Cardiac Malformations Not Up With First-Trimester Ondansetron

December 19, 2018

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.

Palonosetron Available in Prefilled Syringe for Chemotherapy-Induced Nausea, Vomiting

By October 22, 2018

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.

Odds of Marijuana Use Up With Nausea, Vomiting in Pregnancy

August 27, 2018

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%).

Blister Packs for Several Meds Recalled Due to Risk of Harm to Children

By July 09, 2018

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.

Occupational Exposure Limits for Heat Stress Often Exceeded: CDC

July 09, 2018

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.

Labeling for Nausea Drugs Used During Pregnancy Updated With New Warning

By June 27, 2018

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.

Consensus Guidelines for the Prevention of Postoperative Nausea and Vomiting

May 30, 2018

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.

Akynzeo for Injection Available for Chemotherapy-Induced Nausea, Vomiting

By May 08, 2018

The intravenous formulation combines fosnetupitant (prodrug of netupitant), a substance P/NK1 receptor antagonist, and palonosetron, a 5-HT3 receptor antagonist.

FDA Approves New Formulation of Akynzeo for CINV

By April 20, 2018

Akynzeo IV combines fosnetupitant (prodrug of netupitant), a substance P/NK1 receptor antagonist, and palonosetron, a 5-HT3 receptor antagonist.

Bonjesta Now Available to Treat Nausea and Vomiting of Pregnancy

By April 02, 2018

Bonjesta is a multilayer, extended-release formulation that is designed to provide both fast-acting and long-lasting symptom relief.

Is Doxylamine-Pyridoxine Effective for Pregnancy-Related Nausea and Vomiting?

January 18, 2018

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.

Varubi Labeling Updated to Warn of Serious Hypersensitivity Reactions

By January 16, 2018

Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported.

Effective Treatments for Nausea, Vomiting of Pregnancy

December 28, 2017

Early treatment can prevent complications; safe, effective treatment available for more severe cases

New Formulation of Varubi Launched for Delayed CINV

By November 28, 2017

Varubi is a highly selective and potent antagonist of human substance P/neurokinin 1 (NK-1) receptors.

Cinvanti Approved for Chemotherapy-Induced Nausea and Vomiting

By November 10, 2017

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.

Recall: Syringes Labeled for Sedation Med Instead Contain Antiemetic

By November 06, 2017

Dose-dependent serious cardiac arrhythmias may be observed with higher dosages of ondansetron in those patients with certain pre-existing cardiac conditions.

Varubi IV Approved for Delayed Chemotherapy-Induced Nausea/Vomiting

By October 26, 2017

Varubi, a highly selective and competitive antagonist of human substance P/neurokinin (NK-1) receptor, is already available as 90mg strength tablets.

Old Anti-Nausea Agent May Be Effective for Sleep Apnea

By June 07, 2017

"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.

FDA Approves Final Label for Syndros with CII Designation

By May 24, 2017

Syndros is the first FDA-approved dronabinol solution for oral administration, containing the pharmaceutical version of tetrahydrocannabinol (THC).

Motion Sickness Drug May Worsen Vestibular Perception

By April 24, 2017

The researchers concluded that a person's ability to perceive motion was significantly lowered while taking oral promethazine.

Are Antiemetic Prophylactics Being Overprescribed for Chemotherapy?

By March 24, 2017

Study authors identified a total of 8,545 patients undergoing 73,577 administrations of chemotherapy with minimal or low emetic risk.

DEA Designates Syndros as Schedule II Drug

By March 23, 2017

Syndros is anticipated to launch in the second half of 2017. It will be available as a 5mg/mL strength oral solution.

Rescue Tx for Post-Op Nausea/Vomiting Effective in Pivotal Trial

By February 13, 2017

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.

Drug Patch Recalled Due to Incorrect Dosing Instructions

By February 06, 2017

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.

Cinvanti NDA Submitted for CINV Prevention

By January 12, 2017

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).

FDA Announces Antiemetic Drug Discontinuation

By November 17, 2016

The Food and Drug Administration (FDA) has posted a discontinuation notice for Zofran Oral Solution (ondansetron; Novartis).

FDA Approves Bonjesta for Pregnancy-Related Nausea and Vomiting

By November 11, 2016

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.

Motion Sickness Patch Currently in Shortage

By September 16, 2016

The Food and Drug Administration (FDA) is reporting a current backorder status for Transderm Scop (scopolamine; Sandoz) 1.5mg patches.

Anti-Nausea Drug Evaluated in Acute Food Protein-Induced Enterocolitis Syndrome

By August 22, 2016

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).

Baremsis Demonstrates Efficacy for Post-Op Nausea and Vomiting

By August 12, 2016

Acacia Pharma announced positive data from the Phase 3 study of Baremsis (amisulpride) for the potential treatment of post-operative nausea & vomiting (PONV).