News in brief - July 24/31, 2006

Flu vaccine maker gets FDA warning letter - Taking pills regularly, even placebos, improves health - FDA gives warning on antibiotic Ketek - Effective treatment for hot flashes - High-pressure water can cause injury

Flu vaccine maker gets FDA warning letter

The Food and Drug Administration issued a warning letter to Sanofi Pasteur, one of the manufacturers of influenza vaccine, because of sterility problems reported by the company to the government agency. Regulators do not believe, however, that this development will affect flu shot supplies in the fall.

"The deficiencies noted ... are not expected to significantly affect the availability of [influenza vaccine] for the 2006-2007 flu season, but we continue to review the progress made by the company," read an FDA statement issued earlier this month.

Sanofi contacted the FDA in March because of problems with its monovalent concentrates, one of the vaccine's key ingredients. The company's plant in Swiftwater, Pa., was inspected in April, and the agency found that procedures designed to prevent contamination were not always followed.

According to a statement issued by the company, Sanofi has addressed most of the agency's concerns and is working to resolve the remaining ones. The contaminated substance has been destroyed, and Sanofi is still on track to produce at least 50 million flu shots.

Taking pills regularly, even placebos, improves health

Patients who adhere to their medication regimens, even if they are taking only placebos, have a lower risk of death than those who are not as compliant, according to a study published in the British Medical Journal this month.

Researchers at the University of Alberta in Edmonton, Canada, carried out a meta-analysis on studies that reported patient mortality in relationship to how adherent they were to taking recommended drugs. Compliant patients nearly halved their risk of death, and the authors theorize that drug adherence could be a surrogate marker for an overall healthy lifestyle. An accompanying editorial also suggested that people who take their medication might experience healing because the action makes them feel cared for either by themselves or others.

"Patients' adherence to treatments would show that they were caring for themselves while their clinical encounters would reinforce that their doctors were caring for them," wrote Betty Chewning, PhD, director of the Sonderegger Research Institute at the University of Wisconsin, Madison.

FDA gives warning on antibiotic Ketek

The Food and Drug Administration issued an advisory June 29 to alert physicians and patients to the occurrence of rare but potentially hazardous liver injuries from the drug, Ketek, the first approved antibiotic of the ketolide class.

On the market since 2004, Ketek is used to treat acute exacerbation of chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia of mild to moderate severity, including pneumonia caused by resistant strep infections.

The drug has been associated with rare cases of serious liver injury and liver failure resulting in at least four deaths and one liver transplant.

After a safety assessment, the agency concluded that Ketek's benefit to patients outweighs its risks and supported its continued availability.

Patients who experience signs or symptoms of liver problems, including fatigue, malaise, loss of appetite, nausea, yellow skin and dark-colored urine should discontinue the drug and seek medical evaluation, which could include tests for liver function, said Steven Galson, MD, director of FDA's Center for Drug Evaluation and Research.

The warning is being added to the drug's label.

Effective treatment for hot flashes

The drug gabapentin -- marketed as Neurontin -- appeared to be as effective as estrogen in helping to tame hot flashes in postmenopausal women, according to a study published in the July Obstetrics and Gynecology.

University of Rochester (N.Y.) researchers compared the effectiveness of gabapentin and estrogen with a placebo in a 12-week, randomized, double-blind trial with 60 female participants. The women recorded the frequency and severity of their hot flashes in diaries.

"Gabapentin does appear to be as effective as estrogen," said lead author Sireesha Y. Reddy, MD, assistant professor of obstetrics and gynecology at the University of Rochester Medical Center. "Until now its efficacy relative to estrogen was unknown."

Estrogen had been the gold standard treatment for vasomotor symptoms but fell from favor when early results of the Women's Health Initiative in 2002 showed that the hormone posed an increased risk for heart attacks, strokes and breast cancer.

The women taking gabapentin and estrogen reported a 71% to 72% reduction in hot flashes over the course of the study.

Those taking the placebo also reported a decrease in hot flashes, although it was only a 54% reduction.

Gabapentin was approved by the Food and Drug Administration in 1994 to treat epileptic seizures but has been used off-label to treat headaches, shingles pain and other ailments. Scientists hypothesize that the drug may reduce hot flashes by regulating the flow of calcium in and out of cells, which is one mechanism for controlling body temperatures.

High-pressure water can cause injury

The strong spray from a pressure washer can cause serious wounds that might, at first, appear to be minor, according to a new fact sheet from the Centers for Disease Control and Prevention.

The use of high-pressure water to clean debris in flood-damaged areas has become more common in recent years, said the CDC, and the potential for serious injury also increases as these machines often emit streams of water at more than 100 pounds of pressure per square inch.

The agency recommends that the injured area be x-rayed to check for the presence of subcutaneous air or a foreign body, a tetanus vaccination and antibiotics be administered and the patient referred to a surgeon for possible wound debridement.