FDA notified healthcare facility administrators and infection control healthcare professionals of important information regarding the regulatory status of the STERIS System 1 Processor (SS1) used in surgical and endoscopy suites for reprocessing, i.e., sterilizing or disinfecting, medical devices. STERIS has significantly modified the SS1 and FDA has not approved or cleared this modified product. Thus, […]
Valproate Sodium and related products (valproic acid and divalproex sodium): Risk of Birth Defects
Increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies exposed to valproate sodium and related products during pregnancy. SOURCE
Lexiva (fosamprenavir calcium) – Dear Healthcare Professional Letter
GlaxoSmithKline and FDA notified healthcare professionals of a potential association between Lexiva and myocardial infarction and dyslipidemia in HIV infected adults. GSK has modified the existing Warnings and Precautions section of the Prescribing Information to note that increases in cholesterol have occurred with treatment, the importance of lipids management, and a recommendation that triglyceride and cholesterol testing be […]
Norpramin (desipramine hydrochloride) – Dear Healthcare Professional Letter
Sanofi-Aventis and FDA notified healthcare professionals of changes to the Warnings and Overdosage sections of the Prescribing Information for Norpramin (desipramine hydrochloride), indicated for the treatment of depression. The new safety information states that extreme caution should be used when this drug is given to patients who have a family history of sudden death, cardiac […]
Stryker Operating Room System II Surgical Navigation System – Recall
Stryker and FDA notified healthcare professionals of a recall of 23 Operating Room System II Surgical Navigation Systems because there is a potential for the navigation PC SPC-1 component to stop working which could result in the screen freezing, the system updating at a slow rate, or not responding at all. The Navigation System II is […]
Meridia (sibutramine hydrochloride): Early Communication about an Ongoing Safety Review
FDA is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than patients using a placebo. SOURCE
Vicks Sinex Nasal Spray – Recall
Procter & Gamble and FDA notified consumers of a voluntary recall of three lots of Vicks Sinex Nasal Spray in the United States, Germany and the United Kingdom. The bacteria B. cepacia was found in a small amount of product made at its plant in Gross Gerau, Germany. There have been no reports of illness. However, the […]
Cardiac Science Corp. Powerheart and CardioVive Automated External Defibrillators: Initial Communication
Cardiac Science Corporation has received multiple complaints related to defective components in these AEDs that indicate the affected devices may not deliver electric shocks and that the devices’ self-test may not detect the defect in advance of their use. 300,000 Cardiac Science AEDs worldwide are potentially affected by this problem. The G3 Series devices were manufactured […]