Important Information in Prescription Drug Labels

When Public Citizen’s Health Research Group evaluates and writes about the risks and benefits of prescription medications, one of the many sources we review and often reference is the product labeling or drug label approved by the Food and Drug Administration (FDA). But what is a drug label? The answer is not as obvious as it seems.

Drugs often are dispensed to consumers accompanied by many different types of written information, including writing on the packages or prescription bottles, information sheets from the pharmacy or patient guides placed inside the drug’s packaging by a manufacturer.

Yet these materials are unlikely to include the official professional label that the FDA has reviewed and approved. Instead, patients routinely receive an unofficial, non-FDA-approved information leaflet, sometimes referred to as a patient information leaflet. These leaflets are unregulated and historically have failed to provide consumers with useful, scientifically accurate information about the safety or effectiveness of their medications.[1]

Professional labels, by contrast, are generally scientifically accurate and highly regulated, but they are written in technical language and intended to be read by doctors and other health care professionals. Moreover, they traditionally have been accessible mainly through publications targeted at doctors and nurses. That has changed in recent years, and consumers are now able to access professional drug labels directly online.

The details found in a drug’s professional label can be useful to patients but are frequently difficult to understand. Also, some parts of the label may be more helpful than others. Knowledge about these drug labels can be an important tool for consumers seeking to improve their health while avoiding drug-induced injuries.

Finding FDA-approved professional drug labels

The government online resource that is probably the easiest for consumers to use is the DailyMed website, which is available at dailymed.nlm.nih.gov. The DailyMed website offers a complete, up-to-date database of drug labels that can be searched by a drug’s brand name or active ingredient.

For consumers without a computer, you can ask your pharmacists for a copy of the FDA-approved “package insert,” but they may not have a copy available, and many pharmacists routinely will provide only a non-FDA-approved patient information leaflet instead. As an alternative, consumers can view and print the professional drug label directly using public computers at the library (or by asking a friend or relative with a computer). To print a label from the DailyMed website, click on the text “OFFICIAL LABEL (PRINTER FRIENDLY)” near the top of each drug label’s webpage at DailyMed.

Searching DailyMed often yields multiple listings for the same drug, and not all of them are up to date. You can check how old a label is by looking at the date it was last updated, which can be found on the top right of the drug label’s DailyMed webpage or at the bottom of the first or last page of the printed label.

Key sections of the drug label

Here are some of the most important sections to read in a drug’s professional label.

Black-box warnings

When present, the most important part of the drug label is the warning that sometimes appears in a box at the top (sometimes called the “boxed warning” or “black-box warning”). The FDA requires such warnings on certain drugs to highlight risks of particularly serious, often life-threatening adverse effects that are important enough to lead health care professionals to consider not prescribing the drug for certain patients or to prescribe it only after taking precautions to reduce the risk of these adverse effects.[2]

Indications and usage

Another important section of the label is titled “Indications and Usage.” This section describes the uses, or indications, for which the FDA has reviewed and approved the drug. For example, the label for digoxin (LANOXIN) explains that it is used to treat heart failure in adults and children and to control the heart rate in adults with chronic atrial fibrillation (a common abnormal heart rhythm characterized by an irregular and often rapid heartbeat).[3]

Contraindications, warnings and precautions

Other sections of the professional drug label provide additional important information about a drug’s most serious risks.

The “Contraindications” section describes patients who should not use the product at all because serious risks clearly outweigh any possible benefit. For example, the epilepsy drug valproic acid (available in generic only) generally is contraindicated in patients with liver disease or significant liver dysfunction because the drug can cause potentially fatal liver failure in such patients.[4]

The “Warnings and Precautions” section describes serious adverse effects that could result in death, life-threatening adverse effects, hospitalization, long-term disability or birth defects, or are otherwise important enough to potentially affect treatment decisions regarding use of the drug.[5]

Adverse reactions

The section of the label titled “Adverse Reactions” includes an often lengthy list of less serious but potentially common adverse effects. Common adverse effects, such as insomnia or constipation, may be listed in this section even if there may only be weak evidence that the drug causes the symptoms.[6]

Tables in this section frequently show how often a particular symptom occurred in clinical trials of the drug. If a symptom was much more common among subjects taking the drug than among those taking a placebo, it is more likely that the drug was responsible for that adverse effect. (Generally, however, clinical trials may not involve enough subjects to confirm that the drug causes the adverse effect with statistical certainty.) For example, in clinical trials of the antidepressant venlafaxine (EFFEXOR XR), nausea was approximately three to 10 times more common in subjects taking the drug than in those taking a placebo — strong evidence that the drug causes nausea.[7]

Medication Guides for Patients

Some prescription drugs have FDA-approved Medication Guides intended specifically for patients that simplify and summarize important information about the drug that can help patients avoid serious adverse events. Pharmacists are supposed to provide these guides to patients each time such drugs are dispensed but sometimes fail to do so.

The FDA has a webpage at https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=medguide.page that provides a list of drugs that have Medication Guides; the complete guides can be read and printed.

What You Can Do

If you are taking a prescription drug, chances are you have not yet read its professional label. Keep yourself better informed by visiting DailyMed to download the label or by asking for a copy of the FDA-approved label at the pharmacy. Also, talk to your health care professional if you have any questions about information in the drug label.
 

References

[1] Public Citizen. Testimony on the status of written prescription drug information for consumers. July 31, 2003. https://www.citizen.org/article/testimony-on-the-status-of-written-prescription-drug-information-for-consumers/. Accessed May 10, 2021.

[2] Food and Drug Administration. Guidance for industry: Warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products — content and format. October 2011. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm075096.pdf. Accessed May 10, 2021.

[3] Concordia Pharmaceuticals Inc. Label: digoxin (LANOXIN). February 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020405s015lbl.pdf. Accessed May 10, 2021.

[4] Eywa Pharma Inc. Label: valproic acid. May 2020. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=dcce9cbd-ab6d-4ddf-b638-74e336ebc3d8&type=display. Accessed May 10, 2021.

[5] Food and Drug Administration. Guidance for industry: Warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products — content and format. October 2011. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm075096.pdf. Accessed May 10, 2021.

[6] Ibid.

[7] Pfizer, Inc. Label: venlafaxine extended-release (EFFEXOR XR). December 2018. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=53c3e7ac-1852-4d70-d2b6-4fca819acf26&type=display. Accessed May 10, 2021.