Ethex, a manufacturer of Dextroamphetamine Sulfate 5 mg tablets, has voluntarily recalled three specific lots (77946, 81141, and 81142) as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain up to twice the labeled amount of the active ingredient.
Dextroamphetamine Sulfate is a generic medication manufactured by multiple companies in the US. Consumers and caregivers are encouraged to check their prescriptions to determine the source of their tablets. The recalled lots were distributed between January 2007 and May 2008. The 5 mg product is a round, orange tablet debossed with “ETHEX” and “311” on one side. Dextroamphetamine is approved for the treatment of narcolepsy, Attention Deficit Disorder (ADD), and Attention Deficit Hyperactivity Disorder (ADHD) among children and adults.
Adverse events associated with excessive dosing of Dextroamphetamine Sulfate include tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset, and dry mouth. Other, more serious adverse events include tachycardia, hypertension, psychotic episodes, a new onset or worsening of tics, and dyskinesias. Excessive dosing may also result in physical impairment and altered coordination when operating machinery or driving, posing both an individual and public safety risk.
The product withdrawal is voluntary and appears to have stopped widespread distribution of the tablets to the public. The manufacturers believe these tablets were only contained in the recalled lots; however, it is prudent to encourage all patients to check their medication. A significant percentage of Dextroamphetamine tablets are used among children.
Consumers should not use any Dextroamphetamine Sulfate tablets that appear to be oversized. They should speak with their pharmacist and prescribing healthcare provider for further instructions. Because Dextroamphetamine is a Schedule II controlled substance, replacing the pills at the pharmacy may require obtaining a new prescription from the prescriber. Adverse reactions associated with abnormally sized tablets should be reported to FDA’s MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, or on the MedWatch Web site at www.fda.gov/medwatch.
Caution: Review current drug information before administering and monitoring medications.
Drug News is compiled by Susanne J. Pavlovich-Danis, RN, MSN, ARNP-C, CDE, CRRN, who maintains a private practice in Plantation, Fla., and is professor and area chair for nursing at the University of Phoenix, Fort Lauderdale.
References
Ethex Corporation voluntarily recalls three lots of Dextroamphetamine Sulfate 5 mg tablets due to the potential for oversized tablets. FDA Web site. http://www.fda.gov/oc/po/firmrecalls/ethex10_08.html. Accessed December 2, 2008.
Dextroamphetamine Sulfate is a generic medication manufactured by multiple companies in the US. Consumers and caregivers are encouraged to check their prescriptions to determine the source of their tablets. The recalled lots were distributed between January 2007 and May 2008. The 5 mg product is a round, orange tablet debossed with “ETHEX” and “311” on one side. Dextroamphetamine is approved for the treatment of narcolepsy, Attention Deficit Disorder (ADD), and Attention Deficit Hyperactivity Disorder (ADHD) among children and adults.
Adverse events associated with excessive dosing of Dextroamphetamine Sulfate include tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset, and dry mouth. Other, more serious adverse events include tachycardia, hypertension, psychotic episodes, a new onset or worsening of tics, and dyskinesias. Excessive dosing may also result in physical impairment and altered coordination when operating machinery or driving, posing both an individual and public safety risk.
The product withdrawal is voluntary and appears to have stopped widespread distribution of the tablets to the public. The manufacturers believe these tablets were only contained in the recalled lots; however, it is prudent to encourage all patients to check their medication. A significant percentage of Dextroamphetamine tablets are used among children.
Consumers should not use any Dextroamphetamine Sulfate tablets that appear to be oversized. They should speak with their pharmacist and prescribing healthcare provider for further instructions. Because Dextroamphetamine is a Schedule II controlled substance, replacing the pills at the pharmacy may require obtaining a new prescription from the prescriber. Adverse reactions associated with abnormally sized tablets should be reported to FDA’s MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, or on the MedWatch Web site at www.fda.gov/medwatch.
Caution: Review current drug information before administering and monitoring medications.
Drug News is compiled by Susanne J. Pavlovich-Danis, RN, MSN, ARNP-C, CDE, CRRN, who maintains a private practice in Plantation, Fla., and is professor and area chair for nursing at the University of Phoenix, Fort Lauderdale.
References
Ethex Corporation voluntarily recalls three lots of Dextroamphetamine Sulfate 5 mg tablets due to the potential for oversized tablets. FDA Web site. http://www.fda.gov/oc/po/firmrecalls/ethex10_08.html. Accessed December 2, 2008.
