According to reports filed to the FDA and consumers, the Center for Public Integrity has found that Digitek is responsible for 667 consumers’ deaths from April through June 2008. Pharma Live says health experts believe the FDA should have made more “aggressive warnings” to the public. The number of deaths associated with Digitek consumers have increased since the last reporting period.Because all Digitek consumers already have heart disease, the issue is whether or not Digitek has caused an increase in death from heart problems.
In April of this year, Digitek pills were recalled due to a suspicion of Digitek pills containing twice the active ingredient. Actavis Inc., the drug manufacturer, believes none of these pills made it to the public and that the recall was only out of “an abundance of caution.”
Unfortunately, many Digitek consumers are still unaware of the Digitek recall and the number of reported deaths associated with Digitek consumers. The FDA posted a Med Watch Alert for Digitek on April 28, 2008 due to the possibility of some of the pills containing double the active ingredient.
Health experts believe the FDA should have further investigated Digitek’s manufacturers and the FDA should have warned doctors, pharmacists, and consumers of the potential dangers associated with this drug. The FDA believes their actions in informing the public were consistent when compared to other drugs that have caused issues.