A new Perspective in Clinical Pharmacology and Therapeutics outlines the need for improved communication from pharmacogenomic testing
companies and regulators on the role of pharmacogenomics in antidepressant
therapy.
Beginning antidepressant treatment can be an arduous
experience for patients. Some patients fail to respond to first-line
antidepressants, leading to an iterative process of trying different
medications until depressive symptoms improve, while others experience
antidepressant-induced adverse effects. This current situation highlights the
need to make evidence-based improvements to the drug selection and dosing
process.
Some pharmacogenomic information is included on the US Food
and Drug Administration (FDA)-approved labels of a number of antidepressants.
However, the actionability of this information can vary widely between labels
and there is no guidance to clinicians on when to seek pharmacogenomic testing
for a patient. PharmGKB assigns a PGx Level and tags to our drug label annotations to help users easily recognize labels containing actionable pharmacogenomic
information such as recommendations for dose or altered drugs.
The publication’s authors, including Dr. Teri Klein and Dr.
Katrin Sangkuhl (PharmGKB and CPIC), Dr. Andrea Gaedigk (PharmVar), as well as Dr. Kelly Caudle and Dr. Roseann Gammal (CPIC), argue that the inconsistencies in drug labels
combined with the FDA’s recent communications on the safety and validity of
pharmacogenomic testing has created confusion among clinicians and patients about
pharmacogenomics in antidepressant prescribing. They also highlight the work of
CPIC in producing evidence-based clinical guidelines that can be used to guide
drug selection and dosing. In particular, the CPIC guidelines for selective serotonin reuptake inhibitors and tricyclic antidepressants are based on the critical review of decades of scientific evidence.
The article ends with a call for clarity on the level of
evidence required to implement pharmacogenomic-guided prescribing in the clinic,
particularly with reference to sertraline and escitalopram.
