If You Report Drug Side Effects to the FDA Will It Still Be Listening?

Have you ever looked for a drug’s side effects on the web? That is where most people go these days for medication information. It’s a surprisingly terrible way to get drug data. That’s because most drug lists contain both too much and too little evidence simultaneously. What about healthcare professionals? How do doctors, nurse practitioners, physician associates and pharmacists learn about drug side side effects? The most comprehensive source for such data comes from the official prescribing information found at the DailyMed website. Even that database leaves much to be desired. That’s why it is so critical that you report drug side effects to the FDA promptly! But is the FDA’s ability to manage that critical information about to crash and burn thanks to cutbacks in staffing?

The Fatal Flaw in Drug Company Clinical Trial Testing:

When a new medicine gets approved by the FDA, the agency relies almost exclusively upon the information the drug company gathered during clinical trials. Often, such testing lasts only a few weeks. As a result, some adverse drug reactions go undetected for months, years or even decades.

Let’s take antidepressants as an example. Medications such as bupropion, citalopram, duloxetine, escitalopram, fluoxetine, paroxetine, sertraline, trazodone and venlafaxine are taken by over 40 million Americans every day. A pre-print published in medRxiv (Feb. 28, 2025) was titled “Antidepressant Trial Duration versus Duration of Real-World Use: A Systematic Analysis.” The authors analyzed data from 52 placebo-controlled trials involving more than 10,000 participants.

The results were shocking. The median trial duration was barely eight weeks. Most studies lasted for less than three months. And yet the typical patient takes such medications for many years. Perhaps that is why it took so long to discover that stopping drugs like citalopram, duloxetine, and sertraline can lead to some very unpleasant withdrawal symptoms. You can read more about that problem at this link.

We learned about this challenge decades ago by paying attention to our readers. We were also among the first to report that antidepressants like Prozac could trigger suicidal thoughts. This scary complication was not detected in the original clinical trials.

If patients didn’t report drug side effects to the FDA, we fear that the agency would never learn about delayed or devastating adverse reactions. Drug companies do not have an incentive to discover serious problems with their potential pots of gold. No one wants to shoot the goose that is laying golden eggs.

Is the MedWatch System in Trouble?

One of the most important ways we discover unexpected drug complications is through voluntary reports from health professionals or patients. To do this, the FDA instituted its MedWatch system in 1993.

If someone experiences a serious unexpected problem while they are taking a prescription or OTC product, they can report this event directly to the FDA by calling 888-463-6332. Online reporting is also available at www.fda.gov/safety/medwatch.

We cannot emphasize enough how critical this FDA service is. A shocking number of dangerous reactions are not revealed during clinical trials for approval. Instead, they are discovered only when a patient suffers an unanticipated, and possibly disastrous, drug complication.

The Singulair (Montelukast) Disaster:

One example involves the oral asthma medicine montelukast (Singulair). The FDA approved this drug in 1998. Within a decade, the agency had received numerous reports of mood changes and suicidal behavior associated with this medicine. Such problems had not shown up during the initial clinical trials.

As a result of voluntary reports to MedWatch, the FDA warned healthcare professionals and patients in 2009 to be alert to “the potential for neuropsychiatric events with these medications.”

A decade later, the agency strengthened its warning, requiring a boxed warning in the prescribing information:

“Serious neuropsychiatric (NP) events have been reported with the use of SINGULAIR. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide).”

One reader wrote to tell us that Singulair caused her horrible hallucinations. She described:

“a local teenager who was put on Singulair suffered altered moods and eventually committed suicide. He had been a happy, normal teen until he took this medication.”

That is just one example of why the FDA’s MedWatch service is so important. Without this reporting system and its database, prescribers and patients would not know about life-threatening adverse reactions that are discovered long after FDA approval.

Sadly, though, the recent firing of many FDA staff is putting this program at risk. That means the MedWatch system may not work as expected.

Generic Drug Problems…the Never-Ending Nightmare:

We have frequently complained about generic drug quality in our columns. Readers alerted us to problems with the generic version of the antidepressant Wellbutrin. When the FDA investigated generic bupropion, it did so, in part, because of MedWatch reports.

We fear that patients will suffer because of staffing cutbacks. As critical as we have been of the Food and Drug Administration, there is no other organization capable of approving new medicines, monitoring drug safety or detecting food contamination. Without a highly functioning FDA we are all in big trouble!

Learning About Drug Side Effects:

You probably think that health professionals have some insider system for learning about delayed drug side effects. You would be wrong.

Everyone—physicians, nurses, pharmacists and ordinary people—relies upon the exact same source: the official prescribing information agreed upon by the drug manufacturer and the FDA. In other words, we are all drinking from the same well.

How Drug Companies Report Drug Side Effects:

As mentioned above, you can find the original wellspring online at DailyMed.  Should you go there and type in the name of your medicine, you will be overwhelmed with data. Go ahead, try it. Here is a link to the frequently advertised anti-cancer drug Keytruda (pembrolizumab). When you get to the adverse reactions section (#6) you will be overwhelmed.

Most of the online databases report drug side effects that they find in the official prescribing information. This is the way they let doctors and pharmacists know what to tell their patients.

The public-facing drug information sources  also depend upon the same database. They may use different words for some adverse reactions. Dyspepsia may become heartburn and pruritus may turn into itching. The point is that virtually every list of drug side effects on the web originates with the official prescribing information.

Long Lists Are Mind-Numbing!

I have suggested that long lists of drug side effects are pretty much worthless. If you have watched any television in the last decade, you know that drug commercials have proliferated like dandelions after a spring rain.

Trulicity Side Effects:

You have no doubt seen the commercials for Trulicity (dulaglutide):

“I have the power to lower my A1C”

Because the FDA requires pharma companies to report drug side effects, you get this:

“Stop Trulicity and call your doctor right away if you have an allergic reaction, a lump or swelling in your neck, severe stomach pain, changes in vision or diabetic retinopathy. Serious side effects may include pancreatitis. Taking Trulicity with sulfonylurea or insulin raises low blood sugar risk. Side effects include nausea, vomiting and diarrhea, which can lead to dehydration and may worsen kidney problems.”

While the announcer is running through that list in 19 seconds, the small print on the screen adds other side effects including:

“indigestion, fatigue, belly pain, and decreased appetite.”

We doubt that very many people are actually able to read those complications as they scroll past quickly.

What are we to make of such a list? We suspect that most people, including many health professionals, tune out after the first sentence. Most people probably won’t know if they are taking a sulfonylurea.

The announcer admonishes the viewer:

“Don’t take Trulicity if you are allergic to it.”

How would people know if they were allergic to Trulicity if they never received a shot before? Ooops!

And what the heck is pancreatitis? The company has to report serious drug side effects, but the announcer does not have to tell you how incredibly painful it can be or how dangerous it is.

Why You Can’t Trust Drug Lists:

The biggest problem with the online drug databases is the foundation upon which they are built. This system relies heavily upon the way pharmaceutical manufacturers report drug side effects.

To get medicines approved by the FDA, the companies have to perform clinical trials. Not all side effects come to light in such studies.

When additional adverse reactions start to show up, there are no incentives to report drug side effects to the FDA. Then, getting the FDA to change the labeling information can be a bit like pulling teeth. We speak with some authority on this matter because we have tried.

Cetirizine (Zyrtec) and Itching:

In 2010, we started hearing from readers of our syndicated newspaper column that if they stopped Zyrtec (cetirizine) suddenly, they could experience intense itching. After we reported this unexpected complication, we heard from hundreds of people who shared similar stories.

Here is one of our first articles posted originally on May 5, 2010. It generated over 350 comments from readers.

Itching from Cetirizine Withdrawal:
Stopping cetirizine can lead to unbearable itching that may last for several weeks.

We continued to write about this problem and hundreds more readers related their nightmare withdrawal itching.

Although we contacted the FDA repeatedly about this issue, it was very slow to respond. We finally went to the very top of the FDA. Janet Woodcock was at that time the acting FDA Commissioner. You can read our letters to her and her colleagues at this link:

Zyrtec Withdrawal Is a Nightmare
We’ve heard reports from many people that getting off of Zyrtec (Cetirizine) poses a real itching challenge. Is there such a thing as Zyrtec withdrawal?

Eventually, FDA staffers wrote an article titled “Pruritus After Discontinuation of Cetirizine” in the journal Therapeutic Advances in Drug Safety (July 5, 2019).

They acknowledge that quite a few people report drug side effects after they stop cetirizine:

“Our case series provided evidence of an association between the discontinuation of cetirizine and the development of pruritus. The mechanism by which cetirizine causes pruritus upon discontinuation is unknown. Patients and prescribers should have knowledge of this adverse event, given the widespread use and availability of cetirizine, and potential impact on patient quality of life.”

What About the Drug Databases?

You will find no mention of withdrawal itching in labeling for over-the-counter Zyrtec or generic cetirizine. Don’t believe us? Here is a link to the instructions and warnings. The only place you will see the problem we discovered thanks to readers is in the comment section of the website. We have asked the FDA about this oversight. We were not surprised to get no response.

Fluoroquinolone: A Delayed Report of Drug Side Effects

Another example involves fluoroquinolone antibiotics such as ciprofloxacin (Cipro) and levofloxacin (Levaquin). This class of medications has been on the market for more than 30 years.

It wasn’t until 2018, however, that the FDA warned the public that these antibiotics could increase the chance of tears in the aorta, a large blood vessel leading out of the heart. This complication is rare but potentially deadly.

Statins and Diabetes:

Another example involves statin-type cholesterol-lowering drugs and elevated blood sugar. This was not reported in the original clinical trials. However, readers of our newspaper column began reporting their trouble controlling their blood glucose years before most health professionals realized there was a problem. Eventually, studies revealed that this was a true side effect of statins. If doctors don’t report drug side effects, the FDA seems to remain oblivious.

Can Patients Report Drug Side Effects to the FDA?

Once the FDA approves a medication, the drug company has relatively little incentive to continue looking for adverse reactions. It is usually left up to physicians, pharmacists and patients to voluntarily report drug side effects that may be linked to a medicine.

Health professionals are busy people. They rarely have extra time to submit adverse event reports. Nobody pays them to do that.

The only people who have an incentive are the patients. This reader is concerned about the process:

“I have not met a soul who has not had uncomfortable reactions to medications. Many become depressed or lethargic. However, like me, they have been pressured to continue. I have a sister 14 months older than me. She has been on statins for years and her complaints were addressed with antidepressants. Her cholesterol numbers are ideal. However, she rarely leaves her recliner chair and now she is diabetic.

“I myself have tried many blood pressure medications. None have been worth the muscle weakness and pain. I am very healthy and active. Beta blockers make it hard to exercise.

“I’ve also had rashes, runny nose, shortness of breath, wracking dry coughs and full body itching. My current physician says she hears this all the time but if a patient has a heart attack, she miraculously becomes tolerant of the drugs.

“I always report any adverse reaction immediately with the assumption that my reactions are noted, reported and charted. I am not so sure. Who do they report to?

“Ireland has created a system for patients to directly report side effects. Do we have anything like this?”

How Can Patients Report Drug Side Effects?

Patients can report drug side effects directly to the FDA through MedWatch. This online reporting system is relatively easy for most people with internet connections to access, although it may call for some information that is hard to find. That includes things like manufacturer, lot numbers, expiration dates and NDC (National Drug Code number). You can also report by phone: (800) FDA-1088.

It is important to report drug side effects because it is unlikely that drug companies will go out of their way to seek out adverse reactions if they don’t have to. And busy health professionals often don’t have the time. It is you, the patient, who has a vested interest in getting the FDA to acknowledge that some side effects take decades to discover.

We are extremely concerned about recent cutbacks in staffing at the agency, though. If there are not enough skilled health professionals at the FDA to receive patient reports, this vital system could wither and die. If MedWatch becomes ineffective, we will all suffer. Please let your representatives know that we need an effective FDA to monitor drug safety.

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