New drug warning: Steer clear of this brand new Rx with a dangerous ‘family history’

Believe it or not, it looks like type 2 diabetics are being pushed into Big Pharma’s crosshairs…again.

Worse than sugar, bread or alcohol…I’m starting to think the most dangerous thing for diabetics IS the FDA.

Last week it approved yet another dangerous diabetes drug. A drug whose risks I want you to know about now, before it even hits the pharmacy shelf.

We already know just how risky a similar drug is. And this new one doesn’t look much better.
So here’s what you need to know before your doctor brings out his Rx pad…

I’ve warned you about the unknown risks of taking new drugs. But this new one comes with a bad ‘family history’ to begin with.

This latest arrival is called Tanzeum, and it’s designed to mimic a hormone that causes your pancreas to release insulin. You have to inject it once a week.

While Tanzeum may be the ‘new drug in town,’ it’s a member of the GLP-1 gang, which has some skeletons in its closet. Skeletons like cancer, including a rare kind of thyroid cancer, and pancreatitis, which can be deadly.

Back in 2009, I first sounded the alarm about another risky GLP-1 injectable called Victoza. Victoza proved to be so dangerous that, in 2012, Public Citizen sent a petition to the FDA asking that it be removed from the market immediately. The group said that it “puts patients at higher risk of thyroid cancer, pancreatitis (and) serious allergic reactions.”

But on March 25, the FDA sent Public Citizen a letter saying its “request” to halt sales of Victoza “is denied.”

Three weeks later it approved Tanzeum.

And the warnings on the Tanzeum package — including the black box warning about thyroid C-cell tumors — almost look like a Xerox copy of those on the Victoza label!

Could that be why the FDA refused to consider the Public Citizen petition? Because it was just about to approve yet another drug in the exact same family with the exact same risks?

Now, don’t think the FDA isn’t fully aware of these risks.

And wait till you hear how it decided to deal with them!

It’s allowing GlaxoSmithKline, the maker of Tanzeum, to conduct a 15-year study for a rare kind of cancer called medullary thyroid carcinoma. You read that right — 15 years! A full decade and a half after it’s released to doctors, the manufacturer will get back to the FDA to report on how many deadly cancers have turned up!

And that’s not the only thing the FDA wants to hear about…only later, much later.

Glaxo will also be reporting back to the FDA about the heart risks of Tanzeum. But again, not until after this drug has been on the market for years.

Oh, and the FDA did have another condition for Tanzeum’s approval. Glaxo must have a “risk evaluation and mitigation strategy,” called REMS in place, which consists of “a communication plan to inform health care providers about the serious risks associated with Tanzeum.”

“Serious risks” that will come with every prescription filled for Tanzeum. And by 2029, you can bet there will be a lot of them.

Sources:

“UPDATE 1-FDA approves GSK’s Tanzeum to treat type 2 diabetes” Esha Dey, April 15, 2014, Reuters, uk.reuters.com

“GSK receives US approval for once-weekly type 2 diabetes treatment, Tanzeum (albiglutide)” GSK press release, April 15, 2014, gsk.com

“Debate on diabetes drugs gathers pace” Amy Maxmen, April 30, 2012, Nature news, nature.com


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Allan Spreen, M.D.
Dr. Allan Spreen, Chief Medical Advisor

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