Varuna Srinivasan, MBBS, MPH, National Center for Health Research: September 20, 2018
Thank you for the opportunity to speak today. My name is Dr. Varuna Srinivasan. I am a physician with a Master’s in Public Health from Johns Hopkins University. I am a Senior Fellow at the National Center for Health Research, which analyzes scientific and medical data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug and medical device companies, so I have no conflicts of interest.
I have strong concerns about the safety of two drugs in question today
In regards to Lexapro, we appreciate the fact that FDA continues to look at adverse events because the rate of drug prescription has doubled in the past 6 years.
- First and foremost, we are concerned that this safety study will be used to justify advertising and use in 7-11 year olds without evidence that it works. The very short summary of the safety study is not adequate to fully evaluate the results. More information should be provided to the committee. In addition, there is limited evidence that the drug works in adolescents. This is very concerning considering the two out of the three studies done in 7-17 do not show the drug to be efficacious in younger children.
- Clearly there are psychiatric risks of Lexapro for children, and yet there is no clear evidence of the benefits. Using the FAERS to determine the incidence of new or increased adverse reactions is inadequate, given the well-known problem of under-reporting.
Our bottom line is that the FDA has not provided this Advisory Committee with adequate information for you to conclude that the benefits outweigh the risks for children ages 7-11. Lexapro should not be approved for safe and continued use in children under 12. There are also serious questions about whether its benefits outweigh the risks for adolescents as well. More research is needed and the research should be carefully reviewed by the FDA and by this Advisory Committee
In regards to the drug prescribed for ADHD – Intuniv
Intuniv has very serious psychiatric adverse events reported to FDA’s FAERS. FAERS can’t tell us how much of a risk suicidal ideation, homicidal ideation, and aggression are for this drug. Although the number of these adverse events is small in the data provided by the sponsor, it is important to question whether the benefits outweigh the risks given that other treatments are available for ADHD. At the very least, these risks need to be prominently included in a black box warning on the label, so that parents can make informed decisions about their child’s potential use of this drug.
This Advisory Committee has an essential role in protecting children from drugs that may be unsafe or unproven for children. We urge you to urge the FDA to demand better data and require better warnings on labels.