January 2012 Archives

FDA Orders Transvaginal Mesh Manufacturers to Conduct More Safety Tests to Study Serious Risks

January 13, 2012

Vaginal mesh attorneys at Pintas & Mullins Law Firm are warning patients of a recent spike in serious injuries and death associated with the use of defective transvaginal mesh devices. In response to growing number of complications such as pain, bleeding, infection, and erosion reported by women implanted with the mesh sling, federal regulators recently ordered manufacturers to conduct new medical studies to evaluate the safety and effectiveness of these devices.

On January 3, 2012, the U.S. Food and Drug Administration mandated additional postmarket studies from more than 30 transvaginal mesh manufacturers, including Johnson & Johnson, American Medical Systems (AMS) and C.S. Bard. As Bloomberg News is reporting, these mesh manufacturers must provide three years of research data to the FDA in order to determine whether the devices should remain on the market.

The vaginal mesh products were originally approved though the FDA's controversial fast-track approval process, which allows products to reach the market without clinical studies or tests. In 2010, nearly 300,000 women were implanted with a mesh sling in order to treat stress urinary incontinence and pelvic organ prolapse (POP). Unfortunately, studies show that the edges of the mesh fibers can erode through the vaginal wall, tear the body's internal organs, and cause serious pelvic pain and infections. The FDA has already received more than 1,500 reports of serious complications involving transvaginal mesh.

In July of 2011, the FDA acknowledged the serious safety risks associated with transvaginal mesh products and issued a safety alert to patients. At that time, the agency also admitted that it found no benefit in using transvaginal mesh to treat POP in place of other, safer alternatives. An advisory panel recommended that the FDA re-categorize the mesh products as "high-risk" but the agency has yet to act on that recommendation.

Vaginal mesh erosion is one of the most serious side effects that many women have suffered, and requires removal of the vaginal mesh. Other serious and painful complications include bladder perforation, vaginal scarring and recurrent organ prolapse.

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Tekturna Hypertension Drug Linked to Stroke and Kidney Problems among Diabetes Patients

January 11, 2012

Our drug recall attorneys at Pintas & Mullins Law Firm are warning of new research that shows the blood pressure drug Tekturna (Aliskiren) may increase the risk of stroke or serious heart and kidney problems. This is a major setback for the hypertension drug that could potentially lead to a recall, according to recent reports by Bloomberg News.

Tekturna is sold by Novartis and was originally approved in 2007 to lower blood pressure. Tekturna was the 16th best selling drug in 2010 for drug maker Novartis, who recently conducted a study to determine whether the medication could help patients suffering from type 2 diabetes and renal impairment. The ALTITUDE study evaluated the effectiveness of Tekturna in reducing or delaying heart and kidney events, along with the drug's ability to resuscitate sudden death or heart attack patients. Shockingly, the clinical trial came to a halt in January of 2012 when serious safety issues were revealed. Instead of benefiting from the medication, Tekturna study participants actually suffered an increased rate of hypertension, stroke, and renal complications.

As a precautionary measure, Novartis issued a drug warning to healthcare professionals, urging them to stop treating diabetic patients with Tekturna and to consider other, safer alternative treatments as necessary. The drug maker also pledged to stop promoting Tekturna for use in combination with other drugs such as ACE-inhibitors until federal regulators determine whether further changes need to be made. However, for many patients who already suffered serious side effects, these warnings came too late.

The large number of adverse health events recently exposed through clinical trials will likely hurt Novartis financially. Tekturna brought in close to $450 million in sales during the first nine months of 2011, and sales are expected to plummet now that the company has stopped advertising the dangerous drug. Over 1,000 sales jobs could be lost as a direct result of the clinical findings. Analysts suspect that the drug may eventually be sold to another company or completely removed from the market.

Even more concerning to our defective drug lawyers is the harm that many patients have already suffered or the potential harm that they may suffer in the future as a result of using the medication. We are aware that Novartis engaged in off-label marketing, recklessly promoting the use of Tekturna for diabetes patients. In addition to a lack of evidence supporting any positive health benefits for the diabetic population, research now shows that these patients may be seriously harmed by use of the drug.

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