We've blogged a lot recently about the inability - or lack of will - by the FDA to make sure consumers aren't hurt by dangerous drugs. Today I heard another scary story which hits a bit closer to home.
When I arrived at work this morning, I found out that my colleague's grandmother, in her 80s, had taken the heart drug Digitek and was now being detoxed at the hospital to get the drug out of her system. A couple of weeks ago the company recalled Digitek because some of the pills were twice as strong as they should have been. According to the manufacturer's (Actavis Totowa) press release the error,
"poses a risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive Digitalis intake. Several reports of illnesses and injuries have been received."
A class action lawsuit has now been filed againt the company. As is being reported,
It's now 2008 and in the meantime, patients like my colleague's grandmother have been put at extreme risk. Let's hope the courts will hold this company accountable because the FDA obviously can't, or won't."[T]he FDA issued a warning letter to Actavis back in August 2006 for failing to provide periodic safety reports at its oral dose manufacturing plant in Little Falls, N.J. The suit alleges that some of the faulty generic Digitek came out of that plant. The suit also claims that an FDA inspection in early 2006 revealed six potentially serious and unexpected adverse drug events dating back to 1999 for products that included generic Digitek, that weren’t reported to the agency."
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