Epocrates Drug Updates - Editor's Pick

June 6, 2013
MedWatch Safety Alert for Magnesium Sulfate
The FDA recently cautioned against the off-label tocolytic use of magnesium sulfate for more than 5-7 days. Continuous administration to pregnant women for pre-term labor may lead to hypocalcemia, osteopenia, and fractures in the developing fetus. The pregnancy category has been changed from A to D (positive evidence of human fetal risk, but the potential benefits from using the drug in pregnant women may be acceptable in certain situations despite its risks (e.g. preeclampsia and eclampsia)). MedWatch Safety Alert for Magnesium Sulfate

May 30, 2013
Expanded Pediatric Dosing for Sustiva
The FDA recently approved the once daily non-nucleoside reverse transcriptase inhibitor, Sustiva (efavirenz), as part of a regimen to treat HIV-1 infection in children who are at least 3 months old and weighing at least 3.5 kg. Expanded Pediatric Dosing for Sustiva

May 23, 2013
MedWatch Safety Alert for Zolpidem
The FDA recently updated the safety alert for zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist, and generics). Based on the risk for next-morning impairment associated with this insomnia treatment, the label now recommends taking zolpidem at least seven hours before planned awakening. The FDA also warns that patients taking extended-release formulations should avoid driving or other activities that require mental alertness the day after taking the drug because sustained zolpidem levels may cause impairment. These recommendations are in addition to the new lower dose recommendations stated in the January 2013 safety alert. MedWatch Safety Alert for Zolpidem

May 16, 2013
Boxed Warning Added to Pradaxa
A boxed warning was recently added to the prescribing information for the oral anticoagulant, Pradaxa (dabigatran etexilate). Discontinuing treatment may increase the risk of thrombotic events, including stroke. If Pradaxa must be discontinued for reasons other than pathological bleeding, prescribers are encouraged to consider coverage with another anticoagulant. Boxed Warning Added to Pradaxa

May 9, 2013
MedWatch Safety Alert for Valproate Products
The FDA recently advised against the use of valproate products (valproate sodium, valproic acid, divalproex sodium; brands include Depacon, Depakene, Stavzor, Depakote) in pregnant women to prevent migraine headaches, based on evidence of decreased IQ scores in children exposed during pregnancy. These products will remain pregnancy category D for treating epilepsy and manic episodes of bipolar disorder, but will now be category X for migraine prophylaxis. Pregnant women currently taking valproate products for migraine should be tapered appropriately to discontinue the medication. MedWatch Safety Alert for Valproate Products