FDA: Novartis recall may also affect painkillers

January 9, 2012 By MATTHEW PERRONE , AP Health Writer

(AP) -- The Food and Drug Administration is warning patients about a potential mix-up between powerful prescription pain drugs and common over-the-counter medications like Excedrin and Gas-X made at a Novartis manufacturing plant.

The problem stems from major manufacturing problems at a Lincoln, Neb., facility which triggered a sweeping recall of the company's over-the-counter drugs on Sunday. The company has received complaints of broken and chipped pills, and inconsistent bottle packaging that could cause pills to be mixed up. Consumers should not use the products and can contact the company for a refund.

FDA officials warned Monday 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 or injuries.

FDA officials say they are not recalling the painkillers because they are essential medications for many patients and the risks of stray pills are 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 regulators are also concerned about a shortage of Endo's painkillers in coming weeks due to the shutdown of the Nebraska facility. Switzerland-based Novartis voluntarily halted production at the plant last month.

"FDA is working with Endo and Novartis to minimize the degree of impact. The degree of shortage will depend upon how quickly safeguards can be put in place to prevent this manufacturing issue from happening in the future," the FDA said in a statement on its website.

FDA inspectors cited Novartis' plant for dozens of quality control problems last summer, in a report posted to the agency's website. Company officials repeatedly failed to properly follow up on consumer complaints received since 2009. FDA inspectors concluded that none of the 223 complaints received by the plant last year were properly reviewed, according to the report.

Novartis announced Sunday 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.

Customers can also call the company at 1-888-477-2403 Monday to Friday, 9 a.m. to 8 p.m. EST.

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 call Endo Pharmaceuticals' call center at 1-800-462-3636.

Explore further: Swiss pharma giant Novartis recalls drugs in US

shares

Related Stories

Swiss pharma giant Novartis recalls drugs in US

January 8, 2012
Swiss pharmaceutical firm Novartis said Sunday it was recalling four different products sold over the counter in the United States over reports of a malfunction at one of its plants.

Senator warns FDA on danger of newest painkillers

January 8, 2012
Following fatal shootings in two New York pharmacy robberies, a U.S. senator is warning that a new batch of "super painkillers" now under review could force repeats of recent violent robberies that left six people dead.

Recommended for you

In most surgery patients, length of opioid prescription, number of refills spell highest risk for misuse

January 17, 2018
The possible link between physicians' opioid prescription patterns and subsequent abuse has occupied the attention of a nation in the throes of an opioid crisis looking for ways to stem what experts have dubbed an epidemic. ...

Patients receive most opioids at the doctor's office, not the ER

January 16, 2018
Around the country, state legislatures and hospitals have tightened emergency room prescribing guidelines for opioids to curb the addiction epidemic, but a new USC study shows that approach diverts attention from the main ...

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

1 comment

Adjust slider to filter visible comments by rank

Display comments: newest first

Jesse_EngAmer
4 / 5 (1) Jan 09, 2012
Praise should be given to the FDA for handling this properly. However, shouldn't the FDA of acted more preventatively? They knew of the complaints as early as last year. Why was no action taken earlier?

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.