Drug News
Two children died after surgery and IV solution problems
ISMP warns hospitals to educate staff
Two young children recently died from severe postoperative hyponatremia, says the Institute for Safe Medication Practices (ISMP) in a health care warning to providers in August, 2009.
The tragedies underline the need for greater education about the causes, signs, and symptoms of low sodium levels, ISMP says in the ISMP Medication Safety Alert! newsletter, which is available on-line at: www.ismp.org/Newsletters/acutecare/articles/20090813.asp.
In one case the child had an outpatient tonsillectomy and received an IV infusion of plain dextrose in water at a rate that was too high. The child vomited and had seizures that were assumed to be a reaction to an anti-nausea drug, ISMP reports.
The child's lab levels showed critically low sodium levels, but by the time treatment was administered, the child had cerebral edema and eventually died, ISMP says.
In another case, a child had vascular surgery and didn't receive enough sodium in IV fluids postoperatively. When the child became hard to awaken and exhibited seizures, the symptoms were attributed to sleepiness and fidgeting from pain, ISMP reports.
A critical care intensivist recognized the problem, but despite treatment, the child died the next day, the institute adds.
ISMP's recommendations are as follows:
- Hospitals should establish standards of practice for postoperative IV solutions used to hydrate patients, especially children.
- Standards should state that administration of saline in maintenance parenteral fluids is the most important preventive measure to prevent hyponatremia.
- Criteria should include when lab studies need to be drawn to determine electrolyte levels in patients receiving post-op IV fluids over an extended period of time.
- Protocols should be established to identify, treat, and monitor patients with hyponatremia and related conditions.
- Hyponatremia should be included in differential diagnoses for patients presenting with early symptoms.
- All physicians, nurses, and pharmacists need to be educated on fluid and electrolyte balance and the pathophysiology of hyponatremia.
- All hospitals should consider establishing a rapid response team that allows anyone to summon an interdisciplinary team to patient's bedside for full evaluation when they fear something is seriously wrong with the patient.
Flu patient died after treatment with zanamivir inhalation powder
GlaxoSmithKline of Philadelphia, PA, issued a "Dear Healthcare Provider" letter on Oct. 8, 2009, reporting the death of an influenza patient who had received zanamivir (Relenza®) inhalation powder that was solubilized and administered by mechanical ventilation.
GSK advised that health care providers do not reconstitute zanamivir in any liquid formulation or use it in any nebulizer or mechanical ventilator. Zanamivir for nebulization has not been approved by the FDA, and a safety and effectiveness profile for its use by nebulization has not been established, the letter says.
When used incorrectly, there is a risk the lactose sugar in the medication's formulation will obstruct proper functioning of mechanical ventilator equipment, the letter says.
FDA approves pazopanib for treating kidney cancer
The FDA approved pazopanib (Votrient®) for treatment of kidney cancer in October, 2009.
The sixth drug approved for treating kidney cancer since 2005, pazopanib is intended for treatment of advanced renal cell carcinoma. It is an oral medication that interferes with angiogenesis, the FDA reports.
Adverse reactions to pazopanib include heart rhythm irregularities, diarrhea, high blood pressure, hair color changes, nausea, loss of appetite, vomiting, fatigue, abdominal pain, headache, and weakness. The drug also can cause severe and fatal liver toxicity, according to the FDA.
Patients taking pazopanib should be monitored with blood tests to check liver function before and during treatment. Also, patients receiving the drug need to be monitored with periodic electrocardiograms and blood tests to monitor electrolytes, the FDA advises.
Ketorolac tromethamine injection recalled
On Oct. 16, 2009, American Regent of Shirley, NY, voluntarily recalled the 30 mg/mL Ketorolac Tromethamine Injection® due to a potential for particulate matter in conjunction with crystallization causing obstruction of blood vessels and leading to pulmonary emboli or thrombosis.
The medication also might activate platelets and/or neutrophilis to induce anaphylactic reactions, the FDA and American Regent news release report.
The product was distributed nationwide. All hospitals, surgical centers, clinics, and other facilities that have the USP Injection 30 mg/mL in stock should immediately quarantine the product and return it to American Regent, the company says.
The recall does not affect any other strength of Ketorolac Tromethamine Injection.
Questions about the recall are directed to American Regent at (800) 645-1706 or (631) 924-4000.
Two young children recently died from severe postoperative hyponatremia, says the Institute for Safe Medication Practices (ISMP) in a health care warning to providers in August, 2009.Subscribe Now for Access
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