Current Events

The U.S. Food and Drug Administration on Friday issued a recall alert for a Medtronic blood-pumping device called the HeartWare HVAD System, citing a problem that could result in serious health issues or death.

More than seven weeks after the start of a massive E. coli illness outbreak from romaine lettuce that sickened 172 people and caused romaine sales to plummet 45 percent, the Food and Drug Administration says it has no idea who or what caused the contamination.

Agency investigators have not managed to trace the affected lettuce back to one farm, processor or distributor, FDA Commissioner Scott Gottlieb said in an update Thursday. And with the affected lettuce now off shelves and the growing season over, there’s a chance the FDA may never crack the case.

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One of the most significant balancing acts in medicine involves figuring out when—and which—treatments do more harm than good. It’s an issue that has implications for everything from the opioid crisis to the rising rate of ADHD drug overdoses to the generally lavish (and unaffordable) cost of American health care, which still favors the bulk of services provided over demonstrable, cost-effective outcomes.

Powerful prescription drugs draw a big share of the attention on this front. But over-the-counter and non-prescription treatments are an important factor to consider in the dilemma, too. And the Food and Drug Administration (FDA) has been on a recent tear calling out companies (and therapies) that it considers all-steak, no-sizzle, and possibly harmful.
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Pain in her arm and lightheadedness sent Doris Jones to the emergency room at Savannah’s Memorial Health University Medical Center. A scan there soon revealed a shock. A filter placed in her bloodstream years before to catch clots had fractured, and debris was migrating toward her heart.

While the main part of the filter was removed, a broken piece is still lodged in the artery that carries blood to her lungs because doctors couldn’t safely get it out.

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A South Carolina judge declared a mistrial in a case against Johnson & Johnson alleging that exposure to asbestos in its Johnson’s Baby Powder caused a woman’s fatal cancer.

Jurors in Darlington County state court were unable to reach a unanimous decision on Friday in the case brought by the husband of Bertila Boyd-Bostic, according to Judge Jean Toal. The judge said she didn’t know when a retrial would take place.

Boyd-Bostic, 30, and her husband ran a three-person law firm in Columbia, South Carolina. The woman died of mesothelioma, a cancer linked to asbestos exposure.
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Fiat Chrysler Automobiles is recalling more than 51,000 of its 2018 Jeep Cherokees because of a fire risk.

The company said it is unaware of any accidents or injuries related to the defect, involving fuel-supply tubes that could leak. The campaign is limited to SUVs with a 2.4-liter engine and does not include the refreshed 2019 Jeep Cherokee, Fiat Chrysler said.

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A drug manufacturer used the same uncleaned equipment to make pesticides as it did several human drugs, according to a warning letter released by the Food and Drug Administration. The result was that at least two medicines were contaminated with pesticides, the agency noted.

The FDA’s sternly worded letter charged that drug manufacturer Product Quest MFG, LLC of Daytona Beach, Florida, and its manufacturing facility, Ei LLC in Kannapolis, North Carolina, committed “significant violations.” It also noted that the firm’s response to the problems so far were “inadequate” and that its investigations into the extent of the problems were “not thorough and scientifically sound.” The agency levied legal threats if the issues weren’t fixed pronto.
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The U.S. Food and Drug Administration is alerting health care professionals, oncology clinical investigators, and the public about decreased survival associated with the use of pembrolizumab or atezolizumab as single therapy (monotherapy) in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1).

In two ongoing clinical trials (KEYNOTE-361 and IMVIGOR-130), the Data Monitoring Committees’ (DMC) early reviews found patients in the monotherapy arms of both trials with PD-L1 low status had decreased survival compared to patients who received cisplatin- or carboplatin-based chemotherapy.

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SHANGHAI/CHICAGO (Reuters) - Health agencies are investigating an outbreak of bloodstream infections in children from four U.S. states that may be linked to heparin and saline syringes made by Becton Dickinson and Co, the agencies told Reuters. The U.S.
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It seems like a common convenience in a digital age: a car that can be powered on and off with the push of a button, rather than the mechanical turning of a key. But it is a convenience that can have a deadly effect.

On a summer morning last year, Fred Schaub drove his Toyota RAV4 into the garage attached to his Florida home and went into the house with the wireless key fob, evidently believing the car was shut off. Twenty-nine hours later, he was found dead, overcome with carbon monoxide that flooded his home while he slept.

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There is tremendous controversy about a surgical device implanted in more than two million American women. It's a strip of plastic called gynecological mesh. The manufacturers and several medical societies say the implant is safe. But more than 100,000 women are suing. And together, they make up the largest multi-district litigation since asbestos.
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