The manufacturer of the branded product (Plavix®) has written to healthcare professionals to highlight the different salt formulations being used in the generic products and the differences in the approved product licence. The generic products are licensed for use in the prevention of atherothrombotic events (myocardial infarction, stroke or peripheral vascular disease) but are currently unlicensed in acute coronary syndrome (ACS). It remains unclear if this difference exists for clinical, product patent or economic reasons.
The differences still place clinicians and dispensers in a situation where prescribing may result in use of a product outside of the licensed indication. The decision to intentionally prescribe generic clopidogrel outside of the current licensed indication will require consideration of the additional clinical responsibility involved and the likely cost benefits.
Updates to clinical systems will also be required to allow for generic prescribing of the particular salt preparations that are available.
Action: Clinicians need to consider whether they believe that use of generic clopidogrel for ACS is clinically reasonable and implement appropriate procedures at local level.