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FDA issues warning about counterfeit version of ADHD drug
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The FDA issued a warning this week about a counterfeit version of Teva Pharmaceutical Industries’ Adderall 30 mg tablets being sold on the Internet.
Adderall is currently included on the FDA’s drug shortage list because of pharmaceutical ingredient supply issues. Teva continues to release product as it becomes available, according to the FDA.
Preliminary laboratory tests conducted by the FDA revealed that the counterfeit version of Teva’s Adderall 30 mg tablets contained the wrong active ingredients. Adderall, which is approved to treat attention-deficit/hyperactivity disorders and narcolepsy, contains four active ingredients: dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate. The counterfeit product contained tramadol and acetaminophen and none of the active ingredients of the authentic product, according to an FDA press release.
Authentic Adderall 30 mg tablets produced by Teva are round, scored tablets that are orange/peach in color and have the letters “dp” embossed on one side and “30” on the other side. The Adderall 30 mg tablets are packaged only in a 100-count bottle with the National Drug Code (NDC) 0555-0768-02 listed.
The Adderall 30 mg product may be counterfeit if:
- The product comes in a blister package.
- There are misspellings on the package, for example, “NDS” instead of “NDC”; “Aspartrte” instead of “Aspartate”; and “Singel” instead of “Single.”
- The tablets are white in color, round in shape, and are smooth.
- The tablets have no markings on them.
The counterfeit Adderall tablets are round and white and do not have any type of markings. The counterfeit versions of Adderall should be considered as unsafe, ineffective and potentially harmful.
Photos of Adderall to use as comparison can be found on the FDA site: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm305932.htm?source=govdelivery.
Adverse events or side effects from the suspect counterfeit Adderall should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program found at www.fda.gov/MedWatch/report.htm.
Perspective
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Edward A. Bell, PharmD, BCPS
This recent warning from the FDA about counterfeit drug products is, unfortunately, becoming more common. The FDA has been issuing similar warnings about counterfeit medications for several years. As there has been a recent increase in drug shortages, such counterfeit medications may become more commonly available. Most counterfeit medications are purchased on Internet sites. What can health care professionals do? Ask your patients where they obtain their medications. Also, talk to your patients about the dangers of counterfeit medications. Tramadol, an opioid analgesic, was found in this counterfeit Adderall product, and not the stimulants that the real product contains. Not only would this product not effectively control ADHD symptoms, but it also could cause drowsiness or dizziness, and if taken by an adolescent, this may potentially contribute to an automobile accident when the patient is driving.
Talk to your patients and families about purchasing medications from Internet sites. An Internet site selling medications should comply with state and federal laws, and follow criteria established by the National Association of Boards of Pharmacy (including displaying its “VIPPS” seal). The National Association of Boards of Pharmacy recently reviewed more than 9,600 Internet sites selling medications and found that only 3% of them were in compliance with such laws. Warn families not to use Internet sites located outside the US, sites selling medications at very low prices, not requiring a prescription, and sites that cannot be contacted by phone or do not have a pharmacist available to contact.
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