FDA says you can stay on killer drug forever

Our government has just given one of the largest drug makers on the planet a license to kill.

And if you or someone you love has suffered a heart attack or has angina, you could be the next victim.

It’s been four years since AstraZeneca somehow won approval for its dangerous blood thinner Brilinta — a drug that may be the worst ever submitted to the FDA. It’s so dangerous, patients weren’t supposed to take it for longer than a year.

But now the FDA has just given the green light for you to be put on Brilinta for the rest of your life.

And if you don’t act fast, this deadly med could end up killing you — and your doctor will be practically powerless to help.

Blood moneyAstraZeneca’s marketing brochures for Brilinta ought to carry the old Timex slogan: “It takes a licking and keeps on ticking.”

Because Brilinta has had more scandal, disgrace and discredit heaped on it than any drug ever allowed on the market by the FDA.

The big trial that got it approved in the first place, called PLATO, came complete with data that was so garbled and fudged, an FDA official called it “the worst submission” he’d ever seen. It was such a sham that researchers claimed 12 patients who died during the trial reported their own deaths by phone!

That’s how desperate they were to quit Brilinta!

And with good reason. Brilinta can cause uncontrolled bleeding — and unlike other blood thinners on the market, such as warfarin, there’s no antidote to stop it.

So you would think with all that went on with Brilinta, the FDA would have kept it off the market. Or at least have the backbone to stick to its original decision to only let patients stay on it for 12 months.

But instead, when AstraZeneca asked for an approval to give you the drug for three years, the FDA did them one better and said patients could take the drug forever instead.

It’s like they were raising each other in a game of poker — except they were betting with your life!

So what’s this hot new science that led our government to suddenly believe Brilinta was safe? Well, you’re going to want to be sitting down for this one.

This new approval was based on another trial, called PEGASUS. And anyone who could look at the data and think Brilinta is safe for extended use must also believe horses can fly.

Almost 8 percent of the Brilinta patients suffered a stroke, heart attack or died during the trial, compared to 9 percent who took a placebo. That’s a measly 1 percent difference!

But here’s the worst part. Those who took the drug, along with daily low-dose aspirin (a combo the FDA has also approved), had over double the risk of suffering a “major bleed.”

And, again, there’s no antidote!

But none of that is standing in the way of AstraZeneca pushing Brilinta on every doctor its sales team can get its hands on. Even before the FDA announcement, the company was said to have hundreds of sales reps, including more than 150 cardiovascular nurses, “champing at the bit” to start talking it up to docs.

And that’s the real risk here. Because once a drug has been approved for permanent use, it develops what the head of Brilinta marketing calls the “halo effect.”

In other words, doctors come to see the med as safer than it is. And with a drug like Brilinta, that couldn’t be more dangerous.

This was a cash grab, plain and simple. The new approval could be worth $3.5 billion a year for AstraZeneca, and one expert said this is going to “breathe new life into the drug.”

But if your doc recommends Brilinta, make sure you tell him you want something else instead. Because once you start popping this med, breathing new life into you could be a lot more difficult.

Sources:

“AstraZeneca scores FDA nod for long-term Brilinta use” Carly Helfand, September 4, 2015, FiercePharma, fiercepharma.com