Metoclopramide News and Research

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Despite FDA black box warning, prescription of Reglan for premature infants continue

Recently, researchers have observed a disturbing trend in neonatal units across the country: doctors prescribing Reglan -- also known by its generic name, metoclopramide -- to treat premature infants. This alarming development has raised serious concerns from many consumer safety advocates, particularly because the drug was never approved for use in infants.

4 May 2010

Implementation of quality improvement intervention reduces medication use in premature babies: Study

A new study by Pediatrix Medical Group researchers has found that the implementation of a quality improvement intervention significantly reduces the use of a large number of medications in premature babies across a broad neonatal intensive care network.

3 May 2010

Salix Pharmaceuticals receives FDA complete response letter for GIAZO Tablets NDA

Salix Pharmaceuticals, Ltd. today announced the Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for GIAZO™ (balsalazide disodium) Tablets 1.1 g. for the treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older.

29 Apr 2010

Salix Pharmaceuticals announces novel patient and health care provider support program for HE

Salix Pharmaceuticals, Ltd. today announced plans for the Hepatic Encephalopathy Living Program (H.E.L.P.). H.E.L.P. is a first-of-its-kind patient and health care provider support program for the management of hepatic encephalopathy (HE) and will launch on May 24, 2010. The program will provide patients with HE educational materials, co-pay assistance, treatment adherence support and a 24-hour toll-free hotline.

27 Apr 2010

DDW2010 Investor Event to provide update on TARGET 1 and TARGET 2 Phase 3 trials

Salix Pharmaceuticals, Ltd. today announced that the Company will host a DDW2010 Investor Event on Monday, May 3 2010 from 9:00 p.m. to 10:00 p.m. Central Time (10:00 p.m. to 11:00 p.m. ET).

22 Apr 2010

52% migraine sufferers found relief from headache with Aspirin: review

Nearly 9 million people in UK suffer from debilitating headaches called migraine and this leads to a severe impairment in quality of life and affects productivity. The headaches associated with an attack may last for several days often bringing nausea and a general feeling of uneasiness in presence of lights and sounds.

15 Apr 2010

Aspirin can reduce acute migraine attacks

A single dose of 900-1000 mg aspirin can substantially reduce migraine headache pain within two hours, for more than half of people who take it. It also reduces any associated nausea, vomiting, and sensitivity to light or sound (photophobia or phonophobia).

15 Apr 2010

NASDAQ halts trading of Salix Pharmaceuticals stock, FDA Committee to discuss XIFAXAN NDA

Salix Pharmaceuticals, Ltd. today announced that NASDAQ has halted trading of the Company’s common stock this morning. The Gastrointestinal Drugs Advisory Committee of the FDA is meeting today to discuss the efficacy and safety of the New Drug Application (NDA) for XIFAXAN® (rifaximin) Tablets, 550 mg for the maintenance of remission of hepatic encephalopathy.

23 Feb 2010

METOZOLV drug approved for treating gastroesophageal reflux disease

Wilmington Pharmaceuticals announced today the U.S. Food and Drug Administration (FDA) has granted marketing approval for METOZOLV ODT (metoclopramide HCl), an orally disintegrating formulation of metoclopramide for the treatment of gastroesophageal reflux disease (GERD) and diabetic gastroparesis.

10 Sep 2009

FDA approves Salix' METOZOLV ODT for treating diabetic gastroparesis

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the U.S. Food and Drug Administration (FDA) has granted marketing approval for METOZOLV™ ODT (metoclopramide HCl) 5mg and 10mg orally disintegrating tablets. METOZOLV ODT is indicated for the relief of symptoms in adults associated with acute and recurrent diabetic gastroparesis and for the treatment of short-term therapy (4-12 weeks) for adults with symptomatic documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy1.

9 Sep 2009

Metoclopramide versus droperidol for extreme nausea, vomiting during pregnancy

Nausea and vomiting are telltale indicators of pregnancy, affecting more than 80 percent of future mothers. For a few moms-to-be, symptoms can become so severe that hospitalization is required.

6 May 2009

FDA requires boxed warning and risk mitigation strategy for metoclopramide-containing drugs

The U.S. Food and Drug Administration announced today that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use.

1 Mar 2009

Drugs given to stop nausea and vomiting after surgery help only a few people

Between 10 - 28% of people benefit from taking an anti-emetic drug to prevent nausea or vomiting after surgery - this means that if everyone was given the drug the majority of patients would be exposed to the risk of side-effects without gaining any benefit.

19 Jul 2006

Drugs for preventing postoperative nausea and vomiting

Patients coming out of anesthesia after surgery may experience nausea or vomiting, and are frequently given drugs to prevent this. But the majority of patients won't benefit from these drugs, according to a large new review of studies.