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Two lawsuits were recently filed against Mylan Pharmaceuticals Inc., Actavis Group, Actavis Totowa LLC, Mylan Bertek Pharmaceuticals Inc., and UDL Laboratories Inc., makers and distributors of the heart medication Digitek, also known as digoxin, on behalf of patients who took Digitek prescribed by their physicians and as a result suffered complications and died, according to the West Virginia The Record.
A generic form of digitalis – a heart drug – has been recalled in an unusual action that requires pharmacists to personally notify all customers who have purchased it.
Doctors prescribe the drug, Digitek, to treat heart failure and abnormal heart rhythms.
Actavis Totowa, a Totowa, N.J., manufacturer, recalled Digitek after consulting with the Food and Drug Administration. Actavis makes Digitek for Mylan Pharmaceuticals of Pittsburg, Pa.
Actavis counsel John LaRocca said the company recalled Digitek after at least one pill emerged from the manufacturing process at double the appropriate thickness. An FDA statement said: “These tablets may contain twice the approved level of active ingredient than is appropriate.”
Double-strength tablets could lead to toxic levels of digitalis in patients with renal failure.
“We had some concerns about the process,” LaRocca said. He said the company knew of no deaths linked to Digitek use but Actavis and the FDA had received 11 complaints about side effects since 2006.
Actavis has asked pharmacists to instruct consumers to return all unused Digitek pills and to consult their physicians. While recalls often result in the removal of drugs from pharmacy shelves, consumers seldom receive personal notification.
At North Shore Pharmacy in Huntington, supervising pharmacist Ron Wood said, “We never keep the generic [Digitek] in stock, so it [the recall] doesn’t apply.”
Joel Bassuk, pharmacist at Raindew Pharmacy in Manhasset, said he received the recall notice yesterday but he only has about five customers who use the drug.
“They said to immediately examine your inventory and discontinue all lots,” Bassuk said, noting he has had no reports of adverse side effects.
CVS spokesman Mike DeAngelis said the chain had removed all Digitek from its stores. “We went back to see which patients had prescriptions over the past 12 months and contacted them,” DeAngelis said.
SOURCE: Newsday
