Timeline Of Events Leading To Digitek Recall
The recent recall of Digitek (digoxin) is the latest difficulty in a long line of issues surrounding this drug. The team of dangerous medication lawyers at The Abelson Law Firm of Washington DC and Levin Fishbein Sedran and Berman of Philadelphia has been monitoring this situation closely. If you or a loved one may have been harmed by the use of Digitek, call us toll free at 1-888-797-4242 or email us at consult@pillsthatkill.com.
The Food and Drug Administration (FDA) notified the drug’s manufacturer, Actavis, in a warning letter dated August 15, 2006, of its failure to file periodic safety reports at its New Jersey facility. This failure violated Actavis’ adverse medical event reporting obligations, resulting in drugs being marketed without proper clearance and causing at least 26 adverse drug experiences. The warning letter referred to an FDA review conducted in January and February 2006 which found “potentially serious and unexpected adverse drug experiences” dating back to 1999 for several products, including digoxin, that were not reported to the FDA.
From July 10, 2006 through August 10, 2006, the FDA conducted another inspection of Actavis’ New Jersey facility. This inspection prompted the FDA to issue a revised warning letter dated February 1, 2007, which cited “significant deviations from the current Good Manufacturing Practice regulations.” The FDA said the inspection determined that there was “no assurance that the drug products manufactured and released into interstate commerce [by Actavis] have the identity, strength, quality and purity that they purport to possess.” Digitek was one of the affected drug products.
Actavis announced a Class I recall of the drug in an April 25, 2008 press release. This type of recall is extremely serious and is instituted only when there is a reasonable probability that use of the product will cause serious injury or death. The press release was followed by an FDA MedWatch Safety Alert posted April 28, 2008 on the agency's web site. Since then, very little additional information has been distributed.
A May 1, 2008, Newsday.com article, "Pharmacists will call you: Digitek recalled," suggests that the defective Digitek tablets may have been sold for more than a year before the recall. Actavis counsel John LaRocca is quoted as saying that Actavis had some concerns about the process and recalled Digitek after at least one pill emerged from the manufacturing process at double the appropriate thickness. Mr. LaRocca also stated that Actavis knew of no deaths linked to Digitek use, but had received 11 complaints about side effects since 2006.
The consequences of Actavis’ actions are just coming to light as more and more people learn about the recall and discover what role the adulterated Digitek may have played in their health. The double-strength pills released to the public can cause serious medical problems including digitalis toxicity that in certain patients can cause catastrophic injuries and death. Patients may have been exposed to unnecessary risk by the delay in recalling the drug and by Actavis’ failure to provide adequate information about the extent of the problem.
If you suspect you were injured by a Digitek drug defect, contact The Abelson Law Firm and Levin Fishbein Sedran and Berman today toll free at 1-888-797-4242 or by email at consult@pillsthatkill.com. For a free review of your possible Digitek claim, click here for a case evaluation
