How some FDA regulations can actually be a hazard to your health

 

The hidden risks of generic drugs that you won’t hear about from your doctor or pharmacist

Warning: those generic drugs that your health plan forces you to take have a dangerous secret.

They can have serious, possibly life-threatening risks. And you’ll never hear about them, thanks to long-standing FDA laws.

Laws that are letting these dangers slip through the cracks.

And if you are harmed because of one of these bad drugs, well, don’t expect to get your day in court either. Because the industry is protected from that, too.

It’s a win-win-lose situation. And you can guess who the losers are…

It’s called a “safety gap.” But where your health is concerned, it’s more like the Grand Canyon.

We’ve all taken generic drugs — over 80 percent of the prescriptions filled in the U.S. are for them. They cost less, so your health plan sees it as a great place to keep the budget in line.

But the rules are very different for generics. And those rules all favor the companies that make these cheaper versions.

You know that new drugs are especially risky to take because they still have unknown side effects. But what about old ones? Often, terrible, deadly reactions take years or even decades to come to light. And when that happens, the FDA requires that warnings be added to the packaging.

And if the risk is serious enough, your doctor will be notified.

But… if your drug is one of the over 400 generics on the market that is only available in generic form, well, don’t expect to hear about any new dangers that might be discovered.

That’s because the FDA actually prohibits the drug maker from telling you or even sending a letter to your doctor about them.

It’s true! And it’s all because of an old, crazy law that lets these generic drug companies get a free ride…all at the expense of our health.

So these companies have their hands tied — but they love it that way. That’s because they can’t be held responsible if you’re harmed by one of their drugs due to this kind of “label malfunction.”

So, let’s get this straight. A company makes a drug, learns of a danger from that drug but doesn’t have to warn anyone about it, and has no liability when someone is injured or dies as a result. What a way to do business!

As I said, there are hundreds of these drugs being sold that are in this generic “twilight zone.”

Take the popular allergy drug promethazine hydrochloride (originally called Phenergan). During the time when it was still made by the company that held the patent, reports of different bad reactions caused the drug maker to keep adding new warnings. One was a black box warning that it can kill children under two.

The last warning added was about the risk of gangrene with an injection. But after that, the original manufacturer bailed out. That leaves only generic versions of this drug available.

And now, no one will be the wiser if a new danger from this rogue drug emerges.

Another example is isotretinoin, which you know of as Accutane. This risky drug is used to treat acne, and was first approved in 1982. Over the years, horrible side effects have been reported.

In 2009 the original drug company gave up making it. There were just too many lawsuits. So the only kind still on the pharmacy shelf is the generic version. And now, no one’s even looking to see what other side effects might pop up — because no one has any responsibility for them!

I know you must be wondering what you can do about this. I mean, if your doctor and pharmacists aren’t even being told about these dangers, how will you ever know?

Really the only possible way to avoid this is to ask your doctor if a name-brand version is available. If the answer is no, ask for a different Rx. Or, if you can, skip the script altogether.

 

Sources:

 

“Inability of generic drug manufacturers to warn of newly discovered hazards puts patients at risk; serious safety hazards often take years to emerge” PublicCitizen, citizen.org