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E-mail StoryRecall of heart drug worries Bakersfield family
| Thursday, May 1 2008 4:51 PM
Last Updated: Friday, May 2 2008 7:32 AM
The recall of a popular generic heart drug has at least one Bakersfield family worried about adverse effects.
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All lots and strengths of Digitek have been recalled because the pills may contain double the amount of the active ingredient.
Bakersfield resident Donna Jackson heard about the recall Wednesday after she received a phone message from the pharmacy.
Her husband, Weldon, has taken the medicine for the two years since his open heart surgery. It’s unknown how long he has taken the defective pills.
“There’s no telling how many people have died or have been damaged by it,” said Mrs. Jackson, 57, who called The Californian for more information. “This may be the reason he never recovered how he was supposed to.”
Digitek is a form of digoxin manufactured by Actavis Group and used to treat heart failure and abnormal heart rhythms.
A news release from Actavis said, “Several reports of illnesses and injuries have been received.”
The double strength tablets pose a risk to patients with renal failure, the release said. The defective pills can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and a slow heart rate. Death can also result.
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.
Calls to the manufacturer Thursday were not returned.
The products are distributed by Mylan Pharmaceutical, under the “Bertek” label, and by UDL Laboratories, under the “UDL” label, the release said.
Mrs. Jackson found the word “Bertek” on her husband’s pill bottle.
Law mandates that the manufacturer be listed on a drug’s label, Walsh said.
The FDA has inspected the manufacturer’s facility since the error was discovered, she said.
Retailers who have this product should return it to the place of purchase, the release said. For medical questions, patients should contact their physicians.
While Actavis has 50 percent of the digoxin market, the FDA does not foresee a shortage from other manufacturers, Walsh said.
Any customer inquiries should be addressed to Stericycle customer service at 1-888-276-6166, Monday through Friday, 8 a.m. to 5 p.m. EST.
For more information about the recall, go to www.actavis.us.
Any adverse reactions or quality problems experienced with this drug should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178 or by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
Patients can get more information at the MedWatch Web site at www.fda.gov/medwatch.