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FDA Cites Glaxo for 'Misleading' Letters

money.cnn.com

Government regulators have criticized GlaxoSmithKline for downplaying the risks of its breast cancer drug Tykerb, while exaggerating the benefits, in letters to doctors.

The Food and Drug Administration scolded Glaxo over "misleading" promotional materials urging physicians to prescribe Tykerb, a daily pill for patients with advanced breast cancer. FDA posted the Nov. 21 warning letter to its Web site Monday.

Regulators said Glaxo hasn't adequately alerted physicians to Tykerb's risks, including reduced pumping action of the heart's lower left chamber. The drug's label instructs doctors to monitor patients' heart strength before and after starting treatment with Tykerb, but FDA says that information was left out of Glaxo's marketing letters to doctors.

The FDA says London-based Glaxo also omitted precautions and warnings to pregnant women and patients with liver disease.

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