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Nausea/Vomiting - Chemotherapy Induced Blog

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  List of ondansetron products to be voluntarily withdrawn from the U.S. market Reference   Safety Announcement [12-4-2012] The U.S. Food and Drug Administration (FDA) is notifying health care professionals that the 32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

Many Primary Care Docs Don't Know Long-Term Effects of Chemo: Survey

Posted 16 May 2012 by Drugs.com

WEDNESDAY, May 16 – Many primary care doctors don't know the long-term side effects of the chemotherapy treatments that cancer survivors under their care may have been given, a new survey found. On the other hand, most oncologists – though not all – are familiar with the side effects of four common treatments used to treat breast and colon cancer, according to the results of the survey being presented at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago. "While oncologists commonly identify the main late effects of four common cancer drugs, primary care providers did not," study author Dr. Larissa Nekhlyudov said during a Wednesday news conference. "This is not surprising in that primary care providers have different training and exposure to chemotherapy drugs," she noted. "However, these findings emphasize that in the transition of patients ... Read more

Related support groups: Cancer, Zyprexa, Reglan, Olanzapine, Metoclopramide, Nausea/Vomiting - Chemotherapy Induced, Taxol, Cytoxan, Zyprexa Zydis, Cyclophosphamide, Oxaliplatin, Paclitaxel, Adriamycin, Doxorubicin, Eloxatin, Cytoxan Lyophilized, Maxolon, Zyprexa Intramuscular, Neosar, Adriamycin RDF

FDA Approves Strativa Pharmaceuticals' Zuplenz (ondansetron) Oral Soluble Film

Posted 7 Jul 2010 by Drugs.com

WOODCLIFF LAKE, N.J., July 2 /PRNewswire/ – Strativa Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Zuplenz (ondansetron) oral soluble film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting. Zuplenz, a unique formulation of ondansetron, is the first oral soluble film approved by the FDA as a prescription medication. The FDA approval was granted based on clinical study data comparing the bioequivalence of Zuplenz 8 mg to Zofran ODT (orally dissolving tablet) 8 mg. The pharmacokinetic results of these studies demonstrated that a single dose of Zuplenz, taken with or without water and under fed and fasting conditions, was comparable to Zofran ODT. "The FDA approval of Zuplenz marks an important milestone for Strativa as it reinforces our commitment ... Read more

Related support groups: Ondansetron, Nausea/Vomiting - Chemotherapy Induced, Nausea/Vomiting - Postoperative, Nausea/Vomiting - Radiation Induced

Ginger Eases Nausea From Chemo

Posted 14 May 2009 by Drugs.com

THURSDAY, May 14 – Researchers have discovered the nausea-easing powers of ginger that many grandmothers are already familiar with, and report that the spice helped cancer patients who were undergoing chemotherapy. "Ginger at a daily dose of 0.5-to-1 gram significantly aids in the reduction of chemotherapy-related nausea on the first day of chemotherapy, and reduced nausea will lead to improved quality of life in many cancer patients," said study author Julie Ryan, an assistant professor of dermatology and radiation oncology at the James P. Wilmot Cancer Center at the University of Rochester, said during a Thursday teleconference highlighting research that will be presented later this month during the American Society of Clinical Oncology (ASCO) annual meeting in Florida. That dose is the equivalent of 1/4 to 1/2 a teaspoon of ground ginger, she added. The trial participants, mostly ... Read more

Related support groups: Nausea/Vomiting - Chemotherapy Induced

3-Drug Combo Reduces Nausea After Chemo

Posted 11 May 2009 by Drugs.com

MONDAY, May 11 – The addition of the drug casopitant mesylate (CM) to the conventional two-drug regimen of dexamethasone and ondansetron greatly reduces chemotherapy-induced nausea and vomiting (CINV) in patients undergoing highly emetogenic chemotherapy (HEC), a new study concludes. HEC is used to treat many types of solid tumor cancers, including colorectal and pancreatic cancer. Drugs such as dexamethasone and ondansetron are effective in reducing CINV in the first 24 hours after chemotherapy but only provide moderate relief during the delayed phase (24 to 120 hours after chemotherapy). The phase 3 study included 810 patients who were receiving dexamethasone and ondansetron after undergoing HEC. They were randomly selected to also receive either a placebo (269 patients), a single 150-milligram oral dose of CM (271), or three-day intravenous plus oral CM (90-mg intravenous on the ... Read more

Related support groups: Nausea/Vomiting - Chemotherapy Induced

New Drug May Work Better Against Chemo Side Effects

Posted 8 Jan 2009 by Drugs.com

THURSDAY, Jan. 8 – A drug that better prevents the nausea and vomiting that commonly follows chemotherapy treatment for cancer may be on the horizon, Japanese researchers report. Studies headed by a doctor at Juntendo University Hospital in Tokyo found that palonosetron was not only as effective as the common anti-nausea drug granisetron at avoiding the sickening side effects in the first 24 hours after chemo, but is even better at preventing those side effects in the first five days. In the phase III trial, about three-fourths of the people given either drug (both given in combination with dexamethasone) did not experience nausea and vomiting in the 24 hours immediately after receiving a chemotherapy regimen that included drugs most likely to cause vomiting – cisplatin or a combination of anthracycline and cyclophosphamide, according to the study. However, nearly 57 percent of those ... Read more

Related support groups: Nausea/Vomiting - Chemotherapy Induced

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gabapentin, Ativan, lorazepam, dexamethasone, Zofran, Reglan, olanzapine, ondansetron, Marinol, view more... metoclopramide, Decadron, Cesamet, dronabinol, nabilone, Emend, Kytril, Zofran ODT, Anzemet, Adrenocot, Aloxi, Sancuso, Emend for Injection, Maxolon, Dexpak Taperpak, Dexacorten, Medidex, Medidex LA, Emend 3-Day, Baycadron, Primethasone, Zuplenz, Lorazepam Intensol, Decaject, Dexamethasone Intensol, Dalalone, Granisol, Decadron-LA, Hexadrol, aprepitant, fosaprepitant, palonosetron, dolasetron, granisetron, Solurex LA, Dexacen-4, Dexasone LA, Dexone, Dexasone, Dexacort-LA, Solurex, De-Sone LA, Dexone LA