Your message has been forwarded to the Center for Drug Evaluation and Research (CDER), one of the seven centers within the Food and Drug Administration (FDA), for a response.
The side effects listed in the news article were reported as adverse events to the FDA. These individual adverse event case reports are available under a Freedom of Information Act (FOIA) request. For more information on submitting an FIOA request, please see
Freedom of Information
Sincerely,
Division of Drug Information
D202D
This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at FDA_Drug_Info