July 4, 2019

The Milwaukee Journal Sentinel conducted an analysis of data from the FDA and found “at least 34,000 reports to the U.S. Food and Drug Administration of people who died while using biologic drugs since 2004.” The analysis further found, “More than 1 million “adverse events” were reported in people using the drugs during that time, including nearly 500,000 that were deemed serious.”

The Milwaukee Journal Sentinel stated, “While the drugs make up only a small slice of the $450 billion-plus prescription drug industry — they were on pace for about $45 billion last year — they have an outsized effect. Among all prescription drugs over the last 15 years, the biologics Humira and Enbrel are the most-cited in the FDA’s database … Humira was linked to 169,000 reported serious adverse events and 13,000 reports of deaths, followed by Enbrel with 135,000 serious events and 8,000 deaths. Yet neither is among the top 20 prescribed medications in America … Remicade … had 98,000 reports of serious adverse events, including 6,000 reports of deaths.”


A recent scholarly article stated, “Risk of hospitalized infections under biologics among patients suffering from chronic inflammatory autoimmune diseases such as rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PSA), or psoriasis was investigated using administrative data. The hospital discharge records database, the medical prescription database, and the database of exemptions from medical charges were linked at the individual patient level … Patients with chronic autoimmune inflammatory diseases are at risk of serious infections when starting biologics. This risk is higher in the elderly or those with comorbidities. Upper and lower respiratory tract infections are the most common infections. Our findings support prevention policies such as vaccination.”


What Are Biologics?

According to the FDA, biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources – human, animal, or microorganism – and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.

In contrast to most drugs that are chemically synthesized and their structure is known, most biologics are complex mixtures that are not easily identified or characterized. Biological products, including those manufactured by biotechnology, tend to be heat sensitive and susceptible to microbial contamination. Therefore, it is necessary to use aseptic principles from initial manufacturing steps, which is also in contrast to most conventional drugs.

Biological products often represent the cutting-edge of biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have no other treatments available.


If you or a loved one suffered injuries (or worse) as a result of a biologic in the United States, you should promptly seek the legal advice of a biologic claim lawyer in your state who may investigate your biologic drug claim for you and represent you in a biologic claim, if appropriate.

Visit our website or call us toll-free in the United States at 800-295-3959 to find biologic claim lawyers in your state who may assist you.

Turn to us when you don’t know where to turn.