New Report Suggests Big Pharma Isn't Reporting Drug Side Effects

Wednesday, February 4, 2015

A fresh report from a leading prescription medication watchdog suggests drug companies aren’t holding up their end of the bargain of letting consumers know all the details of their product side effects.

The report, out last week from the Institute for Safe Medication Practices, shows pharmaceutical companies don’t turn in complete reports for over half of the instances of drug side effects that take place. We've charted the top 25 prescription drugs on the market and their side effects here.

Each year, the Food and Drug Administration receives close to 1 million drug side effect reports through its Adverse Event Reporting System (AERS). These range in severity from simple headaches and drug non-effectiveness to death.

Under new laws, drugmakers are required to pass along the information they receive about patient side effects. This accounts for around 96% of the reports to the FDA. The rest are logged by doctors or patients themselves through the FDA’s user system.

In examining the roughly 847,000 cases filed for the year between April 2013 and March 2014, the ISMP found the drug companies complete far fewer reports than patients and doctors.

Specifically, patients and doctors, who turn in only 4% of the cases, make complete reports more than 85% of the time. Drug companies, on the other hand, turn in complete reports only about 40% of the time.

For patients and doctors, reporting drug complications is optional. Pharmaceutical companies, however, are required to disclose side effects as soon as they learn about them.

The reporting issues aren’t isolated to the United States either. Recently, drug giant Roche was reprimanded when authorities in Great Britain learned the company had failed to report around 80,000 reports of drug complications. These included 15,000 death reports.

Why don’t pharmaceutical companies turn in as many complete reports as patients and doctors? The companies themselves claim they don’t have access to all the information and don’t have sufficient time to follow up.

However, many point to the negative attention generated when a successful drug racks up a record of side effects. Often, side effect reports lead to new independent research into a drug’s risks, which can lead to costly litigation from those patients who were injured but not properly warned.

For this reason, DrugNews believes stricter standards and tougher penalties are necessary to compel drug companies to report their own shortcomings.



Institute for Safe Medication Practices. A Critique of a Key Drug Safety Reporting System. (January 28, 2015). Retrieved from

Palmer, E. FDA Study Spanks Drugmakers for Poor Adverse Events Reporting. FiercePharma. (February 3, 2015). Retrieved from


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