Say what? Pharma stockholders are first to be warned about deadly drug

AMAG Pharmaceuticals was sure it had a blockbuster on its hands.

Six years ago, the FDA signed off on AMAG’s new iron-boosting drug, Feraheme.

It’s given as a quick injection. It was supposed to make slow, IV iron treatments a thing of the past. And if you had anemia due to kidney disease, this was the drug that was going to change your life.

But it ended lives instead.

The problems started almost immediately. People on Feraheme suffered severe allergic reactions and heart attacks – many of them even died.

You never would have known about it. But a group of whistleblowers came forward to expose Feraheme’s risks and how AMAG’s management allegedly swept the drug’s dangers under the rug.

These whistleblowers weren’t scientists or even doctors – they were Wall Street investors.

Money talks

The FDA just got around to issuing an urgent warning on Feraheme. But investors have been sounding the alarm for years.

Unbelievably, as patients were dropping dead after taking Feraheme, the only people complaining were enraged stockholders worried they were about to lose money on AMAG stock.

Less than 90 days after Feraheme hit the market in 2010, three investment firms filed a lawsuit claiming that AMAG hid “serious post-marketing adverse reactions” to Feraheme from investors.

According to the lawsuit, AMAG even knew about Feraheme deaths, but kept them quiet.

So how did these investors know about the risks of Feraheme when doctors, patients and the FDA didn’t?

When investment firms spend millions of dollars on stock, they pay researchers to monitor their investments closely. And these Wall Street researchers were examining Feraheme and AMAG a lot more closely than the FDA scientists charged with keeping you safe.

Because while investors knew about Feraheme’s dangers in 2010, it wasn’t until last month that the FDA ordered a black box warning on the drug.

The warning claims that Feraheme can cause severe, life-threatening allergic reactions – the very problem AMAG investors have been screaming about.

If you suffer from anemia, especially from kidney disease, here are the most important things you need to know about this drug – things that your doctor may not have heard about yet (that is, unless his stockbroker told him):

• Any prior allergic reaction to any iron drug makes the use of Feraheme very risky. Over half of the patients who had an allergic response to the med had one or more drug allergies to different kinds of pharmaceuticals.
• The drug is now only to be administered as an IV infusion, and for a minimum of 15 minutes. This is in stark contrast to the fast-injection method the FDA originally approved.
• The drug should only be administered in a setting where you can be observed for at least 30 minutes after an infusion.

Remember, IV iron therapy can be risky. Make sure that all other options to treat your anemia have been thoroughly discussed with your doctor before using this method of treatment.

Sources:

“FDA orders stricter warnings for ferumoxytol (Feraheme)” Alicia Ault, March 30, 2015, Medscape, Medscape.com

“FDA Drug Safety Communication: FDA strengthens warnings and changes prescribing instructions to decrease the risk of serious allergic reactions with anemia drug Feraheme (ferumoxytol)” U.S. Food and Drug Administration, March 30, 2015, fda.gov