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Women Don't Have to Suffer Through Severe Morning Sickness, Experts Say

Posted 19 Aug 2015 by Drugs.com

WEDNESDAY, Aug. 19, 2015 – Expectant mothers hit hard with nausea and vomiting in early pregnancy don't need to muddle through debilitating symptoms, new recommendations say. In updating 11-year-old guidelines on treating morning sickness, the American College of Obstetricians and Gynecologists (ACOG) now suggests women pair vitamin B6 and the antihistamine doxylamine to treat persistent, disruptive nausea and vomiting. The medications are sold separately over-the-counter or combined in prescription form. Meanwhile, further review of a commonly used morning sickness drug, ondansetron (Zofran), has prompted ACOG to pull back on supporting its use since more recent data suggest the drug may be linked to birth defects. "I think it's up to each individual patient, in talking with her clinician, to decide what steps they want to take to treat nausea and vomiting," said Dr. Aaron Caughey, a ... Read more

Related support groups: Zofran, NyQuil, Ondansetron, Unisom, Alka-Seltzer, Doxylamine, Nyquil Cold Medicine, Night Time, All-Nite, Diclegis, Zofran ODT, Nausea/Vomiting of Pregnancy, NyQuil Multi-Symptom, Nyquil Cold & Flu, Dextromethorphan/Doxylamine, Doxylamine/pyridoxine, Fast Sleep, Nite Time Cold & Flu, Tylenol Sinus NightTime, Doxylamine/pseudoephedrine

FDA Medwatch Alert: Metoclopramide Injection And Ondansetron Injection by Hospira: Recall - Glass Strand Particulates Caused By Glass Supplier

Posted 3 Oct 2013 by Drugs.com

ISSUE: Hospira, Inc. announced it initiated a voluntary nationwide recall of one lot of Metoclopramide Injection, USP, 10 mg/2 mL (5 mg/mL)and two lots of Ondansetron Injection, USP, 4 mg/2 mL, (2 mg/mL). This action is due to a confirmed vial defect where glass particulate matter (glass strands) were identified as being affixed to the inside of the vial walls. There is potential for the glass particulates to dislodge into the solution. To date, Hospira has not received reports of any adverse events associated with this issue for these lots. BACKGROUND: Metoclopramide Injection, USP, 10 mg/2 mL (5 mg/mL), NDC 0409-3414-01, Lot 28-104-DK (the lot number may be followed by a 01), is packaged in a 2 mL single-dose fliptop vial, with an expiration date of October 1, 2014. Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), NDC 0409-4755-03, Lots 29-484-DK and 29-510-DK (the lot numbers may be f ... Read more

Related support groups: Nausea/Vomiting, Zofran, Reglan, Ondansetron, Metoclopramide, Zofran ODT, Maxolon, Zuplenz

No Risks to Pregnancy Seen With Morning Sickness Drug

Posted 27 Feb 2013 by Drugs.com

WEDNESDAY, Feb. 27 – A drug commonly used to treat severe cases of morning sickness does not appear to be linked to birth defects or other risks to the baby, a large new study suggests. The Danish researchers said the findings, reported in the Feb. 28 issue of the New England Journal of Medicine, do not prove the medication is risk-free. But they said the study should reassure women who need the drug, called ondansetron (Zofran and generics). "We can never say it's 100 percent safe," said Christina Chambers, co-director of the Center for Promotion of Maternal Health and Infant Development at the University of California, San Diego. "But this is a good study that really adds to what we've known," said Chambers, who was not involved in the work. The findings are based on records from more than 600,000 Danish women who were pregnant between 2004 and 2011. Of those women, about 0.3 percent ... Read more

Related support groups: Nausea/Vomiting, Zofran, Ondansetron, Zofran ODT, Zuplenz

FDA Drug Safety Communication: Updated information on 32 mg intravenous ondansetron (Zofran) dose and pre-mixed ondansetron products

Posted 5 Dec 2012 by Drugs.com

This update is a follow-up to the FDA Drug Safety Communication: New information regarding QT prolongation with ondansetron (Zofran)1 on 6/29/2012. Safety Announcement Table 1.  List of ondansetron products to be voluntarily withdrawn from the U.S. market Reference   Safety Announcement [12-4-2012] The U.S. Food and Drug Administration (FDA) is notifying health care professionals that the 32 mg, single intravenous (IV) dose of the anti-nausea drug Zofran (ondansetron hydrochloride) will no longer be marketed because of the potential for serious cardiac risks.  This dose has been removed from the Zofran drug label.  FDA is now working with the manufacturers of all 32 mg dose ondansetron injectable products (brand and generic) to voluntarily recall them from the market.  These drugs are sold pre-mixed in solutions of either dextrose or sodium chloride in plastic containers (See Table 1). ... Read more

Related support groups: Zofran, Ondansetron, Nausea/Vomiting - Chemotherapy Induced, Zofran ODT, Zuplenz

FDA Medwatch Alert: Ondansetron (Zofran) 32 mg, Single Intravenous (IV) Dose: Updated Safety Communication – Product Removal due to Potential For Serious Cardiac Risks

Posted 4 Dec 2012 by Drugs.com

ISSUE: FDA is notifying health care professionals that the 32 mg, single intravenous (IV) dose of the anti-nausea drug Zofran (ondansetron hydrochloride) will no longer be marketed because of the potential for serious cardiac risks. BACKGROUND: The 32 mg, single IV dose of Zofran had been used to prevent chemotherapy-induced nausea and vomiting. A previous Drug Safety Communication (DSC), issued on June 29, 2012, communicated that the 32 mg, single IV dose should be avoided due to the risk of a specific type of irregular heart rhythm called QT interval prolongation, which can lead to Torsades de Pointes, an abnormal, potentially fatal heart rhythm.  These drugs are sold pre-mixed in solutions of either dextrose or sodium chloride in plastic containers. FDA anticipates these products will be removed from the market through early 2013.  FDA does not anticipate that removal of the 32 mg i ... Read more

Related support groups: Zofran, Ondansetron, Nausea/Vomiting - Chemotherapy Induced, Zofran ODT, Zuplenz

FDA Medwatch Alert: Ondansetron (Zofran) IV: Drug Safety Communication - QT prolongation

Posted 3 Jul 2012 by Drugs.com

ISSUE: The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and the public that preliminary results from a recently completed clinical study suggest that a 32 mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) may affect the electrical activity of the heart (QT interval prolongation), which could pre-dispose patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes. GlaxoSmithKline (GSK) has announced changes to the Zofran drug label to remove the 32 mg single intravenous dose. The updated label will state that ondansetron can continue to be used in adults and children with chemotherapy-induced nausea and vomiting at the lower intravenous dose recommended in the drug label, a dose of 0.15 mg/kg administered every 4 hours for three doses; however, no single intravenous dose should ... Read more

Related support groups: Zofran, Ondansetron, Nausea/Vomiting - Chemotherapy Induced, Zofran ODT, Zuplenz

FDA Medwatch Alert: Zofran (ondansetron): Drug Safety Communication - Risk of Abnormal Heart Rhythms

Posted 15 Sep 2011 by Drugs.com

ISSUE: FDA notified healthcare professionals and patients of an ongoing safety review and labeling changes for the anti-nausea drug Zofran (ondansetron, ondansetron hydrochloride and generics). Ondansetron may increase the risk of developing prolongation of the QT interval of the electrocardiogram, which can lead to an abnormal and potentially fatal heart rhythm, including Torsade de Pointes. Patients at particular risk for developing Torsade de Pointes include those with underlying heart conditions, such as congenital long QT syndrome, those who are predisposed to low levels of potassium and magnesium in the blood, and those taking other medications that lead to QT prolongation. BACKGROUND: Zofran (ondansetron) is in a class of medications called 5-HT3 receptor antagonists. It is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. FDA is ... Read more

Related support groups: Zofran, Ondansetron, Zofran ODT, Zuplenz

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Nausea / Vomiting - Postoperative, Nausea / Vomiting - Chemotherapy Induced, Nausea / Vomiting - Radiation Induced

Zuplenz Patient Information at Drugs.com