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

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

Digitalis toxicity can lead to nausea, vomiting, dizziness, low blood pressure, cardiac instability and even death

Digitek is a medication that is widely used in the treatment of various heart conditions, namely atrial fibrillation, atrial flutter and sometimes heart failure that cannot be controlled by other means. Digitalis toxicity is a complication of digitalis therapy, or it may be caused by an acute ingestion of digitalis.

digitalis toxicity

Digitalis toxicity can occur from a single exposure or chronic overmedication, or it may occur in patients with normal blood levels of digitalis if other risks are present.

Risks include taking digitalis medications such as Digitek (digoxin) or digitoxin, along with medications that interact with digitalis such as quinidine, verapamil, amiodarone, and others.

People with heart failure are commonly given diuretics (medications used to pull excess fluid from the body) along with digoxin. Many diuretics can cause potassium loss. Low levels of potassium in the body increase the risk of digitalis toxicity. Digitalis toxicity may also result from low levels of magnesium in the body.

Reduced kidney function will cause digitalis to accumulate in the body rather than being excreted normally through urine. Therefore, any disorders that disrupt kidney functioning (including dehydration) make digitalis toxicity more likely.

Evidence suggests that the incidence and severity of Digitek toxicity has decreased substantially in recent years.

Do you have a Digitek claim?

If you or your loved one has suffered a serious injury or death as a result of Digitek, you may be entitled to compensation for medical expenses, loss of wages, and pain and suffering.

Please contact our Digitek lawyers today by filling out the brief questionnaire, or by calling our toll free number (1-800-898-2034) for a free, no-cost, no-obligation legal evaluation of your case.

Beasley Allen law firm is actively pursuing Digitek recall and digitalis toxicity claims in all 50 states

Our defective drug and product liability lawyers work solely on behalf of individual plaintiffs that were injured by defective products, such as Digitek.

Over the past 29 years, we have successfully handled thousands of defective drug claims, having recovered more than $20 billion in verdicts and settlements for our clients.

Chad Cook is the Digitek lawyer investigating claims on behalf of the firm.

Do you have a Digitek claim?

If you or your loved one has suffered a serious injury or death as a result of Digitek, you may be entitled to compensation for medical expenses, loss of wages, and pain and suffering.

Please contact our Digitek lawyers today by filling out the brief questionnaire, or by calling our toll free number (1-800-898-2034) for a free, no-cost, no-obligation legal evaluation of your case.

Digitek was recently recalled after medication was found to contain twice the appropriate level of the active ingredient

Digitek is a medication that is widely used in the treatment of various heart conditions, namely atrial fibrillation, atrial flutter and sometimes heart failure that cannot be controlled by other medication.

Because patients prescribed Digitek are already under a physician’s care for heart troubles, an incorrect dosage of this medication can be especially dangerous, creating even more cardiac instability and compounding existing problems.

Digitalis toxicity is a complication of digitalis therapy, or it may be caused by an acute ingestion of Digitek.

Do you have a Digitek claim?

If you or your loved one has suffered a serious injury or death as a result of Digitek, you may be entitled to compensation for medical expenses, loss of wages, and pain and suffering.

Please contact our Digitek lawyers today by filling out the brief questionnaire, or by calling our toll free number (1-800-898-2034) for a free, no-cost, no-obligation legal evaluation of your case.