Word: laughren
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...warning warranted? Not at this point, says Dr. Thomas Laughren of the FDA. But the agency will review the risk labels on the drugs and probably launch a formal study of cardiovascular dangers. Over-prescription is another big concern. Nissen notes that 10% of 10-year-old boys are being treated for attention-deficit/hyperactivity disorder...
...years, though it's uncertain that the drugs caused the deaths. In addition, the panel looked at preliminary data suggesting an increased risk of arrhythmias and strokes associated with these medications. "The main purpose of the meeting was to look at study design to review this," explained Dr. Thomas Laughren, director of the FDA's division of psychiatry products...
...clearly wasn't expecting such a bomb to go off in a routine meeting, but now the agency must deal with the fallout. A black box warning is unlikely. "We don't feel the risk is well enough established," said Dr. Laughren. But studies of the cardiovascular effects of these drugs are likely to get underway, and, given how many Americans are already taking them, they are probably long overdue. The FDA will also weigh a unanimous recommendation by the panel to make potential risks to the heart more apparent in the patient guides given out by pharmacies. That topic...
...conduct lengthier studies, the agency now grants an extension of six months of exclusive marketing rights to any company engaging in studies of a drug's effects on a minimum of 100 children for more than six months. "It's a relatively small amount of data," acknowledges Dr. Thomas Laughren, a psychiatrist with the FDA's psychopharmacology division, "but it's better than what we had before, which was nothing...
...trend is not confined to cassettes. Almost one-third of the country's 24,000 movie screens are also bombarding patrons with commercials. "We are purveyors of entertainment that sells," says Terry Laughren, president of Screenvision Cinema Network, the largest distributor of theater advertising...
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