Pradaxa warning! FDA investigating excess bleeding and death claims.

Pradaxa (Dabigatran): Dabigatran is used to help prevent strokes or serious blood clots in people who have atrial fibrillation (a condition in which the heart beats irregularly, increasing the chance of clots forming in the body, and possibly causing strokes) without heart valve disease. Dabigatran is in a class of anticoagulant (''blood thinner'') medications called direct thrombin inhibitors.

According to a CBSnews.com report of January 11, 2012, Patients taking the new anti-clotting drug Pradaxa have a 33% higher risk of heart attack or severe symptoms of heart disease than do patients taking warfarin. The finding, from Cleveland Clinic researchers Ken Uchino, MD, and Adrian V. Hernandez, MD, PhD, is based on data from seven clinical trials that enrolled 30,514 patients. "The risk of [heart attack] or acute coronary syndrome is increased with [Pradaxa] compared with various control treatments, which include adjusted-dose warfarin, [Lovenox], or placebo," Uchino and Hernandez conclude. Acute coronary syndrome -- acute symptoms of serious heart disease -- is usually caused by the rupture of a plaque in a heart artery. In an editorial accompanying the study in the Jan. 9 issue of Archives of Internal Medicine, journal editor Rita Redberg, MD, notes that this isn't the first safety warning issued for Pradaxa. The FDA is investigating an unusually large number of reports of serious bleeding linked to the drug. Japan and Australia already have issued a safety warning. The European Medicines Agency advises doctors to check patients' kidney function before prescribing Pradaxa. And last year the FDA warned patients that the drug breaks down quickly when removed from its original container. "These additional concerns deserve serious consideration in weighing the risks and benefits of [Pradaxa]," Redberg concludes. Despite the apparent increase in heart attack risk, Uchino and Hernandez note that the benefits of Pradaxa -- particularly its ability to prevent stroke in patients with atrial fibrillation -- outweigh its risks. And they note that while the risk of heart attack or acute coronary syndrome is higher in patients on Pradaxa than in those on warfarin, the actual risk of these events is increased by only 0.25% per year. That's still an important added risk for patients who may already be piling up risk factors for heart disease, says Kirk Garratt, MD, clinical director of interventional cardiology research at New York's Lenox Hill Hospital. While absolute risk may not be bad, when added on top of measurable risk it becomes worth noting. "If I have a patient on this drug for 10 years, I'd expect a 5% increased lifetime risk of heart attack," Garratt tells WebMD. "The most important aspect of this study is that it allows us to see a consistent risk across studies and types of patients. That speaks to the conclusion that this study is well done and that the risk is real." By Daniel J. DeNoon Reviewed by Laura J. Martin, MD

If you or a friend or family member has experienced excessive bleeding or a heart attack while taking Pradaxa, you may have important legal rights for damages. Contact Knox Boteler @ Boteler, Finley & Wolfe for more information: 251 433-7766 or knox@bfw-lawyers.com

Polygrip Denture Cream

Polygrip Denture Cream’s manufacturer, GlaxoSmithKline, is under investigation for failing to inform users of this product’s potential safety risks. Polygrip Denture Cream contains 38 milligrams of zinc per ounce. Health experts recommend 8 milligrams of zinc per day for women and 11 milligrams for men. Medical studies have found excessive zinc may purge the body of copper, a chemical needed for normal brain and nervous system function. GlaxoSmithKline has announced that it will stop making Polygrip formulas containing zinc. Common side effects related to this product’s health risk include: loss of balance, loss of sensation in hands and feet and anemia. If you have any questions regarding your or a family member’s health and the use of Polygrip, please contact Knox Boteler at 866-975-7766 or email him at knox@bfw-lawyers.com for additional information. To learn more about this situation, click here.

Surgical Mesh Dangers for Transvaginal Pelvic Organ Prolapse Surgery Patients

Surgical Mesh: Manufactured by numerous companies including, Johnson & Johnson and Boston Scientific Corp.

Used for: Surgical repairs for Pelvic Organ Prolapse (POP) and/or Stress Urinary Incontinence (SUI) surgery. Used in place of stitches surgical mesh is designed to be a permanent implant and has been commonly used in transvaginal POP and SUI surgeries for many years. In POP procedures the mesh is commonly called a “bladder sling.”

Symptoms or Consequences: In July 2011, the FDA announced that a multi-year study of surgical mesh implants found serious complications associated with surgical mesh for POP and SUI procedures. The FDA report also noted, “[f]urthermore it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.” Erosion of the mesh through the vagina is the most common and consistently reported complication. Mesh contraction is also a risk. Both mesh erosion and mesh contraction can cause severe pelvic pain, painful sexual intercourse. Other symptoms may include: Bladder, bowel, or blood vessel bleeding or perforation, bone and hip infections and/or the recurrence of the POP and/or SUI condition.

Additional Information: For more information visit Providence Health Plan

Contact: If you believe you or a loved one may have a claim related to the use of surgical mesh in a POP and/or SUI procedure, please contact Knox at Boteler, Finley & Wolfe (knox@bfw-lawyers.com) for more information and help locating the law firm leading these Mass Tort cases.

Actos linked to Bladder Cancer

Actos: Manufactured by: Takeda

Prescribed for: Actos (pioglitazone) is used in the treatment of diabetes. Actos is used to control blood sugar levels in patients with Type 2 diabetes, which keeps the body from producing enough insulin to properly use the sugar in the blood stream. Type 2 diabetes can also cause the patient to become resistant to insulin. Actos remedies this problem by making cells more sensitive to insulin, thereby making it easier for sugar to pass through the body.

Symptoms or Consequence: May cause bladder cancer. The Food and Drug Administration (FDA) mandated a warning be added to Actos packaging in 2007. A second FDA warning in June 2011 contained specific details of the risk of bladder cancer associated with Actos. A recent study of 193,099 patients over a five-year period found that people who took Actos for at least 12 months or longer were 40 percent more likely to develop bladder cancer. A subsequent FDA Adverse Event report found that Actos was involved in one-fifth of all reported diagnoses of bladder cancer in diabetes drug users.
Additional Information: Read more on this matter at Web MD, and the June 15, 2011 FDA report.

Contact: If you believe you or a loved one may have a claim related to the use of Actos and a diagnosis of bladder cancer, please contact Knox at Boteler, Finley & Wolfe (knox@bfw-lawyers.com) for more information and help locating the law firm leading these Mass Tort cases.