No parent wants to see their child uncomfortable when they are sick. One common symptom that often sends adults seeking relief for the little ones they love is something so simple–a cough. However recent events associated with one of the most common cough remedies on the market have led the FDA to change label warnings and send alerts to parents. Â
The drug Benzonatate (also known as Tessalon Pearls) are a commonly prescribed medication to control cough in children ages 10 and over. The medication, which has been on the market since the 1950’s has been widely used for this purpose. However the recent report of 31 overdoses with the drug have now prompted the FDA to alert parents and caregivers to the risk–especially for small children, of related overdose with improper use or ingestion.
These tiny pearls for cough control are small, clear capsules–with an attractive appearance they can certainly lure an unsuspecting toddler or young child to try.  A slippery exterior makes it easy to swallow and children can quickly take in large amounts. According to the FDA, the age range for overdose with the drug occurred in both children and adults ages 1 to 66. In some cases as many as 30 capsules were swallowed, and in others it took as few as one. For the cases occurring in those older than 10 years, the overdose appeared to be intentional, but of course in the younger cases it was completely accidental.
Of the 31 overdoses, five resulted in death. All deaths were in children younger than two years of age. Other symptoms associated with toxicity included coma, cardiac arrest and convulsions. Symptoms occurred in some cases in as little as an hour–and for the smallest victims it was much faster.
The FDA is recommending new guidelines to help reduce the risk of overdose. First, they recommend that practitioners only prescribe enough pills for a specific episode–dropping the number prescribed from 30 to perhaps as few as 8 or 10. The fewer on hand, the lower the risk of taking too many. Physicians should also be reminding parents to keep the drug out of reach and in the approved containers. While the drug will remain on the market, new labeling information will be added to alert its users to the risk of overdose in children under the age of 10.
Every parent should be careful to ask questions regarding new medications and to be aware of proper storage and safety issues. Working together as a team–both parents and doctors is essential to prevent any more needless deaths.