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Drug Label Warnings: Consumer Beware?

For its latest health safety report, Consumer Reports Health sent staffers to spot check at five individual drugstores in its home base of Yonkers, NY, looking to see if prescription drug labels included mandated key safety warnings and if the pharmacies included the medication guides that are required by the federal government. Consumer Reports “shoppers” went to Costco, CVS, Target, Walgreens and Walmart to fill prescriptions for the generic blood thinner warfarin, also prescribed under the brand name Coumadin; the drug is used to prevent strokes and is one of the 20 most commonly prescribed drugs in the US. Their findings were alarming: 4 of the 5 pharmacies failed to provide the medication guide required for warfarin and certain other drugs. Though all of the pharmacies provided their own CMI, or consumer medication information, they differed from the FDA-approved guide for warfarin and contained conflicting warnings about drinking alcohol while taking it. Warnings are necessary for warfarin because it can cause severe, potentially life-threatening internal bleeding—it’s the second most common drug implicated in emergency room visits in the US. Adherence to drug labels, warning stickers and consumer drug information sheets varied from pharmacy to pharmacy. A certain level of variation was expected because the various pharmacy chains use different software to print labels and instructions. While the Consumer Reports findings are not nationally representative for each chain, they raise significant concern. “We were shocked by what we unearthed,” said Marvin M. Lipman, MD, chief medical adviser, Consumer Reports Health. “We found that critical warnings were absent from some drug labels and information sheets were confusing, loaded with medical jargon and sometimes unreadable due to tiny print. It’s very worrisome to think of consumers taking dangerous drugs without adequate warnings.” Dr. Lipman urges consumers who take warfarin to check with their doctor when starting a new medication or discontinuing an old one because some drugs can either decrease or augment its effect. Part of the problem, according to Lisa Gill, prescription drug editor of Consumer Reports Health, is that there’s no nationwide standard like the “Nutrition Facts” label on food packages or the “Drug Facts” information on over-the-counter medication. “Consumers probably know more about their Cheerios than their prescriptions drugs,” said Gill. While the US Food and Drug Administration (FDA) requires certain details on labels such as a patient’s name and dosage instructions, it does not monitor drug labels. Instead, each state’s board of pharmacy is responsible for their overall content. And whether or not there are warnings on the bottles is left up to the individual pharmacist. “It’s my opinion that the inconsistencies and omissions on drug labels really cry out for uniformity and federal oversight. FDA regulation could solve this,” said Lipman. According to the complete report, which is available online at, there are approximately 1.5 million preventable medication errors each year, one third of which take place outside of hospitals where consumers must fend for themselves and rely on their own ability to follow instructions. Research suggests that many consumers are confused by the printouts that come with their prescriptions and rely heavily on the label that’s attached directly to the bottle. “From a consumer safety point of view, it all comes down to the label on the bottle, though we still urge consumers to read all materials that come with their prescriptions,” said Gill.? Some highlights from the report: Four of the five pharmacies failed to provide a federally mandated medication guide that is required for certain drugs, including warfarin. The prescription filled by Target included four warnings printed directly on the label and a directive to “read the medication guide that comes with this medicine.” Walgreens also had four warnings printed on the label; CVS had three warnings printed on the label; Costco had two warning stickers positioned sideways on the bottle; and Walmart had no warnings of any kind on the bottle. However, a second trip to Walmart did yield three warning stickers on the bottle, as did a third trip to another Walmart in the area. All of the pharmacies provided their own patient materials, known as consumer medication information (CMI). However, they differed from the FDA-approved guide for warfarin and they contained conflicting warnings about alcohol. While Costco and CVS advised patients to “limit or avoid alcohol,” the FDA approved guide recommends abstaining from alcohol all together. Target’s bottle design and labels stood out from the pack, thanks to the chain’s triangular containers, which provide ample space for detailed instructions. The drug information is in large type, the pharmacy details are small and at the bottom of the label, and there’s space for multiple warnings and instructions on the back of the bottles. The Consumer Reports Health investigation suggests that consumers need to be on their guard, particularly when starting a new medicine and their experts recommend following these steps to stay safe:
  • Understand the basics of your medication. Talk to your doctor about how much you should take, when and how often. Take time to talk to the pharmacist—even if he or she seems busy, ask all your questions.
  • Ask about drug interactions. Should any foods, any alcohol, any other medications, supplements and vitamins be avoided?
  • Ask about possible side effects, both common and rare.
  • Read the patient information sheets that accompany your prescription.
  • Know if and exactly when you can stop taking the medication. Some drugs, like antibiotics, should be taken until they’re finished. You might be able to discontinue other medication as you feel better.