US FDA raises alarm against Drug-gene testing

Reepa Agrawal
16 Nov, 2018

In the face of newer developments taking place in the field of pharmacogenomics and pharmacogenetics, US FDA has issued warning against drug-gene testing that is genetic tests predicting drug response. Pharmacogenetic tests look for genetic variants that are associated with variable response to specific medications. These variants occur in genes that code for drug-metabolizing enzymes, drug targets, or proteins involved in immune response. These tests determine if a variant is heterozygous or homozygous, which can impact an individual's response or reaction to a drug.

Personalised treatment strategies as determined by influence of genetic variations on drug response is at present under research. There is no substantial scientific evidence at present and hence FDA has alerted healthcare providers and public to not fall prey to such genetic tests and make therapeutic interventions. This is very important to know as there are many companies which offer such tests to consumers directly. These companies claim that by doing certain tests, response to medications like proton pump inhibitors, anti-depressants, lipid lowering drugs etc can be predicted. For example tests helping to choose one type of antidepressant over another in terms of its safety and efficacy. It has been observed that many patients are taking these tests directly too. FDA urges patients and healthcare providers to not base their treatment plans based on this.

However, there are some FDA-approved drug and genetic test labels, and labels of FDA-cleared genetic tests that provide general information about the impact of DNA variations on drug levels, but do not describe how that genetic information can be used for determining therapeutic treatment. These labels are intended to be informational, but do not indicate that there is sufficient evidence to support making therapeutic treatment decisions based on the information provided by the genetic test. This information can be checked on drug labels.

Nevertheless the field of pharmacogenomics and pharmacogenetic will be a game changer in the future for devising personalised treatment strategies.
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