Posted: Mar 10, 2013 4:07 PM
HOPKINSVILLE, Ky. (AP) - A pain medication that has been recalled by the Federal Drug Administration for undeclared ingredients continues to circulate in parts of southern Kentucky.
Kentucky New Era reported (http://bit.ly/XAACkg ) that the drug, marketed under the name "Reumofan Plus," is being distributed locally in Elkton and a local doctor's office says patients on the drug have had dangerous side effects.
The manufacturer, Reumofan Plus USA, LLC and Reumofan USA, LLC, announced a voluntary product recall last month. Used as a treatment for muscle pain, arthritis, osteoporosis, bone cancer and other conditions, the FDA says undeclared ingredients in the drug could result in serious illness.
An FDA laboratory analysis of Reumofan Plus found that it contains diclofenac sodium, a non-steroidal anti-inflammatory drug, and methocarbamol, a muscle relaxant.
The agency has received reports of deaths, stroke, severe internal bleeding, dizziness, insomnia, high blood sugar levels and other problems associated with the drug since June. FDA has issued an alert telling consumers to stop taking it immediately and consult a health care professional.
The newspaper found a salesman in Elkton, Ray Johnson, who was distributing the product locally. When reached by the newspaper on the phone on Friday, Johnson defended the product, but declined to make any statement.
Dr. Keith Toms, of Generations Primary Care, said three of his patients have taken the drug and had bad side effects. One patient had dangerous liver enzyme elevations, and two diabetic patients had dangerous spikes in blood sugar levels.
Toms said herbal supplement can be sold if they don't claim to treat specific diseases or conditions and the FDA generally doesn't analyze their contents.
"It's the wildlife," Toms said. "People can say all kinds of things about them, and we just don't know."
The FDA said it may follow up on the Reumofan recall with warning letters, seizure, injunction or criminal charges.
Information from: Kentucky New Era, http://www.kentuckynewera.com
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