Following the nationwide recall of Digoxin manufactured by Caraco Pharmaceutical Laboratories, which was issued due to potentially oversized and undersized tablets, other generic drug makers have indicated that they are prepared to supply the U.S. market with safe tablets for heart patients.
Caraco issued a Digoxin recall on Tuesday for all lots of their 0.125 mg and 0.25 mg tablets sold in 100-count and 1000-count bottles distributed before March 31, 2009.
A competing generic drug maker, Lannett Company, Inc., has released a statement indicating that they secured additional active pharmaceutical ingredients required to make Digoxin and that they are prepared to supply the difficult to source medication in a safe and uninterrupted manner in the wake of the Caraco recall.
Digoxin is used to treat heart conditions like atrial fibrillation, atrial flutter, abnormal heart rhythms and mild to moderate heart failure. However, the drug has a very narrow therapeutic index which requires very specific dosing.
Receiving too much of the medication could cause digoxin toxicity, which may result in nausea, dizziness, cardiac instability, vomiting, low blood pressure, bradycardia or death. Receiving too little of the drug could cause it to be ineffective at treating the underlying cardiac problems.
Many users of Digoxin were switched to the generic manufactured by Caraco after a nationwide recall was issued by Actavis Totowa in April 2008, for the Digitek brand of Digoxin. The Digitek recall was also caused by manufacturing problems which resulted in some tablets being commercially released that contained more of the drug then they were supposed to have.
Over 667 deaths have been reportedly linked to a Digitek overdose, highlighting the dangers associated with production problems involving Digoxin.
It is unclear how long Caraco had the production problems that led to the oversized and undersized tablets. In October 2008, the drug maker was warned by the FDA about quality control problems at their Detroit manufacturing facility and the plant is currently under review by the FDA to resolve the manufacturing issues.
