News in brief - June 16, 2003

Counterfeit Lipitor alert - Season's first human West Nile cases reported - AMA questions health claims on food labels - Birthing matters: When a car becomes a "family" car - IOM recommends CDC halt smallpox vaccination program

Counterfeit Lipitor alert

The Food and Drug Administration has ordered the recall of three lots of 90-count bottles labeled as containing the cholesterol-lowering drug Lipitor. The bottles, about 100,000 of them, contain counterfeit pills that pose a significant health risk to consumers.

The bottles repackaged by Med-Pro Inc. of Lexington, Neb., have Med-Pro information in the lower left-hand corner of the label on affected bottles, said the FDA.

The following lots were recalled:

20722V, expiration 09-2004;
04132V, expiration 01-2004;
16942V, expiration 09-2004.

The FDA is urging any patients who have the identified medication to return it to their pharmacies.

Season's first human West Nile cases reported

The Louisiana Dept. of Health and Hospitals and the Washington State Dept. of Health are investigating the year's first suspected human cases of West Nile virus. Louisiana is investigating two cases in the northern part of the state. Confirmation of the possible case in Washington is expected this month.

Many states have noted numerous cases in bird and horse populations over the past few months. "We've been preparing for West Nile virus in our state for some time, and we're not surprised to have a suspected human case," said Washington Health Officer Maxine Hayes, MD, MPH. "This is a reminder that mosquito season is here and we should all take precautions to avoid mosquito bites."

AMA questions health claims on food labels

The AMA is opposing the Food and Drug Administration's intention to allow "qualified" health claims on the labels of conventional foods.

In a May 23 letter to the FDA, the AMA said that, while the FDA's goal of improving American diets is a worthy one, consumer confusion is likely to result if the nation's food industry is allowed to place nutritional labels on food without stringent scientific evidence to back claims. The letter was in response to the FDA's Guidance for Industry published in December 2002 by the FDA's Task Force on Consumer Health Information for Better Nutrition.

The AMA also took the opportunity to continue to express concerns about the quality, safety and efficacy of dietary supplements, especially herbal products. The Association urged the FDA to aggressively regulate these products to protect the public health.

Birthing matters: When a car becomes a "family" car

Approximately one in 300 women give birth in a car on the way to the hospital, according to the results of a telephone survey by Jiffy Lube International released last month. Researchers at the market research firm Ipsos-Insight interviewed 1,000 adults nationwide, finding that one-third of 1% have given birth in a motor vehicle. That rate was slightly higher in large metropolitan areas.

Experts suggested that heavy traffic, bad weather and poor planning may result in expectant mothers not getting to the hospital in time.

The survey also found that 15% of women drive themselves to the hospital before giving birth. Experts advise against this because hormonal changes may make driving unsafe.

IOM recommends CDC halt smallpox vaccination program

The Institute of Medicine would like the Centers for Disease Control and Prevention to stop and assess its smallpox vaccination program before expanding it, according to an IOM report issued last month.

"A break ... may help prevent vaccinating potentially large numbers of additional volunteers less safely than in the first phase of vaccinations," wrote an IOM expert panel. Nearly 37,000 civilian first responders have received the vaccine as of the end of May in phase 1 of the program. Some states have already initiated phase II, which will provide vaccinations to police, fire and other emergency personnel.

The IOM's Board of Health Promotion and Disease Prevention suggested, however, that there needed to be time before the number of people vaccinated greatly expanded to fully study the data produced by phase 1. The committee would also like to see states assess other aspects of their preparedness for a smallpox outbreak.

The report also found that public health's extensive and cautious screening program prevented many of the expected adverse events. Several dozen adverse events have been linked to the vaccine, although no deaths have been definitively linked to it.