On Thursday, the U.S. Food and Drug Administration (FDA) warned consumers not to be fooled by genetic tests that claim they can determine whether a person can benefit more from taking one medication over another for their condition.
In a noteworthy statement, the FDA reminded patients, “sufficient clinical evidence is not currently available for these genetic tests or software programs and, therefore, these claims are not supported for most medications.”
Drug-gene testing, as its known, has become popularized in the past year through companies such as GeneSight. GeneSight, for instance, claims on its website, “By examining your DNA, this simple, painless test lets doctors know which medications may not work for you, so you can get back to feeling like yourself again.” In addition to direct-to-consumer offerings, drug-gene testing is also marketed to doctors and therapists.
According to the FDA, drug-gene tests claim to provide information on how a “patient will respond to medications used to treat conditions such as, depression, heart conditions, acid reflux, and others.”
“They might claim to predict which medication should be used or that a specific medication may be less effective or have an increased chance of side effects compared to other medications due to genetic variations.” The FDA also noted that some providers and consumers may use the results of testing to change their medication — which the FDA recommends against.
“There are also software programs that interpret genetic information from a separate source that claim to provide this same type of information,” explained the FDA.
Limited Number of Cases
The FDA said there are a limited number of cases where some evidence exists to support a correlation between a genetic variant and drug levels within the body.
They note that the labels on medications and medical products that are authorized by the FDA will provide information directly to consumers on how “DNA variations may impact the levels of a medication in a person’s body, or they may describe how genetic information can be used in determining therapeutic treatment, depending on the available evidence.”
“Descriptions for how to use genetic information to manage therapeutic treatment can be found in the following sections of the FDA approved drug labeling: warnings (Boxed Warning, or Warnings and Precautions sections), Indications and Usage, Dosage and Administration, or Use in Specific Populations, as appropriate.”
The FDA emphasized, however, that most genetic tests that make claims about the effects of a specific medicine are not supported by the current clinical evidence or science.
As a reminder, you should not stop or change the medication you’re taking without first talking to your doctor or medication prescriber.
The FDA also suggests that patients should discuss the results of any genetic testing they undertake — on their own or through a doctor’s office — with their health care provider. This importantly includes whether the medication label has information on how to use genetic information to determine dosage.
FDA Recommendations for Health Care Providers and Laboratories
The FDA offers the following advice for clinicians and labs:
If you are using, or considering using, a genetic test to predict a patient’s response to specific medications, be aware that for most medications, the relationship between DNA variations and the medication’s effects has not been established. Check the FDA-approved drug label, or the label of the FDA-cleared or approved genetic test for information regarding whether genetic information should be used for determining therapeutic treatment.
If a patient brings you a test report from a genetic test offered directly to consumers that claims to predict a person’s response to a specific medication, seek information in the FDA-approved drug label regarding whether genetic information should be used for determining therapeutic treatment.
Be aware that 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 treatment decisions based on the information provided by the genetic test.
Know that information regarding therapeutic treatment recommendations for patients with certain genetic variations can be found in the warnings (Boxed Warning, or Warnings and Precautions), Indications and usage, Dosage and Administration, or Use in Specific Populations sections of the FDA approved drug labeling, as appropriate.
Be aware that most genetic tests that make claims regarding effects of a specific medication have not been evaluated by the FDA.
In summary, at this time, patients and providers should generally not be making clinical decisions about medications based on gene-drug testing because the scientific evidence doesn’t support such decision-making for most drugs.