Dangers of asthma med concealed, then hidden on label

Revealed: FDA hides deadly risk for more than 5 years

Dear Reader,

It’s one of those “miracles” of genetic engineering, a high-tech “humanized” antibody, made from hamster ovary cells.

So it shouldn’t be a surprise that there were worries about it from the get-go. Alarms that the FDA pushed aside in its rush to meet approval deadlines.

But despite suspicious cases of cancers and lab monkeys showing a dangerous drop in blood platelet levels, Xolair was approved for allergic asthma back in 2003.

Then in 2009, after more than 6 years of Rx’s, more fears came to light. Things like heart disease, strokes, blood clots, and deadly heart rhythms.

But moving at the speed of dark, the FDA said it would get back to us after reviewing the data.

Now, another five years later, we’ve just heard back.

And what we’re hearing is frightening, even by Big Pharma standards.

Even before these “new” warnings came out, the Xolair package featured a black box warning for one of the most feared of all drug reactions: anaphylactic shock.

Xolair managed to make it to the very top of the FDA’s list for drugs that cause anaphylactic shock and severe hypersensitivity.

But 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 shots can only be given in a doctor’s office. 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. The Institute for Safe Medication Practices says that patients are “paying a substantial price for a drug with a modest effect on allergic asthma.”

But now we know even more about what that “price” may be.

The industry-generated data shows that this drug can significantly up your risk of problems with your heart and brain. Problems like clots, heart attacks, mini strokes, chest pain, and life-threatening pulmonary hypertension.

Those are the same risks the FDA was mulling over in 2009 — all while billions was being raked in by drug makers Novartis and Roche.

Now these big risks — finally acknowledged by the FDA — can’t be found in that black box already on the Xolair package.

You’ll 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.

But it gets even 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.

This spring, it approved Xolair for another condition — one called chronic idiopathic urticarial, 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…

Sources:
“FDA slaps cardiovascular warnings on Roche/Novartis asthma blockbuster Xolair” Arlene Weintraub, September 29, 2014, FiercePharma, fiercepharma.com