Fewer Children Poisoned by Cold Medications After 2007 Restrictions

New research indicates that child drug poisonings have dropped significantly over the past several years, following new label warnings and restrictions placed on cold medication.  

In a study published last month in the medical journal Pediatrics, researchers found major reductions in reports of children accidentally taking over-the-counter (OTC) cold and cough medications, and in parents giving them the wrong doses. Therapeutic errors reported for children under the age of two dropped by more than half.

The research looked at reports of child poisoning involving OTC cough and cold medications from U.S. poison centers between 2000 and 2010.

In 2007, the FDA took most cold and cough medications for children off the market and placed stronger label warnings on adult versions of the drugs.

The drugs often contained acetaminophen, which can cause liver damage, and antihistamines, which can cause children to suffer abnormal heart rhythms and seizures, and can cause some to slip into a coma.

Critics of the drugs said that there was scant evidence that they actually helped alleviate cold and cough symptoms in children.

According to the findings this latest research, unintentional child ingestion of OTC cold and cough medications has dropped 33.4% over the past decade, and incidents of parents giving children the wrong dose of those drugs decreased by 46%. The largest drop came in reports of children under two given incorrect cold and cough drug doses by parents, which fell 59%.

Researchers say most of those declines came after the restrictions and label warning changes.

Acetaminophen Liver Damage

Acetaminphen overdose and liver damage is also a major concern for adults as well as children. In addition to its use in cold and cough medications, it is the primary active ingredient in Tylenol.

The FDA has indicated that acetaminophen overdose is a leading cause of liver failure in the U.S., resulting in more than 50,000 emergency room visits, 25,000 hospitalizations and over 450 deaths annually.  In 2002, an FDA advisory committee meeting found that there are between 1,000 and 2,000 acetaminophen-induced liver failures each year.

In recent years, efforts have been ramped up to bring acetaminophen overdose side effects to the public’s attention and to reduce the amount of liver failure cases linked to the popular analgesic, which is also found in other pain killers and a number of cold medications.

For adults, Johnson & Johnson lowered the maximum recommended dosage on Tylenol and other acetaminophen-based products from 4,000 mg per day to 3,000 mg per day in 2011, after the FDA announced new limits on acetaminophen levels in prescription painkillers like Vicodin and Percocet. But over-the-counter painkillers and drugs with acetaminophen went unaffected.

The company faces more than 100 Tylenol lawsuits involving plaintiffs who allege they suffered a liver injury from acetaminophen. Those lawsuits have been centralized for pretrial proceedings before U.S. District Judge Lawrence F. Stengel in the Eastern District of Pennsylvania as part of an MDL, or Multidistrict Litigation.