FDA Says It Doesn't Know How Long Defective Digitek / Digoxin Pills Were Sold

Actavis Says They Have Received 11 Complaints About Digitek Side Effects That Date Back To 2006

(Posted by Tom Lamb at DrugInjuryWatch.com)

The facts surrounding a late April 2008 recall of Digitek (digoxin) pills that may have twice the usual active ingredient are becoming less clear as we learn more in the days following the FDA's April 28 announcement.

In a May 1, 2008 Newsday.com article, "Pharmacists will call you: Digitek recalled", by reporter Kathleen Kerr, we learn that the defective Digitek tablets may have been sold for more than a year:

"We had some concerns about the process," [Actavis Totowa spokesman John] 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.

As reported previously, this improperly manufactured generic digoxin medication could lead to digitalis toxicity; patients with renal insufficiency are especially at risk.

According to Californian staff writer Emily Hagedorn, in her May 1, 2008 article "Recall of heart drug worries Bakersfield family", the FDA is still trying to get a handle on the magnitude and ramifications of this Digitek recall:

Considering it was voluntarily recalled Friday afternoon, it’s too soon to tell how many people have suffered adverse reactions, said Sandy Walsh, spokeswoman for the Food and Drug Administration. She didn’t know how long the defective pills were sold....  The FDA has inspected the manufacturer’s facility since the error was discovered, she said....  While Actavis has 50 percent of the digoxin market, the FDA does not foresee a shortage from other manufacturers, Walsh said.

Going back to the Newsday.com May 1 article, we get some pharmacy perspective on the Digitek recall:

Joel Bassuk, pharmacist at Raindew Pharmacy in Manhasset, said he received the recall notice yesterday....  "They said to immediately examine your inventory and discontinue all lots," Bassuk said....  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.

As always, we welcome information about emerging drug safety issues:  druginjury@gmail.com.  This situation, in particular, calls for such assistance from anyone who may know more about the extent of this apparent manufacturing problem whereby some digoxin pills may be too potent.  At this juncture, at least, it seems we are not getting much in terms of "specifics" from Actavis, the drug manufacturer, nor the FDA about this Digitek recall.

Comments

[Tom Lamb]

If the Digtek (digoxin) pill or pill bottle had the "Bertek" or "UDL" name on it, then it is covered by the Class 1 recall.

If there were any serious side effects / medical conditions experienced while taking this Digitek, I suggest that you hold onto (but not use) any remaining pills until more is learned about how long the defective "double dose" pills were being manufactured by Actavis and distributed by Mylan or UDL to pharmacies to dispense to patients.

My law firm is investigating cases where the patient has died, been hospitalized, or was diagnosed (by blood test) with digoxin toxicity, also known as digitalis toxicity or poisoning.

Thanks for reading Drug Injury Watch.

Tom Lamb

[Louise]

how do I tell if the pills my mother in law is taking and has been taking for over a year is the drug in question? I have a printout from the pharmacy (family owned) with info on the NDC# but not the manuafacturer. when cross referencing the number, I found the manufacturer, but how do i tell if its the bad medication?

[Tom Lamb]

Chris:

Any possible Digitek legal case concerning the death of your grandfather would depend on the medical records showing abnormally elevated digoxin / Digitek levels in his blood, or showing a diagnosis of digitalis toxicity.

If you find any mention of one or both items in the records, let me know and we would investigate further this possible case.

Thanks for reading Drug Injury Watch.

Tom Lamb

[Chris Alexander]

My grandfather passed away March 14th from complications from an open hearrt surgery. He had been taking Digitek 0.25 MG tab for over 5 years. for the last year and a half, he got very sick and had problems with keeping his white blood cell count up along witn many other sysmtems. He made it through the surgery but soon developed renal failure as well as other complications. We just received the recall notice and it seems more than a coincidence that he deteriorated so quickly (within the last year) prior to the surgery which was his last resort. His Cardiologist could never figure out what was causing his low blood count, shortness of breath, and low blood pressure. What options do we have and what's our next step? Thanks in advance for any and all help. You can email me at understeer88@gmail.com

Chris

[Tom Lamb]

I am sorry to hear about the death of your father-in-law.

If his widow wants to, and when the time is right for her, my law firm can take a look at the events leading up to his death for the purpose of evaluating whether or not there is a possible Digitek case, here. You can complete our online Digitek Case Evaluation Form -- http://www.druginjurylaw.com/DigitekEvaluation.html -- or she can contact me directly by email or phone: thomasjlamb@druginjurylaw.com / 1-800-426-9535.

Thanks for reading Drug Injury Watch.

Tom Lamb

[Sonya Lancaster]

My father-n-law passed away on 5/2/08. He was on the medicine, digitek. We are not really sure if this is what caused his death or not. He was buried on Sunday and my mother-n-law received the letter from CVS about the recall on Monday. We are unsure of what we need to do now, if anything.
If anyone knows, please advice.