Drug safety topics on this blog usually relate to online pharmacies and the dangers posed by rogue sites selling bad meds or real prescription meds sold online but without requiring your prescription; and personal drug importation and the importance of only buying from credentialed online pharmacies. Today I read about the many deaths caused by overdoses of acetaminophen, a popular over-the-counter (OTC) pain-reliever, and felt moved to remind our readers to use great care when taking all medication. Whether or not a drug requires a prescription, in protection of your health, you are responsible for taking medicine as directed, whether by your doctor or on the label of an OTC product.

ProPublica, a non-profit investigative media organization, reported that over 1,500 Americans had died over the past decade from ingesting acetaminophen, usually because they took more than the recommended amounts. Their research is highly critical of the U.S. Food and Drug Administration for moving too slowly to safeguard American from taking too much acetaminophen, whereas other countries have done a much better job.  McNeil Consumer Healthcare, a division of Johnson and Johnson, the makers of Tylenol, which is a leading brand of acetaminophen, is also criticized by ProPublica for hiding research about the medication’s dangers. This is not a criticism of the medication acetaminophen, as ProPublica is clear to point out its benefits and that many medical professionals stand by it – and for good reasons, it helps adults and children reduce their fevers and feel better.

Central to ProPublica’s criticisms is that the medication’s warnings do not include death as a side-effect of taking slightly more than the recommended doses. This is all the more important since studies show that other pain-relievers and fever-reducers, such as Ibuprofen do not cause death at such high rates.

People have sued McNeil and lost because their loved ones who died took more than the recommended dose of Tylenol. The parents of one child who died argued that the label did not warn that death could occur. Our hearts go out in abundance to these parents. To avoid such tragedies, the most important reminder here is that drug safety is often about following directions and is often a matter of life or death.