Zofran – patterns of use – pro

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Ondansetron (Zofran) had been FDA approved for two decades and highly effective for nausea and vomiting. It is indicated for:
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m2.
Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
Prevention of postoperative nausea and/or vomiting.

Because of its expense (greater than $100/dose), for many years it was only used for patients undergoing cancer chemotherapy or after surgical procedures. As the cost dropped (now under a $1 a dose), it is came to be used in many hospital and outpatient settings. A growing area of use is empiric use in nursing homes. The drug is so effective, that some physicians consider using it as needed less morbid that performing a workup to determine the etiology of nausea in these patients.

This strategy needs more data to be considered well supported. Zofran is not a completely innocuous drug.  The U.S. Food and Drug Administration (FDA) recently informed 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. Consequenlty, GlaxoSmithKline (GSK) has announced changes to the Zofran drug label to remove the 32 mg single intravenous dose. While the 8 mg dose is presumably free of this complication, one remains uncomfortable about empiric use of Zofran in  any clinical situation and such a strategy needs to be validated with clinical trials.

Several other uses have been preliminarily explored. During the past decade ondansetron has been increasingly used in the United States for Nausea and Vomiting of Pregnancy (NVP), owing to the lack of a drug indicated by the FDA for this condition; some concern had been voiced about potential increased incidence of cleft palate in the offspring of mothers who took Zofran during pregnancy.  A 2006 double-blind, randomized controlled trial indicated that ondansetron may have value in the treatment of schizophrenia, as an adjunct to haloperidol. Another, albeit small, open-label trial had found ondansetron to be useful in treating antipsychotic-induced tardive dyskinesia in people with schizophrenia. Early studies have also examined ondansetron as a possible treatment for psychosis resulting from advanced Parkinson’s disease. Hewlett and others performed an open label study that suggested that it can decrease symptoms of OCD. Zofran appears to decrease the craving for alcohol, especially in early-onset alcoholics. Researchers at the Stanford University School of Medicine have demonstrated that ondansetron might be useful and effective for treating withdrawal symptoms of opioid addictions. Ondansetron has been useful in irritable bowel syndrome with diarrhea (IBS-D). Two small, placebo-controlled trials showed that ondansetron was found to be as effective as pethidine (meperidine, Demerol) to decrease post-anethsia shivering, when given prior to anesthesia.

In early January of 2012, the Food and Drug Administration approved the first generic versions of Zofran (Ondansetron) Tablets, Orally Disintegrating Tablets and Oral Solution which are indicated to prevent nausea and vomiting associated with surgery, radiotherapy and cancer chemotehrapy. This si a part of the FDA initiative to reduce drug costs by expediting approvals of generics. The indication is narrower than that of brand Zofran, which also includes  postoperative nausea.

Several alternatives exist for opioid induced nausea(OINV). , although currently there are no drugs specifically approved for opioid induced nausea. They include the less expensive compazine and metocopropamide and others. A recent guidelines says that  the drug of choice for preventing OINV is droperidol.

Several alternatives exist, although currently there are no drugs specifically approved for opioid induced nausea(OINV). They include the less expensive compazine and metocopropamide and others. A recent guideline says that  the drug of choice for preventing OINV is droperidol.
Gómez-Arnau JI, Aguilar JL, Postoperative nausea and vomiting and opioid-induced nausea and vomiting: guidelines for prevention and treatment. Rev Esp Anestesiol Reanim. 2010 Oct;57(8):508-24.

Lohitnavy M, Chaijittiprasert K, Polnok S, Lohitnavy O, Taytiwat P. Bioequivalence study of ondansetron tablet in healthy Thai male volunteers. J Med Assoc Thai. 2002 Jul;85(7):808-13.

Frank Porreca, and Michael H. Ossipov, Nausea and Vomiting Side Effects with Opioid Analgesics during Treatment of Chronic Pain: Mechanisms, Implications, and Management Options PAIN MEDICINE Volume 10 Number 4 • 2009

Salvucci AA, Squire B, Burdick M, et al. Ondansetron is safe and effective for prehospital treatment of nausea and vomiting by paramedics. Prehosp Emerg Care 15(1): 34-8, Jan 2011.

Chu LF, Liang DY, Li X, Sahbaie P, Dʼarcy N, Liao G, Peltz G, David Clark J (February 2009). “From mouse to man: the 5-HT3 receptor modulates physical dependence on opioid narcotics”. Pharmacogenet. Genomics 19 (3): 193–205

Zofran, Prescribing Information, 2012

Zhang ZJ, Kang WH, Li Q, Wang XY, Yao SM, Ma AQ (2006). “Beneficial effects of ondansetron as an adjunct to haloperidol for chronic, treatment-resistant schizophrenia: a double-blind, randomized, placebo-controlled study”. Schizophrenia Research 88 (1–3): 102–10. Zullino DF, Eap CB, Voirol P (2001). “Ondansetron for tardive dyskinesia”. Am J Psychiatry 158 (4): 657–8. .

Sirota P, Mosheva T, Shabtay H, Giladi N, Korczyn AD (2000). “Use of the selective serotonin 3 receptor antagonist ondansetron in the treatment of neuroleptic-induced tardive dyskinesia”. Am J Psychiatry 157 (2): 287–9.

Zoldan J, Friedberg G, Livneh M, Melamed E (1995). “Psychosis in advanced Parkinson’s disease: treatment with ondansetron, a 5-HT3 receptor antagonist”. Neurology 45 (7): 1305–8.

Hewlett WA, Schmid SP, Salomon RM (2003). “Pilot trial of ondansetron in the treatment of 8 patients with obsessive compulsive disorder”. J Clin Psychiatry 64 (9): 1025–30.

Corrêa Filho JM, Baltieri DA. A pilot study of full-dose ondansetron to treat heavy-drinking men withdrawing from alcohol in Brazil. Addict Behav. 2013 Apr;38(4):2044–2051

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