Hetero Labs Limited is voluntarily recalling some prescription antiviral tablets manufactured for Camber Pharmaceuticals Inc. because the drugs were exposed to high temperatures during transport, according to the March 21, 2018, US Food and Drug Administration (FDA) Enforcement Report. The recall affects the following antivirals, which were shipped to New Jersey and then distributed across the United States: Hetero Labs initiated the recall February 13, 2018. The classification warns use of affected tablets could cause a temporary health problem. Both valacyclovir and valganciclovir tablets are prescription antiviral medications. Valacyclovir treats cold sores, chickenpox, shingles, and genital herpes, and valganciclovir is used to prevent and treat diseases caused by cytomegalovirus. Herpes simplex virus (HSV) infection of the neonate is uncommon, but genital herpes infections in adults are very common. Thus, although treating an infant with neonatal herpes is a relatively rare occurrence, managing infants potentially exposed to HSV at the time of delivery occurs more frequently. The risk of transmitting HSV to an infant during delivery is determined in part by the mother’s previous immunity to HSV. Women with primary genital HSV infections who are shedding HSV at delivery are 10 to 30 times more likely to transmit the virus to their newborn infants than are women with recurrent HSV infection who are shedding virus at delivery. With the availability of commercial serological tests that reliably can distinguish type-specific HSV antibodies, it is now possible to determine the type of maternal infection and, thus, further refine management of infants delivered to women who have active genital HSV lesions. The management algorithm presented herein uses both serological and virological studies to determine the risk of HSV transmission to the neonate who is delivered to a mother with active herpetic genital lesions and tailors management accordingly. The algorithm does not address the approach to asymptomatic neonates delivered to women with a history of genital herpes but no active lesions at delivery.
Mar 22, 2018. 48,132 bottles of valacyclovir tablets, USP, 1 gram, 30-count NDC. Both valacyclovir and valganciclovir tablets are prescription antiviral. The 2007 International Association for the Study of Pain IASP recommendations for the management of herpes zoster offer the most comprehensive guidance covering treatment of both immunocompromised and immunocompetent patients. IASP recommendations for immunocompetent patients are as follows 1.