• SHARE

The Health, Labor and Welfare Ministry will release reports on the screening of new drugs on its Web site immediately upon their approval — a result of the drug-related deaths of more than 100 Japanese last year, ministry officials said.

The ministry has also instructed pharmaceutical companies to distribute reports on drugs to the medical institutions that buy them.

The ministry will oblige firms to publicize clinical data, including possible side effects, within three months after applications are made for drugs.

It wants to prevent drug-induced health problems by swiftly presenting objective data to medical institutions through the Web site of a government-authorized organization on drug safety.

Previously, it took several months for the reports to appear on the Web site of the Organization for Pharmaceutical Safety and Research.

The move follows the deaths in Japan of 124 people who were administered the lung cancer agent gefitinib from when it was approved in July to December. Many patients were given the drug, whose trade name is Iressa and was developed by AstraZeneca K.K., an affiliate of London-based AstraZeneca PLC.

The ministry was the first agency in the world to approve the drug, and that was after an unusually short screening period of five months. Gefitinib is said to be unique in that it has a completely different molecular structure when compared with conventional drugs.

But the danger of contracting interstitial lung disease with its use was not accurately and swiftly announced, and was apparently one of the chief causes of the deaths.

The ministry also wants the results of toxicity tests, the number of subjects involved in clinical tests and the opinions of those responsible for screening included in the Web site reports, the officials said.

In a time of both misinformation and too much information, quality journalism is more crucial than ever.
By subscribing, you can help us get the story right.

SUBSCRIBE NOW