Xolair is an injectable drug that was first approved for allergic asthma back in 2003. However, from the get-go concerns were raised about this drug and despite suspicious cases of cancers and lab monkeys showing a dangerous drop in blood platelet levels, the American Food and Drug Administration (FDA) pushed forward with its approval.
Then in 2009, more fears came to light with things like heart disease, strokes, blood clots, and deadly heart rhythms. Moving at a snail’s pace the FDA reviewed the data and another five years later, we’ve just heard back… and what you’re about to hear is frightening, even by Big Pharma standards.
Read the (very) fine print
Back in 2003, Xolair was released onto the market with a black box warning for one of the most feared of all drug reactions: anaphylactic shock. In fact, Xolair managed to make it to the very top of the FDA’s list for drugs that cause anaphylactic shock and severe hypersensitivity.
What’s even more frightening is how it can come on. While a life-threatening allergic reaction from Xolair can happen after the first dose, you can also get one after the second… or third… or fourth.
In fact, you can go into severe shock at any time after taking the drug – even after a year or more of treatments.
That’s why Xolair injections can only be administered by a doctor. And then you have to sit and wait for “some time” to see if you need emergency care.
With all those precautions in place, people have still died from shock after getting a Xolair shot… and now, based on the industry-generated data reviewed by the FDA, we also know that this drug can significantly increase your risk of blood clots, heart attacks, mini strokes, chest pain, and life-threatening pulmonary hypertension.
The problem is that these risks – finally acknowledged by the FDA – can’t be found on that black box warning that’s already on the Xolair package.
But you will find them hidden, way, way down in a part of the label called “adverse reactions.” But you’d have to scrutinize that label with a magnifying glass to find it.
It gets worse.
The FDA says that this heart and brain study had so many “weaknesses” that it’s not even sure just how big the risk is!
So, of course, they decide to err on the side of danger… and they didn’t stop there. In the midst of all this uncertainty about how dangerous a drug Xolair is turning out to be, the FDA had an extra gift for Novartis and Roche – the manufacturers of Xolair.
Earlier this year, the agency approved Xolair for another condition – one called chronic idiopathic urticaria, or more simply, chronic hives.
So now a whole new group of patients will be put at extreme risk for very little benefit.
The whole thing is enough to make all of us break out in hives – which was probably their marketing plan in the first place…
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“FDA slaps cardiovascular warnings on Roche/Novartis asthma blockbuster Xolair” Arlene Weintraub, September 29, 2014, FiercePharma, fiercepharma.com
“New glasses may increase risk of falls in older adults, suggests review” Science Daily, May 23, 2014, sciencedaily.com