March 28, 2023

Here is my 5 minute testimony addressing the Joint Meeting of the FDA Pediatric Advisory Committee (PAC) and the Drug Safety & Risk Management Advisory Committee (DSaRM) held on September 27, 2019.

Good afternoon my name is kim woodsack and i’m coming to you from minneapolis minnesota i have no financial conflicts of interest in the matters being discussed today i just wanted to offer my perspective on this very important safety discussion of monte class i like to call myself the accidental advocate i never set out to be a drug safety advocate 16 years

Ago however i was thrown into this world and not by choice in 2003 my husband woody was given an antidepressant for insomnia and five weeks later he took his own life without any history of depression or any other mental illness at the time there were no black box warnings on antidepressants shortly after his death i established woody matters a drug safety

Organization representing the voice of families across the country who live every day with the consequences of a flawed drug safety system i see many similarities between the safety discussions you are having today on monte class and the ones we had on antidepressants back in 2004 and 2006. many of the serious harms were not initially seen in the original clinical

Trials are now coming to light after being on the market for years and taken by millions of people the real world reports of parents watching their children suffer from depression anxiety hallucination paranoia aggression pan attacks are being dismissed by the medical community because there’s no scientific proof they say the risk of serious adverse psychiatric

Events is rare but if this small risk happens to you or your family it’s your 100 percent there is a growing body of new scientific evidence literature and ongoing global studies that has emerged since the drug came on the market showing serious neuropsychiatric side effects and issues with discontinuing the drug yet there’s yet to be a pediatric study looking at

The impact of the drug on a growing child’s brain but we’re testing the drug on alzheimer treatment there’s a general perception that this medication is safe yet there’s a lack of understanding by the medical community of the mechanism which is causing the potential harm in some people the need for black box warnings is real the current warnings for monte class

Found under precautions and prescribing information do not go far enough learn from the antidepressants it took the fda 13 years after they first held hearings in 1991 to finally add black box warnings to these drugs how many lives were lost in between that time of course there’s always the fear of not wanting to scare parents or patients but asthma is a huge

Market there according to cdc there’s one in 13 people have asthma there’s over 25 million americans there’s a lot of money at stake but at the end of the day to us as patients it’s about having information a black box warning should be added when there is a reasonable evidence of an association of a serious hazard with a drug this would send a ser a strong

Signal to the medical community including pharmacists psychiatrics the psychiatrists and the public about the potential for serious neuropsychiatric harms at minimum a med guide should be required however if a parent is unaware or even knows what a med guide is it will not do any good these med guides need to be available at the doctor’s office and given to

Parents at the time the drug is being prescribed so that a conversation can happen maybe we could do some trainings of physicians including the psychiatric community as well as a public awareness and media campaign aimed at patient groups maybe we could require informed consent forms that a patient and and the family signs acknowledging the potential for these

Harms but at the end of the day what if this was your child wouldn’t you want to know if they started to experience things like hallucinations increased agitation thoughts of suicide that it could be their asthma medication trust me i know i would thank you and i appreciate your careful consideration of my comments as you deliberate um the need for additional

Warnings on this on these drugs have a great day

Transcribed from video
My FDA Testimony Regarding Psychiatric Warnings For Singulair/Montelukast By Kim Witczak