Newly approved drugs can be the riskiest ones of all

It’s fun to try the latest and greatest, be it a big purchase or even some crazy new gadget.

But here’s something “new” you never want to take a chance with: Big Pharma’s drugs.

It seems like every month or so, the latest Pharma invention is being heavily advertised on TV for diabetes or psoriasis or overactive bladder. The list goes on and on.

But here’s the truth of the matter: Any drug is dangerous. Its side effects can make you sicker, disable you and even kill you.

New drugs, however, can be even more dangerous.

Some just-out research has discovered that, during the time period it studied, close to one out of three new FDA-approved meds had some kind of major “safety event” during its first few years after hitting the market.

A safety event is a formal way of saying that one or more side effects caused by a drug was so dangerous, even the notoriously nonchalant FDA had to do something about it.

And most of the time, patients taking them are blissfully unaware of the storm clouds gathering over these meds.

Patients or lab rats?

Researchers from Brigham and Women’s Hospital, Yale School of Medicine and several other respected institutions took a long hard look at 222 “novel therapeutics” that the FDA had approved for the years between 2001 and 2010.

And they found during that time nearly a third of those new meds were causing side effects serious enough for the FDA to limp into action. Three were so dangerous they had to be withdrawn from the market!

One of those withdrawn drugs was an Rx laxative called Zelnorm. Three years after the FDA gave Novartis the big green APPROVED stamp on it, the Swiss government analyzed 29 existing studies that revealed those taking Zelnorm had a ten-times higher risk of suffering a heart attack or stroke.

Seriously? The Swiss had to inform the FDA about this danger?

Another was Vioxx.

The Vioxx tragedy was possibly the biggest scandal in the history of FDA-approved drugs.

Five years after Vioxx first started zipping off Rx pads, Merck was forced to withdraw the drug — but not until almost 90,000 Americans suffered heart attacks after taking it. It’s said that close to 40,000 of them died, but some put that figure much, much higher.

By 2007, Merck had paid out nearly five billion dollars to go into a Vioxx settlement fund. The drugmaker wanted to avoid thousands of lawsuits that would have further revealed how the Merck-sponsored study done before Vioxx was approved clearly found the drug could be deadly.

We usually only hear about a big danger from a drug when it’s so bad the media picks it up — but that leaves a whole lot of patients in the dark.

Out of the 222 drugs included in this latest study, the FDA required 61 of them to add “black box” warnings after their initial approval, and the agency simply issued one of its “safety communications” about the newfound risks of 59 others.

It would be great if we checked the FDA’s website or monitored its Twitter feed all the time. But for the most part, unless you scrutinize that new packaging, or your doctor is paying close attention to these announcements, you’re none the wiser.

The researchers said that the meds most frequently associated with these “events” were biologics (which are used to treat arthritis, psoriasis, diabetes and cancer), ones for psychiatric problems and those that are fast-tracked out the agency’s door (no kidding!).

As I told you last month, this is going to be a banner year for new drug approvals. More meds are being rushed out the door than ever before, making it riskier than ever to be on the other side of an Rx.

That’s why before you start up on a new med, you need to do your own research. And part of that should be to find out what older, established drugs are on the market that can treat your condition.

Otherwise, you could end up as just another guinea pig for Big Pharma — unknowingly testing its meds to find out what the real problems are.

“Nearly one in three drugs found to have safety concerns after FDA approval” Brigham and Women’s Hospital, May 9, 2017, ScienceDaily, sciencedaily.com