You have probably seen recent news coverage about off-label uses of anti-malarial drugs to treat or prevent coronavirus. Setting aside the extreme scenario we find ourselves in during a pandemic, off-label drug use is nothing new. In fact, off-label drug use is more common than you may think. What is it, though?
To begin with, pharmaceutical drugs get developed to treat certain symptoms and/or conditions. The Federal Drug Administration then approves the drug for sale for that purpose, and it hits the market. That means the drug may be legally marketed by the manufacturer only for that purpose, but medical providers are free to prescribe the medication for purposes they deem appropriate. This will most commonly happen with medications that have typically been on the market for a long time, as research reveals other areas where the medications may benefit patients. Some common examples include gabapentin, which is FDA approved as an anti-seizure medication, commonly prescribed for nerve pain or restless leg syndrome. Another common example is calcium-channel blockers (typically prescribed for hypertension) that are used in conjunction with other drugs to treat metastatic cancer. In fact, off-label drug prescription is quite common in cancer treatment.
What does that mean for patients? Well, as before, once medications are approved for sale for use, prescribers may prescribe it for any purpose they deem appropriate. A subsequent injury from medication use may then be, under certain circumstances, the responsibility of the prescriber or the pharmacist. Keep in mind that every medication has its range of side effects. These need to be considered when prescribing and dispensing medication. For example, there is uncertainty about the risks and benefits of anti-malarial drug use and coronavirus and heart conditions. Ultimately, the mere fact that its use is off-label does not mean that the provider is liable for subsequent injury: liability for off-label drug use is determined by whether the use is scientifically supported. And the evidence is not yet clear on anti-malarials and coronavirus.
