Actavis Pharmaceuticals Safety Concerns

Over a 3 years span, Actavis 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, 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.

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.