Who is Responsible for Acetaminophen Use?

By Jon Dellaquila, CIS Senior Compliance Associate
jondellaquila@cis-partners.com

Recently the Food and Drug Administration (FDA) received several recommendations from its advisory committee regarding the use of acetaminophen, due to the drug’s ability to potentially cause liver failure. The suggestions offered by the advisory committee include lowering dosage amounts, removing acetaminophen from products that contain other medications, and requiring a black box warning.[1] The scope of this decision and its effect on the general public may be surprisingly large. The products affected include the popular pain killers Tylenol and Excedrin, as well as a variety of cold medicines. Although the FDA does not have to follow the advisory committee’s recommendations, it consistently does. The FDA will more than likely implement a few changes regarding the consumer’s ability to obtain products containing acetaminophen in order to promote safety. However, these products, and the FDA’s regulation of them, may not be the true problem.

The FDA is limited in its ability to inform consumers about the use of any medications, food or drink they choose to consume. It does have the ability to approve and remove products from market, limit the dosage amounts of medications, and require package inserts to be included with them in the hopes of keeping patients informed. However, once the products hit the market shelves and are available over the counter or as prescribed by a physician, the consumers become responsible for their own well being. Patient responsibility may be the root of the acetaminophen issue. The FDA can require acetaminophen doses be lowered from 500 mg to 325 mg in a single pill, and the maximum daily doses be lowered from 4,000 mg to 2,600 mg, but that cannot prevent someone from ingesting more pills to reach the 4,000 mg level if they choose to do so.[2] Regardless of the dosage of acetaminophen contained in any product, the patient will still have the ability to overdose on the medication.

The black box warning for products containing acetaminophen may be the most effective tool in alerting patients that there is concern about their safety when taking any of these medications. It is also possible that the FDA will begin requiring the sale of acetaminophen products behind the counter, as was done with medicines containing pseudoephedrine due to the Combat Methamphetamine Epidemic Act of 2005.[3] Although these two drugs would be sold behind the counter for different reasons, doing so would provide one additional opportunity for the patient to be informed by a pharmacist about the use of acetaminophen.

The FDA does an admirable job of ensuring patient safety, but its power is limited. The ultimate responsibility lies with the consumer. People need to be aware that anything they choose to ingest will impact their health and their body in one way or another. Consumers should do their best to stay well informed, and be aware of what they eat and what medicines they take. So, as a consumer and concerned citizen, please remember to be aware of any medications you may be taking, as well as their dosages. When in doubt, do not hesitate to call your physician or speak to a pharmacist prior to taking any medication.

Sources:
[1]Foxhall, Kathryn. “FDA May Restrict Acetaminophen.” WebMD. 01 Jul 2009. Accessed: 13 Jul 2009.
http://www.webmd.com/pain-management/news/20090701/fda-may-restrict-acetaminophen?page=2

[2]Beck, Melinda. “Taking Pains With a Painkiller.” Wall Street Journal. 10 Jul 2009. Accessed: 13 Jul 2009.
http://online.wsj.com/article/SB10001424052970203577304574272292331942618.html?mod=googlenews_wsj

[3] Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoephedrine, Ephedrine, and Phenylpropanolamine. Food and Drug Administration. 25 Apr 2006. Accessed: 13 Jul 2009
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm072423.htm