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FDA Announces Expanded Recall of All 0.5mg and 1mg Chantix Pills

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The U.S. Food and Drug Administration (FDA) recently announced an expanded recall of Chantix (varenicline) to include all lots of 0.5mg and 1mg tablets. Pfizer is pulling the smoking cessation drug because of concerning levels of N-nitroso-varenicline, which may be associated with an increased risk of cancer in humans.

Timeline of Expanded Recall for Chantix

On July 2, 2021, the FDA first notified patients and providers about the recall of nine lots of Chantix. At this point, Pfizer recalled a limited number of products due to the presence of the nitrosamine. 

Nitrosamines are commonly found in water and foods, meaning that everyone is exposed to them in some way. However, the risk of cancer may increase if people are exposed at high levels over a long period of time. Still, the FDA noted that there was no immediate risk to patients taking the mediation. In fact, the benefits of quitting smoking outweighed the theoretical and potential risk of cancer.

Pfizer continued selling the believed-to-be safe lots of the smoking cessation drug. Then, on July 19, 2021, the company expanded the recall to 12 lots, based on the same concern as the initial recall. 

Approximately a month later, on August 18, 2021, the manufacturers added four more lots to the list. Then, per the most recent update, Pfizer issued a statement about the final expanded recall, which is inclusive of all lots of of the 0.5mg and 1mg tablets. As they work to reduce or eliminate the impurity in future lots, the FDA said that it would not object to “certain manufacturers distributing varenicline tablets containing N-nitroso-varenicline above the acceptable limit intake of 37ng per day but below the interim acceptable intake limit of 185ng per day.”

Connection to Other Recent Recalls

Similarly, the FDA requested the removal of all Zantac from shelves in April 2020. There was concern that the heartburn drug contained unsafe levels of N-nitrosodimethylamine (NDMA), another impurity related to cancer. As a result, multiple lawsuits have been filed against the manufacturers.

Several other drugs, including high blood pressure medications like valsartan and losartan, have been impacted by nitrosamine impurities in recent years. This issue may be caused by changes in manufacturing as well as improved testing methods that allow the components to be identified at very low levels. 

For more information about the halted distribution of Chantix, contact us today.

Additional Reading:

Pfizer Halts Sales of Chantix Due To Possible Carcinogen Contamination

Study Finds That E-Cigarettes Don’t Prevent Smoking Relapse

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According to the results of a new longitudinal study, using e-cigarettes and other tobacco products to prevent smoking relapse is not effective. Nearly 13,000 smokers in the United States participated in this research. It is the first study to report on whether cigarette smokers can switch to e-cigarettes and successfully quit using cigarettes. 

Use of E-Cigarettes to Prevent Smoking Relapse

“Quitting is the most important thing a smoker can do to improve their health,” explained study author John Pierce. “But the evidence indicates that switching to e-cigarettes made it less likely, not more likely, to stay off of cigarettes.” 

Specifically, the research found that 50 percent of former smokers who quit “cold turkey” were still non-smokers as of the second annual follow-up. Only 41.5 percent of former smokers who used an alternative form of tobacco in their quitting efforts found success. “Those who switched to e-cigarettes (or indeed another form of tobacco) were 8.5 percent more likely to relapse to cigarettes,” said Pierce, a professor of family medicine and public health at the UC San Diego Institute for Public Health.

The study did not consider the use of nicotine replacement therapy (NRT), which is specifically designed to help people stop smoking. Those therapies include patches, gum, and lozenges that contain limited amounts of nicotine. 

Harmful History of Vaping

E-cigarettes are often used a nicotine alternative for smokers trying to quit. They work by using an often-flavored liquid called e-juice, which eventually vaporizes. Vaping eliminates the over 7,000 chemicals, including the toxic ones, that are found in a burning cigarette.

Vaping became popular for tobacco cessation after a study out of the United Kingdom found that e-cigarettes helped as many as 70,000 smokers in England quit smoking in 2017. However, their use is now controversial due to potential long-term health effects from chemicals in the vape juice or cartridge.

Additionally, multiple studies determined that teen vaping often leads to cigarette smoking. American youth also dealt with a serious outbreak of a vaping-related lung disease, now known as EVALI (e-cigarette or vaping use-associated lung injury), in 2019. According to the Centers for Disease Control and Prevention, as of February 2020, the illness had killed at least 68 people and sickened over 28,000 e-cigarette users. 

For more information about the investigation into e-cigarettes, contact us today.

Additional Reading:

Big Drop in Youth Vaping Thanks to COVID School Closures

FDA Authorizes Vuse Solo E-Cigarette, Shows Benefit for Smokers

FDA Requests More Time to Determine Ruling About E-Cigarettes

FDA Removes 55,000 Flavored Vaping Products From Market

Lupin Pharmaceuticals Recalls Blood Pressure Tablets Due to Possible Carcinogen Contamination

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Lupin Pharmaceuticals issued a voluntarily recall of irbesartan and hydrochlorothiazide tablets. Tests on API batches of these medications revealed possible contamination with a cancer-causing impurity. Both medicines are used to treat high blood pressure and diabetic nephropathy in hypertensive patients with Type 2 diabetes.

Current Recall for Lupin Pharmaceuticals

“As part of Lupin’s ongoing assessment, analysis revealed that certain tested API batches (but not finished product batches) were above specification limit for the impurity N-nitrosoirbesartan,” the Food and Drug Administration (FDA) reported. N-nitrosoirbesartan is a potential carcinogen for humans. 

Between early October 2018 and late September 2021, Lupin Pharmaceuticals received four reports of illness from irbesartan. Patients taking the combination of irbesartan and hydrocholorothiazide tablets reported no illnesses.

Irebesartan was distributed nationwide in 75mg, 150mg, and 300mg formulas. They were sold through wholesalers, drug chains, mail order pharmacies, and supermarkets. 

Previous Recalls Due to Potential Carcinogen Contamination

This recall is not Lupin’s first experience with possible carcinogen contamination. During the summer of 2020, the company, along with Sun Pharma, Bayshore Pharmaceuticals, and Granules Pharmaceuticals, pulled metformin, a generic diabetes medication, from the shelves due to batch testing results. 

The recalls of metformin were in response to the FDA finding N-nitrosodimethylaine in “sartan”-based blood pressure drugs and heartburn medications, including Zantac. These findings triggered a global recall of all impacted medicines. 

For more information about both the Lupin Pharmaceuticals recall and the Zantac recall, contact us today.

Additional Reading:

Zantac Relaunches With New Name and Ingredient After Recall Due to Increased Cancer Risk

Sanofi Accused of “Widespread” Email Deletion After Zantac Recall

FDA Authorizes Vuse Solo E-Cigarette, Shows Benefit for Smokers

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For the first time, the Food and Drug Administration (FDA) has authorized a vaping device, the Vuse Solo e-cigarette. The agency believes that the product, from parent company R.J. Reynolds, can help smokers quit the use of traditional cigarettes. Vuse is the second most popular vaping brand in the U.S. It is responsible for nearly a third of all retail sales and only sells fewer products than JUUL.

Vuse Solo E-Cigarette

The FDA’s recent authorization applies to the Vuse Solo e-cigarette and its tobacco-flavored nicotine cartridges. Released in 2013, Vuse Solo is a rechargeable device that looks like a traditional cigarette. The agency noted that it rejected 10 requests from the company for other flavored products. It is still reviewing the request to sell a menthol-flavored nicotine cartridge.

Data reported by the company shows that the product helps smokers significantly reduce their exposure to dangerous chemicals found in cigarettes. Although the product is now legally sold in the U.S., the FDA stresses that they are not safe nor “FDA-approved.” Additionally, the agency discourages non-smokers from using them.  

Current FDA Review

For over a decade, e-cigarettes have been sold in the United States with little government research or oversight. Currently, the FDA is in the midst of a review of vaping products to determine what should be allowed to remain on the shelves. The organization has already rejected applications for more than a million e-cigs and related products, primarily due to the potential appeal to youth. However, regulators have delayed decision-making for most major vaping companies, including JUUL.

“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation,” said Mitch Zeller, director of the FDA’s tobacco center, in a statement. “The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products — either completely or with a significant reduction in cigarette consumption.”

For more information about the investigation into e-cigarettes, contact us today.

Additional Reading:

FDA Requests More Time to Determine Ruling About E-Cigarettes

FDA Removes 55,000 Flavored Vaping Products From Market

North Carolina Takes Legal Action Against JUUL

JUUL Labs Faces “Substantive Scientific Review” from the FDA

E-Cigarette, Vaping, and Juul Bans

Singulair Asthma and Allergy Medication Linked to Severe Mental Health Side Effects

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The Food and Drug Administration (FDA) has added a stronger box warning to Singulair and its generic montelukast, a popular asthma and allergy medication, after “continued reports of neuropsychiatric events.” Potential side effects include suicidal thoughts and behaviors, agitation, aggression, attention problems, night terrors, depression, confusion, anxiety, hallucinations, memory problems, obsessive-compulsive symptoms, trouble sleeping or restlessness, and uncontrolled muscle movement or shakiness.

Stories of Singulair’s Severe Side Effects

Toni Dye, a mom from Zephyrhills, Florida, says that her daughter Kayla began taking Singulair at the age of 7. Soon after, she started having anxiety, panic attacks, and anger issues as well as nightmares. “She’d wake up in the middle of the night and be running around the house and just screaming,” Dye said. The change was so drastic that Dye and her husband took Kayla off Singulair after only a few weeks. 

That was 10 years ago. Now, at age 17, Kayla still suffers from anxiety, depression, and panic attacks. “I say that we lost our child because she’s not the same child anymore,” Dye added. “It hurts really bad. I feel guilty for not really looking into the drug.”

Angela Mitchell had a similar experience with her son, who started taking Singulair at 18 months old for severe allergies. After about eight months, she learned of the potential side effects and took him off. “He had become so despondent, so disconnected,” she shared. Additionally, he started exhibiting aggressive behaviors, including wanting to self-harm and harm others. 

Jennifer Brown personally experienced the side effects after only six days of taking montelukast for her asthma. “By the fourth day, I was already picturing myself dying,” she said. 

Recent Response From the FDA

All three women said that no one warned them about the risks for severe mental health side effects. In fact, they belong to a Facebook support group of more than 11,000 people with similar stories, many of which are even more severe and involve suicide. 

Members of this group have long pushed the FDA to take action. In March, the organization announced the requirement of the new box warning. “We are taking this action after a review of available information led us to reevaluate the benefits and risks of montelukast use,” the FDA said in its Drug Safety Communication. “Montelukast prescribing information already includes warnings about mental health side effects, including suicidal thoughts or actions. However, many health care professionals and patients/caregivers are not aware of the risk. We decided a stronger warning is needed after conducting an extensive review of available information and convening a panel of outside experts.” 

A black box warning is the strongest warning that FDA can give to a medication. It is meant to increase awareness, especially for prescribing physicians and pharmacists. This label is the first step towards better education about the harmful side effects of Singulair and montelukast. 

For more information about Singulair and its generic version montelukast, contact us today.

FDA Sued Over Inaction on Dangerous Hair Loss Medication Propecia

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In early September, Public Citizen, on behalf of Post-Finasteride Syndrome Foundation (PFSF), filed a lawsuit against the U.S. Food and Drug Administration (FDA) regarding their inaction on a petition submitted four years ago. PFSF asked, in 2017, that the FDA remove Propecia, a popular medication for male pattern baldness, from market. The drug has been linked to increased risk of depression suicidal ideation, and long-term erected dysfunction. 

Lawsuit History Between PFSF and the FDA

Prescriptions for Propecia, the brand-name version of 1mg finasteride, have increased in recent years, as the medication as well as its generic versions are often seen in television and online advertisements. As an alternative to the initial request for the FDA to withdraw its approval of the drug, PFSF asked that drug manufacturers revise the safety information on the labels to warn consumers of potential side effects. The lawsuit filed last month argues that the FDA has acted unlawfully by failing to respond on the original petition. 

“The FDA needs to act in a timely way to protect the public from the risks associated with use of Propecia,” said Michael Kirkpatrick, who is serving as lead counsel for PFSF. “The FDA’s failure to act exposes consumers to potentially life-threatening harm.”

Risks of Long-Term Use of Propecia

Long-term use of the hair loss medication can lead to post-finasteride syndrome (PFS), which causes sexual dysfunction and psycho-neurocognitive symptoms, including issues related to mood, sleep, stress response, and more. Unfortunately, men with a PFS diagnosis may suffer from these side effects for years after they stop taking the drug.

The increased risk of suicide after taking finasteride has been studied for years. Vigibase, a global database that tracks harmful side effects from pharmacovigilance agencies, reveals 378 cases of suicidal ideation, 39 suicide attempts, and 88 suicides as a result of finasteride use. Moreover, a study from 2020 found that patients under 45 were particularly vulnerable to depression, anxiety, and suicidal thoughts. 

“False information from the FDA leads physicians to dismiss patients, while some even tell them their symptoms are not real,” shared John Santmann, M.D., the head of PFSF. “Without effective treatments for PFS, use of this cosmetic drug can lead to a lifetime of side effects. The drug ruins more lives every day and has no business being on the market.”

For more information about the lawsuit concerning Propecia, contact us today.

Big Drop in Youth Vaping Thanks to COVID School Closures

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While virtual learning during the pandemic has many drawbacks — social isolation and dependence on strong self-motivation, to start — it has at least one notable benefit. A recent government report, completed by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), revealed that youth vaping dropped significantly last year.

Youth Vaping Statistics

Health officials ask that readers use caution as they look at the numbers. Outside experts, however, believe that the decrease is real and makes sense, given that vaping is often done socially. In the national survey, 11 percent of high school students and less than 3 percent of middle school students reported that they had recently used e-cigarettes. These numbers show a 40 percent drop from last year, when almost 20 percent of high schoolers and 5 percent of middle schoolers admitted to recently vaping.

“They found a dramatic drop from last year, and it’s hard to image that doesn’t represent a real decrease in use [among students],” said Dr. Nancy Rigotti of Harvard University, who was not involved in the research. The decline needs to be confirmed by other surveys this year. There is, of course, the fear that the numbers could increase again with many in-person classes back in session. 

If these results prove true, it would be the second big drop in a row. Reporting in 2019 resulted in a peak of 28 percent for high school students. 

New Federal Restrictions for Youth Vaping

Prior to the pandemic, government restrictions began to limit the underage use of e-cigarettes. Towards the end of 2019, the purchase age for all tobacco and vaping products changed from 18 to 21. Then, the FDA banned nearly all of the flavors for cartridge-based e-cigarettes, which first ignited the popularity of teen vaping. Additionally, some kids stopped using e-cigarettes after an uptick in vaping-related illnesses and deaths. Many of these health concerns were related to a filler in black market vaping liquids that contained THC. 

Despite this promising report, government officials believe that roughly two million U.S. teens and pre-teens are still vaping — a number that is much too high. “E-cigarette use among youth remains a serious public health concern,” said CDC specialist Dr. Karen Hacker. In an effort to combat this crisis, the FDA is expected to place even bigger limits on the vaping industry and remove more products from market.

For more information about the investigation into e-cigarettes, contact us today.

Additional Reading:

FDA Requests More Time to Determine Ruling About E-Cigarettes

FDA Removes 55,000 Flavored Vaping Products From Market

North Carolina Takes Legal Action Against JUUL

JUUL Labs Faces “Substantive Scientific Review” from the FDA

E-Cigarette, Vaping, and Juul Bans

FDA Requests More Time to Determine Ruling About E-Cigarettes

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The Food and Drug Administration (FDA) asked for additional time before declaring the outcome of the final e-cigarette ruling, which ultimately determines whether or not e-cigarettes can remain on shelves in the United States. On the deadline date, the agency revealed that it had acted on 93 percent of the submitted applications. “However, there’s more work to be done to complete our remaining reviews and ensure that we continue taking appropriate action to protect our nation’s youth from the danger of all tobacco products,” the regulators said in a statement. 

Flavored E-Cigarettes Removed From Shelves

In total, more than 500 companies filed applications for some 6.5 million products by the September 9, 2020 deadline. The FDA’s official order is to authorize vaping products only if the manufacturing company can demonstrate the items are in the interest of public health. In other words, the FDA must compare the potential good of adult cigarette users switching to a less-dangerous option to the potential harm of young people getting addicted to nicotine.

Thus far, the FDA has ordered more than 946,000 flavored products be removed from shelves. For these vaping liquids, which include flavors like apple crumble and cinnamon toast cereal, the agency believes that manufacturers failed to provide sufficient evidence that the products benefit adult smokers enough to outweigh the potential appeal to young people.

The biggest e-cigarette manufacturer in the U.S. is JUUL. A spokesperson for the company said, “We respect the central role of the FDA and the required thorough science- and evidence-based review of our applications. We remain committed to transitioning adult smokers away from combustible cigarettes while combating underage use.”

Reshaping the Market with Final E-Cigarette Ruling

This sweeping review could reshape the e-cigarette market. If products are authorized to remain on the market, manufacturers should expect stricter controls on marketing. This sort on control has already proven beneficial: Youth vaping fell significantly last year after laws raised the legal purchase age to 21 and removed fruity-flavored e-cigarette cartridges from the market.

The agency hasn’t revealed when its review will be completed but did share that many applications are in the final stages of review.

For more information about the investigation into e-cigarettes, including JUUL products, contact us today.

Additional Reading:

FDA Removes 55,000 Flavored Vaping Products From Market

North Carolina Takes Legal Action Against JUUL

JUUL Labs Faces “Substantive Scientific Review” from the FDA

E-Cigarette, Vaping, and Juul Bans

Pfizer Recalls Smoking Cessation Drug Chantix Due to Increased Cancer Risk

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Earlier this month, Pfizer voluntarily recalled the smoking cessation drug Chantix for high levels of nitrosamine, a carcinogenic compound. The notice posted to the Food and Drug Administration (FDA) website included all lots of 0.5 mg and 1 mg varenicline tablets. It also noted that long-term ingestion can lead to a “potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication.” 

Smoking Cessation Drug Recall

Pfizer first recalled some lots of Chantix in July and added additional lots in August. Recalled drugs include those distributed in the United States, Virgin Islands, and Puerto Rico from May 2019 to September 2021. 

The FDA recognized that the current recall may cause a drug shortage. To lessen this impact to patients, it will allow certain manufacturers to distribute “varenicline tablets containing N-nitroso-varenicline above FDA’s acceptable intake limit of 37 ng per day but below the interim acceptable intake limit of 185 ng per day until the impurity can be eliminated or reduced to acceptable levels.”

In a follow-up notice, the FDA encouraged patients to continue using their current medication until their doctor or pharmacist provides a replacement treatment. Ultimately, the heath benefits of stopping smoking outweigh the cancer risk from nitrosamine in varenicline. 

For more information about the recall of Chantix, contact us today.

Additional Reading:

Pfizer Halts Sales of Chantix Due To Possible Carcinogen Contamination

 

Philips Breathing Machine Recall Over Potential Cancer Risk, Millions In Need of Substitutes

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People who struggle with sleep apnea or other breathing ailments rely on special machines to ensure that they can breathe safely while sleeping. Unfortunately, in June, the Food and Drug Administration (FDA) recalled more than a dozen devices manufactured by Philips. There was concern that the Respironics machines, which deliver pressurized air through a mask, had faulty components that could lead to heath risks. Now, millions of patients face waitlists of a year or more for their much-needed replacements. 

Expanding on their initial declaration, in July, the FDA warned that the risks could be “life-threatening, cause permanent impairment, and require medical attention.” The machines use polyester-based polyurethane foam to dampen sound and vibrations. Over time, it can degrade and result in a user breathing in chemicals or swallowing or inhaling black debris. Possible risks from this exposure include asthma, skin and respiratory-tract irritation, and “toxic and carcinogenic effects” to organs like the kidneys and liver.

Specifically, the recall involves BiPAP (bi-level positive air pressure), CPAP (continuous positive air pressure), and ventilator machines manufactured before April 26, 2021. As the next steps, Philips must submit a repair-and-replacement program to the FDA for the defective parts. However, there are shortages and backlogged orders because of the use of similar devices in hospitals to treat COVID-19. 

Breathing Machine Recall Response from Philips

A spokesperson for Royal Philips, the parent company of Respironics, estimates that up to two million of the recalled devices were in use in the United States, largely by the 24 million Americans who struggle with obstructive sleep apnea. He added that the company was working “expeditiously” to find a solution. They are “already producing repair kits and replacement devices” of about 55,000 units per week, although they have not yet been cleared for shipping. 

Philips advises current users of the impacted machines to register their products and talk to their doctors. Presently, there is no time estimation for the waiting list, forcing many patients to continue using their dangerous devices. As 72-year-old Donald Camp explains, “I believe any risk of cancer is less than the risk of the serious consequences of sleep apnea.” 

How This Recall Impacts COVID-19 Physicians and Patients

Of course, this recall is also problematic for doctors caring for coronavirus patients. “Because the number of people coming into the hospital with severe respiratory symptoms has increased as a result of COVID-19, the demand for these devices has also increased,” explained Dr. David Schulman, a pulmonary and critical care medicine specialist at Emory Healthcare. Without knowing more about the potential risks, it’s impossible for physicians to determine how to best care for patients with breathing issues.

Since the recall, patients in over 20 states have filed about 40 lawsuits against Philips. Unsurprisingly, a multi-district litigation petition has also been filed. Legal experts anticipate that all cases will be consolidated in one state, similar to the handling of lawsuits against opioid manufacturers. Philips set aside about $591 million to cover the repair and replacement orders and other anticipated costs. 

For more information about the recall of Philips breathing machines and multi-district litigation, contact us today.

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