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FDA Reports Details on ADHD Drug Shortages


 

The Food and Drug Administration is reporting current shortages of three drugs that are prescribed in the treatment of attention-deficit/hyperactive disorder: amphetamine mixed salts immediate-release tablets, dextroamphetamine tablets, and methylphenidate HCl.

The shortage of amphetamine mixed salts immediate-release tablets is primarily attributable to an increase in demand. Supply issues were cited by one manufacturer. The three companies involved are releasing the products as they become available.

The shortage of dextroamphetamine tablets (5 mg and 10 mg), made by Teva Pharmaceuticals, is new. The product will be released as it becomes available, the company reported. Dexamethasone injection presentations (5-mg/mL and 10-mg/mL vial [Carpujet]), made by American Regent Inc., are on hold because of the presence of particulate matter. It has "no estimated release date," the company reported. West-Ward Pharmaceuticals has the 10 mg/mL formulation of dexamethasone on back order and expects to have it available by the middle of July.

The shortage of methylphenidate HCl is tied to delays that have been reported by several manufacturers, the FDA noted. Sandoz has reported capacity constraints, and expects sporadic back orders for the next couple of months. Mallinckrodt has reported continued recovery as a result of previously unavailable raw material; the company expects all strengths of methylphenidate IR and ER (extended-release) tablets to be increasingly available as supply recovery continues, with most contracted orders being met. UCB has reported increased demand; the company is currently out of its stock of 5-mg IR, 10-mg IR, 20-mg IR, and 20-mg ER products, with resupply expected by February. Watson Pharmaceuticals Inc. has all three strengths available for contracted customers only. Noven Pharmaceuticals Inc. reports that all Daytrana (methylphenidate transdermal system) products are available.

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