New Concerns Regarding Arthritis Drugs With Troubled History
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Last week, the FDA ordered that warnings for several popular arthritis drugs be strengthened once again due to concerns about increased risks of life-threatening fungal infections. The new warnings would apply to Enbrel, Remicade, Humira, and Cimzia – powerful arthritis drugs that suppress the body’s immune system.
The latest concerns relate to histoplasmosis, a serious fungal infection that can easily be confused with the flu. The FDA reviewed 240 reported cases of histoplasmosis associated with Enbrel, Remicade, Humira, and Cimzia and noted that a 45 of the patients (a staggering 20%) died from the complication. FDA investigators noted a particular concern that physicians may have failed to properly identify the presence of histoplasmosis early enough to initiate proper treatment that might have prevented some of the deaths. The hope is that the addition of a “black box warning” to the drugs’ labels and providing physicians with notifications regarding the risk of histoplasmosis may avoid additional patient deaths. Patients on these medications are being alerted to contact their physicians if they experience persistent fever, cough, shortness of breath, fatigue, or other signs of a fungal infection. Previously, there has also been concern regarding the association of these immune suppressing drugs and other risks including lymphoma, tuberculosis, significant infections, and other potentially fatal side effects.
These powerful arthritis drugs are known as TNF-alpha blockers and have become wildly popular over the past several years. The drugs are extremely costly and must be administered by injection in a physician’s office. The introduction of these drugs to the market and their widespread use over the years has led physicians to open up brand new infusion centers with the sole purpose of administering such drugs. Three of the drugs (Enbrel, Humira, and Remicade) are all considered “blockbusters” – a title bestowed upon drugs that have annual sales in excess of $1 billion. While these drugs are certainly a miracle for those who have failed other treatment options, there is nevertheless concern that the drugs may be over-prescribed (especially in rheumatology practices with in-house infusion centers) and are being over-marketed by the manufacturers to patients who have much safer options available to treat their conditions.
As with any drug, it is critical that patients, with the assistance of their physicians, thoroughly evaluate the risks of a particular medication versus the benefits. It is also important for patients to educate themselves so that they may ask pointed questions of their physicians when such decisions are being made. The internet provides a number of unbiased resources for information regarding drug therapies in addition to sites maintained by manufacturers and disease management organizations.