Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Actavis Inc. has made an agreement with the FDA not to issue any drugs from its Totowa facilities in Morristown, N.J., where Digitek is produced.

According to the Philadelphia Inquirer, the agreement says Actavis cannot resume its practices until it conforms to “the agency’s good manufacturing practice.” Actavis must improve its labs, facilities, and equipment.

Actavis has faced numerous lawsuits over the recalled drug Digitek. One such lawsuit includes the death of a patient and claims that Digitek is an unsafe and flawed drug.

Actavis would not comment if the FDA agreement had influenced the Digitek lawsuits or not.

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.

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U.S. Attorneys in New Jersey are moving to close three Actavis Inc. plants, the company that manufactures Digitek, until they comply with FDA regulations.

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On October 8, John Dingell (D-MI), chairman of the U.S. House Committee on Energy and Commerce, and Bart Stupak (D-MI), chairman of that committee’s Subcommittee on Oversight and Investigations, wrote a letter to the U.S. Food and Drug Administration Commissioner Andrew C. von Eschenbach to request more information concerning the FDA’s procedure for examining manufacturing facilities of the generic drug manufacturer Actavis after several of the company’s products were recalled.

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Many previous Digitek consumers have steered away from Digitek after the recall. However, as Digitek has lost consumers, Lannett Company has only reaped the benefits.

Sales for Lannett’s digoxin, a generic form of Digitek, still have been strong since the recall of Digitek in April of this year.

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Attorneys who take on the pharmaceutical industry as a voice for consumers injured by medications found an unlikely ally this week, in doctors. Noting that the U.S. Food & Drug Administration is often “overwhelmed” by drug safety problems ranging from serious side effects to unsafe manufacturing facilities, editors of the New England Journal of Medicine said patients benefit from information uncovered by attorneys during liability investigations, according to an Associated Press report released Friday.

Journal editor Dr. Jeffrey M. Drazen says the litigation process and the court system is a “key defense mechanism” to insure drug safety and to obtain justice if drug manufacturers have not made the risks involved with its product clear.

The doctors say the FDA is incapable of being the sole guardian of drug safety and that without the information supplied by liability litigation, “the American public would be deprived of a vital deterrent against pharmaceutical company misconduct.”

The opinion was submitted to the Supreme Court as a friend-of-the-court brief in the matter of Wyeth v. Levine, a case expected to be heard later this year. According to the AP story, the case involves Diana Levine, a guitarist who lost her right arm below the elbow after an injection of Phenergan. She sued the drug’s manufacturer, Wyeth, alleging the company had not adequately warned consumers of the risks associated with its product. The case was tried in Vermont, and the court agreed, awarding Levine $7 million.

Wyeth is appealing the case, saying the FDA had approved the drug, and that the state court could not overrule the FDA’s judgment.

However, the editors of the New England Journal of Medicine sided with 47 state attorneys general and two former FDA commissioners in supporting Levine’s position, the AP report states.

Actavis Totowa, the drug manufacturer of Digitek, just announced a voluntary recall, to the retail level, of more than 65 generic drug products manufactured at its Little Falls, New Jersey, facility, according to a release on the company web site. This recall follows an inspection conducted by the Food & Drug Administration, earlier this year, which revealed that operations at the New Jersey facility did not meet FDA standards.

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Over the past 3 years, Activis has faced increasing scrutiny from the FDA over serious safety concerns

In 2006, Actavis, the manufacturer of Digitek, was reprimanded by the U.S. Food & Drug Administration (FDA), which says that an inspection between January and February 2006 revealed six potentially serious and unexpected adverse side effects dating back to 1999 for drugs including digoxin (Digitek), phentermine and phenazopyridine that were not reported to the FDA.

According to a report on In-Pharma Techologist.com, the FDA sent a warning letter to Actavis in August 2006, alerting the company that its manufacturing facility in New Jersey had failed to file periodic safety reports, and had failed to report adverse drug events. Actavis was reprimanded for marketing drugs without proper clearance by not submitting the safety reports.

The report also noted that Actavis was cited for manufacturing several medications without approved applications.

The company insists it has since complied with all medical event reporting obligations that were overdue, and that it had revised its procedures for reporting such events to ensure continuous compliance with FDA regulations.

In April 2008, Actavis issued a Class I recall of Digitek (digoxin) tablets, which were manufactured at twice the proper thickness, which could result in digitalis toxicity. However, subsequent news reports indicate that the product may still have been in distribution up to a year after the initial recall, relying on pharmacists to alert patients prescribed the medication about the possible danger.

Most recently, on August 1, 2008, Actavis announced a voluntary recall, to the retail level, of more than 65 generic drug products manufactured at its Little Falls, New Jersey, facility, according to a release on the company web site. This recall follows an inspection conducted by the Food & Drug Administration, earlier this year, which revealed that operations at the New Jersey facility did not meet FDA standards.

For a list of the most recently recalled drugs, and more information, visit Actavis online.

Actavis was founded in 1956 and today is one of the leading companies worldwide involved in the development, manufacture and sale of generic pharmaceuticals. According to the company’s web site, there currently are more than 400 products in development. Headquartered in Iceland, Actavis has operations in about 40 countries and employs more than 11,000 people.

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