Friday, October 23, 2009

U.S. drug labels omit vital data

In a shocking revelation, two prominent doctors have revealed that most of the times key information telling about the extent of side-effects or the effectiveness of the medicines is excluded from the drug labels in the country.

Because of the omission of important information, the drug ultimately is presented in a way that makes it seem safer and more effective than it actually is. This was written by the doctors in a commentary in the New England Journal of Medicine.

Drs. Lisa Schwartz and Steven Woloshin of the Dartmouth Institute for Health Policy and Clinical Practice in Hanover, New Hampshire, wrote, “Much critical information that the Food and Drug Administration (FDA) has at the time of approval may fail to make its way into the drug label and relevant journal articles.”

The labels on various medicines are actually written by the manufacturers and the FDA finally gives a stamp of approval after discussing the wording.

However, some relevant information might be missing, said Woloshin. He questioned, “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?”

Examples of drug labels where key information was missing
Citing one of the numerous examples, the doctors quoted the case of Sepracor’s four-year-old sleep drug Lunesta that was promoted with an advertising campaign that cost a whopping $750,000 per day in 2007.

The company benefited very much and generated sales of $600 million last year. It even became a wholly-owned subsidiary of Dainippon Sumitomo Pharma Co Tuesday.

The label on the drug only said that Lunesta was superior to a placebo and nothing else was specified.

However, when the tests were conducted and the results were given to the FDA, it came to light that “Lunesta patients still met criteria for insomnia and reported no clinically meaningful improvements in next-day alertness or functioning,” wrote Schwartz and Woloshin.

Another such case in point is that of Takeda Pharmaceutical Co’s insomnia drug Rozerem. The label on the drug did not mention that laboratory statistics have revealed that it still took 31 minutes for adults above 64 years of age, and 24 minutes for younger adults to fall asleep once they consumed the drug.

Not only this, when clinical trials were conducted, the volunteers reported “no subjective improvements in total sleep time, sleep quality, or the time it took to fall asleep.” But all this information was not mentioned on the drug label, the researchers said.

Schwartz and Woloshin stressed in their commentary, “Sometimes what gets lost is data on harms.”

New system to make drug labels clearer in content
Woloshin believes that he and his colleagues have found a better system that can help in clarifying the extent of the dangers and benefits of the drugs to the consumers.

The FDA’s Risk Advisory Committee is also in favor of the new system and the matter will be further discussed next month.

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