There were a record 28,400 reported cases of side effects caused by drugs in fiscal 2002, health ministry officials said Tuesday.
Some were potentially fatal — including serious liver damage. Less serious side effects included hair loss and nausea.
The previous record was set in fiscal 2000, when there were some 27,600 incidents, the Ministry of Health, Labor and Welfare officials said at a meeting on drug safety measures.
The ministry also ordered companies to revise instructions for the use of products in 233 cases during the fiscal year, which ended in March.
Under the Pharmaceutical Affairs Law, drug companies must notify the ministry within 15 days of a doctor reporting a previously unknown side effect, and within 30 days in cases where the side effects are identified in the company’s instructions.
The health ministry also issued urgent safety advisories in connection with six drugs, including Iressa, the controversial anticancer medication that has reportedly caused more than 240 deaths.
From July 30, the health ministry will require doctors as well as drug manufacturers to report side effects in line with a bill to amend the pharmaceutical law, they said.
About 5,300 reports of flaws in medical devices were received in fiscal 2002, an improvement from the approximately 8,800 reports during the previous fiscal year, the officials said.
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