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FDA issues counterfeit Adderall warning

Fake versions of Teva's ADHD drug found to be available from online pharmacies

Fake copies Teva Adderall ADHD drug

The US Food and Drug Administration (FDA) has warned consumers to be careful when purchasing medicines from web-based pharmacies after counterfeit ADHD drugs were found to be available online.

The government agency said the fake versions of Teva's generic copy of the ADHD and narcolepsy treatment Adderall were found to contain the wrong active ingredients and should be considered “unsafe, ineffective and potentially harmful”.

The counterfeits are poor copies of Teva's drug, appearing as white tablets, where Teva's are orange/peach. They also lacki any of the embossed markings found on Teva's product.

Preliminary laboratory tests of the counterfeits drugs revealed they contained ingredients from two pain treatments, the centrally acting synthetic analgesic tramadol and analgesic/antipyretic paracetamol (acetaminophen). 

Legitimate versions of Adderall should contain dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate

Currently on the FDA's drug shortage list, Adderall – which was originally developed by Shire - is in short supply due to active pharmaceutical ingredient supply issues.

“Consumers should be extra cautious when buying their medicines from online sources,” the FDA warned. “Rogue websites and distributors may especially target medicines in short supply for counterfeiting.”

Earlier this year counterfeit versions of Roche's Avastin that had no active ingredient were found in the US supply chain and in 2010 fake versions of GlaxoSmithKline's (GSK) Alli were smuggled into the US.

The counterfeit version of GSK's weight-loss treatment contained the wrong active ingredient and, according to the World Health Organization (WHO), posed “possible serious health risks to the consumer”.

At its world assembly last week WHO delegates approved a draft resolution proposing greater international cooperation on substandard, spurious, falsely-labelled, falsified or counterfeit (SSFFC) medical products.

The WHO singled out “emerging channels of distribution such as internet sales” as a significant threat, saying they require specific solutions.

The plans were welcomed by international pharma industry body IFPMA, whose associate director of public affairs and global health policy Mario Ottiglio said the internet “facilitated trade in counterfeit medicines”.

“We believe that now it is the moment to make efforts to agree on a global agenda which puts patients' safety at the core by adopting the proposed new mechanism,” he added.

The problem is also high on the EMA's agenda, with new European counterfeits legislation expected to come into force during January 2013.

30th May 2012


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