Genentech Is Warned on Omission of Drug’s Risks

U.S. regulators have warned Genentech Inc. about omitting important information in promotional materials on the potential side effects of its Nutropin growth hormone.

In a letter released Wednesday, the Food and Drug Administration said the South San Francisco-based company’s promotions omitted “risk information that is critical to the appropriate use” of Nutropin.

Studies have shown higher death rates with Nutropin, compared with a placebo when given to patients with acute critical illnesses, such as multiple accident trauma or respiratory failure.

“Therefore, the potential benefit of treatment continuation with growth hormone in patients having acute critical illnesses should be carefully assessed in light of the important risks which were not even presented in these promotional materials,” the FDA letter said.

Genentech spokeswoman Tara Cooper said Wednesday that the company was “working with the FDA to quickly rectify the situation and the items in question are no longer in use.”

Analysts said the letter probably would have little or no effect on Genentech’s stock. “Nutropin is not really a growth driver” for the company, said Adam Walsh, an analyst for Jefferies & Co.

Genentech does not break out individual sales for its growth hormone products. As a group, they generated sales of $81.6 million in the second quarter, 12.7% of total sales.

Genentech shares gained 65 cents to $79.15 on the New York Stock Exchange.

Reuters was used in compiling this report.