News in brief - Oct. 23/30, 2006

FDA warns about combining antidepressants, migraine meds - Value of low cholesterol questioned - Can FDA ensure drug safety? - Bacterial threat posed by C. diff - HPV vaccine partnership launched

FDA warns about combining antidepressants, migraine meds

Patients who take a triptan drug along with either a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor are at risk for developing serotonin syndrome, according to a warning from the Food and Drug Administration published this month in Patient Safety News. A MedWatch safety alert was issued in July.

About 20% of patients prescribed a triptan may also be taking these types of antidepressants, the FDA said.

The FDA is asking physicians to discuss the possibility of serotonin syndrome and follow closely those patients who regularly take both of these drugs, particularly when the regimen is being initiated or changed. Patients should be advised to seek medical attention if they experience symptoms of this adverse event.

Value of low cholesterol questioned

The National Cholesterol Education Program recommends physicians attempt to lower the LDL cholesterol of patients at very high risk of heart disease to less than 70 mg/dL. Still, little evidence shows that these efforts, which usually require several different types of drugs, translate into reductions in cardiovascular disease, according to a review in the October Annals of Internal Medicine. The authors did say, however, that evidence is ample to recommend statins for this patient population.

"Current practice guidelines and recommendations often focus on getting LDL as low as possible, but the literature to date doesn't demonstrate that low LDL is what is truly important," said Rodney Hayward, MD, lead author and director of the VA Center for Health Services Research and Development in Ann Arbor, Mich. "But it does show that statins save lives in high cardiac risk patients regardless of a person's LDL level."

The authors are calling for large-scale clinical trials investigating the safety and efficacy of multidrug therapy commonly used to reach these targets. Meanwhile, they recommend that high-risk patients be prescribed the highest doses of statin drugs they can tolerate, regardless of LDL levels.

Can FDA ensure drug safety?

A new analysis of the Food and Drug Administration's capabilities as the nation's drug safety watchdog uncovered numerous problems and urged Congress to step in to provide the agency additional funding and to provide oversight to make sure that changes are made.

The new findings were published in the Oct. 9 Archives of Internal Medicine by five current and former members of the FDA's Drug Safety and Risk Management Advisory Committee. It followed a Sept. 26 report by the Institute of Medicine that also found fault with the agency's ability to approve and monitor drugs for safety.

"Congress has not provided adequate funding and authority to the FDA," said lead author Curt D. Furberg, MD, PhD, professor of public health sciences at Wake Forest University School of Medicine in North Carolina.

Among the problems cited in the Archives analysis: an initial agency approval process that often fails to detect serious adverse drug reactions; the existence of a possible conflict-of-interest situation resulting from the same FDA center that approves drugs having responsibility for taking safety actions; and the FDA's dependence on user fees from drug companies.

Bacterial threat posed by C. diff

Clostridium difficile is making its way from the hospital into the community, according to several presentations scheduled for the Infectious Diseases Society of America's annual meeting in Toronto, Oct. 12-15.

One study describes a community outbreak in Philadelphia among six healthy women, ages 18 to 47. Three of the women were pregnant and all had taken antibiotics in recent months. Another study found that hospitalized patients infected with the bacteria responded better to treatment with vancomycin rather than the typical first-line treatment, metronidazole.

In addition, a dangerous new strain of C. diff was recently identified in Ontario, leading the U.S. Centers for Disease Control and Prevention to recommend that people with severe diarrhea that lasts longer than three days seek medical help.

HPV vaccine partnership launched

Groups from across the health care spectrum last month kicked off the Partnership to End Cervical Cancer, an effort designed to press for the inclusion of the newly approved human papillomavirus vaccine in routine preventive health care for women.

The more than 20 member organizations, which include the American College of Obstetricians and Gynecologists, American Medical Women's Assn., National Medical Assn. and Partnership for Prevention, have formed four committees to address the major policy and public health challenges involved in helping patients gain access to the vaccine.

These committees are: an education panel, which will be tasked with increasing awareness among women regarding cervical cancer's cause and prevention options; an access/coverage committee, which will focus on educating policy-makers; a medical home committee, which will develop and implement recommendations to medical practice guidelines that include routine screening and vaccination; and a health disparities panel, which will be dedicated to ensuring equal opportunity to receive the HPV vaccine.

Cervical cancer, caused by persistent infection with oncogenic HPV is the second most prevalent cancer among women today, taking the lives of more than 270,000 women worldwide every year.