I had a terrible headache the other day. It was killing me, and I was out of my pain meds. So, I ran down to the store and bought a bottle of Excedrin. It usually works on my headaches. But, this time was different. I got very light headed and nauseous. I didn’t have a clue what was wrong. Next thing I realized, hubby was taking me to the hospital because I started vomiting. My diagnosis? ER Dr said that I had overdosed on pain killers. But, I knew there was no way. Come to find out, there was a mix up at the lab, and my over the counter pain meds had been accidentally replaced with a very powerful prescription pain killer, and I had unintentionally overdosed.
Although this story is fabricated and did not actually happen to me, based on a recent announcement from the FDA, it is not out of the question!
Apparently, the Food and Drug Administration is warning patients about a potential mix-up between powerful prescription pain drugs and common over-the-counter medications made at a Novartis manufacturing plant.
The issue stems from manufacturing problems at a Lincoln, Neb., facility which triggered a recall on January 8, 2012 of 1,645 lots of Novartis’ over-the-counter drugs, including Excedrin, Bufferin, NoDoz and Gas-X. The company has received hundreds of complaints of broken and chipped pills and inconsistent bottle packaging that could cause pills to be mixed up. Consumers are advised to stop using the products and contact the company for a refund.
FDA officials warned consumers that some of Novartis’ over-the-counter pills may have accidentally been packaged with powerful prescription painkillers made at the same facility. The opioid drugs are sold by Endo Pharmaceuticals as Percocet, Endocet, Opana and Zydone.
Endo Pharmaceuticals Holdings Inc., of Chadds Ford, Pa., said it is not aware of any confirmed product mix-ups that reached patients or caused any injuries. A spokeswoman for Novartis said late Monday that only Gas-X is produced on the same manufacturing line as the opioid drugs.
However, the company announced it would recall certain bottles of headache medicine Excedrin and caffeine caplets NoDoz with expiration dates of Dec. 20, 2014. The company is also recalling some packages of pain medicine Bufferin and stomach medicine Gas-X with expiration dates of Dec. 20, 2013, or earlier.
At this time, they are not recalling the painkillers because they are essential medications for many patients and the chances of finding a different pill is low.
“The likelihood of finding a wrong tablet in an opiate pain medication dispensed to patients is low and patients should not be unduly alarmed,” FDA’s Dr. Edward Cox told reporters.
Cox said FDA inspectors are currently inspecting the plant and uncovered a manufacturing problem that could allow pills to become stuck in the machinery and carry over to the packaging of other products. FDA officials said the investigation is ongoing and would not comment on potential penalties against Endo or Novartis.
The FDA and Endo Pharmaceuticals recommend patients examine their prescriptions to make sure all the tablets are similar in shape, color, size and marking. If one or more of the tablets look different, patients should return the medicine to their pharmacist.
Patients can also call Endo Pharmaceuticals’ call center at 1-800-462-3636 .
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