Elizabeth Gough-Gordon, Author at MPR

Elizabeth Gough-Gordon

All articles by Elizabeth Gough-Gordon

Issues ID’ed With New Clozapine REMS Website

The Food and Drug Administration (FDA) announced that there have been technical difficulties with the new clozapine risk evaluation and mitigation strategy (REMS) website that may have prevented some pharmacies and prescribers from completing their required certification, resulting in problems with patient access.

AAP Advises No Alcohol at All During Pregnancy

The American Academy of Pediatrics (AAP) has issued a new clinical report in the November issue of Pediatrics emphasizing that no amount of alcohol should be considered safe to drink during any trimester of pregnancy due to the risk of fetal alcohol spectrum disorders (FASDs).

Poor Handwriting Leads to Patient's Death

Trends in Controlled Substance Rxs Highlight Need to Curb Overprescribing

In the first multi-state report from the Centers for Disease Control and Prevention (CDC)’s Prescription Behavior Surveillance System (PBSS), state prescribing practices for prescription opioid pain relievers, benzodiazepines (sedatives/tranquilizers), and stimulants vary significantly despite a similar prevalence of the conditions these medications are intended to treat.

First Reversal Agent for Pradaxa Now FDA-Approved

The Food and Drug Administration (FDA) has grated accelerated approval to Praxbind (idarucizumab; Boehringer Ingelheim) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.

Bunavail Now Available for Opioid Dependence

More Bunavail Coming Soon After FDA Approval

BioDelivery Sciences announced that the Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for Bunavail (buprenorphine and naloxone) buccal film. The approval is related to a manufacturing specification change for the drug.