FDA issues recall alert for Medtronic device that fights heart failure

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.

Medtronic voluntarily notified physicians that 16,399 HeartWare HVAD systems implanted in patients as of May 22 could be susceptible to a...

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Romaine lettuce made 172 people sick. Government investigators might never know why.

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...

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FDA Slams Teething Medicines As Unsafe in Latest Consumer Public Health Push

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...

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FDA issues health alert for clinical trials treating low PD-L1 bladder cancer with pembrolizumab or atezolizumab

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...

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Medicines were tainted with pesticides in sloppy drug facility, FDA warns

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...

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