Japan follows suit on PPA ban

Japan's Ministry of Health, Labour and Welfare has ordered companies to stop producing over-the-counter (OTC) pharmaceuticals containing phenylpropanolamine (PPA).

The move comes nearly two years after the US Food and Drug Administration ordered PPA-containing products off the market, after the ingredient was linked to an increased risk of haemorrhagic stroke.

At that time, Japan stopped short of banning PPA drugs because the doses used there tended to be lower than in the US, although it did issue a warning that patients with cardiovascular disease, and particularly those who had already suffered a stroke, should not take them.

However, the MHLW said on August 8 that it had received five reports of cerebral haemorrhages associated with PPA in OTC drugs, as well as two such cases linked with products available on prescription only, since the FDA's action in November 2001.

The cases were mostly due to individuals taking larger doses than recommended or use of the drug by patients with hypertension, according to the Ministry. The Japanese government is not ordering a recall, but has told companies they should reformulate their products without PPA.

Takeda Chemical Industries responded swiftly by saying that it will cease production and marketing of its Benza cough-and-cold products that contain PPA. Takeda said two of its three Benza lines contain PPA, and it will continue marketing the version that does not. Total sales of the brands were Y9.3 billion (€70m) last year.

Meanwhile, Japanese shipments of OTC medicines rose 1.3 per cent to Y77 billion in fiscal 2002, according to a Nikkei News survey.

Despite a boost from the spread of influenza, the market has not expanded significantly as many cold medicines cannot be differentiated by their active ingredients, says the study.

Market leader Taisho Pharmaceuticals grew its share just 1.7 per cent, while Takeda managed only a 0.5 per cent rise.