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Drug Labels Omit Important Information

Oct 22, 2009 | Parker Waichman LLP

Prescription drug labeling is making headlines today. The Baltimore Sun reports that medical professionals may not always be aware of prescription drug benefits and side effects because important information is often not present on medication labels, citing the New England Journal of Medicine. According to Reuters, labeling information can make a drug appear to be safer than it actually is because labeling in the United States often leaves out side effect severity information or that a medicine has limited efficacy.

Manufacturers write the package insert information for medications, which are then submitted to the Food & Drug Administration (FDA) for approval. Drug companies provide the FDA with supporting documentation regarding the medications’ information; however, doctors do not always receive the necessary data because details have been omitted, reported the Baltimore Sun. Dr. Lisa M. Schwartz and Dr. Steven Woloshin of the Dartmouth Institute for Health Policy and Clinical Practice wrote the article describing the issue.

The authors cited Sepracor’s sleep medication Lunesta, pointing out that the drugs’ sales topped $800 million last year, wrote the Baltimore Sun. Lunesta’s labeling simply states it is better than a placebo, but does not indicate by how much. An agency review on Lunesta studies revealed that, yes, the drug performed better than a placebo, but in one test only, said the Baltimore Sun. Typically patients taking Lunesta had trouble falling asleep and were not more alert upon waking, the Baltimore Sun added.

Referring to results provided to the FDA on the “largest and longest study,” Schwartz and Woloshin wrote "Lunesta patients still met criteria for insomnia and reported no clinically meaningful improvements in next-day alertness or functioning," quoted Reuters. Reuters explained that labeling problems can make a drug appear either safer or more effective, citing the New England Journal of Medicine commentary. "Much critical information that the Food and Drug Administration has at the time of approval may fail to make its way into the drug label and relevant journal articles," wrote Drs. Schwartz and Woloshin, quoted Reuters. Manufacturer-written labeling is negotiated with the FDA and, said Woloshin in a telephone interview with Reuters, critical information can be left out. "How can I decide if the potential harms of this drug are worth the risk if I don't know how well the drug works, and vice versa?" he asked.

Reuters also discussed Rozerem, an insomnia medication marketed by Takeda Pharmaceutical Company. In this case, labeling omitted laboratory information that found it took a full 31 minutes for adults age 64 and older and 24 minutes for people under the age of 64, to fall asleep after taking Rozerem. Those taking a placebo fell asleep in 38 minutes. Participants also reported, quoted Reuters, "no subjective improvements in total sleep time, sleep quality, or the time it took to fall asleep."

"Sometimes what gets lost is data on harms," said Schwartz and Woloshin, referring to Novartis' cancer medication Zometa.  "Sometimes what gets lost is data on harms," said Schwartz and Woloshin, referring to Novartis' cancer medication Zometa. The drug was approved in a 4 milligram dose and labeling warned that a higher 8 milligram dose had shown increased kidney toxicity during testing. However, the label did not include detailed data from FDA review documents about increased death rates with the higher dose. In 2007 the FDA added strengthened instructions not to use a dose higher than 4 milligrams, but the label still does not include information on death rates associated with an 8 milligram dose.

According to Woloshin, he and his team developed a better labeling format that was unanimously endorsed by the FDA's Risk Advisory Committee last year; a meeting on the issue is scheduled for November, said Reuters.


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