Drug labels on pharmaceutical products sold in the US often provide an incomplete picture of the drug in several ways, a new report has stated. Information relating to the full extent of side effects that can be associated with them can be under-provided, according to the pair of doctors behind the report. Simultaneously, the labels can overrate the drugs' true effectiveness, Dr Steven Woloshin and Dr Lisa Schwartz stated in the article, published by the New England Journal of Medicine.

"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", they said.

Medication Labels

Drug manufacturers are responsible for producing the medication labels that are fixed onto their products, although the US Food and Drug Administration is involved in the wording aspect. Vital data, though, can be missed off.

For example, in 2005 pharmaceutical firm Sepracor launched a sleep aid for insomniacs called Lunesta. Lunesta's label states that it works more effectively than a placebo, but this may not be the case, according to the report. In a trial of the drug, "Lunesta patients still met criteria for insomnia and reported no clinically meaningful improvements in next-day alertness or functioning", the two doctors asserted.

Sepracor is reported to have replied that in-depth product information is available on demand.

Drug Labelling

Another insomnia medication is Takeda Pharmaceutical's Rozerem, and its drug labelling also came under scrutiny. The label provided with it did not mention the length of time that would pass between taking it and falling into a state of sleep (31 minutes and 24 minutes for people over or under the age of 64, respectively). A placebo - by way of comparison, would be expected to take 38 minutes to become effective. People who had taken Rozerem, said the study, did not feedback info highlighting "subjective improvements in total sleep time, sleep quality, or the time it took to fall asleep."

Risk-related data was also included in the report, and here Novartis came under the spotlight. Its drug Zometa, which is prescribed to patients with cancer, came at one point with a label that highlighted an elevated kidney damage risk when the medication was taken in 8mg doses. 19 per cent of those prescribed Zometa in 4mg form were noted to have died - an equal amount to those that passed away who were taking an equivalent. However, the death rate in respect of 8mg Zometa was 33 per cent. It took seven years before the drug's label was amended to fully warn doctors of the risks associated with the 8mg variety of this medication. Specifically, they were advised against issuing 8mg Zometa prescriptions in any instance.

No response to the new report has so far been provided by either Takeda or Novartis.