How Serious Is The Novartis Painkiller Mix Up?

Following on the heels of the announcement by the Center For Disease Control (CDC) that poisonings by prescription pain killers known as opioids has now beaten out car accidents for the #4 slot in the top ten of things that kill Americans, Novartis has recall thousands of its over-the-counter (OTC) products that may mistakenly have opioids in them.

That’s right, the Swiss drug maker has been advised by the U.S. Food and Drug Administration (FDA) to issue a nationwide warning to consumers that several of their OTC medications may be mixed up with powerful painkillers. Officials advised consumers to stop using the products following hundreds of complaints about broken or incorrect tablets winding up in pill bottles.

Novartis Recall

Novartis recalled 1,645 lots of OTC drugs. These drugs may have accidentally been packaged at the Lincoln, Neb., facility with powerful prescription painkillers made at the same facility. The opioid drugs are sold by Endo Pharmaceuticals Holdings Inc., of Chadds Ford, Pa.

Novartis OTC drugs recalled:

• Excedrin
• Bufferin
• NoDoz
• Gas-X

Opioids that these packages may contain:

• Percocet
• Endocet
• Opana
• Zydone

Initially Novartis is recalling only 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.

Denials and Corporate Positioning

The FDA conducts periodic inspections on drug manufacturing facilities, because some of the worst problems with both prescription and OTC drugs happen at the production and packaging point. During one of these recent inspections, FDA inspectors discovered a manufacturing fault that could allow pills to become stuck in the machinery and carry over to the packaging of other products.

The agency says the investigation is ongoing and would not comment on potential penalties against Endo or Novartis. Though the agency is having Novartis recall their OTC drugs, FDA officals say that the painkillers are not being recalled because they are essential medications for many patients and the risks of stray pills are low. Hoever, regulators are concerned about a possible shortage of Endo’s painkillers due to the shutdown of the Nebraska facility.

“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.

So, even though this recall is probably not going to cost Endo much at all, they still came out with a statement saying that it is “not aware of any confirmed product mix-ups that reached patients or caused any injuries,” regardless of the hundreds of public complaints to the FDA, which, if the company had been doing its due diligence, it would be monitoring. In fact, any complaints or notifications are required to be addressed by the company within a matter of days according to FDA rules.

A spokeswoman for Novartis said late yesterday that only Gas-X is produced on the same manufacturing line as the opioid drugs.

“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.

Check Your Medicine Cabinet

What alerted consumers to a problem was broken and mismatched pills in their OTC bottles and packages. This is scary because they, or their children, might take pills that could potentially kill them. Particularly with OTC drugs that have a very low instance of overdose, thus, people often take beyond the recommended dose for extreme headaches or gas pains.

Look closely at your prescriptions and look for the expiration dates. The FDA recommends customers 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.

Consumers should visit www.novartisOTC.com for a full list of recalled products, and they can call Novartis at 1-888-477-2403, Monday through Friday, 9 a.m. to 8 p.m. EST. Patients can also call Endo Pharmaceuticals’ call center at 1-800-462-3636.

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How serious is the Novartis painkiller mix up?

Very serious. The FDA goes through steps to assure that OTC drugs are okay for the general public. That means that young people and elderly people, small people and large people, will not be adversely effected for taking the recommended dose as labeled. However, prescription dosage is on a case by case basis, prescribed only by a doctor, in order to treat serious medical ailments. Exspecially in the case of Opioids.

Opioids are so dangerous that Washington state has changed state law to require all pain medications to be scrutinized and overseen by pain medication specialists outside of the patient’s physician. This is to avoid the rash of deaths and addiction associated with these highly volatile medications.

The CDC warning and the changes to Washington State laws should be enough to show that both Novartis and Endo are taking this issue far too lightly. Announcing the recall on a Sunday when nobody is watching the news and playing the denial game is no way to save patients from the potentially deadly consequences of this situation.

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