FDA Reports 561 Deaths Related to Philips Machines Since 2021
The FDA announced Wednesday that there have been 561 deaths related to the use of Philips’ recalled ventilators and machines for treating obstructive sleep apnea since 2021, according to Reuters. More specifically, in 2023, the FDA received more than 7000 medical device reports between July and September, including 111 reports of death related to the use of these machines. Consequently, Philips announced earlier this week that it would not sell new devices in the US to treat sleep apnea in the coming years as it works to comply with a settlement with the FDA; the company explained that it had reached a consent decree that spells out the improvements it needs to make at its Respironics plants in the US. This agreement followed the recall of millions of ventilators and breathing devices in 2021 because of concerns that foam used to reduce noise from the devices could degrade and become toxic, carrying potential cancer risks.
FDA Warns of Contaminated Copycat Eye Drops
The FDA warned the public against copycat eye drops due to infection risk, according to CBS News. The FDA explained on Wednesday that these eye drops, namely South Moon, Rebright, and FivFivGo, are offered in packaging that could easily be mistaken for Bausch + Lomb’s Limify eye drops, an over-the-counter product approved for redness relief. These copycat products claim to address conditions, such as glaucoma, treated with prescription drugs or surgery, but the agency has received reports related to these eye drops, including eye irritation, quality concerns, and infection. Consequently, the FDA tested South Moon and Rebright eye drop samples, and it found the former to be tainted with burkholderia cepacian complex, a group of bacteria that could cause an antibiotic-resistant infection. It also found that the 2 eye drops lacked brimonidine tartrate, the active ingredient in Limify. Conversely, the FDA could not obtain FivFivGo samples, and it advised against using Rebright eye drops despite not finding contamination. Overall, the FDA advised eye drop users to only buy products from reputable retailers, like state-licensed pharmacies.