Skip to Main Content

The regulatory system for reporting side effects caused by prescription drugs is producing its own kind of side effect — incomplete information about injuries that patients may have suffered. And the reason for the lack of data is that many drug makers are filing patchy reports, according to a new analysis published in the Pharmacoepidemiology and Drug Safety.

At issue is the Adverse Event Reporting System maintained by the Food and Drug Administration. The database is the key method for collecting side effect data. Both doctors and consumers can voluntarily report problems to the agency or a drug maker. But drug companies are also required to investigate and report side effects that may be attributable to their products.

Drug makers typically file the vast majority of reports of a serious or fatal outcome to the FDA. Yet compared with the side effect reports turned in by physicians and consumers, drug makers generally fail to include key data that the FDA might use to assess future warnings. For this reason, one of the study authors contends there are still wider implications.


“With increasing pressure for the FDA to approve drugs fast but with less clinical testing, it is a major concern that postmarket surveillance has major problems that are not being addressed,” said Thomas Moore, a senior scientist the Institute for Safe Medicine Practices, a nonprofit that tracks drug safety issues. “It is time for the FDA, the medical community, and industry to start work on a badly needed modernization” of this “critical tool” for monitoring safety.

The analysis found that in 2014, the FDA received 528,192 new reports of a serious or fatal side effect, of which 4.7 percent were filed with the agency directly by doctors and consumers. Of those, 86 percent included complete information about four important data points – patient age and sex, the date the side effect occurred, and a specific medical term to describe the problem.


By contrast, drug makers filed 95.3 percent of side effect reports, but most were incomplete. For instance, 40 percent of so-called expedited reports — those that must be filed within 15 days of learning of a serious side effect — were incomplete. And 51 percent of periodic reports, which drug companies generally file up to 90 days later, were similarly incomplete.

For instance, among the reports of serious side effects submitted by drug makers to the FDA, nearly 38 percent lacked the patient’s sex and age, and 47 percent did not have the date when the problem occurred. Overall, reports involving patient deaths offered the least amount of complete information for all of the key data points.

Moore suggested the reporting system has not kept pace with changes in pharmaceutical marketing. Since the last upgrade in 2001, interactions between patients and physicians, and patients and drug companies, have evolved, partly thanks to the Internet. This means a report may not be based on spontaneous information.

We asked the FDA for comment and will update you accordingly.

As for the drug makers, the analysis reviewed 25 companies that submitted 5,000 or more reports in 2014, and the overall performance was not very good. Less than 25 percent of the reports filed by two companies — GlaxoSmithKline and Gilead Sciences — contained all four key data points. The best performance was turned in by Biogen, which filed complete reports 67 percent of the time.

A Gilead spokeswoman wrote us that “patient safety is of the utmost importance to Gilead. Gilead monitors the safety of all its medications, reports adverse events in a timely manner, and is compliant with FDA and other health authority safety reporting requirements.”

As for Glaxo, the analysis noted that one episode likely accounted for the poor showing. In 2014, the company submitted more than 20,000 side effects reports related to a settlement of legal claims involving its Avandia diabetes pill. Although the FDA required Glaxo to file the reports lickety split, the company ”apparently had no further information immediately” about patient age, sex, event date, or a medical term.

[UPDATE: An FDA spokesman later  sent us this: The FDA is “aware that the quality of adverse event reports may vary,” although only requires four data elements in a report for it to be filed: “an identifiable reporter,” “an identifiable patient,” “an identifiable adverse event” and a “suspect product.”

“The system does not reject electronically submitted cases on the basis of content quality beyond those elements… Improving the quality of information in (the reporting system) is of great interest to FDA, but is challenging because of the voluntary nature of reporting.”

He also acknowledged that a majority of FDA’s safety-related labeling changes come from these reports as the sole source.”]

  • I am 75 yr old female. Have reported side effects to proton pump inhibitors that I have been taking for 20 years +.also Thiazide diuretic,doing my own research the reported side effects appear to be the same for both drugs in some cases, please how can I get my GP to take me seriously. My 44 year old son who has been taking proton pump inhibitors for many years is having problems with the electrical of his heart and has ended up in the cardiac unit several times recently and remains unwell and having cardiac MRI this week, we can’t get anyone to discuss the possibility that this is possibly caused by PPI’s ,how can we be taken seriously , no one will even discuss this, we have both had colonoscopy,s and endoscopies, in my case I have polyps non cancerous, diveticular disease ,irregular pulse ,thumping pulse on left side of head skin rash , white spots on areas of skin, hair loss, have taken myself off PPI’s heartburn is much worse than it ever was before I took the drip but now have normal pulse and BP no thumping in head blood sugar is within normal range, had been told I was insulin resistant. Etc , no one is in the slightest bit interested in the fact that this appears to be side effects of this drug.

  • Blood pressure medications have been a big problem, required ER visits, when you tell them it’s the medication good luck, it goes no where,best part they want you to continue taking that same medication, it took 4 years to realize it was the medication, by stopping it, it’s taking 1 year and a half to get over the problem it was creating, my Doctor ask me to start medication back up, it took 2 weeks for problem to come back, he switched it to another drug that took a day for problem, so my question is when you tell your Doctor the medication is the problem, it appears they do not want to hear it. I’ve just been to the Er twice this month for Abdominal pain in the same area, and when you eat foods the problem is worse, they wanted me to continue taking that same drug and I refused because it was the same pain caused by others, they switched it to another drug and that same problem was back, I’m now on a third drug see how that goes, years ago they had me taking COREG up to 100mg and my pee was coming out dark brown and I was on that dose for a week, when getting bp check and told them what was going on they told me it was to much, so did the COREG do damage to where the other Betta blockers can no longer be taken or is it the fillers in medication the problem, beings the Doctor’s seem to be lost, and do not want hear it’s the medication

Comments are closed.