Drug side effect reports have skyrocketed over recent years, leading researchers to reconsider the value of FDA's adverse event system.

Pharmaceutical Pills

The US Food & Drug Administration received over 1 million reports of pharmaceutical drug side effects and complications in 2015, marking a five-fold increase in adverse event reporting over the last 12 years. The agency's statistics have not been finalized for 2016, but analysts from the Milwaukee Journal Sentinel and Medpage Today expect last year's total to match the record set in 2015.

Side Effect Data Gets Renewed Attention

In 2004, patients and doctors filed only 206,000 reports of adverse events linked to prescription drugs. Those numbers, a new analysis has found, have been growing steadily over the years, reaching around 1.2 million by 2015. At the same time, public health researchers and pharmaceutical manufacturers have been presented with an unprecedented amount of data to identify emerging safety risks. The information, however, remains untapped, experts at Medpage Today say, in part because the FDA discourages investigators from using it.

The FDA has long held that adverse event reports cannot be considered evidence of a causal link between any drug and suspected side effects, plastering each report with warnings that dissuade researchers from using the data to estimate risks. Those qualifications, however, haven't prevented the agency itself from using adverse event data to monitor safety issues. In 2015, for example, hundreds of side effect reports tipped FDA researchers off to a serious issue with the migraine patch Zecuity, which was soon taken off the market.

Despite Flaws, FDA System Given Second Look

There's no doubt that FDA adverse event reports present an incomplete picture of drug side effects. In fact, the Government Accountability Office condemned the federal agency's postmarketing safety program in 2005, estimating that the system captured only 1% to 10% of the actual problems experienced by patients. Critics of the FDA's system point out that reporting is usually voluntary. Doctors and patients are allowed to submit, but only pharmaceutical manufacturers are required to do so. Joseph Ross, MD, an associate professor at Yale's School of Medicine has tried to use adverse event reports in his own research, but found the system "very, very clumsy."

Rapid increases in reporting, though, have prompted some independent researchers to rethink how the data should be used. "Sheer numbers have some scientific weight," says Thomas Moore, Senior Scientist at the Institute for Safe Medication Practices. "If 500 people report a problem, it is unlikely that they are all wrong." Moore has a point. In the analysis performed by Medpage Today and the Milwaukee Journal Sentinel, seven out of the ten most-reported drugs had already been slapped with "black box" labels, the FDA's harshest warning. Those same ten drugs account for one in five adverse event reports submitted between 2013 and 2015.

Autoimmune Drugs Dominate Side Effect Reports

Leading the pack are prescriptions to treat autoimmune disorders, including psoriasis and rheumatoid arthritis, which can increase the risk for life-threatening infections and lymphoma, a family of cancers that begin in the immune system. Now approved to treat 10 autoimmune conditions, Humira has been linked to 209,000 side effect reports since 2013 - including over 4,200 patient deaths. Revlimid, a drug approved to treat rare immune system cancers like multiple myeloma, was named in 69,000 reports over the same time period. The drug is implicated in around 10,000 deaths, but like the FDA's other top-ranking prescriptions, Revlimid's prescription is limited. Many of the most-reported drugs are designed to treat conditions that affect 1% or less of the US population.

The Legal Herald

About Laurence Banville

Attorney Contributor:

Laurence P. Banville, Esq. is the managing partner of Banville Law. He is a regular contributor on several topics including negligent security cases, child sexual abuse and Dram Shop and liquor liability cases.

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