Christina Spicer  |  May 19, 2019

Biologic Overview

A biologic is a complex medication isolated from a living organism, opposed to traditional drugs which are chemically synthesized.

Biologics can include sugars, proteins, genetic information, cells, tissues, or some combination of these components. A biologic may be isolated from human, animal, or microorganism sources or they may be created through biotechnology methods.

There are numerous applications for biologics, including vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. More recently, biologics have taken center stage in the treatment of chronic or autoimmune conditions including rheumatoid arthritis, Chron’s disease, ulcerative colitis, certain cancers, plaque psoriasis, and more.

Common biologics include Humira, Remicade, Cosentyx, Taltz, Dysport, Lemtrada, Zinbryta, Praxbind, and more. There are countless biologics currently approved by the U.S. Food and Drug Administration.

Unfortunately, these drugs carry the risk of side effects. Common side effects may include allergic reactions, injection site reactions, chills, weakness, diarrhea, nausea, vomiting, rash, itching, high blood glucose levels, cough, and constipation. Less common side effects may be severe, including anaphylaxis, cancer, heart failure, lung disease, and more.

Although most individuals assume that disease-modifying drugs or autoimmune medications are always biologics, there are medications which work in a similar way without being in the biologic class. One example is Xeljanz, a rheumatoid arthritis drug which is taken through an oral tablet. This drug is not a biological medication, and therefore may not have the same risk for side effects as biologics do.

However, recent FDA reports suggest that Xeljanz may not be any safer than biologics.

In February 2019, the FDA released a safety announcement to inform the public that Xeljanz may be associated with an increased risk of blood clot injuries. This includes pulmonary embolisms and deep vein thrombosis.

Deep vein thrombosis is a clotting phenomenon that occurs in the deep veins in the legs. When someone is at rest for a long time, for example on a long flight, the blood in their veins may begin to clot – known as deep vein thrombosis.

If the clots formed by deep vein thrombosis move up the body to the lungs, they can cause blockage within the blood vessels of the lungs. This is called pulmonary embolism, and can be life threatening if a blockage cuts of blood supply to and from the lungs.

According to the FDA, the risk for pulmonary embolism and deep vein thrombosis was discovered during an ongoing safety trial ordered by the agency when the drug was approved for rheumatoid arthritis treatment.

“This trial will continue and is expected to be completed by the end of 2019. We are working with the manufacturer to evaluate other currently available safety information for tofacitinib and will update the public with any new information based on our ongoing review,” the FDA noted in their safety announcement.

The agency says that Xeljanz patients should immediately seek medical attention if they experience symptoms of pulmonary embolism. These symptoms include sudden shortness of breath or difficulty breathing, chest pain, back pain, coughing up blood, excessive sweating, and clammy or bluish colored skin.

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