FDA Roundup: August 18, 2023

SILVER SPRING, Md., Aug. 18, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

On Thursday, the FDA provided an update to the list of ultraviolet (UV) wand products that may present a risk of injury. Do not use these UV wands because they may expose the user or any nearby person to unsafe levels of ultraviolet-C (UV-C) radiation and may cause injury to the skin, eyes, or both after a few seconds of use. The FDA will continue to update the list as corrective actions are implemented by manufacturers and if the FDA discovers additional products are unsafe.
On Wednesday, the FDA authorized marketing for BlueWind Medical’s Revi System, a Tibial Neuromodulation System intended for use in the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency. The device consists of an active implantable wireless neurostimulation component intended to be placed in the vicinity of the tibial neurovascular bundle for peripheral nerve stimulation. Since the implant has no battery, the wearable unit transmits energy via magnetic coupling to the implant, which consequently generates electrical pulses stimulating the tibial nerve. These electrical pulses stimulate the nerve along the leg, reaching the sacral plexus and entering the spinal cord, relieving symptoms of urinary incontinence alone or in combination with urinary urgency.
On Wednesday, the FDA approved Sohonos (Ipsen Biopharmaceuticals, Inc.), the first treatment for fibrodysplasia ossificans progressiva (FOP). Sohonos reduces extra-skeletal bone formation in adults and children (aged 8 years and older for females and 10 years and older for males) with FOP, a rare disease where connective tissue such as muscle, tendons and ligaments gradually turn into bone tissue, causing limited movement, deformities, and severe disability. The most common adverse reactions were dry skin, lip dry, arthralgia, pruritis, pain in extremity, rash, alopecia, erythema, headache, back pain, skin exfoliation, nausea, musculoskeletal pain, myalgia, dry eye, hypersensitivity, peripheral edema, and fatigue. View the full prescribing information for Sohonos.
On Wednesday, the FDA issued an advisory cautioning pet owners not to feed their pets certain lots of Darwin’s Natural Pet Products raw cat and dog food after FDA samples from these lots tested positive for Salmonella. Salmonella poses a serious threat to the health of pets and the people who care for them.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.