Ondansetrona: Não use mais que 16 mg!

FDA: Single Dose of IV Ondansetron Should Not Exceed 16 mg Due to Risk of QT Prolongation Tags: Arrhythmias ondansetron Pain Management ROCKVILLE, Md -- June 29, 2012 --

The US 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) may cause QT interval prolongation, which could pre-dispose patients to develop 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 3 doses; however, no single intravenous dose should exceed 16 mg. Information from the new clinical study will be included in the updated drug label.

The FDA will evaluate the final study results when available, and will work with GSK to explore an alternative single dose regimen that is both safe and effective for the prevention of chemotherapy-induced nausea and vomiting in adults. The new information on QT prolongation does not change any of the recommended oral dosing regimens for ondansetron. It also does not change the recommended lower dose intravenous dosing of ondansetron to prevent post-operative nausea and vomiting. As part of the ongoing safety review of ondansetron, the FDA continues to assess data about the risk of QT prolongation and will update the public when more information becomes available. Additional Information for Healthcare Professionals (updated from 9/15/2011)· ECG changes including QT interval prolongation have been observed in patients receiving ondansetron. In addition, Torsade de Pointes has been reported in some patients receiving ondansetron.

 - The use of a single 32-mg intravenous dose of ondansetron should be avoided. New information indicates that QT prolongation occurs in a dose-dependent manner, and specifically at a single intravenous dose of 32 mg.

 - Patients who may be at particular risk for QT prolongation with ondansentron are those with congenital long QT syndrome, congestive heart failure, bradyarrhythmias, or patients taking concomitant medications that prolong the QT interval - Electrolyte abnormalities should be corrected prior to the infusion of ondansetron.

- The lower dose intravenous regimen of 0.15 mg/kg every 4 hours for 3 doses may be used in adults with chemotherapy-induced nausea and vomiting. However, no single intravenous dose of ondansetron should exceed 16 mg due to the risk of QT prolongation.

- The new information does not change any of the recommended oral dosing regimens for ondansetron, including the single oral dose of 24 mg for chemotherapy induced nausea and vomiting.

- The new information also does not change the recommended lower dose intravenous dosing to prevent post-operative nausea and vomiting.

SOURCE: US Food and Drug Administration

Limite de prescrição de Acetominofen nos EUA

Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit: Drug Safety Communication

Thursday, January 13, 2011

ISSUE: FDA notified healthcare professionals that it has asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, predominantly combinations of acetaminophen and opioids, to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients. This action will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen. A Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) will be added to the label of all prescription drug products that contain acetaminophen.

BACKGROUND: Acetaminophen, one of the most commonly used drugs in the United States, is widely and effectively used in both prescription and over-the-counter (OTC) products to reduce pain and fever. Examples of prescription products that contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet). OTC products containing acetaminophen (e.g., Tylenol) are not affected by this action. Information about the potential for liver injury is already required on the label for OTC products containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk of acetaminophen related liver injury from OTC products. No drug shortages are expected, because the 3-year implementation period should permit adequate time for necessary reformulations.

RECOMMENDATION: Healthcare professionals were reminded to advise patients not to exceed the acetaminophen maximum total daily dose (4 grams/day), and not to drink alcohol while taking acetaminophen-containing medications.

Healthcare professionals were encouraged to inform patients that there is no immediate danger to patients who take these combination pain medications, and patients should continue to take them as directed by their health care provider. The Drug Safety Communication provides additional information for healthcare professionals, information for patients, a data summary and a list of all affected products. 

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