FDA Warning On Fake Adderall

 

 

 

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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.

But what you get when you order these meds is anyone’s guess. 

 

The FDA has an online FAQ on Buying Medicines and Medical Products Online. 

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Lancet: 1/3rd Of Malaria Drugs Fake Or Sub-Standard

 

Credit  CDC 

 

 

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An eye-opening report from The Lancet today, which indicates that a large percentage of the anti-malarial drugs used in Asia and sub-Saharan Africa are either fake, or are of inferior quality.

 

Ominously, using drugs that contain too little of their intended active ingredient can contribute to pathogens developing increased and widespread resistance over time.

 

 

The problem isn’t new, but is apparently more widespread than previously thought.   The authors divided `Poor Quality’ drugs into three categories.

 

• Falsified (fraudulently manufactured with fake packaging and usually no or a wrong active pharmaceutical ingredient)
• Substandard (products resulting from poor manufacturing with no intent to deceive, usually with inadequate or too much active pharmaceutical ingredient);
• Degraded (good-quality drugs that are degraded by poor storage after leaving the factory)

 

Follow the link to the Lancet article (full access with free registration) is below.

 

Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa

Gaurvika ML Nayyar BS , Joel G Breman MD , Paul N Newton MRCP , James Herrington PhD

Summary

Poor-quality antimalarial drugs lead to drug resistance and inadequate treatment, which pose an urgent threat to vulnerable populations and jeopardise progress and investments in combating malaria. Emergence of artemisinin resistance or tolerance in Plasmodium falciparum on the Thailand—Cambodia border makes protection of the effectiveness of the drug supply imperative.

 

We reviewed published and unpublished studies reporting chemical analyses and assessments of packaging of antimalarial drugs. Of 1437 samples of drugs in five classes from seven countries in southeast Asia, 497 (35%) failed chemical analysis, 423 (46%) of 919 failed packaging analysis, and 450 (36%) of 1260 were classified as falsified.

(Continue . . . )

 

 

A problem of longstanding, the CDC’s website has more on the problem of fake Malaria drugs, and what steps travelers should take if the must purchase medication abroad.

 

Counterfeit and Substandard Antimalarial Drugs

What Are They?

Counterfeit (fake) antimalarial or other drugs are deliberately made to look like brand name drugs. However, they may have no active ingredients, they may have less than the required amount of active ingredient, or they may contain ingredients which are not what is described on the package label. Counterfeiters tend to focus on the more expensive brands. Substandard drugs are found even among cheaper products, because some manufacturers try to avoid costly quality control and good manufacturing practices.

The quality of commercially available drugs varies greatly in malaria-endemic countries:

• The amount of the active ingredient can vary due to lack of regulations and poor quality control practices in many of these countries.
• Some pills may release very little if any drug due to poor formulation techniques.
• Chemical break-down of some drugs can occur due to poor storage conditions, especially in warm and humid tropical climates.
• Some drugs may be contaminated with other substances.
• Counterfeiters may also obtain expired drugs and repackage them with new expiration dates.

Where Do You Find Them?

Worldwide prevalence of counterfeit and substandard products is summarized in a Drug Quality Report matrix by the U.S. Pharmacopeia Drug Quality and Information (USP DQI) Program. Information on domestic (U.S.) issues regarding counterfeit and poor-quality drugs is provided by the U.S. Food and Drug Administration.

 

For example, in Cambodia in 1999, counterfeit antimalarial drugs were responsible for the deaths of at least 30 people. A 2001 survey in Southeast Asia showed that among 104 tablets presented as the antimalarial drug artesunate, 38% did not contain any artesunate.

When Buying Drugs, Take the Following Precautions

• Travelers should buy in their home country all the medicines they will need before their trip.
• Travelers should write down the drug's generic and brand names as well as the name of the manufacturer. In case they run out, they can look for the correct product.
• Make sure that the drug is in its original packaging.
• Inspect the packaging because many times poor quality printing indicates a counterfeited product.
• Be suspicious of tablets that have a peculiar odor, taste, or color, or that are extremely brittle

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