China's top medicine watchdog has asked manufacturers, doctors and patients to look out for side effects of the drug Airuohua (leflunomide), used to treat arthritis.
The warning from the State Food and Drug Administration (FDA) followed media reports of five deaths in Japan caused by a similar product of French manufacture called Arava.
Arava, manufactured by the pharmaceutical giant Aventis, caused lung dysfunction in five patients by the end of last month.
To date, however, there have been no reports of similar incidents in China. In a statement on its website, the administration said Airuohua is "an effective drug" to treat rheumatoid arthritis.
The ingredients, however, remain in the body for a long time before the metabolic process drives them out.
The administration has asked the pharmaceutical company producing the drug and doctors prescribing it, to closely observe and monitor its side effects. Meanwhile, patients must follow the directions and doctors' instruction when taking the drug, said the administration, adding that they should consult doctors if they experience problems with the respiratory system.
Already, there are some confirmed side-effects to taking Airuohua including a rise in glutamic-pyruvic transaminase (GPT), rash, diarrhea, hair-loss, nausea and a drop in the number of white blood cells.
Airuohua's manufacturer, the Suzhou Changzheng Cinkate Pharmaceutical Corporation Ltd, said their product differs from the French one in preparation, processing and quality standards, even though they share the same active ingredient, leflunomide.
However, company officials also cautioned that doctors should closely monitor users with lung problems and be careful when prescribing the drug to those with infected lungs.
According to the company, as many as 100,000 patients have used Airuohua. No problems similar to those in Japan have been reported.
The French product, Arava, is not on sale in the Chinese market.
(China Daily February 20, 2004)
