Off-Label Drug Use

1. What is off-label drug use?

a. Off-label drug use is when doctors prescribe medications for unapproved uses

b. FDA cannot control how doctors prescribe

c. 20% of Rx in US are fore off-label uses

2. Why use a drug for off-label purposes?

a. Tried all other options without success

b. Literature to support drug’s use, even if limited

c. Different dosage form

d. Dosage for which there is evidence that a higher dose may be effective

e. Drug is generic so there is no financial benefit for a manufacturer to obtain approvals

3. What are the risks?

a. Balance between effectiveness and risk is tilted toward risk

b. Investigational studies with close monitoring of safety

4. Approvals

a. Experimental

b. Benefit unknown

c. Risks unknown

d. Plan must pay for all consequences

5. Examples

a. Gabapentin for anxiety

b. High dose/strength opiates for pain

c. Stimulants for weight loss

d. Anti-epileptic medications for mood disorders/bipolar disease

e. Examples of atypical antipsychotics include Seroquel, Zyprexa and Abilify. They are being used to treat an array of conditions off-label, including anxiety, attention-deficit disorder, sleep problems, behavioral problems in toddlers and dementia.

f. Antipsychotics to treat dementia

g. Cancer treatment – estimated 50% are off-label

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