The agency issued the warning after the manufacturer, Teva Pharmaceuticals alerted the FDA that customers purchased the counterfeit version of Teva’s Adderall 30 mg tablets online from Internet sellers, Shelly Burgess, an FDA spokeswoman told me Thursday by email.
According to the press release
, when the FDA conducted laboratory tests on the counterfeit tablets, the active ingredients usually in authentic Adderall were no where to be found. In fact, it contained the wrong ingredients.
For instance, in order for Adderall to treat ADHD and narcolepsy, it contains four active ingredients – dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate.
But instead of these active ingredients, the counterfeit product contained tramadol - the active ingredient found in the popular arthritis pain reliever, Ultram, and acetaminophen, the active ingredient found in Tylenol.
Why would rouge sites go through all this trouble?
Counterfeiters are drawn to drugs such as Adderall, in part, because the drug has been in short supply since late last year. ABC
News reports the nationwide shortage of Adderall in pharmacies may have led some to purchase the medication on the Internet.
“If it offers dramatically low prices from market value, this is a red flag,” Burgess told ABC News.
In her email, Burgess added: "In some instances, current and anticipated shortages of medications can create the opportunity for unscrupulous players to introduce non-FDA approved products into the drug supply that are unsafe and ineffective or even counterfeit.
According to ABC news, the agency is grappling with how best to regulate rogue online sites that sell fake and potentially harmful medications. The FDA can issue warning letters to the sites highlighting its unsafe practices, but are not able to ensure that it can be stopped.
“These sites can shut down and pop back up under a different name the next day,” Burgess told ABC
Since there is no tracking system for rogue websites that sell fake medication, it is unclear how many people have bought the imitations online.
"While we were informed of 2 reports from Teva, we do not know the full extent of the distribution of this counterfeit medicine because it is being offered for sale on the internet," Burgess told me.
So what do you look for in a safe internet site? ABC reports trustworthy websites are licensed by state board of pharmacy and contain a list of the boards on the site. The site should also have a licensed pharmacist available to answer questions the consumer may have. Sound websites also require prescription verification before dispensing any pharmaceutical medication.
Counterfeit Adderall vs Authentic Adderall
The counterfeit Adderall tablets are round, white and do not have any type of markings, such as letters or numbers, the news release says.
Any product that resembles the tablets or the packaging in the photos below and claims to be Teva’s Adderall 30 mg tablets should be considered counterfeit.
The Adderall 30 mg product may be counterfeit if:
1. The product comes in a blister package.
2. The counterfeiters didn't seem to care much for spell check.
“NDS” instead of “NDC”
“Aspartrte” instead of “Aspartate”
“Singel” instead of “Single”
3. The tablets are white in color, round in shape, and are smooth.
4. The tablets have no markings on them.
Finally, authentic Adderall 30 mg tablets produced by Teva are round, orange/peach, and scored tablets with “dp” embossed on one side and “30” on the other side of the tablet. Teva’s Adderall 30 mg tablets are packaged only in a 100-count bottle, not a blister pack.
Anyone who suspects they have taken the counterfeit Adderall are encouraged to report any side effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program found online
, the press release said.
The counterfeit versions of Adderall should be considered as unsafe, ineffective and potentially harmful.
And for consumers who believe they have received counterfeit Adderall should contact the FDA’s Office of Criminal Investigations (OCI) at 800-551-3989 or http://www.fda.gov/OCI