Epocrates Drug Updates - Editor's Pick
January 31, 2013
MedWatch Safety Alert for Samsca
The FDA recently notified healthcare professionals about the risk of liver toxicity associated with Samsca (tolvaptan). Although the data came from a trial using higher doses for an off-label indication (autosomal dominant polycystic kidney disease), the data are not adequate to exclude the possibility of increased risk at usual doses for the labeled indication (hypervolemic and euvolemic hyponatremia). Liver tests should be performed promptly in patients reporting symptoms of liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. Samsca should be discontinued if liver injury is suspected, and should not be re-initiated in definitive cases.
Recent Updates
January 24, 2013
New Drug Monograph for Cometriq
The FDA recently approved the tyrosine kinase inhibitor, Cometriq (cabozantinib), to treat progressive, metastatic medullary thyroid cancer. New Drug Monograph for Cometriq
January 17, 2013
MedWatch Safety Alert for Zolpidem
The FDA recently recommended a lower bedtime dose of zolpidem products (including generic formulations, Ambien, Ambien CR, Edluar, and Zolpimist) due to the risk for next-morning impairment. Blood levels of zolpidem may be high enough in the morning to impair alertness and the ability to drive, even if the patient feels fully awake. The risk for impairment is highest for patients taking extended-release formulations and for women, who appear to eliminate zolpidem more slowly than men. MedWatch Safety Alert for Zolpidem
January 10, 2013
MedWatch Safety Alert for Incivek
The FDA recently added a boxed warning to the prescribing information for the hepatitis C protease inhibitor, Incivek (telaprevir). The FDA received reports of serious skin reactions, including some fatal, in patients taking Incivek in combination with peginterferon alfa and ribavirin. Patients who experience rash with systemic symptoms or a progressive severe rash should immediately stop all three drugs and receive urgent medical care. MedWatch Safety Alert for Incivek
December 27, 2012
New Drug Monograph for Nexafed
A new formulation of the decongestant pseudoephedrine will be available to consumers that impedes the extraction and conversion of pseudoephedrine to methamphetamine. New Drug Monograph for Nexafed
December 20, 2012
New Drug Monograph for Linzess
The FDA recently approved the oral drug, Linzess (linaclotide), to treat chronic idiopathic constipation and irritable bowel syndrome with constipation in adult patients. New Drug Monograph for Linzess
New Drug Monographs
- Juxtapid (lomitapide)
- Pedia Relief (chlorpheniramine / dextromethorphan / pseudoephedrine)
- Uceris (budesonide)
- argatroban (first-time generic for Argatroban)
- Cometriq (cabozantinib)
- Mono-Linyah (norgestimate / ethinyl estradiol)
- drospirenone / ethinyl estradiol (first-time generic for Yasmin)
- Iclusig (ponatinib)
- Jetrea (ocriplasmin)
- Minivelle (estradiol transdermal)
- Quillivant XR (methylphenidate)
- Raxibacumab (raxibacumab)
- Tri-Linyah (norgestimate / ethinyl estradiol)
- VariZIG (varicella zoster immune globulin (human))
- rizatriptan (first-time generic for Maxalt and Maxalt-MLT)
- Tenivac (tetanus/diphtheria toxoids (Td))
- tiagabine (first-time generic for Gabitril)
- butoconazole vaginal (first-time generic for Gynazole-1)
- candesartan cilexetil / hydrochlorothiazide (first-time generic for Atacand HCT)
- Dasetta 1/35 (norethindrone / ethinyl estradiol)
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