Problems with Xolair

I just read a story on Webmd (dated September 29th, 2014) about potential problems with omalizumab (Xolair). The makers of Xolair were conducting a safety test, and their study showed a "slightly increased but serious" risk for heart attack and mini-stroke (called TIA's or transient ischemic attacks.)

Uh oh!!

 Xolair is used for patients whose allergic asthma can't be controlled by using other asthma medications. Some doctors also use Xolair to treat chronic hives.

Son #2 has had Xolair injections for the last 7 years. He is one of the small percentage of people with asthma who has severe asthma.  Son #2 has been hospitalized 8 times, and two of those hospitalizations were ICU admissions. We did EVERYTHING the doctor would outline -what medications to take/when/how much - but he would still end up in the hospital. He would suddenly go from bad to worse.

I remember one time when Son #2 suddenly became worse in the Emergency Room - it even scared the doctor! He said, "I was right here, what happened??!!" I told him Son #2 has severe asthma and doesn't respond to asthma medication and treatments like most asthma patients. Patients with severe asthma are VERY difficult to treat.

For us, Xolair has kept our son out of the hospital. Shortly after starting Xolair injections, I noticed that when he would start to get sick, instead of thinking "Oh no! Here we go again!!", I could give him a breathing treatment - and he would actually get better!! Before he started Xolair, it didn't matter what we would do - nothing would seem to help. He would have to be hospitalized and monitored around the clock by a respiratory therapist, doctor and nurse. They would give him breathing treatments every 2-4 hours, give him an IV with powerful steroids, and monitor his breathing.

All that seemed to change once he started Xolair. BUT - every family is different. Son #2 has been slowly weaned off the Xolair injections over the last year. He seems to be doing well and his asthma doesn't seem as severe as it has been in the past.

I am VERY concerned about anything that can raise your risk of heart attack and mini stroke. 

This quote from WebMd article did catch me eye:

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." 

I wonder if the study was done correctly? Back in college, I took an epidemiology class, and we learned how to design a scientific study. It has to be done a certain way, or the results will be invalid. It makes me wonder what "weaknesses" they found in the study. I wonder if they will now have to repeat the study? 

 

I also noticed this quote from Webmd:

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. 

Hmm..... so maybe patients are having heart problems and mini strokes but recovering? The FDA report lists heart attacks and other heart problems too. It's worth taking the time to read.  It may be rare that these problems happen, but it's good to know what to watch for. 

Until then, if you are on Xolair, talk to your doctor about the risks. The FDA is adding the warning about heart problems and mini stroke to the Xolair label. In the past, the label has also had a warning about anaphylaxis and an increase in cancer.

As with any medication, it's important to weight the benefits with the risks. If you or your child is having Xolair injections, ask your doctor what they would recommend.