Diabetes Drug Candidate Appears Safe: FDA
A potentially important diabetes medication called Onglyza appears to be free from heart-related side effects seen in similar treatments, according to U.S. Food and Drug Administration briefing documents posted online.
An FDA panel of outside experts will meet Wednesday to review safety data on the drug, the Associated Press reported. The panel will then make a recommendation on whether the drug should be approved for use in the United States.
The FDA, which generally follows the advice of its expert panels, could make a decision about Onglyza by the end of April.
Bristol-Myers Squibb and partner AstraZeneca are seeking approval to market Onglyza to reduce blood sugar levels in patients with type 2 diabetes, the APreported.
Studies conducted by the companies indicate the level of heart attacks, deaths and other cardiovascular problems appeared well within new FDA safety limits, the agency said in the briefing documents.
-----
U.S. Task Force Urges Docs to Screen for Depression in Teens
Primary care doctors should routinely screen adolescents, ages 12 to 18, for major depression, says the U.S. Preventive Services Task Force. The benefits of screening outweigh any risks if doctors can assure accurate diagnosis, treatment and follow-up, according to the task force.
That's a change from 2002, when the task force concluded there wasn't sufficient evidence to recommend or oppose screening for adolescents. The task force said there's still not enough evidence to make a recommendation about depression screening for children ages 7 to 11, USA Today reported.
In an article in the journal Pediatrics, the task force noted that questionnaires can accurately identify depression in adolescents, and that there's new evidence that therapy and/or some antidepressants can help depressed teens. They emphasized the need for careful monitoring, because it's been shown that antidepressants can increase suicidal behavior in teens.
About 1 in 20 teens suffers depression, which is associated with lower grades, more physical illness, increased drug use, and early pregnancy, USA Todayreported.
-----
Triathlons Can Pose Deadly Heart Risks for the Unprepared: Study
Triathletes take note: A new study finds that participants in these swim-bike-run athletic events face at least twice the risk of sudden death as marathoners do, theAssociated Press reported. And, it's the swimming section of the race that's the riskiest.
About 1,000 triathlons are held each year, and several hundred thousand Americans try one, often without adequate preparation or check-up to see if they have any hidden physical problems, the study suggested. "It's something someone just signs up to do," often without proper training or a medical checkup to rule out heart problems, Dr. Kevin Harris, lead author and a cardiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital, told the AP. Harris presented his study over the weekend at the American College of Cardiology annual meeting in Orlando, Fla.
While the risk for sudden death is low -- about 15 out of a million participants, according to Harris, -- it's not inconsequential because of the numbers of people who take part in triathlons. Stress and cold water for the swimming section -- often the first of the three events in the competitions -- can constrict blood vessels and make the heart work harder or aggravate pre-existing problems, Harris told the AP.
Doctors offered these tips for would-be triathletes, the AP said:
- Get a checkup to make sure you don't have any hidden heart problems.
- Start training long before the event and include open-water swims, not just laps in a pool. Acclimate to the water temperature before a race and wear a wetsuit if the water is too cold.
- Check that race officials have medical staff and defibrillators on site.