Tag Archives: e-cigs

Quick Hits: Interim FDA Head Named, Inactive Ingredients in Drugs and Allergic Reactions & More

The Trump administration has named Ned Sharpless, MD, currently director of the National Cancer Institute (NCI), to become the interim head of the FDA. Sharpless is expected to take the top position at the FDA when current FDA Commissioner Scott Gottlieb, MD, steps down in a matter of weeks. Last week, Gottlieb made a surprise announcement that he would be resigning to spend more time with his family. Sharpless has held the top position at the NCI since October 2017. He also runs the National Institute on Aging Laboratory of Genetics and Genomics’ aging biology and cancer section. Although Sharpless has been named interim FDA commissioner and Gottlieb’s successor will need to be confirmed by the Senate, there are indications Sharpless may be nominated as the permanent commissioner since Gottlieb favors him as his successor. Posted March 12, 2019. Via The New York Times.

Patients should be aware that most drugs contain inactive ingredients that may cause an allergic reaction. An analysis of more than 42,000 medications found they contained almost 360,000 inactive ingredients. Researchers found that 38 of those ingredients can cause an allergic reaction, and 93% of medications had at least one of them. Lactose was the most common allergen found in medications; 45% of the medications contained sugar. About a third of the drugs contained food dye, another substance that can cause an allergic reaction. Researchers say healthcare professionals should advise their patients not just about allergies to medications, but also to inactive ingredients that may cause an allergic reaction. Posted March 13, 2019. Via Science Translational Medicine.

The FDA has released proposed rules that would severely restrict the sales of flavored e-cigarettes as part of the agency’s efforts to combat youth smoking. The rules would limit sales of flavored vaping pods to websites, vape shops and other stores that can ensure age restrictions are enforced. FDA Commissioner Scott Gottlieb also noted that the agency could even remove certain flavors from sale if it felt that were being marketed specifically to underage customers. In addition, the FDA has moved up by a year the date that manufacturers of electronic nicotine delivery system (ENDS) products to submit applications to keep their products in the market, to August 8, 2021. Posted March 13, 2019. Via FDA.

Quick Hits: Fish Oil Doesn’t Help Asthma, E-Cigs and Heart Disease & More

Fish oil doesn’t help improve uncontrolled asthma in adolescents and young adults who are overweight or obese. Researchers recruited overweight or obese participants between the ages of 12 and 25 who had poor asthma control despite using a daily inhaled corticosteroid. Some of the participants took fish oil daily for 25 weeks and the others took a placebo pill with soy oil. Researchers theorized that because omega-3 fatty acids have anti-inflammatory properties, fish oil pills might ease asthma. However, there was no difference in asthma symptom reduction between the two groups. Posted January 25, 2019. Via the Annals of the American Thoracic Society.

People who use e-cigarettes or vaping devices have a higher rate of heart attack, heart disease and stroke. Researchers analyzed results from the 2016 Behavioral Risk Factor Surveillance System, a phone survey. More than 400,000 people responded, of whom almost 67,000 reported using an e-cigarette at least once. E-cigarette users had a 59% higher risk of heart attack, 40% higher risk of heart disease and 71% higher risk of stroke compared to those who didn’t use e-cigs. The results have yet to be published in a peer-reviewed scientific journal, but will be presented at the American Stroke Association’s International Stroke Conference on February 6. Posted January 30, 2019. Via American Stroke Association.

A company that manufactures a male sexual enhancement supplement is recalling some of its product because it contains prescription erectile dysfunction medication. The product is Silver Bullet 10x, manufactured by Nature’s Rx. The FDA says that the product, which is sold online, contains sildenafil and tadalafil, which are, respectively, the active ingredients in Viagra and Cialis. Some of the ingredients in Silver Bullet 10x include horny goat weed, icariin and ginger root. Posted January 29, 2019. Via FDA.

Could the FDA Be Doing More to Curb Teen E-Cig, Vaping Use?

One of the FDA’s biggest campaigns last year was to stem the dramatic rise in teen e-cigarette and vaping use. The agency has previously called on e-cig and vaping manufacturers to come up with plans to curb marketing to teens. Apparently, FDA Commissioner Scott Gottlieb isn’t happy with the progress made by manufacturers, and has now threatened to potentially remove their products from shelves.

“I’ll tell you this: If the youth use continues to rise, and we see significant increases in use in 2019, on top of the dramatic rise in 2018, the entire category will face an existential threat,” Gottlieb said last week in comments at a public hearing on reducing teen e-cigarette and tobacco use.

“It matters if the e-cig makers can’t honor even modest, voluntary commitments that they made to the FDA,” he added.

Gottlieb is right to be angry with e-cig and vaping manufacturers, as use of their products by teens has skyrocketed. In fact, I’d consider teen vaping perhaps the greatest health threat to young people.

The National Youth Tobacco Survey, released in November, found that between 2017 and 2018, e-cig use among high school students spiked 78%, and 48% among middle school students. About 1.5 million young people took up e-cigs between 2017 and 2018.

One of the reasons so many teens are drawn to vaping devices is that the liquid pods used in them have candy-like flavors, such as mint and vanilla, that are obviously geared toward them. Late last year, the FDA proposed new restrictions on the sale of flavored pods in an effort to stop those under the age of 18 from getting their hands on them. The restrictions aren’t yet in effect, and it is unclear how much they will curb teen use.

But the FDA can – and should – go further. They can start by severely restricting the various types of marketing that e-cig makers use to target youths. In 2016, about four out of five middle and high schoolers said they had seen an e-cigarette ad.

The agency should also stop giving e-cig and vaping makers breaks in abiding by regulations that went into effect in 2016 requiring them to submit their products for a safety review by August 2018. Last year, the FDA extended that deadline to August 2022.

The younger someone starts using a nicotine product, the more difficult it is for them to quit. Many health officials have called e-cigarette use by teens an epidemic. It is incumbent upon the FDA to use all the tools at its disposal to reverse it.

Quick Hits: FDA Raids E-Cig Manufacturer, Asthma Drugs’ Side Effects & More

The FDA conducted a surprise inspection of JUUL Labs as part of the agency’s effort to gain more information on the e-cigarette company’s sales and marketing practices. The FDA reportedly seized more than 1,000 documents. The action comes just weeks after the FDA ordered JUUL and four other manufacturers to come up with plans to curb use of e-cigs by teens. JUUL has the largest share of the e-cig market, and its sales grew more than seven-fold from 2016 to 2017, according to newly released data from the CDC (Centers for Disease Control and Prevention). The CDC also noted that JUUL has among the highest nicotine content of e-cigs available. Posted October 2, 2018. Via CDC.

More than half of people with asthma that take oral steroids such as prednisolone experience significant side effects, according to a new survey. Asthma UK, a charitable organization, interviewed 1,200 patients with severe asthma, most of whom had at least two asthma attacks in the prior year and were on an oral steroid. Of those on a steroid, about 56% experienced weight gain, 55% had trouble falling asleep, 43% were more irritable and more easily upset. And 37% said they were more anxious and had less energy. Asthma UK said that healthcare providers should use newer biologic-based drugs known as monoclonal antibodies to treat asthma, as they have been shown to reduce asthma attacks by up to 50%. Some of these medications include Xolair (omalizumab), Cinqair (reslizumab) and Nucala (mepolizumab). However, they are more expensive than oral steroids. Posted October 2, 2018. Via The Times.

About 20% of people with Alzheimer’s disease use two or more psychotropic drugs that can raise the risk of experiencing adverse events. Researchers in Finland examined the medical records of more than 70,000 people diagnosed with the disease. Antipsychotics were eight times as likely to be prescribed in those with Alzheimer’s compared to those without the disease. The use of at least two psychotropics together was three times more common among people with Alzheimer’s. The most common combination was an antidepressant with either an antipsychotic or benzodiazepine, a class of medications used for anxiety and sleep. Use of acetylcholinesterase inhibitors, a first-line dementia treatment, such as Aricept (donepezil), was associated with less risk for psychotropic polypharmacy, while use of Namenda (memantine), another dementia drug, was associated with a higher risk. Posted October 1, 2018. Via European Neuropsychopharmacology.

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How Best to Quit Smoking

By Diane Archer
JustCareUSA.org

Smoking is the top cause for preventable death in the US. If you smoke, the good news is that it’s never too late to quit smoking, even if you are over 65. The only question is how best to quit smoking. Harvard Health offers expert advice.

No matter how long you have been smoking, quitting smoking reduces your health risks. Very quickly, your blood pressure and your circulation improve. You also lower your risk of getting lung cancer. That’s why Medicare pays for counseling to help you quit smoking. Moreover, you can save a bunch of money by quitting.

Different people use different methods to quit. Though it’s not easy. Nicotine is addictive. If you are trying to quit without success, talk to other people you know who have found a way. And if you have Medicare, take advantage of the Medicare smoking cessation counseling benefit.

Experts suggest it is best to use 2 approaches in combination to quit: behavior strategies and medicines. There are a number of behavior strategies, which can be as simple as text message services (which you can get for free through www.smokefree.gov), or self-help, or counseling. For people with depression or anxiety, addressing those conditions is important as well. The evidence is slim that acupuncture or hypnosis work to help people quit smoking.

Nicotine replacement therapy (NRT) as well as a 12-week course of oral medications such as Chantix (varenicline) and Zyban (bupropion) can also be helpful. Chantix, however, contains a “black box” warning about the potential for serious psychiatric events — including suicidal ideation — associated with the drug.

There are many forms of NRT, including gum, nasal spray, patches, lozenges, and inhalers. Using different types of NRTs at once, a short (gum or spray) and long-acting (patch), NRT is said to be more effective. Talk to your doctor or health care provider about the appropriate dose and how to address any side effects.

People can also use nortriptyline, which is an antidepressant, though it is not FDA approved for smoking cessation. It can be effective, but it can also lead to dry mouth, constipation, and weight gain. Again, talk to your doctor about which medications to use.

The FDA does not approve of e-cigarettes as a way to quit smoking. But experts say that smokers who otherwise won’t quit smoking should consider e-cigarettes. They also say that cigarettes and e-cigarettes should not be used in combination.
This article originally appeared on JustCareUSA.org. Republished with permission. 

Quick Hits: FDA Threatens E-Cig Manufacturers, Elderly Polypharmacy and Falls & More

Saying youth smoking of e-cigarettes is reaching “epidemic proportions,” the FDA has ordered the manufacturers of the 5 top e-cigarettes to come up with plans on how to curb use by teens. The agency also threatened to pull flavored e-cigarettes – which are especially appealing to young people – from the market if they can’t demonstrate how they can keep the devices away from children. The manufacturers receiving letters are Juul Labs Inc., Vuse, MarkTen XL, Blu and Logic. Data from Nielsen Research indicates that Juul has more than two-thirds of the e-cigarette market. About 2.1 million middle and high school students used e-cigarettes last year, according to the CDC. Over the summer, the FDA said it issued more than 1,300 warning letters and fines to retailers who illegally sold e-cig products to minors as part of an undercover operation, the largest coordinated enforcement effort in the agency’s history. Posted September 12, 2018. Via FDA.

Elderly people that take several medications for sleeping, pain or incontinence are twice as likely to fall and suffer broken bones compared to those not taking any drugs. Researchers analyzed data on more than 70,000 older adults living in New Zealand. Those who were taking more than 3 Drug Burden Index medications – drugs that sedate or affect one’s cognition – were twice as likely to break their hip than those on no drugs, researchers reported in the Journals of Gerontology. Between 20% and 30% of those who broke their hip died within a year. Lead author Hamish Jamieson, PhD, of the University of Otago, Christchurch, New Zealand, said that multiple medications can cause falls in the elderly because of side effects in each of the medications and drug-drug interactions than can create additional side effects. Posted September 11, 2018. Via University of Otago.

The FDA has issued warning letters to 2 companies for making unsubstantiated medical claims in selling products containing the herb kratom. The agency says that Chillin Mix Kratom and Mitra Distributing make claims that their kratom products can relieve opioid withdrawal and treat conditions including depression, anxiety and high blood pressure. The FDA noted that kratom may contain substances that contain opioids and the plant may have a high potential for abuse. Over the last year, the FDA has issued several public warnings about potential dangers associated with kratom. In February, the agency said it identified 44 deaths associated with the use of kratom. Posted September 11, 2018. Via FDA.

Quick Hits: E-Cigs and Heart Attacks, Influencing Doctor Prescribing & More

Using e-cigarettes daily can significantly increase a person’s risk of having a heart attack. Researchers analyzed responses from almost 70,000 people that took part in the National Health Interview Survey. About 3.6% of current and former e-cigarette users reported having a heart attack, and 6.1% of those who used an e-cigarette daily had a heart attack. People that said they used both conventional cigarettes and an e-cigarette every day were 4.6 times more likely to have a heart attack than those who had not used either product. Posted August 22, 2018. Via American Journal of Preventive Medicine.

Writing letters to physicians that prescribe more of a drug than other doctors may help them cut down on those prescriptions. A study examined prescriptions for the antipsychotic drug Seroquel (quetiapine). The Centers for Medicaid and Medicare Services sent letters to about 5,000 doctors that had written the most Seroquel prescriptions. The letter said that they wrote many more prescriptions for the drug than the average for their state, and included a statement that they had been “flagged as a markedly unusual prescriber.” After following the doctors’ Seroquel prescribing for the next 2 years, researchers found that the prescriptions declined by 16%. Posted August 1, 2018. Via JAMA Psychiatry.

The FDA has approved the first generic version of EpiPen, an epinephrine-containing injection used for emergency treatment of allergic reactions. The approval comes as there is a nationwide shortage of the auto-injector. Mylan, the pharmaceutical company that sells the EpiPen brand version, has been heavily criticized for drastically increasing the price of the product. One pen used to cost $50. A 2-pen set now costs around $600. Last year, the FDA reported at least 7 deaths linked to EpiPens that failed to deploy properly. Posted August 16, 2018. Via FDA.

Are E-Cigs Effective As a Smoking Cessation Tool?

Although some argue that e-cigarettes may help people quit smoking or have less harmful consequences than traditional cigarettes, a new study found that many e-cigarette users also use regular cigarettes, undermining the argument that e-cigs are a smoking cessation tool. The study also found that respiratory symptoms were most common among people who used both regular cigarettes and e-cigs.

Researchers in Sweden looked at more than 30,000 adults ranging in age from 20 to 75 years old. Among e-cig users, nearly two-thirds were current smokers, 18.3% were non-cigarette smokers and 15% were former smokers.

Respiratory symptoms were most common among those who used both e-cigs and tobacco cigarettes and former smokers who didn’t use e-cigs, according to the study, published in JAMA Network Open. Those symptoms included wheezing, long-standing cough and difficulty bringing up phlegm during coughs.

“The medical community needs to be careful when recommending e-cigarettes to patients as a smoking cessation method or as a safer alternative to conventional cigarettes, especially as their efficacy as a smoking cessation method is still ambiguous,” the researchers wrote. “Our study seems to indicate that the present use of e-cigarettes does not adequately serve as a smoking cessation tool.”

‘Juice Box’ E-Cig Liquids Draw Ire of Federal Regulators

The FDA and the Federal Trade Commission are cracking down on manufacturers selling e-liquids used in e-cigarettes because some are allegedly packaging them to resemble kid-friendly food products such as juice boxes, candy or cookies and are using cartoon-like imagery.

Federal regulators issued 13 warning letters to the companies, advising that changes must be made to the products immediately. Several of the companies were also cited for illegally selling the products to underage children.

The warning letters gave examples of the products being sold online, including “One Mad Hit Juice Box,” which resembles children’s apple juice boxes, such as Tree Top–brand; “Vape Heads Sour Smurf Sauce,” which resembles War Heads candy; and “V’Nilla Cookies & Milk,” which resembles Nilla Wafer and Golden Oreo Cookies.

“No child should be using any tobacco product, and no tobacco products should be marketed in a way that endangers kids – especially by using imagery that misleads them into thinking the products are things they’d eat or drink,” FDA Commissioner Scott Gottlieb said in a news release.

The companies must respond within 15 days, detailing the specific changes that will be made in order to resolve the concerns mentioned in the warning letter. If the companies fail to comply, they may face serious consequences, such as product seizure or an injunction.

Quick Hits: Lamictal Warning, FDA Crackdown on E-Cigs & Drug Take Back Day

Lamictal (lamotrigine), a drug used to treat seizures and bipolar disorder, can cause a rare but very serious immune system reaction known as hemophagocytic lymphohistiocytosis (HLH). HLH can cause severe inflammation throughout the body and result in someone being hospitalized or even death, especially if not diagnosed and treated immediately. This alarming side effect has prompted the FDA to require that a new warning about the risk be added to lamotrigine’s label. The agency is advising patients to stop using lamotrigine if they develop a fever or rash after taking the medication, and to visit their doctor immediately to get checked out. Patients should also stop taking lamotrigine if HLH – or another serious immune-related adverse reaction – is suspected or identified. Posted April 25, 2018. Via FDA.

The FDA will work to limit the use of e-cigarettes such as JUUL among children by coordinating a large-scale undercover crackdown on their sale, both in stores and online. Over the course of nearly 2 months, the FDA has uncovered 40 violations for illegal sales of JUUL products to minors and has issued 40 warning letters for those violations. The agency recently issued a request asking JUUL Labs to provide further information that offers an explanation as to why children are so drawn to the nicotine-infused product. FDA Commissioner Scott Gottlieb, MD, indicated that the agency also contacted eBay to vocalize concerns regarding the listings of JUUL products on the eBay website. According to the report, eBay has cooperated throughout the process and has removed the listings from its website. The agency’s continued efforts will be included in the Youth Tobacco Prevention Plan. Posted April 24, 2018. Via FDA.

The DEA (Drug Enforcement Administration) is hosting National Prescription Drug Take Back Day, when you can discard unwanted, unused or expired prescription medications. According to the 2015 National Survey on Drug Use and Health, 6.4 million Americans abused controlled prescription drugs. The majority of abused prescription drugs were generally obtained from the home medicine cabinet of family and friends. In an effort to address this issue, the DEA will give you the opportunity to visit an official collection site near you and discard unused or expired prescription drugs hassle-free from 10am to 2pm on April 28. Posted April 24, 2018. Via DEA.

 

Quick Hits: Are Smokeless Tobacco Devices Safer, Another Muscular Dystrophy Drug & More

Smokeless tobacco devices that are marketed as a safer alternative to traditional cigarettes may not be as harmless as claimed, according to new research. IQOS – which stands for “I quit original smoking” – is a new “heat not burn” smokeless tobacco product manufactured by Philip Morris International (PMI), the biggest tobacco company in the world. PMI has conducted and published several extensive studies evaluating the effects of their new IQOS device. However, researchers from the University of California note that “these studies appeared in a journal that may have a deficient review process, emphasizing the need for independent evaluation of the iQOS.” Researchers conducted an independent review. Results indicated that people who use the iQOS heat stick tend to speed up their puff rate to breathe in more nicotine because the device only lasts for 6 minutes, after which it automatically shuts off and requires recharging. Published March 13, 2018. Via Tobacco Control.

Sarepta Therpeutics plans to submit an application for another Duchenne muscular dystrophy drug (DMD). In 2016, the FDA approved Sarepta’s currently marketed DMD drug, which went against the recommendation of a panel of independent advisors who said eteplirsen did not demonstrate clear efficacy in treating the rare muscle-wasting disease. Now, the company has submitted an application for the approval of golodirsen, which is a drug used to treat patients with DMD. This drug is said to help produce a smaller but functional form of dystrophin protein. A review conducted by Sarepta indicated that golodirsen significantly increased dystrophin protein production in 25 boys with confirmed deletions of the DMD gene amenable to exon 53 skipping. Published March 12, 2018. Via Sarepta.

The FDA is continuing to work with Abbvie and Biogen on the withdrawal of their multiple sclerosis drug from the market. Earlier this month, MedShadow reported that Zinbryta (daclizumab) would be voluntarily pulled from the market worldwide after reports of brain inflammation and severe liver damage. The FDA stepped in to assist with the process in order to “ensure a well-organized withdrawal from the market in the United States.” Furthermore, the agency wants to make sure that doctors are equipped with the necessary information to carefully transition their patients using Zinbryta to another treatment. Zinbryta will not be administered to new patients nor will new patients participate in clinical studies.The company has started notifying doctors and patients and Zinbryta will only be available for patients as needed until April 30, 2018. The FDA says that patients should not stop taking the medication without consulting their doctor. Published March 14, 2018. Via FDA.

Quick Hits: Antidepressants and Ovarian Cancer, Limiting Opioid Scripts & More

Antidepressants are not linked to ovarian cancer, according to a new study. Although there have been a few studies over the years showing a link between certain classes of antidepressants and the development of tumors, researchers from Shengjing Hospital of China Medical University are suggesting otherwise. The research team thoroughly analyzed data from observational studies that examined the connection between antidepressant use and cancer from 1984 to 2017. The results from this large-scale review indicated that there is not a significant association between antidepressant use and the risk of ovarian cancer, which is contrary to initial findings. Posted February 5, 2018. Via British Journal of Clinical Pharmacology.

Opioid prescriptions for Medicare enrollees would be limited to 7 days under a request from the Centers for Medicare & Medicaid Services. The agency has also proposed that patients who are considered “potentiators” of opioid misuse and opioid-related adverse events be closely monitored, especially those who take Neurontin (gabapentin) and Lyrica (pregabalin). According to the agency, there has been a significant increase in gabapentin use to treat pain. Via CMS. Posted February 2, 2018.

Senate Democrats want the FDA to reject a new alternative cigarette that will be marketed as less risky. Ten Democrats sent a signed letter requesting that the FDA to reject Philip Morris’ risk application for its new iQOS smoking device. The letter was sent after most of the FDA’s scientific advisory panel reported mixed findings on the new product. According to the advisory panel, the tobacco company did not prove whether its new “heat not burn” cigarette reduced harm compared to tobacco cigarettes. However, the advisory panel concluded that iQOS exposes users to lower levels of harmful chemicals. The senators also referenced the Family Smoking Prevention and Tobacco Control Act, noting that modified risk tobacco products must significantly reduce harm and benefit the health of the population. Posted February 7, 2018. Via The Hill.