Lost in Transmission–Key Facts Not Found in PDR

Critical details about drug safety and effectiveness are often missing from the official prescribing information. That’s the conclusion of two Dartmouth researchers writing in the New England Journal of Medicine.
Dr. Lisa Schwartz and Dr. Steve Woloshin scoured clinical trial data submitted to the FDA for drug approval. They found that some important information was missing from the official label. For example, a drug called Zometa prescribed to cancer patients was tested at both 4 and 8 mg doses. The higher dose was no more effective but significantly more harmful. It was more likely to cause kidney damage and death. The label as published in the Physicians’ Desk Reference (PDR) did not fully reflect the severity of the danger.
Another example of inadequate information on the label was described with the sleeping pill Rozerem. The clinical trial data revealed that the drug did not improve sleep quality, total sleep time, number of awakenings or the ease of falling back to sleep. It did shorten the time it took to fall asleep by 7 to 14 minutes, making its approval a squeaker. The label, however, does not reflect the marginal nature of its benefit. Schwartz and Woloshin call for the creation of Prescription Drug Fact Boxes with easy to read tables of benefits and harms.
[New England Journal of Medicine, Oct. 29, 2009]