The FDA is studying data from ongoing safety tests of the asthma medication Xolair, the agency’s August 2009 MedWatch Safety Alert said. Xolair (omalizumab) is an injected medication that controls asthma in patients with year-round allergies who don’t respond well to inhaled treatments. The alert said the FDA has data showing that Xolair increases patients’ chance of developing cardiovascular problems, including potentially fatal heart attacks and strokes. The agency has not yet made a decision and suggests that patients continue taking the medication, but talk to their doctors about its risks and benefits and the ongoing study.
That study, named EXCELS, compares 5,000 patients taking Xolair to a control group not taking the drug. Preliminary results suggest that the group taking Xolair had a disproportionate rate of adverse events involving the heart and brain compared to the control group. Those adverse events included ischemic heart disease, heart arrhythmia, heart failure, high blood pressure, blood clots and strokes. Xolair already has a black box warning, the strongest available, warning patients about the risk of a life-threatening allergic reaction called anaphylaxis. That threat, while rare, led to a requirement that doctors administer the drug — which was previously self-administered by patients — and observe patients for two hours after.
As a defective prescription drug attorney, I suspect that another black box warning may be ordered if the study turns up strong evidence of a link between Xolair and cardiovascular problems. The FDA has already signaled that it plans to pursue safety issues more thoroughly than it did under the last presidency, and the problems the study allegedly turned up include potentially life-threatening and disabling health problems. A stroke can not only kill, but leave patients partially paralyzed or with permanent, lifelong problems with speech and memory. (That’s on top of the known risk of anaphylaxis, which can kill very quickly if the patient does not get treatment.) The drug is not used widely, but with side effects this serious, Xolair maker Genentech and distributor Novartis could face huge liability from patients who are killed or permanently disabled by what they thought was a life-saving allergy medication.
At the Lowe Law Firm, we represent clients from around the United States who were seriously injured in this way — by taking a drug that was supposed to make them feel better. Our dangerous medication lawyers hold drug makers legally responsible for selling drugs with serious safety defects, or for failure to adequately warn patients about such defects — including documented attempts to outright suppress information. In a pharmaceutical liability lawsuit, injured patients can claim compensation for their injuries, physical pain and emotional suffering, as well as payment of all of the medical bills and lost wages the tainted drug caused. Our goal is always to get patients the best possible recovery, so that they can get the health care they need, support their families through a difficult time and eventually get back on their feet.
If you or a loved one was harmed by taking Xolair or any other prescription drug, you should call our dangerous drug lawyers as soon as possible for help. For a free consultation on your injuries and your rights, please contact us online or call 1-877-678-3400.