Image Español Hyperbaric oxygen therapy (HBOT) is well known for treating scuba and deep-sea divers affected by the rapid change in pressure around them. But did you know that HBOT is also used to treat a variety of other health problems, including carbon monoxide poisoning and diabetic foot ulcers? If you are considering the use…
Philips Respironics Recalls Certain Continuous and Non-Continuous Ventilators, including CPAP and BiPAP, Due to Risk of Exposure to Debris and Chemicals
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. The recall described in this notice is the same one that was announced in the FDA Safety Communication on June 30, 2021. Recalled Product Continuous Ventilator, Minimum Ventilatory Support,…
FDA D.I.S.C.O. Burst Edition: Approval of Padcev (enfortumab vedotin-ejfv) for locally advanced or metastatic urothelial cancer and Darzalex Faspro (daratumumab and hyaluronidase-fihj) with pomalidomide and dexamethasone for multiple myeloma
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on two recent FDA cancer drug approvals. On July 9, 2021, FDA approved enfortumab vedotin-ejfv (brand name…
Philips Respironics Recalls Certain Ventilators and BiPAP Machines Due to Potential Health Risks from PE-PUR Sound Abatement Foam
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Mechanical ventilation devices: Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent 200, BiPAP V30, BiPAP A30/Hybrid/A40 Serial Numbers: Devices manufactured before April 26, 2021, all serial numbers…
How Safe are Color Additives?
Color additives give the red tint to your fruit punch and the green hue to your mint-flavored toothpaste. They are dyes, pigments, or other substances that can impart color when added or applied to a food, drug, cosmetic, or the human body. They can be found in a range of consumer products—from cough syrup and…
Vero Biotech Recalls GENOSYL DS; Nitric Oxide Delivery System Due to Software Error
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product GENOSYL DS; Nitric Oxide Delivery System Model Number: 601588-01 Serial Numbers: All Devices Manufacturing Dates: March 15, 2021 to April 5, 2021 Distribution Dates: March 15, 2021…
Accidental Exposures to Fentanyl Patches Continue to Be Deadly to Children
[embedded content] Accidental exposure to medication is a leading cause of poisoning in children. Young children, in particular, have died or become seriously ill after being exposed to a skin patch containing fentanyl, a powerful opioid pain reliever. If you suspect that a child has been exposed to a fentanyl patch, call 911 and seek…
“Poppers” de nitrito
Image Los proveedores de atención médica están reportando un aumento de muertes y hospitalizaciones relacionadas con la ingestión o inhalación intencional de productos de nitrito para uso recreativo, incluyendo aquellos para mejorar la experiencia sexual. Estos productos, conocidos comúnmente como “poppers”, contienen sustancias químicas similares al nitrito de amilo, un medicamento que se receta para…
Statins: Drug Safety Communication – FDA Requests Removal of Strongest Warning Against Using Cholesterol-lowering Statins During Pregnancy
[Posted 07/20/2021] AUDIENCE: Patient, Health Professional, OBGYN, Cardiology, Endocrinology, Pharmacy ISSUE: The FDA is requesting revisions to the information about use in pregnancy in the prescribing information of the entire class of statin medicines. These changes include removing the contraindication against using these medicines in all pregnant patients. A contraindication is FDA’s strongest warning and is only…
Pfizer Issues a Voluntary Nationwide Recall for Twelve Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content
Summary Company Announcement Date: July 16, 2021 FDA Publish Date: July 19, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description N-Nitroso Varenicline content above ADI level Company Name: Pfizer Brand Name: Brand Name(s) Product Description: Product Description Smoking cessation treatment Company Announcement Pfizer is voluntarily recalling two lots of Chantix 0.5mg Tablets, two…