When was phenacetin banned?

2.2. Case–control studies

Case–control studies have been used almost exclusively to examine the association between consumption of analgesics and various cancers of the urinary tract. In all of the studies available to the Working Group, the cumulative use of groups of pharmaceuticals was assessed by asking study subjects about their retrospective use. In most epidemiological studies reviewed, it was rather difficult to estimate the effect of phenacetin separately from the effect of other analgesics, as various pain-relieving substances are often combined in the same pharmaceutical product.

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Table 2.1

Case–control studies of cancer of the urinary tract and consumption of analgesic mixtures containing phenacetin.

2.2.2 Cancer of the kidney parenchyma

Two early case–control studies from the USA and Australia, which included kidney cancer patients diagnosed in the late 1970s and early 1980s, i.e. in the decade following the withdrawal of phenacetin from these markets, reported an increased risk of kidney cancer among regular users of phenacetin-containing preparations (McLaughlin et al., 1984; McCredie et al., 1988). However, the US study findings were not statistically significant, and the Australian study did not show any positive trend in risk by increasing cumulative intake of phenacetin.

Three further case–control studies from the USA, Canada and the People’s Republic of China with recruitment of patients with renal cell cancer diagnosed in the late 1980s did not report significant associations with use of phenacetin, even in cumulative doses of more than 1 kg (McLaughlin et al., 1992; Kreiger et al., 1993; Chow et al., 1994). Similarly, a large international multicentre case–control study from six well defined geographic areas in Australia, Denmark, Germany, Sweden, and the USA did not link renal cell cancer with consumption of phenacetin-containing preparations (McCredie et al., 1995).

In a large case–control study from California, a statistically significant elevation in risk of renal cell cancer was associated with use of each of four chemical classes of analgesics included in the analysis (Gago-Dominguez et al., 1999). However, no clear increase in risk was observed even with an increase in maximum weekly intake doses of phenacetin.

2.2.3 Cancer of the urinary bladder

Two small case–control studies from Australia (McCredie et al., 1988) and one study from the USA (Piper et al., 1986), with recruitment of bladder cancer patients during the late 1970s and early 1980s, reported a positive association with use of phenacetin-containing analgesics. In the US study, heavy use, defined as daily use of phenacetin-containing analgesics, was associated with a non-significant increased risk of bladder cancer; in the Australian study, lifetime use of phenacetin of 0.1 kg or more was associated with a significant 2-fold increased risk.

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In a large study from California (Castelao et al., 2000), any use of phenacetin-containing analgesics was related to a non-significant increase in bladder cancer risk, however, it was associated with a significant increase in relative risk estimates by an increasing cumulative lifetime consumption of phenacetin. Furthermore, in a cancer-registry-based case–control study from the USA, risks of bladder cancer were evaluated in association with use of analgesics and anti-inflammatory drugs (Fortuny et al., 2007). Based on information obtained through an in-person interview, the investigators found a significantly increased risk of bladder cancer in association with use of phenacetin-containing analgesics. A positive, statistically significant trend was observed with reported increasing duration of use.

These findings were not corroborated in a medium-sized German case–control study, in which no elevation of the relative risk estimate for bladder cancer was found in subjects with a lifetime consumption of phenacetin of 1 kg or more (Pommer et al., 1999). [The Working Group noted that phenacetin was banned in 1986 from the pharmaceutical market of the Federal Republic of Germany before reunification, and patients included in the study were diagnosed during 1990–94, i.e. less than 10 years after the ban.]

In another large case–control study from Spain (Fortuny et al., 2006), ever use of phenacetin was slightly, but non-significantly, more prevalent among cases than among controls. [The Working Group noted that in this study, most cases and controls were interviewed more than 10 years after phenacetin-containing preparations were withdrawn from the Spanish market, and few participants only reported use of this compound.]

Background: Phenacetin is an analgesic that causes renal diseases and cancers of the upper-urinary tract (UUT). It was banned in most countries from the late 1960s. This study aimed to evaluate, for the first time, the long-term population impact of the phenacetin ban on UUT cancer rates.

Methods: We used cancer registry data from Australia, where phenacetin was widely used, to study age- and sex-specific incidence trends of cancers of the renal pelvis and the ureter after the phenacetin ban (1979). Incidence rate ratios and average annual percentage change (AAPC) were calculated to quantify changes in rates over time.

Results: Incidence rates of renal pelvis cancer decreased by 52% in women and 39% in men between 1983-1987 and 2003-2007. The decline in women was stronger in states where the use of phenacetin was the most widespread, e.g. New South Wales (AAPC: -4.1%; 95% CI -5.3, -2.9) and Queensland (AAPC: -3.3%; 95% CI -4.9, -1.8), and after the mid-1990s. Incidence rates of ureteral cancer remained stable for both sexes throughout the study period.

Conclusions: Our findings strongly suggest a beneficial impact of the ban on phenacetin on the incidence of renal pelvis cancer in Australia, particularly among women.

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