Department of Information and Tourism, Taipei City Government

The US FDA recently issued a drug safety update for the Parkinson's drug StalevoR (which includes a combined formulation of the three active ingredients entacapone, carbidopa, and levodopa). According to recent clinical findings there appears to be some increased risk of prostate cancer among long-term StalevoR users compared to those taking combined carbidopa and levodopa, but whether any causal link exists between StalevoR and an increased risk of prostate cancer remains to be determined and requires further evaluation. So, the US FDA has urged healthcare professionals to exercise caution when regarding the risk of prostate cancer associated with the drug, while reminding patients to not stop taking their medication unless directed to do so by their healthcare professional

After review, the Department of Health has determined that there have been 4 approvals issued for drugs containing these three combined active ingredients, as indicated for “drug induced parkinsonism tremors, where levodopa (L-DOPA) / DOPA decarboxylase inhibitor therapy fails to achieve clinical therapeutic stability for Parkinsons disease patients.” The National adverse drug reaction (ADR) reporting system shows no reports of possible adverse prostate cancer reactions involving use of the drug.

The Food and Drug Administration continues to monitor the US FDA evaluation of the drug's efficacy, and remind physicians when prescribing the drugs for their patients, to carefully evaluate the relative risks and benefits, and ensure close monitoring for any adverse reactions. Patients who experience any symptoms should immediately see their prescribing physician, but should not stop taking their medication unless directed to do so by their healthcare professional. Additionally, the Food and Drug Administration, Department of Health, has already established a proactive drug safety monitoring mechanism. Besides the Adverse Drug Reaction reporting system and the National Medical Product Defect Reporting System, we constantly review clinical safety data to ensure we can protect the public's medication safety. We remind healthcare providers and patients who suspect any signs of a possible post-consumption (administration) Adverse Drug Reaction to contact the Food and Drug Administration, Department of Health's National Reporting Center of Adverse Drug Reactions in Taiwan, on the drug adverse event reporting hotline at 02-2396-0100, or online at: http://adr.doh.gov.tw.

Source:Home-Department of Health,TAIWAN,ROC