First-trimester ondansetron use is associated with a small increased risk for oral cleft but no increased risk for congenital malformations or cardiac malformations, according to a new study.
The prefilled syringe is part of the Company's Simplist portfolio and is the first FDA-approved prefilled delivery version of palonosetron hydrochloride (HCI) to become available.
The prevalence of prenatal marijuana use was 5.3% by self-report or toxicologic test findings; prevalence was greater among females with severe and mild versus no NVP (11.3 and 8.4, respectively, vs 4.5%).
The recall affects approximately 470,000 units that include drugs packaged with 3 to 10 tablets per blister card. The blister packs were developed for use in hospitals, however some were sent to retail pharmacies and were likely dispensed for in-home use.
For the same 25 cases, a Heat Index screening threshold of 85 degrees Fahrenheit could identify potentially hazardous levels of workplace environmental heat when WBGT was unavailable. Six fatalities occurred when the Heat Index was <91 degrees Fahrenheit.
The Warnings and Precautions section for both products has been updated to inform clinicians that there have been reports of false positive urine screening tests for methadone, opiates, and phencyclidine phosphate (PCP) with doxylamine succinate/pyridoxine hydrochloride use.
The latest Consensus Guidelines for the Management of PONV (CGM-PONV) recommend an assessment of a patient's baseline risk for PONV using a validated risk score based on independent predictors.
The intravenous formulation combines fosnetupitant (prodrug of netupitant), a substance P/NK1 receptor antagonist, and palonosetron, a 5-HT3 receptor antagonist.
Akynzeo IV combines fosnetupitant (prodrug of netupitant), a substance P/NK1 receptor antagonist, and palonosetron, a 5-HT3 receptor antagonist.
Bonjesta is a multilayer, extended-release formulation that is designed to provide both fast-acting and long-lasting symptom relief.
The researchers found that the improvement in symptom scores was greater with doxylamine-pyridoxine versus placebo (0.73 points; 95% confidence interval, 0.21 to 1.25) when the last observation carried forward imputation was used for missing data.
The approval of Cinvanti was supported by Phase 2 bioequivalence data of Cinvanti and Emend IV (fosaprepitant dimeglumine; Merck), where patients treated with Cinvanti experienced fewer adverse events vs. patients treated with Emend IV, including substantially fewer infusion-site reactions.
Dose-dependent serious cardiac arrhythmias may be observed with higher dosages of ondansetron in those patients with certain pre-existing cardiac conditions.
Varubi, a highly selective and competitive antagonist of human substance P/neurokinin (NK-1) receptor, is already available as 90mg strength tablets.
"Expanded and pivotal clinical trials must still be conducted to fully establish the best approach to cannabinoid therapy in obstructive sleep apnea," said lead author Professor David Carley.
Syndros is the first FDA-approved dronabinol solution for oral administration, containing the pharmaceutical version of tetrahydrocannabinol (THC).
Study authors identified a total of 8,545 patients undergoing 73,577 administrations of chemotherapy with minimal or low emetic risk.
Acacia has announced positive results from its final pivotal Phase 3 study investigating BAREMSIS (amisulpride injection, formerly APD421) for the rescue treatment of patients who develop post-operative nausea and vomiting (PONV), despite having received prior antiemetic prophylaxis.
Sandoz announced a voluntary recall of three lots of Transderm Scop (scopolamine) patches due to a discrepancy in the product labeling for the pouches and outer carton.
Heron Therapeutics announced the submission of the New Drug Application (NDA) for Cinvanti (HTX-019) to the Food and Drug Administration (FDA) for the prevention of chemotherapy-induced nausea and vomiting (CINV).
The Food and Drug Administration (FDA) has approved Bonjesta (doxylamine succinate and pyridoxine HCl extended-release tablets; Duchesnay), a fixed-dose combination drug product for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.
A retrospective study found that the nausea and vomiting preventative treatment, ondansetron, was more effective than traditional therapy in inducing remission of vomiting in patients with acute food protein induced enterocolitis syndrome (FPIES).
Acacia Pharma announced positive data from the Phase 3 study of Baremsis (amisulpride) for the potential treatment of post-operative nausea & vomiting (PONV).