News in Brief: Week of Sept. 19-23

September 21, 2011 07:05 pm News Staff

This roundup includes the following news briefs:

Abnormal Heart Rhythm Risk Prompts Anti-nausea Drug Label Changes

The FDA is notifying(www.fda.gov) health care professionals that an ongoing safety review of the anti-nausea medication ondansetron hydrochloride (and ondansetron base), which is marketed as Zofran and in generic form, has prompted a label change warning clinicians and patients about the drug's potential adverse cardiac effects.

Specifically, ondansetron may increase patients' risk of developing prolongation of the QT interval that can lead to development of torsades de pointes, a potentially fatal abnormal heart rhythm. Patients at particular risk for developing this abnormal rhythm include those with underlying heart conditions, such as congenital long QT syndrome; those who are predisposed to hypokalemia or hypomagnesemia; and those taking other medications that can cause QT prolongation.

According to the FDA, the label change will warn physicians to avoid use of ondansetron in patients with congenital long QT syndrome. In addition, the revised label will include recommendations for electrocardiographic monitoring of patients using the drug who have electrolyte abnormalities, such as hypokalemia or hypomagnesemia, congestive heart failure or bradyarrhythmias, as well as those who are taking other medications that can prolong the QT interval.

Ondansetron, which is a 5-HT3 receptor antagonist, is indicated to prevent postoperative nausea and vomiting, as well as that caused by cancer chemotherapy or radiation therapy. FDA officials have directed Zofran's manufacturer, GlaxoSmithKline, to conduct comprehensive research to determine the degree to which the drug may provoke QT prolongation.

Health care professionals and patients are encouraged to report adverse effects associated with use of ondansetron to the FDA's MedWatch Safety Information and Adverse Event Reporting Program(www.accessdata.fda.gov).

Health Care Costs Derail Income Gains, Study Says

Rising health care costs have left families with diminishing incomes while adding to the federal budget deficit, says a study(content.healthaffairs.org) (abstract) published in the September Health Affairs.

The average American family of four experienced an annual increase in income from $76,000 to $99,000 from 1999 to 2009. But nearly all of these income gains were erased by higher health care spending, according to the study. The typical median-income family of four with employer-based health insurance would have pocketed $545 more per month in 2009 compared to 1999 if medical inflation had not outstripped general inflation. When actual increases in health insurance premiums, out-of-pocket health spending and taxes for health care are taken into consideration, that same family had only $495 more per month in available income, the study authors say.

HHS Grants Intended to Help States Fight 'Unreasonable' Premium Rate Increases

HHS has awarded grants(www.healthcare.gov) of $109 million to 28 states and the District of Columbia to help combat premium rate increases that are considered "unreasonable." The agency also released a new report, "Rate Review Works(www.healthcare.gov)", detailing how previous rate review grants are being used to fight premium hikes.

According to the Patient Protection and Affordable Care Act, health insurers wanting to increase their rates by 10 percent or more in the individual and small group market are required to submit their requests to experts to determine whether the rate increases are unreasonable. The Affordable Care Act also requires insurance companies to publicly justify unreasonable premium rate increases.

The newly awarded grants will help states review proposed health insurance rates and hold insurance companies accountable for disclosing information about unjustified rate increases, according to HHS.


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