Counterfeit ADHD drug Adderall prompts FDA warningFrom MedCityNews

by Admin on May 30, 2012 · 0 comments

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A counterfeit version of a drug to treat Attention Deficit Hyperactivity Disorder, or ADHD, is being sold online according to U.S. regulators amidst a shortage of the drug.

The counterfeit drug, a version of Adderall produced by Teva Pharmacuticals (NASDAQ: TEVA), has its U.S. headquarters in North Wales, Pennsylvania.

Tests by the U.S. Food and Drug Administration revealed that the 30 mg tablets to treat narcolepsy as well as attention deficit disorder contain improper ingredients. Instead of the four active ingredients that the drug contains — dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate — the counterfeit version contained tramadol and acetaminophen, which are ingredients in medicines used to treat acute pain.

The counterfeit Adderall tablets are round, white and do not have any type of markings, such as letters or numbers.

There has been a shortage of Adderall in the past year. Although Teva does not break out sales figures for its generic version of Adderall, it makes an instant release version of the drug. Additionally, as a result of legal settlements, both Teva and Impax Laboratories are the authorized generic sellers of Adderall XR, which is manufactured by Shire (NASDAQ: SHPGY).

Shire’s 2011 product sales of Adderall XR increased 48 percent to $532.8 million, representing approximately 12 percent of the company’s total revenues, according to Shire’s annual report.

The shortage has led to finger pointing with some accusing Shire of slowing down production of the drug to boost sales of the drug, which had declined in previous years, but the drug maker has maintained it has been hamstrung by DEA quotas.

In a Reuters story published at the beginning of the year, the DEA parked the blame for the Adderall shortages squarely on manufacturers. A Teva spokeswoman told Reuters in that article the catalyst for the problem is the quota system, not the business.

President Barack Obama issued an executive order last year to investigate the shortages.

via MedCity News

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