What are the Dangers of Using an "Off-Label" Prescription?
“Off-label” is the term used when a drug is prescribed (or a device is used) for a purpose that has not been approved by the FDA. Almost 20% of all drugs are prescribed “off label," being used to treat conditions other than which they were intended. Often this occurs because the manufacturer of the drug pays doctors on its payroll to write unproven opinions, without any supporting data, in order to increase sales of the drugs. Other well-meaning doctors listen to these company-paid doctors, not knowing they are on the company payroll and often do not know themselves that the use is “off label” and unproven. That’s why YOU need to know if the drug prescribed to you has been proven to be safe and effective for your condition. You must ask your doctor about whether it is an “off label” use.
The FDA approves drugs for specific uses only after the drug has been subjected to clinical trials which demonstrate both the effectiveness of the drug and its safety. When a doctor chooses to prescribe a drug “off-label,” he or she is giving patients a treatment for a condition that has not been rigorously tested.
While some off-label uses for drugs have been studied and do make sense, many more have been found to be dangerous to patients.
What types of dangers?
When drugs are prescribed for uses for which they haven’t been properly tested and approved, the results are not predictable. Negative results have run the gamut from useless to tragic.
Here are a few examples:
Quinine:
Approved use: Treatment for malaria.
Off-Label: Treatment for nighttime leg cramps. There are no studies demonstrating positive results.
Potential side effects: Kidney failure, heart problems.
Zprexa:
Approved use: Extremely powerful sedative that calms hallucinations; treatment for schizophrenia and bipolar disorder
Off-label: Treatment for older patients as a sleep aid
Potential side effects: Diabetes, high blood sugar, weight gain
Paxil:
Approved use: In adults only: Major Depressive Disorder, Obsessive Compulsive Disorder, Panic Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder, and Post Traumatic Stress Disorder.
Off-label: Childhood and adolescent depression. Studies showed Paxil to be no better than placebo (a sugar pill) at relieving symptoms.
Potential side effects: Suicidal ideation; suicide in children, teens and young adults.
Gabitril:
Approved use: Treatment for epilepsy.
Off-label: Treatment for anxiety, insomnia and pain.
Potential side effects: Use in non-epileptic patients led to seizures in some of them.
Actiq:
Approved use: For terminal cancer patients only: pain relief.
Off-label: Relief of any chronic pain.
Potential side effects: Opiate, 100 times more potent than morphine. Extremely addictive. Respiratory depression, sedation and cardiac arrest.
Ask your doctor
Off-label prescribing is not restricted by law, and may in some cases actually be beneficial. Your doctor can prescribe any drug he or she thinks is most appropriate for your treatment. But while some drugs have solid scientific evidence to support their off-label use, the majority of them do not. Your doctor may not volunteer information to you about your prescription—or may not even know he’s prescribing it off label, but you still need that information in order to make an informed choice.
Any time your doctor writes you a prescription, or offers you a “free sample” of a new medication, you should ask him these questions:
-
Has this medication been approved by the FDA to treat my condition?
If the answer is no, then ask about why he thinks it works. - Why do you think that this drug will be better treatment for my condition than one that has been approved by the FDA specifically for my condition?
- What evidence supports the use of this drug in my case?
- Is there an alternative treatment for my condition?