Avian Flu Diary: The Narrow Margin

# 9427

Earlier this year the FDA imposed long awaited new limits on the amount of acetaminophen (APAP) allowed in prescription opioid/APAP prescriptions like Vicodin and Lorcet to 325mg in order to reduce the risk of liver damage in patients taking these meds for chronic pain.

Over the counter (OTC) formulations, however, continue to be sold in both the regular 325mg and `extra strength’ 500 mg doses, and APAP is commonly found in scores of multi-ingredient `cold remedies’, increasing opportunities for consumers to inadvertently `double-up’ on their consumption of the drug.

While well tolerated when taken as directed, APAP in larger doses is a hepatotoxin; it overwhelms and destroys the liver. In fact, APAP poisoning is the biggest cause of acute liver failure in the United States (cite).

A study published in 2011 in the American Journal of Preventive Medicine (see Emergency Department Visits for Overdoses of Acetaminophen-Containing Products) found that - in the United States alone – there are an estimated 78,414 ER visits each year due to acetaminophen (aka Tylenol, paracetamol, APAP) poisoning.

Although most of these were intentional overdoses (69.8%), more than 13,000 ER visits were described as due to `therapeutic misadventures’ . . . or accidental overdoses.

The problem with acetaminophen is that there is a relatively narrow margin between the maximum therapeutic dose and a potentially toxic (and sometimes fatal) overdose.

Add in the concurrent consumption of alcohol – common during the holidays – and you further exacerbate its toxicity.

With last week’s warning (see CDC: Early Data Suggests Potentially Severe Flu Season) a lot of people will be turning to OTC medications from their home medicine cabinet for symptom relief. Which is why each year I try to do a piece on some of the hidden dangers of these commonly used medications.

In Kids, Colds, And OTC Meds we looked at the continuing trend of parents – against the advice of the CDC – to use OTC medications to treat cold and flu symptoms in toddlers under the age of four.

And the year before, we looked at inconsistent and confusing dosing instructions provided by many manufacturers of OTC medications (see JAMA: Inconsistent Dosing Instructions For OTC Meds).

Another study in 2010 (see Inappropriate Use Of OTC Medicines In Children) reported that inappropriate use, and incorrect dosing of OTC meds lead to a large number of accidental drug poisonings each year.

Unfortunately, accidental and intentional poisonings from OTC medications are all too common. In October of 2012 the AAC (Acetaminophen Awareness Coalition) launched a Know Your Dose campaign to help educate consumers about the safe use of the popular pain reliever.

Credit – Acetaminophen Awareness Coalition

For parents whose young children are ill, the impulse to `do something’ to alleviate their misery is particularly strong. But all medicines - even those available over-the-counter – have risks. And for very small children, the FDA and the CDC believe those risks outweigh any benefit they might derive from these types of products.

This Q& A from the CDC.

Questions and Answers for Parents about Over-the-Counter (OTC) Medicines

For adults, over-the-counter pain relievers, decongestants and saline nasal sprays may help relieve some symptoms. Remember, always use over-the-counter products as directed.

For children, over-the-counter pain relievers, decongestants and saline nasal sprays may help relieve some symptoms. Not all products are recommended for children of certain ages.

These medicines may help relieve symptoms such as runny nose, congestion, fever and aches, but they do not shorten the length of time you or your child is sick.

Q: What pain relievers can I give my child?

A: For babies 6 months of age or younger, parents should only give acetaminophen for pain relief. For a child 6 months of age or older, either acetaminophen or ibuprofen can be given for pain relief. Be sure to ask your child’s healthcare provider for the right dosage for your child’s age and size. Do not give aspirin to your child because of Reye's syndrome, a rare but very serious illness that harms the liver and brain. Learn more about Reye’s syndrome.

Q: Should parents give cough and cold medicines to young children?

A: The Consumer Healthcare Products Association (CHPA), a group that represents most of the makers of nonprescription over-the-counter (OTC) cough and cold medicines, recommends that these products not be used in children under 4 years of age. The Food and Drug Administration (FDA) supports this recommendation. Overuse and misuse of OTC cough and cold medicines in young children can result in serious and potentially life-threatening side effects.

Q: What can parents do to help their children feel better if they are too young to take cough and cold medicines or the healthcare provider advises against using them?

A: Parents might consider clearing nasal congestion in infants with a rubber suction bulb. Also, a stuffy nose can be relieved with saline nose drops or a clean humidified or cool-mist vaporizer.

Q: Should parents give cough and cold medicines to children over 4 years of age?

A: Cough and cold symptoms usually go away without treatment after a certain amount of time. Over-the-counter cough and cold medicines will not cure the common cold, but may give some temporary relief of symptoms. Parents should consult their child’s healthcare provider if they have any concerns or questions about giving their child a medication. Parents should always tell their child’s healthcare provider about all prescription and over-the-counter medicines they are giving their child.

Q: What should parents and doctors be careful of if they want to give cough and cold medicines to children over 4 years of age?

A: Always keep medications in original bottles or containers, with the cap secure, and up and away from children. Children getting into and taking medications without adult supervision can lead to serious and potentially life-threatening effects. Avoid giving more than one cough and cold medicine at a time to children. Two medicines may have different brand names but may contain the same ingredient. Some cough and cold medicines contain more than one active ingredient. Also, follow directions carefully to avoid giving too much medication; the right amount of medication often depends on your child’s age and weight.