Sept. 29, 2014 -- A safety study done by the maker of the asthma drug omalizumab (Xolair) suggests it poses slightly increased but serious risks for heart attacks and mini-strokes known as TIAs (transient ischemic attacks), the FDA says.
Because of certain "weaknesses" in the 5-year study, the FDA says it is "unable to definitively confirm or determine the exact increased level of these risks with Xolair."
Omalizumab, also approved to treat a type of chronic hives, already carries a boxed warning on its label about the risk for a rare but potentially life-threatening allergic reaction called anaphylaxis. The FDA says it will add label information about the new potential risks, which include chest pain and blood clots.
The safety study did not find that people taking omalizumab had a higher rate of death from ischemic stroke or heart disease compared to people not taking it, though.
Also, the FDA will revise the drug's label to say it cannot rule out a potential risk for cancer. It noted that some earlier clinical trials spotted a slightly higher cancer rate among people taking omalizumab compared to people who did not receive the drug. The new study did not uncover any difference in cancer rates among these two groups, but "limitations" in the study mean we can’t be sure there’s no difference.
More information about the announcement is available on the FDA web site.
To report problems with omalizumab, contact MedWatch, the FDA's safety information and adverse-event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online here, with postage-paid FDA form 3500, available here, or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.