The Food & Drug Administration (FDA) approved Amiodarone, manufactured by Wyeth, on January 5, 1999. Amiodarone is prescribed too treat heart rhythm disorders such as atrial fibrillation and atrial flutte. Doctors are prescribing this drug for off-label use without warning their patients about the drug’s life-threatening side effects or that the FDA had not approved their treatment as safe and effective.
Amiodarone (brand names: Cordarone and Pacerone) has been linked to severe side effects such as blindness, lung damage, and Toxic Epidermal Necrolysis (TEN). Many patients some left blind or with severely damaged lungs say doctors or pharmacists never told them about the drug’s life-threatening side effects or that the FDA hadn’t approved the treatment as safe and effective.
Toxic Epidermal Necrolysis (TEN) is a rare condition that causes large portions of the epidermis, the skin’s outermost layer, to disengage from the layers of skin below. The main cause of Toxic Epidermal Necrolysis (TEN) is a severe drug reaction.
In response to an investigation by Knight Ridder, that the FDA said it would require all Amiodarone prescriptions be dispensed with a special patient medication guide detailing the drug’s dangers and what conditions it is approved to treat. Patients were supposed to begin receiving the FDA-approved warning guides by early 2004, however six months later they are still under development and not being disseminated.
Amiodarone Causes Serious Side Effects
Amiodarone can be highly toxic to patients and causes a wide range of serious side effects. In some studies, as many as 17% of patients have experienced lung damage with 10% dying from it. Rarely do doctors inform patients of off-label prescribing, which means using a drug in ways the FDA never approved. While legal, such use can upset the balance between risk and benefit that’s crucial to get a drug approved and on the market.
In 2004 doctors wrote nearly 2.3 million prescriptions for Amiodarone to treat atrial fibrillation and other unapproved conditions accounting for 82 percent of it sales, according to a Knight Ridder analysis of drug industry data published last fall.
Off-label prescribing involves a doctor using a drug in ways the FDA never approved and therefore aren’t listed on its label. While going off-label is legal, such use can upset the balance between risk and benefit that is crucial to get a drug approved and on the market.