The IB News today reported on the recall and subsequent litigation surrounding Digoxin (Digitek). As reported, Digitek “double dose” tablets were distributed to patients nationwide. Manufacturers ignored FDA warning letters and FDA “Revised” warning letters. These warnings letters, particularly a February 1, 2007, warning letter cited Actavis Totowa (the manufacturer) for significant deviations from Good Manufacturing Practice Regulations. These “deviations” were noticed by the FDA during inspections conducted between July 10, 2006 and August 10, 2006. While it was the hope of the FDA that Actavis would correct the problem, the drug company did not and instead distributed defective tablets.
We know, drug manufacturers often place profits over people. This profit motive can be seen in many problematic drugs on the market today. In the case of Reglan (also known as metoclopramide). Wyeth failed to properly warn of the real risk of tardive dyskinesia. When Reglan (metoclopramide) was first approved, Wyeth told the FDA that the risk of contracting tardive dyskinesia was 1 in 500. But, it was not. The real risk of tardive dyskinesia has been estimated as 1 in 8. Since the drug is widely prescribed many people are at risk. In the case of Digitek, the number of persons at risk is much lower because the drug is not widely prescribed. However, Digitek is quite dangerous in double dosages and poses a deadly danger for those who ingested the drug.
Consumers ingesting either Digitek, Reglan or metoclopramide should contact an attorney to determine their rights to recover for possible personal injuries they may have sustained as a result of ingesting these drugs.