in the blood which controls blood clotting.

The Dangers of Pradaxa (Dabigatran) Part 3 of 3: Serious Vascular Risks

By Independent Staff Writer

Pradaxa, the drug which less than a couple of years ago seemed like a dream come true for the hundreds of thousands of patients who were taking Warfarin or Coumadin has had its initial glow tarnished by the ever-increasing number of reports of serious side effects from use of the drug. Although Warfarin has been used as a stroke inhibitor and for those suffering from atrial fibrillation since the 1950’s, it comes with certain restrictions and its own set of side effects. Those who are on a Warfarin regimen must have regular blood tests taken, and must also be very careful of foods and other prescription drugs they mix with Warfarin.

However, there is a significant difference in the way Warfarin and Pradaxa work in the body, most notably the fact that in the event Warfarin causes excessive bleeding, the effects can be reversed by administering a dose of Vitamin K. When Pradaxa causes excessive bleeding there is no known antidote, leaving the patient vulnerable to literally bleeding to death. Pradaxa is a direct thrombin inhibitor which, in the initial 18,000 person trial, showed great promise in reducing strokes and helping those patients with atrial fibrillation lead a healthier life. The manufacturer of the drug, Boehringer Ingelheim, has been accused of rushing through the initial trial in order to get their drug on the market before other potential rivals, ignoring some potential risks in the process.

Transvaginal Mesh: A Brief History of the Problematic Implant

By Independent Staff Writer


While the past three years have brought an influx of complications and problems related to the transvaginal mesh implant, the device has actually been in use for over half a century. Surgical mesh made of metallic or polymer screens was developed for use in abdominal hernia surgeries in the 1950’s, however gynecologists soon saw the advantages of using the mesh in the surgical repair of stress urinary incontinence and pelvic organ prolapse. These problems are relatively common among women who have had children, undergone a hysterectomy or are post-menopausal. During such events, the muscles and ligaments which surround the pelvic organs can weaken, allowing those organs to slip out of their natural place, or prolapse.

FDA Approves Surgical Mesh for Abdominal Surgeries
Surgical mesh was originally approved for abdominal applications; since pelvic organ prolapse surgeries were performed abdominally in the 70’s, the mesh appeared to be a good solution for POP surgeries as well. Prior to the development of mesh, hernia repair was performed using suture techniques which garnered recurrence rates from 24-54%. Once the mesh began to be widely used to repair hernias, the recurrence rates dropped to 10-20%, however placement and fixation of the mesh was crucial for a positive outcome. In the late 1980’s surgeons began positioning the mesh with an overlap of 5 cm in all directions around the hernia defect, and the recurrence rates dropped as low as 3.5%.

Transvaginal Use of Mesh
Following several decades of success in using the mesh implants, the 1990’s brought such great advances in surgical techniques as well as in the mesh technology itself that gynecologists began using the mesh in both SUI and POP transvaginal surgical procedures. At this time there was still no “official” surgical mesh product available for these procedures, therefore the surgeons simply cut the mesh themselves whenever they used the abdominal mesh in vaginal applications. Manufacturers of the mesh saw an opportunity, and began producing kits which included both the mesh as well as tools which supported the surgical delivery and insertion.

FDA Approval for Transvaginal Use
Actual FDA approval of the mesh for transvaginal surgeries did not take place until a mesh developed by Boston Scientific was approved in 1996 for use in stress urinary incontinence surgeries. Unfortunately, the year following that approval saw problems with this particular mesh product with over 120 patients reporting serious side effects. Even though Boston Scientific’s ProteGen was voluntarily pulled from the market in 1999, the manner in which FDA approval was granted allowed subsequent products to be approved using the ProteGen as a predicate device.  Even though surgeons had been using mesh in pelvic organ prolapse surgeries for many years, it was finally granted FDA approval for this particular application in 2002.

Unexpected Problems Arise
Although for the most part the mesh products worked well in the areas of the abdomen which were limited in flex, the pelvis has a much different physiology. Pelvic regions such as the vagina tend to be highly flexible and much more delicate than the abdomen, and the stiff, inelastic mesh did not work as well with the fragile tissues. In many cases the mesh would shrink and become rigid, pulling at the delicate surrounding areas and even eroding through the tissue walls.

Johnson & Johnson Accused of Concealing Ortho Evra Risks

By Megan Breckenridge, Staff Writer

SULLO & SULLO, LLP

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HOUSTON — Millions of women across the country rejoiced in 2002 when a new, convenient alternative to daily oral contraceptive pills hit the market.

Ortho Evra, a hormone-containing patch, was praised by public health experts and consumers alike because it eliminates one of the major barriers to perfect birth control use: Remembering to take a daily pill. The patch can be placed on the arm, back or abdomen—anywhere it adheres well and won’t be damaged—and needs only to be changed once a week. Since it’s introduction, over 40 million prescriptions for Ortho Evra have been written, and TIME Magazine named it one of the best inventions of 2002.

But in 2005, the Food and 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, while those in the patch are absorbed directly into the patient’s blood stream. The latter causes a higher concentration of medication, specifically estrogen, to enter a patient’s body, increasing the risks of pulmonary embolism—a specific type of blood clot—as well as stroke and heart attack.

The first fatality publicly blamed on Ortho Evra occurred in April 2005, when a Manhattan fashion student collapsed in a New York City subway station. An autopsy found that a blood clot had moved into the victim’s lung, which the medical examiner ruled a side effect of the birth control patch.

By November of 2005, the FDA had received 21 reports of life-threatening blood clots and other ailments associated with Ortho Evra. But it wasn’t until 2006, when a study was published that confirmed women using the patch were twice as likely to suffer from venous thromboembolisms (VTEs) as those taking oral birth control pills, that the FDA requested that the Ortho Evra label be changed to include a stronger safety warning.

According to an NBC news report, broadcast September 22, 2010, leaked patient reports from Johnson & Johnson show that the company knew 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 Johnson & Johnson, Dr. Patrick Caubel, quit over frustration that the company ignored his data showing elevated levels of complications and mortality associated with the patch.

Another former vice president, Dr. Joel Lippman, claimed in a lawsuit that he was fired by Johnson & Johnson because he expressed concerns about the patch’s dangerously high estrogen levels prior to its coming to market. The company, he says, “disregarded his concerns and launched the product anyway.”

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. To date, the company has spent $68 million to quietly settle Ortho Evra lawsuits.

Unfortunately, Ortho Evra remains on the market, despite countless calls to have it pulled. In spite of its risks, the patch is still a big money maker for Johnson & Johnson, which has earned $1.6 billion on its sales.

In response to NBC’s news report, the company issued the following statement:

Thank you for your inquiry to Ortho Women’s Health & Urology, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. We believe it is inappropriate to comment on the details around ongoing litigation and therefore are not providing responses to your individual questions beyond the statement below:

ORTHO EVRA has been a safe and effective birth control option for women and their healthcare providers since 2002. It addresses a birth control need and provides another choice for women who, with the counseling of their healthcare provider, do not want or are unable to take a birth control pill every day. Ortho Women’s Health & Urology has regularly disclosed scientific data regarding ORTHO EVRA to the FDA, the medical community and the public in a timely manner, and when used according to the FDA-approved label, ORTHO EVRA remains a safe and effective method of hormonal birth control. It also, like all methods of hormonal birth control, has benefits and risks which, as a prescription medicine, should be the subject of discussion between a woman and her healthcare provider. These benefits, risks and other important safety information are contained in the Detailed Patient Labeling, which is part of the ORTHO EVRA® Prescribing Information, and can be found at http://www.orthoevra.com/sites/default/files/assets/OrthoEvraPI_0.pdf.”

— Jeff Christensen, spokesperson, Johnson & Johnson

If you or someone you know were injured while using Ortho Evra, please contact the experienced team at Sullo & Sullo, LLP. We will aggressively represent women who have suffered heart attacks, strokes, blood clots and other serious injuries while using this drug. Call us at 713.839.9026 or visit our website at www.sullolaw.com for a free legal consultation today.