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Antidepressant makers ordered to cite suicidal risk in labeling

Feb 8, 2006 | www.tmcnet.com

The health ministry has ordered drugmakers to revise the labeling for their antidepressant drugs to include a warning on an increased risk of suicide, the first order of its kind in Japan, according to ministry officials.

Twelve types of drugs will be subject to the measure, the officials told Kyodo News, adding that they include not only the group of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs, which are known to trigger suicidal behavior among minors, but also nearly all antidepressant drugs prescribed by doctors.

In October 2004, the U.S. Food and Drug Administration ordered all manufacturers of antidepressant drugs to revise the labeling to include greater warnings that alert healthcare providers to an increased risk of suicidal thinking and behavior.

Because the drugs are administered differently in Japan than in Europe and the United States, the Ministry of Health, Labor and Welfare worked to revise the labeling based on an investigation by the Pharmaceuticals and Medical Devices Agency, an independent administrative organization to help people suffering from side effects even though they have used drugs correctly.

The drugs affected by the measure include Paxil (paroxetine hydrochloride), Tofranil (imipramine hydrochloride) and Toledomin (milnacipran hydrochloride).

Increasing cases of abuse of antidepressants, often dubbed "happy drugs," among minors, have become a social problem in Europe and the United States.

The ministry has requested that the manufacturers clearly state in the labeling that users must exercise caution when administering the drugs because they are associated with an increased risk of suicidal thoughts among people diagnosed with depression.

According to the FDA, suicidal tendencies have doubled among minors using the SSRIs and other types of antidepressant drugs. In 2002, antidepressants were prescribed to about 11 million children in the United States.

"Doctors have prescribed antidepressant drugs carefully because depression sufferers have a tendency to plan suicides," said an official at the Pharmaceutical and Food Safety Bureau's Safety Division of the ministry.

"The revision is not likely to cause a major change in the medical field, but it is necessary to call for an even greater warning," the official added.


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