New reports are highlighting concerns about biological medications, which could put patients at risk for certain deadly adverse events. Biological medications, or biologics, are pharmaceutical drugs derived from animal cells. Despite their successful treatment of autoimmune disorders like arthritis and psoriasis, consumers have reported over one million adverse events due to these treatments.
Biologics treat conditions that are not life threatening, and yet 34,000 people have lost their lives in a manner associated with the medications. The sheer number of adverse events begs the question: do consumers have the facts they need regarding these relatively new medications?
The Advent and Rise of Biologics
In the past couple of decades, biologics have flooded the market. Unlike many pharmaceutical products, biologics are cultured in a laboratory setting. They are derived from animal cells, rather than the frequently used chemical processes of many drugs. Biologics are not manufactured in pill form, rather patients take them intravenously or by injection.
Biologics are designed to treat autoimmune disorders of the skin, joints, and gastrointestinal tract. Examples include:
- Rheumatoid arthritis (RA)
- Multiple Sclerosis (MS)
- Crohn’s disease
- Certain cancers
- Cystic fibrosis
Treatment of these disorders has been revolutionized with the addition of biologics, but there are known risks. Additionally, not everyone who qualifies for biologic treatment can afford the hefty price tag. Some biologic products cost as much as $40,000 per year.
Despite the considerable cost, demand has increased steadily by 50 percent from 2013 to 2018. The reason for the demand is simple: biologics are extremely effective in treating extremely uncomfortable conditions. Some patients even celebrate full remission of symptoms.
Side Effects and Adverse Events Related to Biologics
As with most pharmaceutical products, biologics come with the risk of side effects. The most serious possible side effect is an increased susceptibility to infections. For patients whose disorders are not life-threatening, the threat of a possibly fatal infection may not be worth the risk. After all, it’s not as if adverse events are a rare occurrence.
An adverse event is defined by the U.S. Food and Drug Administration (FDA) as any undesirable experience associated with a medical product. Current data suggests that more than one million adverse events reports have been filed since 2004, including:
- 34,000 deaths
- 500,000 reports of “serious” adverse events
A “serious” adverse event involves:
- Permanent damage
- A life-threatening complication
Recording adverse events does not, however, imply a causal relationship between the medication and the injury.
FDA Warnings of Adverse Events
Amid the reports of injury and death, the FDA has long had concerns about the safety of biologics. In the last 20 years, the agency has released a couple dozen warnings and safety communications. The hope is that these warnings would give the public the information they need to make an educated decision about using biologic medications. Among the FDA warnings were concerns about:
- Fungal infections
- Bacterial infections
- A rare viral brain infection
- Flesh-eating bacteria
- Liver failure
- Heart failure
- Neurological conditions
- Lymphoma and other cancers
In 2011, the FDA issued a black box warning about histoplasmosis specifically. A black box warning is the most stringent warning the FDA issues. Histoplasmosis is a life-threatening infection caused by fungus. Since the introduction of biologics to the pharmaceutical market in 2001, the rate of histoplasmosis infections causing hospitalization increased by 15 percent. About one in five patients hospitalized for this fungal infection die.
Disproportionate Representation in the Adverse Events Database
In addition to being a possible cause for the significant increase in histoplasmosis hospitalizations, biologics have the ignoble distinction of being the most frequently cited prescription drugs in the FDA’s database for the last 15 years. For products that make up barely 10 percent of the total pharmaceutical market, this representation is extreme.
Two drugs in particular, Humira and Enbrel, appear more than any others. Remicade has also been linked to a number of adverse events. These biologic medications have been linked individually to:
- Humira – 169,000 adverse event reports with 13,000 related deaths.
- Enbrel – 135,000 serious adverse event reports and 8,000 related deaths.
- Remicade – 98,000 serious adverse event reports and 6,000 deaths.
These are disturbing figures for drugs that are not even in the top 20 of the most-prescribed medications.
Ignoring Safety Protocols Among Massive Demand
Either adverse event reports and FDA warnings are not enough to dampen demand for these products, or consumers are truly not aware of the risks. There are more than 20 FDA-approved biologic drugs available for purchase at this time.
However, patients interested in these medications must undergo screening for infections before they can begin treatment because using these drugs weakens the immune system. Biologics are not safe for patients with long-term infections like tuberculosis and hepatitis.
According to a study published in The Joint Commission Journal on Quality and Patient Safety, only about a quarter of patients who take biologics are appropriately screened for infections. The screening process is a series of quick and inexpensive tests, so there doesn’t seem to be a compelling reason that physicians would omit to perform the testing prior to prescribing.
It does seem to indicate that the majority of patients are not receiving all relevant facts from doctors about the very real risks of infection while taking these medications.
Who is at Risk for Adverse Events from Biologics?
All consumers who take biologics have an increased risk of infection because the medication impairs the immune system of virtually every patient. Of particular concern, however, are patients who take biologics for debilitating immune disorders. Biologics are a popular and effective treatment, and many patients may consider the increased risk of infection well worth the improvement to their overall quality of life.
Still, patients should carefully weigh the risks and benefits of taking biologic medications before doing so.
Have You Developed a Severe Infection While Taking Biologics?
For pharmaceutical products, the question is whether or not the public has enough information about the risks and side effects to make informed decisions about their health. The influx of data suggesting that biologics can be harmful seems to indicate manufacturers skipped some important information gathering steps and due diligence in their pre-market studies.
FDA approval is not immunity from liability. Many of the companies who sell biologic medications complied with the FDA approval process, and yet have still offered products to consumers that have turned deadly. Consequently, manufacturers can be held liable for damages suffered by consumers.
If you have developed an infection while taking biologic medications, or have suffered other serious adverse events, contact Drug and Device Watch. Our legal professionals can help you understand your legal rights, and determine if you have an actionable claim.
To find out more, call us toll free at 888-458-6825, or you can fill out our online form to schedule a free consultation.