1. What is an "off-label" drug?
An "off-label drug" is use of a drug in ways other than described in the FDA-approved label. It is legal for physicians to prescribe medications for off-label uses; however, it is not legal for drug companies to promote unapproved uses or distort information about a medication's off-label benefits.

2. Why would anyone use a drug for any reason other than what it was intended?
Many prescription drugs can provide benefits for patients that are not the drug's primary purpose. For example, aspirin, once thought only a pain killer, has been proven to increase blood circulation and prevent heart attacks. This is an acceptable medical practice when done by an experienced physician. When a drug company specifically markets a drug for an off-label purpose, it violates Federal law, and can cause serious injuries in patients.

3. What are the most common uses of off label drugs?
Off label uses of FDA-approved drugs can include:

• Antidepressants - used for insomnia and pain
• Opioid analgesics - used for pediatric pain
• Anticonvulsants - used for a variety of pain problems
• Corticosteroids - used for cancer pain
• Antiarrythmics - used for neuropathic pain
• Beta-blockers - used for migraine
• NSAIDs - used for nonarthritic pain
• Amphetamines - used for opioid-induced sedation
• Clonazepam - used for anxiety

4. What should I do if my doctor prescribes a drug for off label use?
Here are some tips for the next time your doctor prescribes any medication:

• Ask about the risks and benefits - Ask if the drug has been approved for your condition and about the potential benefits and risks involved.
• Talk to the pharmacist - Ask the pharmacist to review the package insert with you before filling the prescription.
• Do some research - Look up the drug in medical reference book or on the Internet. Check whether your condition is an approved use, what the proper dose is, and what the proper duration of use is.
• Inquire about other options - If you are not comfortable with a drug that does not meet FDA-approval for your condition, tell your doctor.

5. Do I need to hire a lawyer to represent me?
It is always good to hire a lawyer to represent you any time you plan to sue a person or company. A lawyer can provide you with expertise in the field you are suing. If you have been injured due to an off-label drug, contact Gary C. Johnson, P.S.C. today to discuss your possible case.