The Food and Drug Administration (FDA) is alerting healthcare providers and the public that counterfeit Botox (onabotulinumtoxin A; Allergan) has been found in the United States and may have been distributed to doctors’ offices and clinics.
The FDA deems these suspect products unsafe because the manufacturing, quality, storage, or handling cannot be confirmed according to U.S. standards. Medications bought from foreign or unlicensed sources may be misbranded, adulterated, counterfeit, contaminated, improperly stored/transported, ineffective, and/or unsafe.
Similarities between the counterfeit and FDA-approved versions exist. However, the FDA-approved Botox shows the active ingredient as “OnabotulinumtoxinA” on the outer carton and vial. The counterfeit version can be identified by any of the following indicators:
- Vial is missing the lot number
- Outer carton does not have entries next to the LOT: MFG: EXP:
- Outer carton and vial display the active ingredient as “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA”
Botox is a neuromuscular blocker currently approved for prophylaxis of headaches in adults with chronic migraine; severe primary axillary hyperhidrosis when topical agents are inadequate; treatment of upper limb spasticity in the flexor muscles of the elbow, wrist and finger in patients ≥18yrs; cervical dystonia in patients ≥16yrs, to reduce severity of abnormal head position and neck pain; strabismus or blepharospasm related to dystonia in patients ≥12yrs; and adults who have an inadequate response to or are intolerant of an anticholinergic drug: in overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency or urinary incontinence due to detrusor overactivity associated with a neurologic condition (eg, spinal cord injury, multiple sclerosis).
Healthcare providers are recommended to verify with Allergan to ensure their distributor is authorized. A list of authorized Botox suppliers can be found here.
For more information call (800) 551-3989 or visit FDA.gov.