Premature and Low Birth Weight Infants Face Increased Sepsis Risk: Study
Researchers note that infection rates have declined as better infection controls among premature infants see wider use in the U.S., but more could be done
Researchers note that infection rates have declined as better infection controls among premature infants see wider use in the U.S., but more could be done
FDA announced the Makena withdrawal after post-marketing studies failed to show the pregnancy drug provides any benefits in preventing preterm births
Experts have determined the pregnancy drug Makena provides little to no benefit and puts pregnant mothers and their children at risk of adverse health events.
The manufacturer claims it is trying to provide help to an underserved population of black women, yet raised the price of Makena from $15 to $15,000 when it bought the rights to the drug, critics note.
Lack of any clinical benefits from the drug reducing preterm births has resulted in calls for Makena to be removed from the market in U.S.
Abbott and Mead Johnson put preemies at risk of long-term NEC complications without warning parents or healthcare providers about the risks of cow's milk based formula, according to the lawsuit.
Complications led to one of the twins dying at less than a month old, according to the NEC lawsuit
Makers of Similac and Enfamil face a lawsuit alleging a premature infant NEC diagnosis was caused by the formula products
In 2019, a panel of FDA scientific advisors determined that the risk of Makena side effects outweigh any benefits for expecting mothers.
Necrotizing enterocolitis was linked to a seven-fold increased risk of death among premature infants, the study found.