shipment out of china is at all time high
the rmb actually did not appreciate at all this year, on trade weighted basis, as it went up against usd and down against euro, and stayed more or less even vs the yen
and, oh, speaking of poison and news, and not designed, spec-ed, manufactured, and sourced out of china ...
online.wsj.com
Possible Suicide Link
Prompts FDA to Probe
Merck Asthma Drug
By JENNIFER CORBETT DOOREN
March 28, 2008; Page B6
The Food and Drug Administration said it is investigating a possible association between the widely used asthma medication Singulair and behavioral changes, including suicide.
Singulair, made by Merck & Co., is approved to treat asthma and allergy symptoms such as sneezing and stuffy noses, as well as to prevent exercise-induced asthma. The FDA said in a so-called early communication that it is reviewing postmarketing reports of behavior and mood changes, suicidal thoughts and actions, and actual suicides by patients who took Singulair. The regulator also asked Merck to look at its own database for signs of trouble.
Early communications are a recently developed tool the FDA uses to tell consumers and health-care professionals that the agency is looking into a particular safety concern but that it hasn't reached any conclusions.
Singulair, first approved in the U.S. in 1998, was Merck's top-selling product in 2007, with $4.3 billion in sales. The product is approved as an asthma treatment for use in people at least a year old.
It is expected to take about nine months for the FDA to review whether Singulair is linked to suicidal thoughts and behavior. The agency said "posting this information does not mean that FDA has concluded there is a causal relationship between the drug product and the emerging safety issue."
The FDA said Merck updated the prescribing information and patient information for Singulair four times in the past year to include reports of adverse events that include tremors, anxiousness, depression and suicidal thinking and behavior. Reports of suicidal thinking and behavior were added to Singulair's label in October, and the FDA said Merck recently started communicating the changes to doctors and patients.
George Philip, Merck's head of product development for Singulair, said the company is in "discussion with the FDA on these issues," noting that postmarketing reports alone don't mean Singulair contributed to suicides. In a statement Thursday, Merck said it has received a "very limited number" of suicide-related postmarketing reports. Merck, of Whitehouse Station, N.J., said there weren't any reports of suicide in clinical studies involving 11,000 patients.
The FDA said Singulair is effective and that patients shouldn't stop taking it without talking to their doctors.
Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com |
