Did you know doctors can prescribe a medication to treat a condition that the medication is not approved to treat? This legal and common practice is known as off-label prescribing. Taking an off-label drug in many cases can be beneficial but is not without risks. Find out if your prescriptions are off-label and what questions you should ask.
Virginia Aparicio
Off-label prescribing is the legal use of drugs to treat a condition or disease not specified on the FDA-approved packaging label or medication insert. The medication insert (the sheet that is typically stapled to your medication bag) contains information about warnings, side effects and usage which lists the disease or condition the drug is approved to treat.
According to the FDA, about 20% of prescribed medications are off-label. One off-label use is when chemotherapy drugs approved to treat a specific type of cancer are also used to target other cancers. Another is antidepressants prescribed for chronic pain. A third example is when a drug is approved as a treatment in one form such as a capsule but provided in another such as an oral solution.
There are a variety of reasons why a doctor may prescribe an off-label medication to their patient. One reason is that there might not be a FDA-approved drug to treat that specific disease or medical condition. Last year, due to the lack of effective treatment, the malaria drug hydroxychloroquine was used off-label to treat COVID-19. One look at the medication insert for hydroxychloroquine and, aside from the long list of potential side effects and recommended precautions, you will see its approved usage does not include COVID-19. Also, the FDA has warned that the drug is unlikely to be effective in treating COVID-19.
Another reason a patient may be prescribed an off-label drug is when approved treatments for a condition have been unsuccessful or inaccessible. Using an off-label medication is an alternative that could benefit the patient. The drug approval process is often lengthy and expensive. Seeking further uses for a drug may not be within the manufacturer’s interest if their drug is already out on the market. As required by law, for a drug to be FDA-approved, the drug company must submit clinical data to the FDA to review showing the drug is safe and effective. Keep in mind “safe” refers to the benefits of using a drug for a particular use outweighing the potential risks. It does not mean the drug does not have side effects.
Off-label medications can provide patients with improved care when a drug may not be available to treat a condition. Talk to your doctor if you are curious about off-label use or have concerns about your medications. Most physicians and pharmacists are happy to answer your questions. You may want to ask:
What is the medication approved for?
Are there other drugs or therapies that are approved to treat my condition?
What research is there to support the use of this drug to treat my condition?
What are the benefits or side effects of off-label treatment?
Will my health insurance cover this medication for this condition?
For more information, visit www.fda.gov.
January 27, 2021 at 04:11AM
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VIRGINIA APARICIO: Taking off-label drugs is not without risks - Goshen News
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