Report: Some Drugs Sold Without Safety Information

June 28, 2011-- Drug labels often lack crucial safety warnings, according to a new investigation by Consumer Reports. In addition, some pharmacies don't include medication guides required for some drugs by the federal government, the magazine reported.

Even within large chain stores, the drug information given is inconsistent, the researchers found.

"Our small spot check reveals major differences among the warnings on the bottle and among the patient information material," says Lisa Gill, prescription drug editor for Consumer Reports Health. "It's shocking that the FDA medication guide was not included in four of the five prescription bags."

"Consumers need to be ever vigilant, especially when you consider how many medication errors there are," she says. About 1.5 million preventable medication errors occur each year, according to Consumer Reports. About one-third of those occur outside of hospitals.

The new report follows a Supreme Court decision last week ruling that consumers cannot sue makers of generic drugs under state law for allegations of inadequate warnings. The ruling was necessary, the justices said, because state law has to yield to federal law. Some state laws require changes or updates as new information about drug risks are discovered, which might happen years after name-brand drugs have come on the market but soon after generics do. However, federal law requires warning labels on brand and generic drugs to be identical.

Missing Medication Guides

The investigation focused on two topics. The researchers looked at whether drugstores provided a federally mandated medication guide required for certain medicines. They also looked at information given to consumers -- on drug labels, warning stickers, and printed information -- to see if it varied from store to store.

The investigators filled a prescription for warfarin. It is a blood thinner and a commonly prescribed drug.

They went to pharmacies in these stores:

• Costco
• CVS
• Target
• Walgreens
• Walmart

Four of five pharmacies did not provide the federally mandated medication guide required. It is required for warfarin and more than 130 other drugs. 

"Costco got it right," Gill tells WebMD.

When Consumer Reports asked representatives from the other four stores what went wrong, it heard from Target and CVS that the information is automatically printed out but it somehow didn't make it to the consumer.

"Walmart and Walgreens did not respond" to calls from Consumer Reports, Gill says.

When the researchers looked at the information provided, they found it varied from store to store, and even from the same store.

• Target had four clear warnings.
• Walgreens had four warning stickers.
• CVS has three warning stickers.
• Costco had two.
• Walmart had none. (On two later visits, Walmart had three warnings each.)

All the pharmacies did provide their own patient materials, Gill says. However, they differed from the guide approved by the FDA for warfarin. They also had conflicting information about alcohol. Two stores advised customers to limit or avoid alcohol. But the FDA guide recommends not drinking alcohol at all when on the drug, according to Consumer Reports.

Also, sometimes the font size used in printed material was so small it was difficult to read. Medical jargon was another problem.

Part of the problem, according to Consumer Reports, is that there is no nationwide standard, similar to the Nutrition Facts labels on food packages or the Drug Facts labels on over-the-counter medication. Instead, each state pharmacy board sets the rules, the report says.