FDA investigates after the outcome of the STRIDE study
An international clinical trial called STRIDE-PD was carried out in patients with Parkinson's disease. 245 were allocated to treatment with Stalevo (levodopa + carbidopa + entacapone) and 222 to treatment with levodopa + carbidopa. They were given treatment for a period ranging from 2.6 to 4 years. 62.7% of patients were men and their mean age was 60 years.
More cases of prostate cancer occurred in the group treated with Stalevo than in the group treated with levodopa + carbidopa (9 vs 2 i.e. 3.7% vs 0.9%). Prostate cancer is common in men aged 60 years and over, so the phenomenon may not necessarily be due to Stalevo. Differences in the number of cases of cancer have not been recorded in other studies, but patients were monitored for shorter periods of time.
FDA, the regulatory agency of the US has decided to investigate further. It has issued a statement saying that it has not reached any conclusions and advising patients NOT to stop treatment with Stalevo or Comtan (entacapone)
Source: Food and Drug Administration