News Briefs: Clinical Practice Updates

This roundup includes the following brief clinical practice updates:

The FDA is requiring manufacturers of products that contain the analgesic propoxyphene, such as the brand-name medications Darvon and Darvocet, to strengthen the products' labels, including their boxed warnings, to emphasize the potential for overdose. The agency said in a July 7 news release that manufacturers also will be required to provide medication guides that stress the importance of using the products as directed.

The FDA said it took this action after receiving data linking propoxyphene, which is a member of the opioid class of drugs, to fatal overdoses. The agency, however, denied a petition from a public interest group requesting a phased withdrawal of propoxyphene, saying the benefits of the medication at recommended doses outweigh safety risks.

The agency also is requiring a new study to assess the effects of propoxyphene on the heart at higher than recommended doses. Other research will look at how often elderly patients are prescribed propoxyphene compared with other pain relievers, as well as at the differences in their respective safety profiles. Findings from the studies could lead to additional regulatory action, FDA officials said.

The FDA is reviewing safety data for insulin glargine, a long-acting insulin analogue marketed as Lantus, after recent study findings raised concerns about a link between use of the product and an increased risk for cancer. However, FDA officials said in a July 1 news release that patients should not stop taking insulin therapy without consulting their physician.

According to the FDA, all four studies that evaluated the product had shorter periods of patient follow-up than generally is considered necessary to evaluate cancer risk from drug exposure. The agency also said inconsistencies in findings among the four studies raise concerns as to whether an association between the use of insulin glargine and cancer truly exists.

In addition to reviewing many sources of safety data for insulin glargine, including the newly published observational studies, data from all completed controlled clinical trials, and information about ongoing controlled clinical trials, FDA officials said discussions are ongoing between the agency and the product's manufacturer, sanofi-aventis, about whether additional studies evaluating the safety and efficacy of this drug are indicated.

FDA officials are not advising physicians to stop prescribing the product, which is approved for use as a once-daily subcutaneous injection. However, the agency encourages physicians and patients to report side effects associated with the use of insulin glargine to MedWatch, the FDA's adverse events reporting program.

The CDC has launched the Environmental Public Health Tracking Network, a Web-based surveillance tool that scientists, health professionals and the public can use to track environmental exposures and chronic health conditions.

According to a July 7 CDC press release, the resource pairs environmental information from across the country, such as levels of air and water pollution, with prevalence information for certain chronic conditions, including asthma, cancer, childhood lead poisoning and heart disease, allowing localized comparisons of the two metrics.

Although it is known that exposure to lead and airborne pollutants contribute to chronic illnesses, many other connections between environmental irritants and health problems have remained unproven because detailed health and environmental data have existed separately until now.

The CDC is funding tracking projects in 16 states and New York City that, to date, have led to 73 public health actions to control potential illnesses from environmental exposures. For example, Massachusetts ranks third in the nation for prevalence of asthma. When the state's public health network tracking staff conducted asthma surveillance and indoor air quality assessments in schools, a significant association between mold and moisture and the prevalence of asthma was found. Based on those data, Massachusetts staff members are working with school officials to correct such problems and to enact policy changes for reducing mold and moisture in schools.

In March, the CDC received funding to expand environmental public health tracking to five more locations. Eventually, the agency hopes to expand the tracking network to all 50 states.

Foodborne illness outbreaks remain an ongoing problem, with the CDC currently investigating multistate Escherichia coli outbreaks linked to cookie dough and beef products.

In response, HHS and the U.S. Department of Agriculture, or USDA, announced July 7 that the two agencies are taking several actions based on key findings of the Food Safety Working Group established in March.

The working group, which comprises the FDA, the Food Safety and Inspection Service, the CDC, the Department of Homeland Security, the Department of Commerce, the Department of State, the Environmental Protection Agency, and several offices of the White House, called for the following specific steps:

Other findings and recommendations from the Food Safety Working Group can be viewed online.