Got Side Effects From Drugs? Report Them To the FDA
Over the past few years, the numbers of recalled pharmaceuticals has grown as new drugs are rushed to market before their safety is proven. Want to help improve drug safety? If you experience any serious side-effects from pharmaceutical or suspect drug interactions be sure to report these instances to the FDA. Here's how:
Download this form.
The FDA strongly recommends that you ask your health care provider to fill it out because he or she can "provide clinical information based on your medical record that can help" the FDA evaluate your report. If you can't or don't want to give the form to your doctor, you can fill it out yourself.
Either fax the form to the FDA at 1-800-FDA-0178 or mail it back using the postage-paid addressed form.
Or
Call FDA at 1-800-FDA-1088 to report by telephone
The FDA, via a program called MedWatch, also collects data on other drug problems. You should report these as well. Here is what MedWatch is concerned with:
1) Serious adverse event
* death
* life-threatening situation
* requires admission to hospital or longer-than-expected hospital stay
* permanent disability
* birth defect, miscarriage, stillbirth, or birth with serious disease
* requires medical care to prevent permanent damage
2. Product quality problem
* suspected counterfeit product
* potentially contaminated product indicated by suspicious odor or unusual color
* inaccurate or unreadable product labeling
3) Product use error
* mixing up products with similar drug names or packaging
* taking wrong dose of a drug because of confusing dosing instructions on label
4) Problem with different manufacturer of same medicine
* not getting same results from a generic drug as a brand name drug, or from another generic
Reporting by Consumers [FDA]
FDA 101: How to Use the Consumer Complaint System and MedWatch [FDA]
(Photo: Mike Burns)
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Comments:
I'm trying to report my death, but I'm having trouble filling out the form...
@Shadowfire: You're supposed to give the form to your doctor to fill out. I'm sure the FDA won't mind if you wait until your next checkup.
I got a few side affects from these Alli pills I'm taken. Note to self: "Never eat the cheese enchiladas while taken Alli".
I just had a really bad experience with one of my medications, although it's a widely known side-effect. I was taking a muscle relaxant because I hurt my back, and I got the worst case of dry mouth known to man. The thing is, I stopped taking the medication about 10 days ago and I'm still sitting here miserable... I can't quench my thirst and I've consumed more mints and chewed more gum than the last five years combined. I'm PO'd.
EDIT: I hope that the medication did not cause permanent damage to my salivary glands.
yes, please. i provide product support for a pharmaceutical company. and while i can also report the adverse events for you, by filling out the form and sending it to our drug safety department who sends it to the FDA, it's faster to tell them directly. of course, if you tell them and tell me again later - i still have to report it again.
but people reporting side effects and events - it may not be listed in the prescribing information right now, but if enough people say it and a pattern shows up then it's going to get in there eventually and you and your doctor can better protect your health.
i don't know about all the other companies, but the one i work for and all of my coworkers, we may gripe about how long it takes to file the forms but we actually DO want people to be able to make an informed decision about our product and make the choice for themself if the risks of side effects are worth the benefit of the medication.
i can't stress enough how important it is to do this, both as someone who works in the field of pharmaceuticals and someone who has had really bad reactions to some medications in the past, it helps everyone in the long run
@DePaulBlueDemon: I had a doc prescribe some pill for my back pain. I looked it up in the PDR and found that one of the more common side effects was hallucinations. I didn't bother filling the prescription and I got a different doc.
Your PDF link to the downloadable form is broken.
@DePaulBlueDemon: They can do things if you can't make saliva. You should consider calling your doc. I had a relative with sarcoidosis, a somewhat atypical case, that attacked the salivary glands so he had no saliva for over two years. They can alleviate the discomfort and, if it persists, do some things to try to fix it. (And with his sarcoidosis, it eventually just went away on its own.)
My one tip is, until your saliva kicks back into gear, make sure your water is fluoridated. (You CAN get fluoridated bottled water if you look, if you're anti-tap.) Without saliva to protect your teeth, you need to be careful to get enough fluoride.
@DePaulBlueDemon: I sweat SO MUCH now that I am on one med. I wake up drenched, and I was a person who almost never sweat before, so it's quite a change.
But I don't want to kill myself, so hey! Positive net gain!
@H3ion: A doc gave my kid a prescription because he has had problems sleeping. The main and prominent side effect was death. It was some blood pressure lowering medication. Yea, that one went in the trash and we are done with that doc.
@catastrophegirl: Sometimes you have to realize your having a side effect too. I have seen doctors scoff at side effects or changes patients mention. I suffered for months with a side effect I had written off as caused by something else. I heard about it when the FDA released a warning. Stopped taking the drug, side effect went away. I was miserable for two years and had no idea is was a medication causing it.
Doctors really need more education on the drugs they prescribe and side effects. Half the doctors I have been in contact with understand a rare side effect I had on a common medication. The other half swear it doesn't exist even though it is in the standard drug documentation.
@bohemian: well part of my job is people asking me if what they are experiencing is a side effect because of situations like that. i don't always know, so i report to the FDA exactly what they tell me. sometimes it's pretty obvious [may cause headache] and sometimes it's not [4% of people have reported slight hair thinning]
but if enough people say it, then it can be tracked and a pattern recognized.
i mean, everybody gets a headache once in a while and the causes for them are numerous. but if 50% more people taking product x get a headache than in the usual population - well, it becomes obvious that product x may cause headaches!
Ah yes, I remember reporting to my psychiatrist 10 years ago that the Paxil she'd put me on had caused me to gain 30 pounds in mere months. "Paxil doesn't cause weight gain," replied she; "it actually causes weight LOSS." So yeah, I was simply a gluttonous loser.
Within a year the findings began to come out: Paxil and some other SSRIs cause weight gain in many if not most patients using them for more than a few months.
Sometimes it's really hard being a patient. The docs think they have everything figured out; we're just a bunch of hypochondriacs.
If the FDA can't stop all the companies that have the fake boner pill ads at night, why should I believe it can help us with anything?
@DePaulBlueDemon: you may want to check into biotene and oasis brand mouth moisturizers and mouthwashes. they are over the counter in the toothpaste aisle. i find that both of them really help for me [sjogren's syndrome]
@ElizabethD: So let me get this straight. Your psychiatrist, who was presumeably worried enough about you being depressed to prescribe the anti-depressant Paxil, tells you "It can't possibly be the drug, you're just a lazy glutton!"
Well played doc! Well played!
Might I suggest looking up another shrink. :)
@pschroeter: I believe that is because most of the "boner pills" are "herbal supplements" rather then drugs. So they are not under FDA authority.
"Serious adverse event: death"
Um, er, so how do we report this?
@DePaulBlueDemon: good luck! [i had 9 teeth crack from lack of calcium because of sjogren's causing chronic dry mouth - save your teeth!]
@twophrasebark: generally that one is reported by a family member or a doctor/doctor's office. the disease i work with is a chronic illness and lasts people all their lives and we serve a few hundred thousand people, so death happens with the usual frequency in that population. and we report them all.
i had one last week in fact.
This is a good idea; let the public be your guinea pigs.
Aren't something like 50%+ of FDA committee members also pharmaceutical representatives? Definite conflict of interest.
When you report that the drug you're taking has an adverse side effect, and the people fielding those complaints have a financial interest in the drug you're complaining about I don't think those complaints are going to get much traction.
If you're an American taking drugs approved by the FDA, that should be warning enough to stop taking those drugs!
off topic but that photo made me laugh....I spent too many late evenings in that position.