Bisphosphonate Study Confirms Atypical Thigh Fracture Risk
New research has confirmed the link between bisphoshonates, such as Fosamax, and atypical femur fractures, a type of thigh fracture that occurs spontaneously, without any major leg injury. The study, published in the Archives of Internal Medicine, also found that the risk of atypical thigh fractures increases the longer a ...
Metal-on-Metal Hip Replacement Concerns Grow in Canada
Canadian patients and doctors are voicing more concerns about metal-on-metal hip replacements, as health regulators around the world continue to investigate the safety of the devices. According to a report from the CBC, four companies have recently either recalled or suspended sales of metal-on-metal hip replacement devices, while a number ...
Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device
Wright Medical Inc. took steps in to 2006 to convince the U.S. Food & Drug Administration (FDA) to reject pre-market approval of rival Smith & Nephew’s Birmingham metal-on-metal hip implant. Wright Medical, which makes two metal-on-metal hip replacement devices, the Conserve and the Lieneage device, filed a citizen petition ...
Actos, Avandia May Up Risk for Diabetic Macular Edema
A newly published study is raising concerns that patients who take Actos or Avandia may face an increased risk of developing diabetic macular edema, an eye disorder that can result in vision loss. The study, published in the Archives of Internal Medicine, found that type 2 diabetics who use thiazolidinediones, ...
Smokers More Vulnerable to Joint Replacement Failures
People who smoke cigarettes before and after receiving a total joint replacement, such as a hip replacement device or knee implant, are far more likely to endure revision surgeries on those implants than people who don’t smoke.
U.K. Regulators Issue Additional Guidance for Metal-on-Metal Hip Implant Recipients
Regulators in the U.K. are once again issuing advice to doctors and other healthcare professionals involved in the follow-up of patients with metal-on-metal hip replacement devices. In an alert issued by the Medicines and Healthcare products Regulatory Agency (MHRA), guidance is provided for four groups of metal-on-metal hip implant ...
Smith & Nephew Recalls Metal-on-Metal Hip Implant Component
Medical device maker, Smith & Nephew, just issued a recall for a metal-on-metal hip implant component, a part of one of its all-metal hip replacement systems.
Fracking Boom Changing Way of Life in Pennsylvania's Northern Tier
In just a few years, the impact of hydraulic fracturing (fracking) drilling on northeastern Pennsylvania is hard to miss. Thousands of natural gas wells have been opened in that area specifically in the last five years as companies look to exploit the vast Marcellus shale formation about two miles below the ...
EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects
Regulators in Europe have again asked Boehringer Ingelheim, the manufacturer of the blood thinner Pradaxa, to update the drug’s label with additional information regarding Pradaxa bleeding side effects. According to the European Medicines Agency (EMA), the new guidance should include more specific information on when Pradaxa must not be used, ...
Another Metal-on-Metal Hip Replacement Lawsuit Filed in DePuy ASR Hip Implant Litigation
A vital food safety program was saved from budget cuts this week, enabling the country’s largest—although considered by experts to be far too small—produce-safety testing program to continue.Zyprexa Gets FDA Attention Following Two Patient Deaths
Zyprexa is an antipsychotic medication manufactured by Eli Lilly used to treat disorders such as schizophrenia and bipolar disorder. This drug, however, has caught the attention of the U.S. Food and Drug Administration (FDA) when two patients died after receiving the injections. The FDA is now investigating Zyprexa, which is manufactured by Eli Lilly. Continue reading
Despite Prior Objections, Chrysler to Recall 2.7 Million Jeeps
Despite intense objections last week, Chrysler Group has agreed to recall 2.7 million Jeeps. The announcement was made hours before a government deadline on the issue.
In a rare move, Chrysler had defied a National Highway Traffic Safety Administration (NHTSA) recall request maintaining its Jeeps were safe and challenging the regulator’s collision data analysis. The NHTSA said that the rear-mounted gas tanks in 1993-2004 Jeep Grand Cherokees and 2002-2007 Jeep Liberty vehicles are too vulnerable to leaking and could catch on fire in a rear-end crash, according to ABC News previously. Although the NHTSA can call for a recall, the agency requires a court order to enforce that demand. Continue reading
Class Action Lawsuit: Goodman and Amana Air Conditioners Allegedly Violated Consumer Warranties
Since 2007, Goodman and Amana manufactured and sold central air conditioners that are both defective and breach warranties that were not honored, according to a recently filed class action lawsuit.
The complaint indicates that defective evaporator coils cause the air conditioners to work improperly. In fact, the defective evaporator coils “improperly and prematurely leak refrigerant under normal use.” The complaint also states that, “As the air conditioners leak refrigerant, they are unable to function properly and are thus unfit for their ordinary and intended purpose.” Continue reading
Many Popular Medications Contain Cancer-Causing Compounds, May Increase Cancer Risks
Cancer is devastating, killing about 600,000 people every year. Cancer is, in fact, the second-leading cause of death in the United States. Yet, despite consumers’ proactive measures to avoid cancer-causing products, some pharmaceuticals might contain carcinogens, ameliorating the best consumer efforts.
Medications we routinely take may contain dangerous ingredients. Consider that the U.S. Food and Drug Administration (FDA) does mandate that pharmaceutical companies test their products for so-called “carcinogenicity” in animals, yet even if the drugs test positive for increased tumor risks, that does not automatically get those drugs rejected, according to The Gazette. In fact, those very drugs may end up making their way to market. Continue reading
Supreme Court Decision Allows Regulators to Sue Over Generic-Drug Deals
In a decision handed down on Monday, the U.S. Supreme Court ruled that pharmaceutical companies that pay rivals to keep less-costly generic versions of best-selling drugs off the market can be sued by the Federal Trade Commission (FTC) for potential antitrust violations.
The justices, in a 5 to 3 vote, threw out lower-court rulings that said such agreements, called pay-for-delay agreements, are legal, provided they did not keep a generic drug off the market beyond the term of the brand-name drug’s patent, The New York Times reports. Continue reading
InFuse® Bone Graft No Better than Traditional Graft, Review Finds
An independent, dual review, found that Medtronic’s InFuse® product provided limited benefits. The bone graft product was also found to cause potential harm, including a small increased risk of cancer and works no better than traditional bone grafts, according to the review.
The U.S. Food and Drug Administration (FDA) approved InFuse® in 2002 for use in fusing damaged vertebrae in the lower spine; InFuse® was not approved for use on the upper, or cervical, spine, where it is now widely used, according to Bloomberg Businessweek. In fact, the FDA released a July 1, 2008 notification warning that the InFuse® bone graft had been associated with serious complications, including excessive swelling in the neck, compressed airways, difficulty breathing, problems swallowing, and nerve damage, when used in cervical spinal fusions. Continue reading
Asbestos Continues to Cause Significant Mesothelioma Risks
One case of mesothelioma is proving to be an example of what new generation asbestos lawsuits are looking like.
In one case, the plaintiff suffered from chest pain, traveled nationwide for major surgery, underwent chemotherapy, had to manage debilitating pain, and was dealing with a lawsuit that had not been finalized at the time of his death, according to The Wall Street Journal. His attorneys are suing an array of firms they believe exposed the now-deceased plaintiff to asbestos at some point during his life. Continue reading
European Drug Regulator Urges Caution in Use of Painkiller Diclofenac
The European Medicines Agency (EMA), Europe’s drug regulator, warned on Friday that the painkiller diclofenac, especially in high doses, carries extra heart attack risks, which should be taken into consideration by doctors prescribing the drug.
“Patients who have serious underlying heart or circulatory conditions, such as heart failure, heart disease, circulatory problems or a previous heart attack or stroke, should not use diclofenac,” the EMA said in a statement. The EMA’s warning comes after a large international study showed that long-term, high-dose use of non-steroidal anti-inflammatory (NSAID) painkillers such as diclofenac and ibuprofen increases the risk of a major vascular event—heart attack, stroke, or death from cardiovascular disease—by around a third, Reuters reports. Continue reading
How Safe is Robotic Surgery?
Personal injury lawsuits allege that the da Vinci robotic surgical system marketed by Intuitive Surgical has caused severe internal injuries, including burns, tears, and other complications, some of which have resulted in death or chronic pain and disability. da Vinci lawsuits fault aggressive marketing tactics used by Intuitive Surgical to convince hospitals to purchase the expensive surgical robot, and allege that a combination of design flaws inherent in the robot, coupled with poor physician training on the device, have resulted in serious injuries.
In fact, some 89 deaths have been linked to the robotic surgical systems since 2009. According to the U.S. Food and Drug Administration (FDA), it has received more than 200 reports of burns, cuts, and infections, since 2007, according to NBC News. Continue reading
FDA Warning Letter Issued to Edwards Lifesciences
Following a month-long U.S. Food and Drug Administration (FDA) inspection of the Edward’s Lifescience manufacturing facility in Draper, Utah, the agency issued a detailed warning letter to the medical device maker. The inspection also prompted a couple of recalls and a letter to investors.
In its letter, the agency cited seven manufacturing violations. Some, according to a MassDevice.com report, led to recalls. Violations included “failure to validate” manufacturing processes that the FDA said, “cannot be fully verified by subsequent inspection and test.” The inspectors also noted six customer complaints concerning Edwards’ QuickDraw cannulae, which broke during cardiac procedures. The inspectors pointed out that Edward’s Lifesciences does not appropriately validate its ovens’ temperatures, which is critical to maintain proper manufacturing bonding, MassDevice.com wrote. Continue reading
