Health Highlights: March 19, 2008

On Tuesday, the FDA said it issued an approvable letter for ceftobiprole, which means the agency wants more time to inspect study locations and review data. It's not clear whether new studies will have to be conducted or how long the extended review will take,Bloomberg Newsreported.

The drug, developed by Johnson & Johnson and Basilea Pharmaceutica AG, has also been submitted for approval in Europe, Canada and Switzerland.

Ceftobiprole is among a number of new antibiotics being developed to fight MRSA, which sickens about two million Americans a year and costs about $20 billion a year to treat,Bloombergreported. MRSA causes nearly two-thirds of all skin infections in emergency rooms. About one in 20 patients hospitalized with MRSA dies, according to the U.S. Agency for Healthcare Research and Quality.

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FDA Cautions on COPD Inhaler and Stroke Risk

The U.S. Food and Drug Administration cautioned Tuesday that a respiratory inhaler used for chronic obstructive pulmonary disease may heighten the risk for stroke.

The agency said that German drug maker Boehringer Ingelheim, which manufactures Spiriva HandiHaler, reported that ongoing safety monitoring identified a possible increased risk of stroke in patients who take the medicine.

The inhaler contains tiotropium bromide and is used to treat bronchospasm associated with COPD, the FDA said in a prepared statement, adding that additional information is needed to further evaluate this preliminary information.

Boehringer Ingelheim reported that it has conducted an analysis of the safety data from 29 placebo-controlled clinical studies involving 13,500 patients with COPD, the FDA said. In 25 of the clinical studies, patients were treated with Spiriva HandiHaler, which is a once-daily, long-term maintenance medicine. In the other four, patients were treated with another formulation of tiotropium approved in Europe, Spiriva Respimat.

Based on data from these studies, the FDA statement said, the preliminary estimates of the risk of stroke were eight patients per 1,000 patients treated for one year with Spiriva, and six patients per 1,000 patients treated for one year with a placebo. That translates to an estimated excess risk of any type of stroke due to Spiriva to two patients for each 1,000 patients using Spiriva over a one-year period.

The FDA said it was working with the drug maker to evaluate the potential link, and it cautioned patients using Spiriva to not stop using the medication without talking to their doctors.

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Stress Common Among U.S. College Students: Survey

Stress is a major problem for many U.S. college students, according to a survey that included 2,253 undergraduate students, ages 18-24, at 40 schools nationwide.

Four in 10 students said they were stressed often, nearly 20 percent said they felt stress all the time, one in five said they had felt too stressed to be with friends or do homework, and about the same number said things had been so bad in the past three months that they had given serious consideration to dropping out of school, the survey found.

The poll was conducted for theAssociated PressandmtvU, a television network available at many colleges and universities.

Among the other findings:

Many students said they had symptoms such as: difficulty concentrating, sleeping and being motivated; agitation; worry; being too tired to work; eating problems; and feeling lonely and depressed.About one in six said they had friends in the past year who had discussed committing suicide, and about one in 10 respondents said they had seriously considered suicide themselves.Primary sources of stress included school work and grades, financial problems, relationships and dating, family problems, and extracurricular activities.Women were more likely than men to feel stressed -- 45 percent vs. 34 percent.White students reported more stress than black and Hispanic students.About 26 percent of students said they considered talking to a counselor or getting other professional help, but only 15 percent said they actually did so.