FDA Cites Glaxo for 'Misleading' Letters

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 sent to physicians in March after the approval of 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.

Regulators also cited Glaxo for exaggerating the effectiveness of Tykerb. The drug was approved based on two assesments of a large, patient study of the drug: one assesment showed a 43 percent decrease in patients' risk of tumor growth and another that showed a 28 percent decrease. However, the materials from Glaxo only highlight the assesment with the 43 percent reduction, according to FDA.

The FDA has asked Glaxo to stop distributing the letters and to outline a plan for correcting its marketing message by Dec. 6. FDA warning letters are not legally binding, but the agency can take companies and individuals to court if the warnings are ignored.

A spokeswoman for Glaxo said the promotional letters were first issued after Tykerb's approval in March, and have not been used since then.

"We will work with the agency to address its concerns," said spokeswoman Sarah Alspach.

Shares of GlaxoSmithKline plc rose 8 cents Tuesday to $50.28 in morning trading.