FDA Classifies Previous Endologix AFX Safety Notice as Class I Recall

Endologix® Inc. (Nasdaq: ELGX), a developer and marketer of innovative treatments for aortic disorders, announced today that it has received notice that the U.S. Food and Drug Administration (FDA) has classified a voluntary recall action that Endologix took in July of this year as a Class I recall. The July recall involved Endologix’s issuance of a Safety Notice to healthcare professionals (HCPs) using the AFX® Endovascular AAA System.

The Safety Notice, dated 20 July 2018, provided updated information on comparative AFX Type III endoleak rates, patient-tailored surveillance recommendations, and recommendations for intervening through an AFX device or re-intervening on an AFX device. No product was removed from the field as part of this recall.

The July 2018 Safety Notice followed several earlier communications. Safety Notices from Endologix issued in late 2016 and early 2017 requested that all remaining AFX Strata devices be returned from the field and emphasized that Endologix had not manufactured AFX Strata grafts since 2014. On September 28, 2017, the FDA issued a letter to HCPs to raise awareness of an increased occurrence of Type III endoleaks after endovascular aneurysm repair (EVAR). On June 19, 2018, the FDA issued an updated letter to HCPs indicating the increased risk for Type III endoleak appears to be specific to one device at this time, the AFX with Strata device. (https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm611039.htm)

“As outlined at our Investor Day on October 2, 2018, the AFX Strata product was removed from global inventory in the first half of 2017. Our current commercially available versions of the AFX system, the AFX DuraplyTM and AFX2TM products, are manufactured using a different ePTFE processing methodology and include additional product improvements,” noted John Onopchenko, Chief Executive Officer of Endologix. “These AFX Duraply and AFX2 products, while part of the July 2018 Safety Notice providing updated recommendations to HCPs on how to re-intervene on or through these products, were not the subject of the voluntary product removal actions in December 2016/January 2017. Furthermore, AFX Duraply and AFX2 products were not the subject of the June 19, 2018 FDA letter to HCPs. Through our comprehensive system of post-market surveillance, anonymized registry data, and the only randomized trial to compare EVAR systems (the LEOPARD trial), we have a strong and growing evidence base that supports the use of the AFX Duraply and AFX2 systems for patients with AAA. We are proud of, and committed to, advancing our collaborative work with the FDA on behalf of our patients, customers, and the broader clinical community.”

https://www.businesswire.com/news/home/20181005005529/en/FDA-Classifies-Previous-Endologix-AFX-Safety-Notice

Many Young Drug Abusers Not Tested for Hep C

Too few teens and young adults with an opioid addiction are tested for hepatitis C, even though they’re at high risk for the liver infection, researchers say.

In 2016, hepatitis C killed more than 18,000 Americans, making it the most common cause of death from a reportable infectious disease, according to the U.S. Centers for Disease Control and Prevention.

“We’re missing an opportunity to identify and treat young people who are at risk for this deadly infection,” said Dr. Rachel Epstein, lead author of the new study.

“Screening for [opioid addiction] and other drug use, and then testing for hepatitis C in those at high risk, can help us do a better job of eliminating this serious infection, especially now that very effective hepatitis C medications are approved for teenagers,” said Epstein, a postgraduate research fellow at Boston Medical Center.

Her team studied the electronic medical records of more than 269,100 teens and young adults, ages 13 to 21. Between 2012 and 2017, the patients had visited one of 57 federally qualified health centers that provide health care to underserved communities in 19 states.

Of the 875 people with diagnosed opioid addiction, only 36 percent were tested for hepatitis C. Of those, 11 percent had been exposed to hepatitis C and almost 7 percent had evidence of chronic hepatitis C infection, the researchers found.

Overall, 2.5 percent, or more than 6,800 teens and young adults who visited the health centers, were tested for hepatitis C. Of those, 122 tested positive for it. Those most likely to be tested were black, had any substance use disorder, and were ages 19 to 21.

The study was presented Thursday at IDWeek, a meeting of infectious disease specialists, in San Francisco.

Injection drug users who share needles often spread hepatitis C. It’s possible that doctors don’t test suspected opioid abusers because the drugs are available in pill form, which doesn’t increase the risk of hepatitis C. However, studies show many youths who misuse prescription opioid pills eventually begin injecting drugs, the researchers noted.

Current guidelines only recommend hepatitis C testing for known injection drug users.

“The issue is complicated by the fact that not enough at-risk youth are screened for opioid or other drug use for a variety of reasons, including lack of time, comfort level between clinician and patient, and privacy and stigma concerns,” Epstein said in a meeting news release.

“And even when drug use is identified, there’s a belief that youth are less likely to test positive for hepatitis C, which isn’t necessarily the case as we show in our study. Clearly, this is an overlooked group that is at high risk,” she concluded.

Research presented at meetings is usually considered preliminary until published in a peer-reviewed medical journal.

More information

The American Academy of Family Physicians has more on hepatitis C.

SOURCE: IDWeek, news release, Oct. 4, 2018

https://consumer.healthday.com/general-health-information-16/drug-abuse-news-210/many-young-drug-abusers-not-tested-for-hepatitis-c-study-finds-738281.html

Working Out When Under the Weather

Every now and then you might not feel well enough to exercise and decide to skip a workout. But if you have a cold that could last a full week, you probably won’t want to find yourself facing a fitness setback once you’ve recovered.

Here’s how to stay in the game.

The general guideline is that you should be able to work out if your symptoms are from the neck up, like a stuffy nose from a cold, but not when you have the whole-body achiness of the flu. Easy or moderate exercise, such as walking rather than running, should be fine. Some experts say it could even be beneficial.

But you don’t want to spread germs at the gym, so work out at home to avoid infecting others. And remember to cut back on the intensity and length of your usual workout as needed to avoid further taxing your body and risking injury.

If you’re sick enough that you need to significantly scale back your usual workout, a call to your doctor’s office is warranted — beyond whether it’s safe to exercise with your particular illness, ask whether you need an office visit. Even if you get the go-ahead to exercise, tread lightly so you can see how your body responds. Stop if necessary — pay attention to any clues that you just can’t handle the physical exertion you’re attempting.

If you have the full gamut of flu symptoms, like fever, fatigue and body aches, even moderate exercise is out. You might need to wait 2 to 4 weeks after recovery before you get back to high-level workouts. Return at a slow pace and gradually build up to avoid stressing your system.

What about exercise when you have a chronic condition?

Health experts say exercise may help you better manage it, especially if the illness is characterized by inflammation, such as an inflammatory bowel or rheumatic disease, because exercise engenders an anti-inflammatory response in the body. But you may need to sit out a severe flare, such as a rheumatoid arthritis attack.

And always follow your doctor’s advice if you need to take any medications that make it unsafe to exercise.

More information

The Mayo Clinic has more on how to tell if you’re too sick to exercise.

https://consumer.healthday.com/fitness-information-14/misc-health-news-265/working-out-when-under-the-weather-736855.html

First user-fitted hearing aid approved

The first hearing aid that doesn’t require the assistance of an audiologist or other health care provider has been approved by the U.S. Food and Drug Administration.

The Bose Hearing Aid is a user-fitted device for people aged 18 and older with mild-to-moderate hearing loss, the agency said Friday in a news release.

“Today’s marketing authorization provides certain patients with access to a new hearing aid that provides them with direct control over the fit and functionality of the device,” said Dr. Malvina Eydelman, director of the FDA’s Division of Ophthalmic, and Ear, Nose and Throat Devices.

Some 37.5 million adults in the United States report having hearing loss of some degree, the FDA said. Common risk factors include aging, exposure to loud noises and certain medical conditions.

The Bose device was evaluated in clinical studies involving 125 people. When participants self-fitted the device and used a cellphone app to program and make adjustments to the device settings, they “generally preferred those hearing aid settings over … professionally-selected settings,” the FDA said.

While users may fit, program and control the device on their own, some state laws require that hearing aids be obtained from a licensed dispenser, the agency said.

Bose Corp. is based in Framingham, Mass.

 Explore further: Implanted hearing device approved

https://medicalxpress.com/news/2018-10-user-fitted-aid.html

Health insurers may discourage use of non-opioid alternates for lower back pain

Public and private health insurance policies in the U.S. are missing important opportunities to encourage the use of physical therapy, psychological counseling and other non-drug alternatives to opioid medication for treating lower back pain, a study led by researchers at Johns Hopkins Bloomberg School of Public Health has found.

The Bloomberg School researchers looked at Medicaid, Medicare and major commercial insurers‘ 2017 coverage policies for non-drug options for treating chronic lower back pain—a common pain condition that is often treated inappropriately with prescription opioids. They found that insurers have inconsistent policy terms for non-drug treatments, and provide little or no coverage for interventions such as acupuncture and psychological counseling, treatments which do have some scientific backing.

A key finding was that insurers did not have clear and consistent coverage policies for several lower back pain treatments that have been found effective in some studies. Acupuncture, for example, was expressly covered by only five of the 45 examined plans.

“This study reveals an important opportunity for insurers to broaden and standardize their coverage of non-drug pain treatments to encourage their use as safer alternatives to opioids,” says study senior author Caleb Alexander, MD, MS, associate professor of epidemiology at the Bloomberg School.

The study, to be published Oct. 5 in the online journal JAMA Network Open, follows a complementary study by the same research team of major insurers’ policies on prescription drugs for pain, published in the same journal in June. The two studies are the most comprehensive of their kind, and were conducted with funding and technical assistance from the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC).

CDC officials estimate that 49,031 Americans died from opioid overdoses in the 12-month period ending in December 2017. In 2016, more than 40 percent of those deaths were due to prescription opioids. This epidemic has been encouraged by a several-fold increase in opioid prescriptions since the turn of the century—most of which are thought to be medically unnecessary. Current CDC guidelines note that “Non-opioid therapy is preferred for chronic pain outside of active cancer, palliative, and end-of-life care.” HHS has urged insurers to design their coverage policies accordingly.

To gauge how far insurers have moved towards this goal, Alexander and colleagues examined 15 Medicaid, 15 Medicare Advantage and 15 major commercial insurer plans for 2017 covering non-drug treatments for lower back pain. The 45 plans were applicable in 16 states, chosen for the diversity of their geography, wealth and opioid-epidemic impact.

Of the fifteen Medicaid plans assessed for psychological coverage, just three plans covered psychological interventions. “We were perplexed by the absence of coverage language on psychological interventions,” Alexander says. “It’s hard to imagine that insurers wouldn’t cover that.”

Even for physical therapy, an important and well-established method of relieving lower back pain that was covered by nearly all plans, specific coverage policies were inconsistent. “Some plans covered two visits, some six, some 12; some allowed you to refer yourself for treatment, while others required referral by a doctor,” Alexander says. “That variation indicates a lack of consensus among insurers regarding what model coverage should be, or a lack of willingness to pay for it.”

The researchers interviewed 43 executives representing the evaluated plans; these individuals indicated that their organizations have been trying to expand access to non-drug therapies in response to the opioid epidemic. Overall, however, their remarks suggested that insurers were not yet doing enough to coordinate non-drug and drug coverage policies, such as requiring patients to try physical therapy for their lower back pain before covering long-term opioids.

Alexander emphasizes that while many of the covered non-drug therapies, such as acupuncture and chiropractic interventions, might seem untested, there is significant evidence for their effectiveness in treating lower back pain.

The findings, to Alexander and colleagues, suggest that there is still a lot of room for improvement in coverage policies, particularly an expansion and standardization of non-drug treatment coverage and policy terms—a change that should encourage more use of non-drug treatments by patients before they resort to opioid painkillers.

“In the last few years we have seen many insurers modifying their policies to reduce the vast overuse of opioids, but clearly we still have a long way to go,” says Alexander.

 Explore further: Health insurance plans may be fueling opioid epidemic

More information: “Coverage of Non-Pharmacologic Treatments for Lower Back Pain Among Public and Private Insurers in the United States” JAMA Network Open (2018).

https://medicalxpress.com/news/2018-10-health-policies-discourage-non-opioid-alternatives.html

New targets to inhibit pulmonary fibrosis

In a study out this week in Science Translational Medicine, an international team led by researchers at Vanderbilt University Medical Center sheds new light on the cause of pulmonary fibrosis and demonstrates a way to impede the disease in mice.

The study results imply that certain drugs already at market might be able to be repurposed to inhibit or halt this major respiratory disease.

“I’m very excited by the implications of our study for drug repurposing and the important benefits that might accrue for a great many patients with lung disease,” said Wonder Drake, MD, professor of Medicine and Pathology, Microbiology and Immunology, who led the study with Lindsay Celada, Ph.D., research instructor in Medicine.

“I’m doubly excited at the prospect of these clinical trials proceeding right here at VUMC. A combination of clinical investigative talent and research infrastructure makes VUMC the natural place to advance our lab’s findings into the clinical realm.”

People with pulmonary fibrosis are perpetually short of breath. Connective tissue in their lungs has become thickened or scarred, reducing the supply of oxygen to the blood.

Fibrosis occurs in a number of diseases affecting the lungs, among them sarcoidosis and idiopathic pulmonary fibrosis (IPF). Median survival with IPF is approximately three years. Pulmonary fibrosis can also occur in response to bleomycin, a drug in use since the 1960s to treat cancer.

Pursuing cues from an assortment of previous findings, the new study uncovers a common immunological mechanism underlying these three distinct disease types.

In both IPF and bleomycin-induced fibrosis, previous studies had indicated connections with a pro-inflammatory cell signaling protein called interleukin-17 (IL-17A). Meanwhile, people studying sarcoidosis had found dysfunction in a type of white blood cell, the CD4+ T cell.

Drake had traced this dysfunction to upregulation of PD-1, or programmed cell death protein 1, a cell surface receptor that inhibits autoimmunity.

Fibroblasts are cells that produce the structural framework of animal tissues, including wound-healing tissues. IPF in particular has been shown to involve overactivation of lung fibroblasts.

The team placed normal lung fibroblasts in culture with CD4+ T cells harvested from people with IPF or sarcoidosis. Type 1 collagen production, a hallmark of fibrosis, results in both these cultures; but not so in the case of CD4+ T cells from patients with healthy lungs.

Employing an array of techniques and covering a lot of ground, the study introduces a causal story that starts with PD-1 upregulated CD4+ T cells, leading to increased expression of a gene transcription activator called STAT3, and then on to increased production of IL-17A, resulting in fibrosis.

“Though they haven’t typically been considered important in pulmonary fibrosis, we’re showing a central role in a range of diseases for CD4+ T cells with PD-1 upregulation,” Celada said.

With its wide scope, the study brings attention to three potential drug targets for which drugs are already available: blocking PD-1 can significantly reduce fibrosis in mice, the team shows; using human cells in vitro, they show that chemical inhibition of STAT3 reduces components of fibrosis, such as collagen production; and finally, the study brings added attention to the role of IL-17A in sarcoidosis pulmonary fibrosis.

 Explore further: Blocking the molecular source of idiopathic pulmonary fibrosis

More information: Lindsay J. Celada et al. PD-1 up-regulation on CD4+ T cells promotes pulmonary fibrosis through STAT3-mediated IL-17A and TGF-β1 production, Science Translational Medicine (2018). DOI: 10.1126/scitranslmed.aar8356

https://medicalxpress.com/news/2018-10-reveals-inhibit-pulmonary-fibrosis.html

Euro watchdog urges curbs on on fluoroquinolone, quinolone antibiotics

The European Medicine Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of systemic and inhaled fluoroquinolone and quinolone antibiotics following a safety review.

“Very rarely, patients treated with fluoroquinolone or quinolone antibiotics have suffered long-lasting and disabling side effects, mainly involving muscles, tendons, and bones, and the nervous system,” the EMA said in a news release.

The PRAC also advised that some medicines, including all those that contain a quinolone antibiotic, be removed from the market.

The PRAC recommended that the remaining fluoroquinolone antibiotics should not be used to treat infections that might improve without treatment or are not severe (such as throat infections); to treat patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic; or to treat mild or moderately severe infections unless other antibacterial medicines commonly recommended for these infections cannot be used.

They should also not be used to prevent traveler’s diarrhea or recurring lower urinary tract infections.

The PRAC further recommended that fluoroquinolone antibiotics be used with caution in the elderly, patients with kidney problems, patients who have had an organ transplantation, or those who are being treated with a systemic corticosteroid, as these patients are at higher risk of tendon injury caused by fluoroquinolone and quinolone antibiotics.

The PRAC recommends that healthcare providers advise patients to stop taking a fluoroquinolone antibiotic at the first sign of a side effect involving muscles, tendons, or bones (such as inflamed or torn tendon, muscle pain or weakness, and joint pain or swelling) or the nervous system (such as feeling pins and needles, tiredness, depression, confusion, suicidal thoughts, sleep disorders, vision and hearing problems, and altered taste and smell).

The PRAC safety review was announced in early 2017, as reported byMedscape Medical News, and covered the fluoroquinolone antibiotics ciprofloxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin, and rufloxacin; and the quinolone antibiotics cinoxacin, nalidixic acid, and pipemidic acid.

In 2016, the US Food and Drug Administration (FDA) enhanced warnings about the link between fluoroquinolones and disabling and potentially permanent side effects involving tendons, muscles, joints, nerves, and the central nervous system.

In July, the FDA ordered label changes for fluoroquinolones to strengthen warnings about the antibiotics’ risks for mental health side effects and serious blood sugar disturbances, as reported by Medscape Medical News.

The PRAC recommendations will now be sent to EMA’s Committee for Medicinal Products for Human Use (CHMP), which will adopt the Agency’s final opinion.

The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU member states. The new restrictions on the use of fluoroquinolones and quinolones will become applicable after a Commission decision is issued.

https://www.medscape.com/viewarticle/903029