Orthopedic Alerts for Patients - Implant Recalls

Alerts and implant recalls for patients with orthopedic bone and joint conditions.

Men who take testosterone supplements for cardiovascular, sexual and physical function probably won’t see any benefits, researchers report. Researchers at Georgetown University collected data that suggests testosterone replacement therapy has no beneficial effect on health conditions. The 2016 study analyzed 156 randomized control trials from 1950 to 2016 that compared testosterone to placebo for sexual function, mood or cognitive function and cardiovascular health. Study results revealed testosterone therapy provided no consistent benefits and placebo was just as effective as testosterone.

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Johnson & Johnson’s Janssen Pharmaceuticals knew about a faulty device and data in a Xarelto (rivaroxaban) regulatory trial that suggests they put participants at risk, The BMJ reports. Janssen withheld data about problems with the INRation device from the U.S. Food and Drug Administration, the investigators said. The device monitored patients using warfarin during phase III of the ROCKET AF trial and may have compromised data and patient safety.

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A new medical study showed that patients who took opioid painkillers three months after hip replacement surgery were more likely to need revision surgery at one and five years than those who stopped taking the drugs. Experts also worry about an increase in opioid overdoses. Opioids are powerful painkillers that are the equivalent of morphine, such as OxyContin, Percocet and Vicodin — these drugs are also highly addictive.  Maria C.S. Ignacio and colleagues at the University of South Australia found that 42 percent of patients who needed revision surgery were still taking opioids one year after the original hip replacement.

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Patients who suffered trauma and received inferior vena cava (IVC) filters to prevent blood clots in the lungs had no survival advantage, researchers reported. The study published in JAMA Surgery showed no decrease in death rates in patients who received IVC filters to prevent pulmonary embolism or deep vein thrombosis after trauma. To gather data, Dr. Shayna Sarosiek and colleagues at the Boston University School of Medicine reviewed information from 451 IVC recipients and 1,343 controls at Boston Medical Center. Researchers found that IVC filters did not save a significant number of these patients and doctors removed just 8 percent of the filters after 3.8 years.

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The U.S. Food and Drug Administration issued a Drug Safety Communication on May 18, 2016 warning that Type 2 diabetes medication Invokana (canagliflozin) could cause an increase in leg and foot amputations. The toes are the most affected. Johnson & Johnson’s Invokana is a popular medication that helps control blood sugar in people with Type 2 diabetes. It also comes in a formula with metformin called Invokamet. The drug belongs to a class of drugs called SGLT2 Inhibitors. These drugs work by passing excess sugar out of the body through urine. In 2015, J&J’s blockbuster drug brought in $1.3 billion — about double what it made in 2014 — according to J&J’s Annual Report.

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The U.S. Food and Drug Administration released a safety communication informing the public of stronger kidney injury warning labels on SGLT2 inhibitors that treat Type 2 diabetes, including J&J’s Invokana/Invokamet (Canagliflozin) and Farxiga/Xigduo XR. “Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk,” the FDA said. From the time the FDA approved these medications in 2013 to 2015, the agency received 101 reports of acute kidney injury — 73 caused by Invokana and 28 by Farxiga. Of these cases, 96 patients required hospitalization, and 22 of these cases required admission to intensive care.

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New research suggests that popular heartburn drugs called proton pump inhibitors (PPIs) such as Prevacid (lansoprazole), Prilosec (omeprazole) and Nexium (esomeprazole) may damage arteries leading to an increased risk of heart attack, kidney failure and dementia. In the 2016 study published in Circulation Research, John P. Cooke and colleagues at the Houston Methodist Research Institute exposed endothelial cells — the cells that line the walls of arteries — to Nexium for the clinical equivalent of months or years. They compared the results of those cells to those exposed to another class of heartburn medications called H2 blockers, which includes Zantac (ranitidine).

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The U.S. Food and Drug Administration warned that taking more than the recommended dose of the popular diarrhea medicine Imodium (loperamide) can cause severe heart problems and even lead to death. Pharmacists worry that some with opioid addiction are turning to the low cost drug to reduce withdrawal symptoms or get high. “The majority of reported serious heart problems occurred in individuals who were intentionally misusing and abusing high doses of loperamide in attempts to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria,” the agency said in its safety communication.

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In the wake of two multi-million dollar jury verdicts, Johnson & Johnson faces another wave of lawsuits filed by women and surviving members of families who claim the company’s talcum powder caused ovarian cancer. Plaintiff’s attorneys want the drug giant to pull its iconic baby powder and other talcum products from the market. Two juries recently found J&J liable for hiding the risk of ovarian cancer linked to its Johnson’s Baby Powder and Shower-to-Shower products. The first February verdict awarded Jackie Fox’s estate $72 million after she filed a suit in Missouri claiming talcum powder caused ovarian cancer.

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