Health News Roundup: US FDA adds 'boxed warning' for Amgen's bone loss drug Prolia; US FDA adds 'boxed warning' for Amgen's bone loss drug Prolia and more
The so-called boxed warning, issued on Friday, comes after the health regulator in 2022 started a review into the risk of very low blood calcium in patients with advanced chronic kidney disease, particularly ones on dialysis, and Prolia. Exclusive-US FDA finds new manufacturing lapses at Eli Lilly plant U.S. inspectors recently uncovered new manufacturing problems at an Eli Lilly plant that has been under scrutiny by federal investigators, according to government records obtained by Reuters.
Following is a summary of current health news briefs.
US FDA adds 'boxed warning' for Amgen's bone loss drug Prolia
The U.S. Food and Drug Administration added a serious warning on the prescribing information for Amgen's drug Prolia to treat bone loss as it increases the risk of severely low calcium levels in certain patients. The so-called boxed warning, issued on Friday, comes after the health regulator in 2022 started a review into the risk of very low blood calcium in patients with advanced chronic kidney disease, particularly ones on dialysis, and Prolia.
Exclusive-US FDA finds new manufacturing lapses at Eli Lilly plant
U.S. inspectors recently uncovered new manufacturing problems at an Eli Lilly plant that has been under scrutiny by federal investigators, according to government records obtained by Reuters. The U.S. Food and Drug Administration inspection in July at Lilly's Branchburg, New Jersey, plant detected eight separate deficiencies. They included problems in tracking manufacturing process and quality controls, as well as lapses in its calibration of equipment and failure to properly maintain facilities and equipment, the inspection report shows.
Mother and son survive Zambia's deadly cholera outbreak
Sandra Nyendwa used to drink unfiltered water in Zambia's capital Lusaka without concern, until she and her seven-year-old son got cholera in an outbreak sweeping the country. Both fell badly ill last week, joining more than 10,000 people infected by the disease that has killed at least 432 since October, according to government figures.
US CDC expands probe into charcuterie meats as salmonella cases rise
The U.S. Centers for Disease Control and Prevention (CDC) warned against some more brands of charcuterie meat sold at Costco and Sam's Club as the agency expands a probe into a multi-state salmonella outbreak. The CDC, in an updated post on Thursday, asked people to throw away all the packs of Fratelli Beretta's Antipasto Gran Beretta charcuterie meat bought at Costco and Busseto's Charcuterie Sampler bought at Walmart's Sam's Club.
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