Avian Flu Diary: FDA Warning On Fake Adderall

# 6356

Counterfeit drugs are a problem that has been around for some time, but appears to be getting worse as manufacturing delays and drug shortages send desperate customers in search of new sources for medications that they need.

A little more than a week ago, we saw from the Lancet: 1/3rd Of Malaria Drugs Fake Or Sub-Standard, and when the H1N1 pandemic was just getting started, we looked at the burgeoning business of selling fake antivirals in Spamalot: Fake Tamiflu

Yesterday the FDA issued a warning on a new internet drug scam, one that is selling counterfeit Adderall – a medication commonly used for attention deficit hyperactivity disorders (ADHD) and narcolepsy.

In recent months, Adderall has been one of hundreds of drugs that have come in short supply (see FDA’s Current Drug Shortages list), prompting some desperate parents and patients to seek online sources for the drug.

Unfortunately, what some of these people got was not Adderall – but a potentially dangerous mixture of Tramadol and acetaminophen.

Here is the FDA announcement, with information on how to spot fake, or counterfeit medications.

FDA NEWS RELEASE

For Immediate Release: May 29, 2012
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA warns consumers about counterfeit version of Teva’s Adderall

Tablets purchased on the Internet contain wrong active ingredients

The U.S. Food and Drug Administration is warning consumers and health care professionals about a counterfeit version of Teva Pharmaceutical Industries’ Adderall 30 milligram tablets that is being purchased on the Internet. Adderall, which is approved to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy, is a prescription drug classified as a controlled substance – a class of drugs for which special controls are required for dispensing by pharmacists.

FDA’s preliminary laboratory tests revealed that the counterfeit version of Teva’s Adderall 30 mg tablets contained the wrong active ingredients. Adderall contains four active ingredients – dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate. Instead of these active ingredients, the counterfeit product contained tramadol and acetaminophen, which are ingredients in medicines used to treat acute pain.

Currently on the FDA’s drug shortage list, Adderall is in short supply due to active pharmaceutical ingredient supply issues. Teva continues to release product as it becomes available. Consumers should be extra cautious when buying their medicines from online sources. Rogue websites and distributors may especially target medicines in short supply for counterfeiting.

The counterfeit Adderall tablets are round, white and do not have any type of markings, such as letters or numbers. 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 counterfeit versions of Adderall should be considered as unsafe, ineffective and potentially harmful.

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 with the National Drug Code (NDC) 0555-0768-02 listed.

Pictures of the counterfeit version of Teva’s Adderall 30 mg tablets and packaging

The Adderall 30 mg product may be counterfeit if:

1. The product comes in a blister package.

2. There are misspellings on the package.

“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.

Pictures of authentic Adderall 30 mg tablets (immediate release) by Teva (front and back side of tablet)

Anyone who believes they have the counterfeit version of Teva’s Adderall 30 mg tablets should not take or should stop taking the product. Consumers should talk to their health care professional about their condition and options for treatment.

Consumers and health care professionals are encouraged to report adverse events or side effects from the suspect counterfeit Adderall to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online: www.fda.gov/MedWatch/report.htm.

Download form 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.

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.

The problem isn’t just limited to Adderall and Tamiflu.

While there are scores of legitimate online pharmacies, it doesn’t take much searching to find sites (particularly out of India and Asia) that offer to sell everything from antibiotics to narcotics – often without a prescription.