Ethex Dextroamphetamine Sulfate Recall: Oversized Tablets

Ethex Corporation announced yesterday a Dextroamphetamine Sulfate recall for three lots of their generic psychostimulant drug after it was discovered that some tablets could be oversized. This is the second major Ethex recall this year due to manufacturing defects that resulted in double strength tablets, as they previously recalled Morphine Sulfate extended release tablets in June.

In a press release issued on October 15, 2008, Ethex Corporation indicated that they recently discovered that some tablets from three different lots of Dextroamphetamine Sulfate 5 mg tablets could be oversized, containing up to twice the labeled amount of active ingredient.

Double strength Dextroamphetamine tablets could pose an increased risk of side effects already associated with the drug, such as hypertension, blurred vision, tachycardia, dizziness, upset stomach, tremors, insomnia, headache, decreased appetite and dry mouth.

Dextroamphetamine is a psychostimulant which produces increased wakefulness, energy and self-confidence. It is primarily used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy. The Ethex Dextroamphetamine is a generic version of brand name drugs Dexedrine and Dextrostat.

The recalled Dextroamphetamine were distributed between January 2007 and May 2008 under the “ETHEX” label. The 5 mg tablets are round and orange in color with “ETHEX” and “311” on one side. The recall applies to lot numbers 77946, 81141 and 81142.

Ethex indicates that they have not received any reports of unexpected Dextroamphetamine side effects or injuries caused by double strength tablets, but they found a small number of oversized tablets in the lots which had not yet been distributed.

 
In June 2008, Ethex issued a Morphine recall for similar reasons after 60 mg extended release tablets were found to be double strength. The double strength morphine has been associated with a number of serious and life-threatening adverse reactions among users who suffered a morphine overdose. Since morphine is an opioid, if it is taken in excess it can cause low blood pressure and respiratory depression, which could be fatal.

However, Ethex is not the only generic drug maker who has issued a recall this year after discovering that they sold tablets that contained more of the drug than they were supposed to. In April 2008, Actavis Totowa issued a Digitek recall for their generic digoxin heart drug which was sold under the Mylan and UDL labels.

Thousands of users who were given the oversized digoxin tablets to treat irregular heartbeats and heart failure have reported suffering side effects of a Digitek overdose, known as digoxin toxicity. As of last month, at least 64 Digitek lawsuits have been filed in federal court as a result of the Actavis manufacturing defect and hundreds more cases are still being investigated by product liability lawyers.

The FDA and Ethex have requested that any consumers who experienced an adverse reaction or received oversized Dextroamphetamine Sulfate 5mg tablets, should file a report with the FDA’s MedWatch Program. Lawyers who are investigating potential Dextroamphetamine cases on behalf of consumers have recommended that any unused pills be preserved for testing if a serious injury was caused and the consumer intends to file a legal claim.