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

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.

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

the following are answers to the most frequently asked questions (FAQ) regarding the Digitek recall

Q: Why is Actavis recalling Digitek(digoxin)?
A: This voluntary all-lot recall is due to the possibility that some tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than is appropriate.

Q: What should I do if I’m taking Digitek (digoxin)?
A: Patients should contact their physician to get a new prescription. All inquiries related to returning your product or the recall should be addressed to Stericycle customer service at 1-888-276-6166 (option 1 for consumers or option 2 for wholesalers/distributors and retailers.

Representatives are available Monday through Friday, 8 am to 5 pm EST.

What should I do if I was seriously injured as a result of Digitek?
You should contact contact an attorney to review your legal options as soon as possible. While product liability laws vary by state, you have a very limited time in which to file a claim against the manufacturer. If you have legal questions, you may contact Beasley Allen for a free legal consultation.

Please contact Wendi Lewis at 1-800-898-2034, extension 308. Or online at www.digitek-legal.com.

Representatives are available Monday through Friday, 8 am to 5 pm EST.

Q: How can I report serious side effects from, or reactions to, Digitek (digoxin)?
A: If you wish to report an adverse experience from taking digoxin, you are directed to select option “3” from the menu provided on the Stericycle answering service where you will be directed to an Actavis representative who will process your information.

You may also report adverse side effects via the FDA’s online reporting form.

If you need medical attention or have any inquiries regarding your treatment, however, you should contact your physician.

Q: What is Digitek (digoxin)?
A: Digitek is the brand name for digoxin tablets, USP 0.125 mg and 0.25 mg, manufactured by Actavis and distributed by Mylan Pharmaceuticals, Inc. under the Bertek and UDL labels. It is prescribed for oral use to treat heart failure and abnormal heart rhythms.

Q: Where is Digitek (digoxin) manufactured?
A: Digitek is manufactured in the United States by Actavis Totowa, in New Jersey.

Q: Is the recall just in the United States, or also in other countries?
A: The recall is only in the United States.

Severe Digitek Side Effects

An individual who has taken the recalled Digitek may experience the following side effects:

• bradycardia (abnormally slow heart beat)
• cardiac instability
• nausea
• dizziness
• low blood pressure (hypotension)
• vomiting

These are the Digitek side effects described in the voluntary recall announcement by Digitek’s manufacturer, Actavis Totowa LLC. The U.S. Food and Drug Administration (FDA) also listed these side effects as the reason for its April 2008 Safety Alert regarding Digitek.

Common Digitek Side Effects

Digitek has other, more common side effects that may appear even with a dosage that is not mistakenly doubled (as in the recalled Digitek). These side effects include:

• abdominal pain
• adverse cardiac effects
• confusion and mental disturbances (e.g., hallucinations, anxiety, delirium, and depression)
• diarrhea
• dizziness
• gynecomastia (enlargement of male breasts)
• hemorrhagic necrosis of the intestines
• intestinal ischemia
• maculopapular rash (a flat, red areas on the skin covered with small bumps, as in measles)
• nausea and vomiting
• thrombocytopenia (low platelet count in the blood, making an increased risk of bleeding)
• visual disturbances (blurred or yellow vision; the appearance of blurred outlines/halos)

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.