Latest ‘black box’ asthma treatment gets FDA okay

Marcus Faulk was just 20 when he took a deep breath from an inhaler that was supposed to help control his asthma.

Moments later, he was dead.

Marcus was just one of millions of asthmatics being prescribed a dangerous class of long-acting beta agonist (LABA) inhalers – powerful drugs that may be killing four times as many people as asthma itself.

Even the FDA admits it will be two more years before it fully understands just how dangerous these LABA inhalers are.

But our government is using a reckless scientific gamble to keep LABA inhalers on the market and in our medicine cabinets. In fact, it may have just given the greenlight to another potential killer.

Leaving us breathless

The warning label for GlaxoSmithKline’s COPD drug Breo Ellipta doesn’t just warn. It threatens and practically screams in big bold letters:

RISK OF ASTHMA-RELATED DEATH.

That’s not exactly the kind of warning you want to see on your asthma inhaler.

But when the FDA recently approved Breo for asthma, it continued a long and dangerous game it’s playing with millions of lives.

You see, everyone understands that LABA inhalers like Breo, Advair and Symbicort can be deadly. They can force your bronchial passageways to swell up like a balloon – a sensation one user compared to having your lungs collapse.

Back in 1994, a major trial called SMART had to be cut short because it found LABA inhalers were causing a huge spike in hospitalizations and deaths.

And around 10 years ago, researchers from Cornell and Stanford estimated that for every five asthma-related deaths, four were being caused by LABA inhalers.

Stanford professor Shelley Salpeter said she was particularly worried that the drugs were endangering lives and “worsening asthma control without any warning.”

But instead of taking LABA inhalers off the market, the FDA limped into action with two new ideas.

First, it demanded that a black-box label be put on LABA meds warning that they could cause asthma-related deaths. (Remember, many of these are drugs prescribed to treat asthma!)

And then the FDA decided that LABA drugs should only be used by asthmatics when combined with an inhaled corticosteroid like Flovent or Beclovent.

There was no proof that this combination would make LABA inhalers any less deadly. And, believe it or not, no one will know for sure until a major study wraps up in 2017.

But the FDA decided to act on a hunch – and wager with your life – while keeping LABAs on the market and approving new drugs like Breo.

Of course, not everyone is so confident that the deadly problem with LABA inhalers has been fixed. An FDA advisory panel voted 18-2 to ban Breo for kids under 17.

And one of the votes in favor of Breo was cast accidentally.

When a major public health group testified before the FDA last month, it asked that the agency not even think about approving Breo until the 2017 study results come in. It said the FDA should wait to learn more about its “potentially life-threatening risks” before putting it on the market.

But the FDA turned a deaf ear and cleared Breo with its well-inked rubber stamp.

If your doctor recommends Breo for your asthma (or if you’re currently taking any other LABA drugs like salmeterol, formoterol, arformoterol and vilanterol), here are some things you should know about and discuss with him.

• Drugs like LABAs do not take the place of a rescue inhaler.
• Even the FDA warns that LABAs should only be used for the shortest time necessary to control your asthma symptoms. Given the runaway sales for brand-name drugs like Advair and Symbicort, it’s clear that patients are being left on these drugs for extended periods.
• LABA drugs should never be added to the mix if your asthma is already well controlled. They’re not going to improve your asthma – and there’s a good chance they’ll make it worse.

Sources:

“FDA okays Breo Ellipta for asthma in adults” Megan Brooks, Medscape, April 30, 2015, medscape.com

“FDA should not rush to approve asthma treatment, Public Citizen tells advisory committee” Public Citizen, March 19, 2015, citizen.org