Analysis: Reports of drug side effects increase fivefold in 12 years

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More than 1 million reports of drug side effects were filed with the U.S. Food and Drug Administration in 2015, a fivefold increase since 2004, according to an analysis by the Milwaukee Journal Sentinel and MedPage Today.

Numbers aren’t final for 2016, but are expected to match that all-time high.

Drugs used to treat diseases such as rheumatoid arthritis, psoriasis, multiple sclerosis, a type of cancer and diabetes are among those with the greatest number of reports. Many of the drugs are for conditions that occur in 1% or less of the population, but several have seen increasing use in recent years.

For years, the FDA’s adverse events system has been derided because of its largely voluntary nature — only drug companies, not doctors or patients, are required to report problems. As a result, the system likely only was capturing a small percentage of cases.

In recent years, the number of reports filed has been multiplying, prompting more independent researchers and drug companies to use the data as a way to detect safety problems, the Journal Sentinel and MedPage Today found.

But experts say the information still is largely untapped and — if used more — could become an important alarm that warns of dangerous drugs after they hit the market.

The surge in reports could indicate a growing number of harmed patients or more vigilant reporting of adverse events, a goal of the FDA. Experts say both likely play a role.

Twelve years ago, there were 206,000 reports of side effects from medications filed with the FDA — complaints as frivolous as flatulence, as serious as death.

By 2015, the most recent full year of data, the number had grown to 1.2 million.

The FDA has long discouraged use of the system for research purposes. When it distributes the database, it attaches warnings that say the reports aren’t evidence drugs caused the problems listed, that the data can’t be used to estimate risk and that it should not be used to compare drugs.

In 2005, the Government Accountability Office estimated the system only captured 1% to 10% of all adverse reactions. Despite the explosion in reports, that remains the most recent estimate of how many cases are caught by the system.
Strength in numbers

The increased volume of reports has researchers, insurance companies and even some pharmaceutical groups re-imagining how the data can be used.

“Sheer numbers have some scientific weight,” said Thomas Moore, senior scientist at the Institute for Safe Medication Practices, a nonprofit watchdog group focused on drug safety. “If 500 people report a problem, it is unlikely that they are all wrong.”

For all its warnings about the limitations of the system, the FDA itself has relied on the reports to guide its actions. Case in point: a patch used to treat migraine headaches.

In September 2015, the Zecuity patch was allowed on the market after years of give-and-take with FDA officials. The patch, which looks like a large armband, released a drug through the skin to fight migraines. An early version failed to get approval after the FDA raised concerns that it could “cause severe burns and permanent skin lesions.”

The patch was redesigned and tested on 58 people, none of whom reported problems. The FDA could have required more clinical testing, but instead chose to approve the redesigned patch and rely on “postmarket surveillance.” In other words, the safety of the product would be linked to reports of side effects.

The FDA ordered Teva, the manufacturer, to report adverse events within 15 days of receiving any complaint.

Nine months later there were hundreds of reports of blisters, burns, scars and pain. On June 2 of last year, the agency said it was “investigating the risk of serious burns and permanent scarring.” A week later, Teva voluntarily pulled the product.

The company said it worked with the FDA to pinpoint a problem but noted because the root cause was not identified, the product remains off the market.

However, others say the voluntary and cumbersome nature of the system makes the value of the information limited.

“As a physician, I have tried to use it and it is very, very clumsy,” said Joseph Ross, an associate professor of medicine at Yale University School of Medicine.

He said the system only provides a numerator — the number of adverse event reports for a drug — without establishing the denominator, the number of people using that drug.

In doing its own analysis, the Journal Sentinel and MedPage Today found that among the 10 drugs that accounted for the most reports, seven carry “black box” warnings, the FDA’s most stringent alert for serious or potentially life-threatening side effects.

The 10 drugs account for one out of every five reports filed since 2013. Yet, none is on the top-10 list of most prescribed drugs as determined by IMS Health, a drug market research firm.

“We are concerned,” said Michael Carome, deputy director of Public Citizen’s Health Research Group. “It reflects that the FDA has allowed drugs to come to market without adequately ensuring safety.”
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