WHO Pharmaceuticals Newsletter 2004, No. 06
(2004; 13 pages) View the PDF document
Table of Contents
Close this folderREGULATORY MATTERS
View the documentACTRA-RX AND YILISHEN - Presence of undeclared sildenafil
View the documentADALIMUMAB - Serious infections if used together with anakinra
View the documentANTIDEPRESSANTS Label to warn of increased suicidality in children; Patient Medication Guide to advise on risks and precautions to be taken
View the documentATORVASTATIN - Interaction with grapefruit juice
View the documentBLACK COHOSH COMBINATION #2; YELLOW DOCK COMBINATION #3 - Presence of aristolochic acid
View the documentCELECOXIB - Withdrawn in Turkey
View the documentEPOETIN ALFA - Label change to reflect thrombosis risk
View the documentETANERCEPT, INFLIXIMAB - Reports of serious infections
View the documentINFLIXIMAB - Lymphoma warning added to US Remicade label
View the documentISOTRETINOIN - Enhancement to risk management programme
View the documentLEVOTHYROXINE SODIUM - Dysphagia and risk of choking
View the documentMIFEPRISTONE - Important labelling changes proposed
View the documentPERGOLIDE MESYLATE - Label change: risk of cardiac valvulopathy
View the documentREMINYL AND AMARYL - Reports of medication errors
View the documentVALDECOXIB - Label updated to warn about skin reactions
Open this folder and view contentsSAFETY OF MEDICINES
View the documentFEATURE
 

ACTRA-RX AND YILISHEN - Presence of undeclared sildenafil

USA. The Food and Drug Administration (FDA) has warned consumers not to purchase or to consume Actra- Rx or Yilishen, two products promoted and offered for sale on websites as dietary supplements for treating erectile dysfunction and enhancing sexual performance in men. The FDA has found that these products contain undeclared prescription strength sildenafil. Sildenafil, when taken together with certain prescription drugs containing nitrates (such as nitroglycerin) may cause a significant lowering of blood pressure to an unsafe level.

These drugs should therefore be taken only under medical supervision. The FDA is advising consumers who use Actra-Rx or Yilishen to stop taking these products and to consult their health-care providers regarding erectile dysfunction treatment.

Reference:

FDA Talk Paper, 2 November 2004. Available on the Internet at www.fda.gov

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Last updated: May 3, 2013