Orthopedic Alerts for Patients - Implant Recalls

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

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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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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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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A recent study published in the BMJ revealed Johnson & Johnson’s DePuy Pinnacle metal-on-metal hip implants have a high revision surgery rate because of manufacturing problems and high levels of metal particles release into the bloodstream. Dr. David Langton, of University Hospital of North Tees in Stockton, UK, and fellow researchers initiated the study. “Although the use of MoM hip devices has declined dramatically in the past five years, hundreds of thousands remain in situ, with the long-term future uncertain,” Langton and colleagues wrote. In the study, researchers identified patients with metal DePuy Pinnacle hips implants. They looked at devices implanted from 2003–2009 and followed up with patients one a year.

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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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Lawyers for patients suing Johnson & Johnson and Bayer over severe bleeding injuries caused by the blockbuster blood thinner Xarelto say the drug makers failed to provide clinical trial data, the New York Times reported. Documents filed in court say a re-analysis conducted by Duke published by the New England Medical Journal of Medicine was missing key information that could have affected clinical trial data comparing Xarelto to warfarin in its 2011 ROCKET-AF study. J&J and Bayer stayed silent and helped deceive editors of the journal, lawyers said. The trial in question compared the safety of Xarelto and warfarin.

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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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After months of deliberation, the U.S. Food and Drug Administration announced it is mandating stronger warnings and more studies for Bayer’s controversial Essure Permanent Birth Control device. The decision ignited a social media firestorm among women who say the device caused them severe, permanent injuries and led to hundreds of fetal deaths. Essure is a permanent birth control device made up of two nickel-titanium coils that doctors implant into a woman’s fallopian tubes. In about 3 months, scar tissue forms, blocking the tubes and preventing eggs from being fertilized. But, tens of thousands of women have spoken out about severe complications linked to the device, including organ perforation, severe pain and ectopic pregnancies.

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