Excedrin Brands Recalled Due to Faulty Packaging

By Pat Anson, PNN Editor

One of world’s most widely used over-the-counter pain relievers has turned into a real headache for GlaxoSmithKline (GSK).

The British pharmaceutical giant has recalled over 433,000 bottles of Excedrin because of holes found in bottles of five Excedrin brands: Excedrin Migraine Caplets, Excedrin Migraine Geltabs, Excedrin Extra Strength Caplets, Excedrin PM Headache Caplets and Excedrin Tension Headache Caplets.

There have been no reports of any injuries as a result of the faulty bottles, but GSK recalled them because of the risk of Excedrin tablets falling out and being swallowed by young children. Under U.S. federal law, the tablets must be sold in child resistant packaging.

“While the likelihood there are bottles on the market with holes is low, we are asking anyone who has purchased large-sized Excedrin (50 count and above) to check their Excedrin products and if there is a visible issue, contact GSK Consumer Relations at 1-800-468-7746 for a full refund. If your Excedrin bottle is not damaged, the product is safe to use as directed on the label,” GSK said in a statement.

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“We take product safety very seriously at GSK and while we have not received any complaints or safety concerns to date on this potential problem, we are still letting consumers know so they can check their Excedrin bottles themselves. We sincerely apologize for any inconvenience, and please be assured we are working closely with the bottle manufacturer to fix this problem as quickly as we can.”

The bottles were sold at pharmacies, stores and online from March 2018 through September 2020. There was no explanation given for what caused the holes or why it took so long for GSK to recognize there was a problem and order a recall.

In January, GSK temporarily halted production of Excedrin Extra Strength and Excedrin Migraine due to “inconsistencies” in their ingredients. That led to spot shortages of the pain relievers.

In 2012, an Excedrin manufacturing plant in Nebraska was shut down for several months after Excedrin bottles were found to contain broken and stray tablets for other medications. At the time, the Excedrin brand was owned by Novartis.

An FDA investigation found that Novartis failed to adequately investigate hundreds of consumer complaints of foreign products found in over-the-counter drugs produced at the Nebraska plant. GSK now holds majority ownership of Excedrin through a joint venture with Novartis.

A recent study found GSK to be the most heavily fined drug company in the United States.  GSK paid nearly $9.8 billion to settle 27 cases brought against it for bribery, corruption, improper marketing, pricing violations and selling adulterated drugs.

Production of Two Excedrin Brands Halted

By Pat Anson, PNN Editor

Spot shortages of Excedrin are being reported after a pharmaceutical company halted production of two leading brands of the pain reliever due to “inconsistencies” in their ingredients.

GlaxoSmithKline (GSK) says consumers are not at risk, but as a precaution it has indefinitely suspended all production and distribution of Excedrin Extra Strength and Excedrin Migraine.

“Through routine quality control and assurance measures, we discovered inconsistencies in how we transfer and weigh ingredients for Excedrin Extra Strength Caplets and Geltabs and Excedrin Migraine Caplets and Geltabs,” GlaxoSmithKline said in a statement.

“Based on the available data, GSK believes that the product does not pose a safety risk to consumers. However, as a precautionary measure, GSK Consumer Healthcare has voluntarily implemented a discontinuation of production and distribution.”

Some drug stores in upstate New York have already run out of Excedrin Extra Strength and Excedrin Migraine. GSK said other Excedrin products are still available and urged consumers to ask their pharmacist for advice on alternative pain relievers.

“We are working hard to resolve the issue as quickly as possible, but at this point in time cannot confirm a definite date as to when supply will resume,” the company said.

In 2012, an Excedrin manufacturing plant in Lincoln, Nebraska was shut down for several months after Excedrin bottles were found to contain broken tablets and stray tablets for other medications. That led to a recall and shortages of Excedrin products around the world.

At the time, the Excedrin brand was owned by Novartis. An FDA investigation found that Novartis failed to adequately investigate hundreds of consumer complaints of foreign products found in over-the-counter drugs produced at the Nebraska plant. Novartis spent millions of dollars re-tooling the plant and shifted some production to third-party manufacturers.

GSK now holds majority ownership of Excedrin through a joint venture with Novartis. GSK did not say where the new production problems originated.

A Pained Life: Teaching the Reality of Pain

By Carol Levy, Columnist

Excedrin, which makes an over-the-counter pill for migraine sufferers, has a wonderful TV ad.

A sufferer wanted to show her mother what she sees and experiences when she has a migraine. Excedrin developed a simulator that does exactly that (click here to see it).

The mother puts on the device and sees the visual disturbances her daughter sees when she has a migraine attack. As she removes the device the mother turns to her daughter, hugs her and says, “I'm so sorry. I didn’t know.”

How wonderful, I thought. If only...

If only there was a way to simulate the pain of constant, intractable chronic pain.

If only there was a way to get our message across, and in a visceral way.

Too often we are told, even by medical professionals:

“It can't be that bad.”

"I had a sprained ankle so I get your pain.”

“It's all in your head. You just don't want to (go out, work, be a part of the family, the community, the world, etc.)”

It is common for a pain sufferer to write in the comment section of articles on chronic pain the following:  

“I wish doctors would have chronic pain, even if only for a day or two so they would get it.”

When I had the worst of my trigeminal neuralgia, I could not tolerate any touch to my forehead on the affected side. This meant I could not wash that part of my face or my hair. As a result I would get a big buildup of soap and dirt in the area which, because of a facial paralysis and my eye not being able to close well, caused eye infections.

The only way to clean the area was to put me under general anesthesia. The nurses and doctors were wonderful about it, the doctor having shampoo in his locker in case I forgot mine.

When someone asks me about the pain and they say outright or make expressions indicating they don't believe me, I trot out my general anesthesia anecdote. Then they get it. After all, why would a doctor or a patient take the risk of anesthesia without a real need to do it?

I recall a TV show, maybe it was Doogie Howser, MD, where medical students went through a simulation of what it is like to be a patient. They were given cloudy glasses to feel the disorientation of being unable to see clearly. They also put pebbles in their shoes to feel the discomfort of severe pain when you are trying to get around.

I had hoped maybe they did actually do this at a medical school somewhere, but no matter what words I put into Google Search, I could not find anything. The closest are programs where actors are hired to portray various illnesses to help teach students better diagnostic skills, insight and empathy.  But no actors had the role of being in chronic pain.

How can we teach the students?

I didn’t realize when I started writing this I would feel so frustrated by the question.  I guess I expected I would find a pithy answer.

Unfortunately, part of the answer is that students come from the general population, which often cannot accept the level of pain we feel. So they bring that skepticism and disbelief with them.

It would be unethical to put them in actual pain.

But maybe if we could show them the impairment, if we could find a simulator to allow them to feel the frustration of being unable to tie a shoe, go out in the slight breeze without the triggering of exquisite pain, or even walk, we too might too hear a “I'm so sorry. I didn’t know.”

And wouldn’t that be wonderful.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.” 

Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Does Excedrin Reduce Empathy?

By Pat Anson, Editor

A popular over-the-counter pain reliever may do more than just relieve minor aches and pains. Ohio State researchers say acetaminophen -- the active ingredient in Excedrin and hundreds of other pain medications -- can also make us feel less empathy for the physical and emotional pain of others.

"We don't know why acetaminophen is having these effects, but it is concerning," says Baldwin Way, an assistant professor of psychology at Ohio State’s Wexner Medical Center's Institute for Behavioral Medicine Research.

“Empathy is important. If you are having an argument with your spouse and you just took acetaminophen, this research suggests you might be less understanding of what you did to hurt your spouse's feelings."

Acetaminophen -- also known as paracetamol – is the world’s most widely used over-the-counter pain reliever. The study findings were published in the journal Social Cognitive and Affective Neuroscience.

Way and his colleagues divided 80 college students into two groups, giving half of them a liquid containing 1,000 mg of acetaminophen, while the other half drank a placebo solution that contained no drug. The students didn't know which group they were in.

After waiting an hour for the drug to take effect, the students read eight short scenarios in which someone suffered some sort of physical or emotional pain. For example, one scenario was about a person who suffered a knife wound and another was about a person whose father died. Participants were then asked to rate the pain of each person on a scale ranging from 1 (no pain at all) to 5 (worst possible pain).

Students who took acetaminophen rated the pain of the people in the scenarios to be less severe than those who took the placebo.

"These findings suggest other people's pain doesn't seem as big of a deal to you when you've taken acetaminophen," said Dominik Mischkowski, co-author of the study and a former PhD. student at Ohio State, who is now at the National Institutes of Health.

In a second experiment, students met and socialized with each other briefly. Each participant then watched, alone, an online game that purportedly involved three of the people they just met. In the game, two of the students excluded the third person from the activity.

Participants were then asked to rate how much pain and hurt feelings the students in the game felt, including the one who was excluded.

Results showed that people who took acetaminophen rated the pain and hurt feelings of the excluded student as less severe than the participants who took the placebo.

"Participants had the chance to empathize with the suffering of someone who they thought was going through a socially painful experience," Way said. "Still, those who took acetaminophen showed a reduction in empathy. They weren't as concerned about the rejected person's hurt feelings.

“Because empathy regulates pro-social and anti-social behavior, these drug-induced reductions in empathy raise concerns about the broader social side effects of acetaminophen, which is taken by almost a quarter of U.S. adults each week.”

An earlier Ohio State study found that acetaminophen also dulls emotions.

The pain reliever has long been associated with liver injury and allergic reactions such as skin rash. In the U.S. over 50,000 emergency room visits each year are caused by acetaminophen, including 25,000 hospitalizations and 450 deaths.

What Does a Migraine Look Like?

By Pat Anson, Editor

Sometimes there’s an aura. Or bright lights. Or blurred vision.

About a billion people worldwide suffer from headaches caused by migraines, which affect three times as many women as men. Most non-sufferers understand the headache part, but explaining what a migraine looks like isn’t easy – which is why the makers of Excedrin invented a simulator to help people better understand  migraines and the impact they can have.

"Migraines are more than bad headaches – the pulsing pain can be debilitating, and the associated symptoms like nausea and extreme sensitivity to light and sound, really impact people's lives," said Dr. Elizabeth Seng, a New York based psychologist.

GSK Consumer Healthcare brought together several migraine sufferers and had them explain the symptoms they most often experience during a migraine episode, including aura, sensitivity to light and blurred vision. The symptoms were then replicated with the simulator and conducted in a controlled environment from everyday life – like riding the subway or going to a restaurant -- to give non-sufferers the chance to safely experience the full range of migraine symptoms

Many found the experience unsettling and nauseating, as you’ll see in this short video that Excedrin recently began airing on TV and over the Internet:

Excedrin partnered with Andy Cohen, a best-selling author, TV personality, producer and migraine sufferer, to help spread awareness about the impact migraines can have on relationships with friends, spouses and co-workers. He hopes the simulator will help non-sufferers better understand the migraine experience.

"Growing up with migraines, I experienced firsthand how debilitating an episode can be and how much it can affect relationships with loved ones," said Cohen. "In my experience, both personal and professional, I've seen how migraines can become a third party in relationships – creating tension in, sometimes, already murky waters."

Migraine affects about 36 million adults in the United States, according to the American Migraine Foundation. In addition to headache pain and nausea, migraine can cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. About half of people living with migraine are undiagnosed.