US FDA warns Bayer on hemophilia therapy promotion

A number of Bayer AG promotions for its hemophilia treatment Kogenate FS ae misleading because they fail to include ample information about risks and directions for use, U.S. regulators said in a letter released on Tuesday.

The Food and Drug Administration objected to letters to patients and doctors about a free trial program for Kogenate FS.

“By failing to include sufficient information on risks and adequate directions for use, you have encouraged the potentially unsafe use of Kogenate FS,” the FDA said in a letter to the company.

The agency told Bayer to stop using the letters or any similar promotions that are misleading.

The most common potential side effects from Kogenate FS include reactions at the injection site, dizziness and rash.

A Bayer spokeswoman could not immediately be reached for comment.

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