Bad enough when Florida college students feel they need to enhance their performance on finals with Adderall, a potentially addictive drug containing dextroamphetamine and amphetamine normally prescribed by physicians to control symptoms of attention deficit hyperactivity disorder (ADHD) as well as a treatment for narcolepsy (a sleep disorder that causes excessive daytime sleepiness and sudden attacks of sleep).
Now the FDA has issued a warning that a counterfeit version of the 30 milligram tablet being sold on the Internet is unsafe, ineffective, and potentially harmful.
Preliminary laboratory tests indicate that the counterfeit tablets contain the wrong active ingredients: Tramadol (an opiate agonist used to treat moderately severe pain) and acetaminophen (Tylenol).
According to the CDC, by 2007 about 9.5 percent, or 5.4 million school-aged children had been diagnosed with ADHD. From 2009 to 2010, Reuters reported that Adderall prescriptions had increased another 13.4 percent with more than 18 million prescriptions written for the drug.
Adding to the increased demand for Adderall has been its growing popularity and abuse among non-ADHD college students who believe it gives them an edge on exams.
Like many drugs, Adderall has recently landed on the FDA’s drug shortage list. Taking advantage of the situation, rogue online sites and distributors have targeted the drug for counterfeiting.
The counterfeit Adderall comes in a blister pack of tablets that are smooth, round, white, and do not contain any markings. The FDA has posted a link to photos of the counterfeit pills and notes that any product that resembles the tablets or packaging and claims to be Adderall 30 mg pill should be considered counterfeit.
In contrast, authentic Adderall 30 mg tablets manufactured by TEVA are round and orange/peach in color, with “dp” embossed on one side of the tablet and “30” on the other side.
Teva’s Adderall 30 mg tablets are packaged only in a 100-count bottle with the National Drug Code (NDC) 0555-0768-02 listed.
In October of last year President Obama signed an executive order calling for relief of all drug shortages. So far that has only minimally affected the supply of Adderall.
Anyone who believes they have the counterfeit version of Teva’s Adderall 30 mg tablets should not take or stop taking the product and contact the FDA’s Office of Criminal Investigations (OCI) at 800-551-3989.
They should also talk to their healthcare professional about their condition and options for treatment.
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 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.