To Get Warning Label
The Food and Drug Administration warned doctors yesterday about reports of suicidal thinking in some children and adolescents taking Strattera to treat attention-deficit hyperactivity disorder.
Manufacturer Eli Lilly & Co. said a black-box warning, the most serious, will be added to the drug's label. The company said a study showed that instances of suicidal thinking were rare.
The FDA said children and adolescents taking Strattera, which also goes by the generic name atomoxetine, "should be closely monitored for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior."
Eli Lilly said that in clinical trials of 1,357 patients, five youths taking the medication reported suicidal thoughts, while none of 851 patients taking a placebo reported any. One young person taking Strattera attempted suicide but survived.
Paxil Study Suggests
Risk of Birth Defects
A study has suggested that the antidepressant Paxil may be associated with birth defects.
Paxil's manufacturer, GlaxoSmithKline, said it will include the findings in the list of precautions.
A retrospective study found increased numbers of babies born with birth defects to women who were taking Paxil during the first trimester compared with women on other antidepressants.
The FDA released the letter this week. The drug, which goes by the generic name paroxetine, is already classified as a "Category C" drug for pregnant women -- meaning studies of its effects on a pregnancy have not been performed.
Based on the study, the company said it has not concluded there exists a definite, causal link between the drug and the increased incidence of birth defects, citing another survey of births that did not find a comparable increase.
Many Chinese Bats
Infected With Viruses
Many species of bats found across China are infected with viruses similar to the SARS virus, an international team reported yesterday in the journal Science.
Zhengli Shi of the Chinese Academy of Sciences in Beijing and colleagues sampled more than 400 bats of various species in China and found that up to 70 percent of some species showed evidence of infection with SARS-like viruses.
This would support the idea that bats are the natural host of the virus. Animals that act as reservoirs carry and spread a virus without themselves becoming ill.
Severe acute respiratory syndrome first emerged in China in 2002 and spread around the world via jet in 2003, infecting about 8,000 people and killing more than 700. Strict quarantines and other measures stopped its spread.
Animals such as palm civets were found to be infected, but the study showed that they were not the true reservoir of the SARS virus.
Earlier this month, a team of Hong Kong researchers reported that bats found in Hong Kong carried a virus very similar to the SARS virus.
Shi, Wendong Li and colleagues studied other bats found in four areas of China. They found that 28 to 71 percent of the bats, depending on the species and location, had evidence of infection with a SARS-like coronavirus. Theirs was different from the virus found by the Hong Kong researchers, they said.
-- From News Services