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.

GsK IMAGE

“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.

GlaxoSmithKline Most Heavily Fined Drug Company

By Pat Anson, PNN Editor

The pharmaceutical industry has long been criticized for engaging in illegal or unethical activities, such as fraud, kickbacks and price gouging. A new study published in JAMA shines a light on the scale of the problem, finding that Big Pharma paid over $30 billion in financial penalties for illegal activities in the United States.

Researchers looked at state and federal settlements from 2003 to 2016 and found that almost every large pharmaceutical company had paid a fine for illegal activity. The biggest transgressor was GlaxoSmithKline (GSK), which paid nearly $9.8 billion to settle 27 cases brought against it for bribery, corruption, improper marketing, pricing violations and selling adulterated drugs. In one settlement alone, GSK was fined $3 billion for encouraging doctors to prescribe its antidepressants to children.  

The fines paid by GSK were over three times higher than the amounts paid by Pfizer ($2.9 billion) and Johnson & Johnson ($2.6 billion) during the study period. Researchers say only four of the 26 drug companies they analyzed were not assessed a penalty.

TOP 10 MOST HEAVILY FINED DRUG COMPANIES

1. GlaxoSmithKline $9.8 billion

2. Pfizer $2.9 billion

3. Johnson & Johnson $2.6 billion

4. Abbott Laboratories $2.5 billion

5. Merck $2.1 billion

6. Eli Lilly $1.8 billion

7. Schering-Plough $1.6 billion

8. Wyeth $1.6 billion

9. Bristol Myers Squibb $1.4 billion

10. Novartis $1.2 billion

“Among the large pharmaceutical companies included in this study, 85% had evidence of financial penalties for illegal activities. Given the scope and nature of the illegal activities involving financial penalties, physicians and regulators should exhibit vigilance over the activities of large pharmaceutical firms,” wrote lead author Denis Arnold, PhD, a professor of business ethics at Belk College of Business, University of North Caroline at Charlotte.

“Four firms were not found to have penalties for illegal activities during the sample period. This may indicate an ability for illegal activity to be undetected, although these firms may instead have effective ethics and compliance programs.”

Because the study period ended in 2016, it did not include any recent settlements with drug companies involving opioid litigation. Nor did it cover fines paid outside the U.S., such as the $490 million fine that GSK paid for bribing Chinese doctors to prescribe its medications.

“This has been a deeply disappointing matter for GSK," chief executive Sir Andrew Witty said in a formal apology to the Chinese government in 2014.

Not much has changed at GSK over the years. This year the company agreed to pay $4.5 million in fines in Australia for marketing and price violations involving the pain relief gel Voltaren.  The British pharmaceutical giant was also recently fined $2.8 million by Romania for failing to supply the country with asthma medication.

Drug company executives rarely serve prison time for illegal activities and the large fines do not appear to be much of a deterrent against unethical behavior. The nearly $9.8 billion paid by GSK amounts to less than 2 percent of its total revenues during the study period. On average, GSK’s illegal activities went on for over seven years before the company stopped them, according to the JAMA study.

GSK did not respond to a request for comment for this story.    

Fraud Alert for Speaker Programs

In recent years, federal watchdogs have become increasingly concerned about the use of speaker fees, free meals, entertainment and other kickbacks paid by healthcare companies to promote their drugs and medical devices. In the last three years, companies paid nearly $2 billion to healthcare providers for speaker-related services.

In a special fraud alert released this week, the Office of Inspector General (OIG) for the Department of Health and Human Services warned against the practice, saying high-priced speaker programs “may be subject to increased scrutiny.” The OIG cited cases where speaker programs were held at wineries, stadiums and restaurants where expensive meals and alcohol were served at no charge to attendees.

“OIG is skeptical about the educational value of such programs. Our investigations have revealed that, often, HCPs (healthcare providers) receive generous compensation to speak at programs offered under circumstances that are not conducive to learning or to speak to audience members who have no legitimate reason to attend,” the report warns.

“Furthermore, studies have shown that HCPs who receive remuneration from a company are more likely to prescribe or order that company’s products. This remuneration to HCPs may skew their clinical decision making in favor of their own and the company’s financial interests, rather than the patient’s best interests.”

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.

Australians Lead Global Pain Survey

By Pat Anson, Editor

Australians have more aches and pains than anyone else in the world, but are least likely to complain about it.

Germans say their pain stings, the Chinese have a dull pain, in Japan it throbs, and the Poles say they’re numb from it.

And the Italians? Those Latin lovers are least likely to let pain interfere with their sex lives.

Those are some of the odder facts that emerged from a consumer research survey of 7,000 people in 14 countries conducted by GlaxcoSmithKline (GSK), a British pharmaceutical company.

The so-called Global Pain Index found that overall body pain – defined as aches in your muscles, tendons, ligaments and joints – truly knows no borders and is widespread throughout the world, but it affects people differently depending on where they live.

The survey found that Australians (97%) are most likely to report pain, followed by Russia (95%), China (94%), the UK (93%) and the United States (90%).

Swedes and Germans (88%) are least likely to feel pain.

The Chinese are most likely to complain about their pain (71%), followed by Mexicans (69%), Brazilians (57%) and Italians (55%). Only about a third of Australians complain about their pain.

People in the UK are most likely to see pain as just another part of life, even though it affects them negatively in a variety of ways. Over half (55%) say they cannot have sex because of body pain, two-thirds say it disrupts their social life, and 62% say pain has hurt their work performance.

Only about half (53%) the people in the UK know what is causing their pain.  

“Many people in the UK are taking the attitude that body pain is something you can ignore and hope it goes away, but this approach isn’t working. The findings of the GSK Global Pain Index have shown us that the UK is one of the countries where most people report feeling pain, but it also illustrates that we need a better understanding of our pain and how to treat it,” says Dr. Sarah Davis, a general practitioner in London.

“Pain is hurting every aspect of our lives in the UK, stopping people from enjoying time with friends and family, from enjoying the hobbies and sports they enjoy and hurting their prospects at work.”

The survey was conducted by the research firm Edelman Berland from November 2014 through January 2015 in Australia, Brazil, Canada, China, Germany, Italy, Japan, Mexico, Poland, Russia, Saudi Arabia, Sweden, UK and the United States.