FDA Had Documented Multiple Safety Violations At ByHeart Factory In Pa.
The baby formula that is suspected to have caused several cases of infant botulism was not manufactured at the Pennsylvania plant, where inspectors found mold and thousands of dead insects, The New York Times reported. The findings prompted worry about ByHeart's overall safety.
The New York Times:
Infant Formula Company Tied To Botulism Outbreak Had Known Problems
ByHeart, the company linked to a botulism outbreak in infants, shut down one of its manufacturing plants this year after federal investigators found a series of safety violations, including a leaking roof and hundreds of dead bugs where infant formula was produced. Inspection reports by the Food and Drug Administration detailed significant problems at the company’s site in Reading, Pa. Although the reports did not involve the plants that made the formula recalled in the botulism outbreak, food experts say the findings raise concerns about the company’s safety record. (Jewett and Creswell, 11/13)
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The Texas Tribune:
Why Texas’ Newest Rural Hospital Can’t Deliver Babies Anymore
On April 14, Texas’ oldest operating rural hospital gave way to its newest. Olney Hamilton Hospital had been serving this small town, 100 miles west of Fort Worth, for more than a century, bearing witness to generations of births, deaths and everything in between, while struggling to survive amid the slow hollowing out of rural health care in Texas. (KIibanoff, 11/13)
MedPage Today:
Dads' Valproate Use May Raise Red Flags For Kids' Neurodevelopment
Children whose dads took valproate up to 3 months before conception were more likely to have neurodevelopmental disorders, data from Denmark, Norway, and Sweden showed. Compared with children whose fathers took lamotrigine or levetiracetam, kids with fathers exposed to valproate had a higher risk of a neurodevelopmental disorder diagnosis up to age 12 years ... reported Sandrine Colas, MPH, PhD, of Sanofi in Gentilly, France, and co-authors. (George, 11/13)
The Wall Street Journal:
A Couple Wagers Time, Hope And $300,000 On A Quest For Children
Lisa Cast wondered if it was time to abandon her dream of giving birth. She and her spouse, Michelle Cast, had exhausted their fertility healthcare benefits and gone into debt for fertility treatments they say surpassed $300,000. Finances weighed on the couple, and, at age 42, Lisa faced long odds that worsened as time passed. (Dockser Marcus, 11/13)
Katie Couric Media:
Menopause Newsflash: There’s a New Non-Hormonal Hot Flash Medication
The U.S. Food and Drug Administration has approved a non-hormonal treatment for hot flashes. Lynkuet is a daily pill that relieves this common menopause symptom by manipulating the body’s internal thermostat. The medication, which is known generically as elinzanetant, is produced by Bayer, and is the second drug of its kind to be greenlit by the FDA. It was cleared after three randomized clinical trials showed it significantly reduced the frequency and severity of hot flashes, which about 75 percent of women experience during the menopausal transition. (11/12)
The New York Times:
Sharon Camp, Mother Of The ‘Plan B’ Contraceptive Pill, Dies At 81
Sharon Camp, a public policy expert and advocate for women’s reproductive health who was known as the mother of Plan B, the emergency contraceptive pill, and who founded what was surely one of the world’s smallest pharmaceutical companies to bring it to market, died on Oct. 25 in La Plata, Md. She was 81. Talcott Camp, a cousin, confirmed the death, in a rehabilitation facility, but did not specify a cause. (Green, 11/14)
