Who Tells the FDA if a Drug Has Side Effects?

Should Your Doctor or Your Pharmacist Report Side Effects?

Have you had this happen?

The doctor puts you on a new-to-you medicine.

Suddenly, you start…

Feeling fatigued
Feeling dizzy
Feeling really thirsty
Having a constant stomach ache
Having blurry vision
Not being very hungry anymore
Eating much more due to extra hunger
Being constipated
Having to run to the bathroom all the time
Having sore muscles
Having ringing in your ears
Having nosebleeds
Noticing a rash on your skin
Or so many other things that could start happening out of the blue.

What do you do?

Should you tell someone? Will it go away on its own?

You ask the pharmacist. Do they pooh-pooh you and say that’s not one of the reported side effects and that it must be from something else?

You know you.

You know this is the only thing that’s changed in your routine lately.

Could this strange new thing happening to you be from the new medicine?

It sure can!

Before making assumptions, you should get checked out by your doctor to rule out anything else that could be causing it.

A closer look at the drug approval process.

How DOES the manufacturer find out what side effects a drug has?

The US drug development and approval process takes about 10 years, unless there has been a request for accelerated approval.¹

Median cost for the clinical trials is about 19 billion dollars.¹

There are usually several phases of Clinical Trials they do before the FDA grants approval to put the medicine on the market.

They cannot possibly catch all of the side effects that can happen. They catch the majority, but sometimes a side effect is much more significant than they know, and it’s not discovered in the Trials.

And there’s you, with a weird effect happening to you, not listed in the drug’s literature.

So, what can you do?

You have the power to report that side effect. To the Feds.

That’s right, my friend.

You can and should tell your doctor. But — your doctor probably will NOT report it to anyone.

They will probably just switch you off of that medicine and try a different one for you.

We as consumers have the ear of the government.

The FDA regulates our drugs.

They are in charge of making sure a medicine is as safe as can be in the years before it’s put on the market. They rely on the accurate reporting of the results of the Clinical Trials.

What are Clinical Trials?

Clinical Trials are an important part of the drug manufacturing and approval process.

The years after the medicine is manufactured but before we can use it in the general public are called the Clinical Trial phase of that process.

Clinical Trials are where the manufacturer recruits people with certain age, gender, disease state, or other parameters to try out their medicine. They usually have study guidelines, including a controlled environment, so the people running the studies can stay close to the participants and mark anything down that happens (record side effects and effectiveness or not).

That’s how the package insert and the printout that comes to you at the pharmacy has the side effects listed. It’s generally based on what the Clinical Trial scientists observed and reported during the clinical trial.

BUT –

Some medicines made it onto the market as safe, when in fact they ended up not being safe.

Here are some articles, for instance, on Vioxx, Bextra, Seldane, Tequin, Darvon. There are many more out there that have been removed from the market after having been available for years, causing more harm than good to the general public.

Because of consumers like you and me, reporting through the method I’m going to point you to, the FDA decided to remove these medicines for good.

The Clinical Trial phase is meant to:

see if the medicine is effective for what the manufacturer says they made it to do, and to
see if the medicine is generally safe, and to
mark down the incidence of side effects and record what those are.

After market, people must keep reporting the side effects they experience.

Clinical Trials can’t go on indefinitely, so there’s really not as much data as they would like.

That’s where you and I come in.

When we report our side effect, the incidence of that side effect listed can change.

Let’s say that less than 1% of people experienced dizziness with a certain medicine pre-market. Then after market, lots more people experienced it but no one ever reported that, or very few people.

Do you think the packaging or databases of drug information will have the correct percentages listed?

That’s right – no, they won’t.

If we all report what we experience, the FDA can have a better handle on making the manufacturers report the correct side effect profile of their drugs, so consumers and their doctors can be more correctly informed.

It’s paying it forward.

And, as already mentioned, many drugs have been removed from the market due to the true side effect panel that came out after it was on market.

The link to the FDA MedWatch reporting tool

You can:

fill it out online, or
call them to report it: 1-800-FDA-1088, or
print it, fill it out by hand, and mail it in.

The best part? No guesswork. It states right on the form to report it even if you aren’t sure the medicine caused it.

Better safe than sorry.

References:
https://www.fda.gov/drugs/development-approval-process-drugs, accessed 9/8/19.