Off-label Use - Examples of Off-label Use (and Non-use)

Examples of Off-label Use (and Non-use)

• Actiq (oral transmucosal fentanyl citrate), a Schedule II controlled substance, is used off-label to treat moderate to severe chronic, non-malignant pain even though it is FDA-approved solely for breakthrough pain in cancer patients.
• Bevacizumab (Avastin) has been used against wet age-related macular degeneration, as well as macular edema from diseases such as diabetic retinopathy and central retinal vein occlusion.
• Buprenorphine has been shown experimentally (1982–1995) to be effective against severe, refractory depression.
• Bupropion, when sold under the brand name Wellbutrin is indicated for depression. It is also sold as a smoking cessation drug, under the name Zyban. In Ontario, Canada, smoking cessation drugs are not covered by provincial drug plans. Thus, a physician can write a prescription for Wellbutrin to assist with giving up the habit of smoking. It is also given to try counter the SSRI effects on the libido, anorgasmia and anhedonia.
• Carbamazepine, or Tegretol, has been used as a mood stabilizer and is accepted treatment for bipolar disorder.
• Dexamethasone and Betamethasone in premature labor, to enhance pulmonary maturation of the fetus.
• Doxepin, has been used to treat Angiodema and severe allergic reactions due to its strong anti histamine properties.
• Gabapentin, approved for treatment of seizures and postherpetic neuralgia in adults, is used off-label for a variety of conditions including bipolar disorder, essential tremor, hot flashes, migraine prophylaxis, neuropathic pain syndromes, phantom limb syndrome, and restless leg syndrome.
• Magnesium sulfate in obstetrics for premature labor and preeclampsia.
• Methotrexate (MTX), approved for the treatment of choriocarcinoma, is frequently used for the medical treatment of an unruptured ectopic pregnancy. There is no FDA-approved drug for this purpose and there is little incentive to sponsor an unpatented drug such as MTX for FDA-approval.
• The SSRI medication sertraline (Zoloft) is approved as an anti-depressant but is also commonly prescribed off-label to help men suffering from premature ejaculation.
• Stimulants such as Amphetamine (Adderall) and Methylphenidate (Ritalin) are indicated for childhood attention deficit disorder Benzphetamine (Didrex)(ADD/ADHD), but are often prescribed to treat this condition in adults, as well. Atomoxetine (Strattera), a non-stimulant norepinephrine reuptake inhibitor is currently the only drug (In the United States) indicated for adult ADD. In Australia dextroamphetamine is indicated for adult ADHD treatment. While Atomoxetine is also indicated for the treatment in Australia, it represents only a minor percentage of the drugs prescribed for the condition, due to its prohibitively high price, and it not being currently subsidised by the Government's Pharmaceutical Benefits Scheme. By contrast, the stimulant medications methylphenidate and dextroamphetamine are. Stimulants are also used off-label to treat depression, usually in conjunction with a standard antidepressant drug.