Regulatory Focus™ > News Articles > Consumers Warned of Fake Adderall in US

Consumers Warned of Fake Adderall in US

Posted 30 May 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) warned consumers on 29 May of counterfeit copies of Teva Pharmaceutical Industries' attention deficit hyperactive disorder (ADHD) drug Adderall, saying some consumers had obtained copies of the drug containing the incorrect active pharmaceutical ingredients (APIs) through an online pharmacy.

ADHD drugs like Adderall use a combination of APIs known as amphetamine salts. In the case of Adderall, the drug contains dextroamphetamine saccarate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate.

These drugs have been experiencing shortages since late 2011 thanks to a complicated web of supply controls. Because of its potential for abuse, amphetamine salts are controlled via a DEA-administered quota system which determines the medical need for a drug and then releases stock of the API to manufacturers.

Critics maintain the system has directly led to shortages of the drug by under-assessing the medical need for the drug, while DEA has fired back saying blame lies solely with industry and its manufacturing and distribution choices.

Regardless of the true cause of the shortages, the situation has consumers looking to find stock of the drug wherever possible. For some, this involves traveling to numerous pharmacies in the hope of finding available supplies of the drug. For an increasing amount of other consumers, this involves going online in the hopes of bypassing pharmacies altogether.

And therein lies the root of the counterfeit Adderall, says FDA.

"Rogue websites and distributors may especially target medicines in short supply for counterfeiting," wrote FDA in a press release. Its findings add to research released in February in the International Journal of Clinical Practice, which found much of the rise in counterfeiting was attributable to consumers' use of online pharmacies.

"Although many consumers acknowledge some degree of risk with purchasing medications via the Internet, speed, convenience and cost often prompt these purchases," said Dr. Graham Jackson, author of the study.

In the case of counterfeit copies of Teva's Adderall, not only are the counterfeit medicines fraudulently sourced, but they also fail to contain the correct API's. Instead of containing the combination of amphetamine salts, the counterfeit medicines contain a combination of tramadol and acetaminophen, which FDA notes "are ingredients in medicines used to treat acute pain."

FDA also explained the counterfeits in question did not appear to be particularly sophisticated. Counterfeit copies of the drug were of the incorrect color, had incorrect markings and contained numerous misspellings on its packaging.

Read more:

FDA - FDA warns consumers about counterfeit version of Teva's Adderall

Regulatory Focus - ADHD Drugs Remain in Short Supply

Regulatory Focus - Journal: Counterfeit Market Doubling, Risking Supply Chains

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