Don’t use oral benzocaine products for teething, FDA warns

Fda Cleared Indications for Use

The recovery of patients undergoing total shoulder arthroplasty (TSA) can be adversely affected by a number of complications. Autologous platelet gel (APG), produced by activating platelet-rich plasma (PRP). has been shown to improve hemostasis and wound healing and reduce infections in some surgical procedures. Activated platelet-poor plasma (PPP) has also been used as a hemostatic agent. This...

Assessment report for meprobamate-containing medicinal products for oral use

Reported adverse event cases of methemoglobinemia associated with benzocaine products.

BACKGROUND Methemoglobinemia (MHb) is characterized by abnormal levels of oxidized hemoglobin that cannot bind and transport oxygen. When induced by benzocaine anesthetic spray and other chemicals, it can result in cyanosis and life-threatening complications. METHODS From 818 439 adverse event reports received by the US Food and Drug Administration from November 1997 through March 2002, we ex...

Additively manufactured medical products – the FDA perspective

Additive manufacturing/3D printing of medical devices is becoming more commonplace, a 3D printed drug is now commercially available, and bioprinting is poised to transition from laboratory to market. Despite the variety of technologies enabling these products, the US Food and Drug Administration (FDA) is charged with protecting and promoting the public health by ensuring these products are safe...

Edible Cannabis Products: It Is Time for FDA Oversight.

The legalization of cannabis (marijuana) for medical and recreational purposes in states throughout the United States has greatly increased its availability and use by adults and teens. Much of the earlier research on cannabis focused on its administration by smoking. Very little recent research has been conducted on the administration of cannabis by the oral route, the presumption apparently b...