Equate poisonings of children under 5

The reports, as CPSC published them

1. Emergency room

   Made Dec 20, 2011 · , sent to the company Jan 5, 2012 · , published by CPSC Jan 20, 2012

   The product, in the report: Equate Brand Nicotine Lozenges, 4mg-in a tube with a “child-resistant” cap

   On Tuesday, April 5th at 7:00am, our 22-month old son, who had been left alone for less than a minute, found and opened one of my husband’s Equate brand nicotine lozenge tubes. He ingested at least one, possibly ½ of another lozenge (for a total of between 4-6mg), leading him to immediately develop symptoms of nicotine poisoning (vomiting, drooling, cardiac arrhythmia, and lethargy).

   We immediately called poison control who gave us further possible symptoms of nicotine poisoning, (including hypotension, difficulty breathing, cardiac arrhythmia, and seizures), and they recommended we immediately call EMS. We called EMS and due to our rural location, decided to meet them half way to the hospital.

   Upon transferring our son to the ambulance, they immediately hooked him up to a heart monitor and a blood pressure cuff and inserted an IV into his arm. He continued to vomit and drool but his heart rate and blood pressure remained normal. The bumpy 20 minute EMS ride was the worst twenty minutes of my life and as a parent I prayed that his symptoms would improve and not get worse.

   Luckily for us, his symptoms appeared to improve the closer we got the hospital and by his 2nd hour of observation in the hospital, he appeared to be his normal self (despite his continued drooling, which continued EVEN AFTER our 4 hour stay in the hospital).

   What we learned about nicotine poisoning throughout this process was disturbing. We believe he only ingested about 4-6mg of nicotine and our ER doctor told us that the LD 50 for children (Lethal dose for ½ the population) is 12mg. He ate one third the potentially lethal dose. Nicotine poisoning can lead to abnormal heart rate (cardiac arrhythmia), sweating, stomach pain, loss of strength, drooling, seizures, hypotension, vomiting, difficulty breathing and POSSIBLY DEATH. We take full responsibility for not watching our child and for him having access to the bottle of nicotine lozenges. With this being said, I will say that even though the bottle of Nicotine lozenges was up on a cabinet where we thought it was out of his reach, he still managed to get it down and open it.

   What enrages us it that, in our opinion, the bottle was not child proof and that the warning label was completely inadequate. If only three 4mg Lozenges can cause death in 1/2 the population of children, then more specific wording such as “MAY CAUSE DEATH” needs to be on the label.

   Other name brand nicotine products (such as “[REDACTED]” Lozenges) ARE child proof (they are individually wrapped in plastic containers, and covered in foil, that are almost impossible for an adult to open!) This bottle was not difficult to open. All he did to open the bottle was press down on the cap and turn it.

   According to the Department of Health and Human Services, part of the FDA, in a written response to our concerns via our Senator, their response was “we confirm that the Equate Nicotine Lozenges that (were) purchased (are) consistent with the approved application (ANDA-Abbreviated New Drug Application) because it contained a child-resistant closure system that requires the cap be pushed down in order to open. Many products are required to have child-resistant closures under the Poison Prevention Packaging Act, which the U.S. Consumer Product Safety Commission (CPSC) enforces and regulates. If Mr. and Mrs. ___ feel the type of child-resistant closure found on Equate Nicotine Lozenges is inadequate, we suggest they contact the CPSC with their concerns.” Hence, our communication with you.

   Our opinion is that if a 2 year old can open the bottle in less than 60 seconds, then it is NOT child-proof and barely child-resistant. The only warning label on the bottle (that is inside the main box which my husband had thrown away, and the only container that I saw in the middle of this incident) was in fine print and stated “Nicotine lozenges may have enough nicotine to make children and pets sick”. It failed to state failed to state “this product, if taken in excess, could lead to seizures, difficulty breathing, cardiac arrhythmia, AND POSSIBLY DEATH”.

   This situation could have been avoided by the bottle being child-proof (not “Child-Resistant”) and possibly by having a better warning label. We hope other parents see this message and choose not to purchase this product if they have young children and that our message can prevent an incident like this from happening to other families such as ours.

   Model

   Nicotine lozenges 4mg

   Bought from

   Wal-mart

   Bought

   Apr 1, 2011, about then

   Where

   Appomattox, Virginia: Home/Apartment/Condominium

   Who was involved

   Age 1, Male

   The reporter’s relation to them

   My Child

   As this report names them

   Brand Equate, made or sold by PERRIGO COMPANY

   How badly, in CPSC’s words

   Injury, Emergency Department Treatment Received

CPSC’s disclaimer

Sources