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FDA Warns Dollar Store About Tainted OTC Drugs

Nov. 15, 2019 — Dollar Tree has been sent a warning letter for selling over-the-counter (OTC) drugs made by foreign companies with serious, multiple violations of federal manufacturing laws, the U.S. Food and Drug Administration says.

The drugs include Dollar Tree’s Assured Brand OTC drugs and other drug products sold by Dollar Tree Co., which operates stores under the Dollar Tree and Family Dollar names.

The contract manufacturers used by Dollar Tree to make the OTC drugs have received warning letters from the FDA for violations such as not testing raw materials or finished drugs for pathogens and quality.

In its warning letter to Dollar Tree, the FDA outlines a number of corrective actions the company needs to take, including a system to ensure that they do not import impure drugs.

Dollar Tree said that it is cooperating with the FDA and plans to meet with the agency, CNN reported.

“We are committed to our customers’ safety and have very robust and rigorous testing programs in place to ensure our third-party manufacturers’ products are safe,” Randy Guiler, vice president of investor relations at Dollar Tree, said in a company statement.

“Each of the items referenced in the report are topical, and not ingestible, products. As always, we are cooperating with the U.S. Food and Drug Administration [FDA]. We plan to meet with the FDA in the near future and expect that our plans will satisfy their requirements in all regards,” the statement said, CNN reported.

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Most Popular BP Drugs Might Not Be the Best

By Robert Preidt
HealthDay Reporter

FRIDAY, Oct. 25, 2019 (HealthDay News) — Millions of Americans take an ACE inhibitor to help curb their high blood pressure — in fact, these drugs are the most widely used antihypertensives in America.

However, a new international study of nearly 5 million patients is casting doubt on the notion that the drugs are as effective as another class of blood pressure medicines.

Common ACE inhibitors include drugs such as benazepril, captopril, enalapril, fosinopril and lisinopril, among others.

The new study should “help guide physicians in their clinical decision-making,” said study author Dr. George Hripcsak. He’s chair of biomedical informatics at Columbia University’s College of Physicians and Surgeons, in New York City.

American College of Cardiology and American Heart Association guidelines recommend starting blood pressure treatment with any drug from five different classes of medications. Those classes include: thiazide diuretics; ACE inhibitors; angiotensin II receptor blockers (ARBs); dihydropyridine calcium channel blockers and non-dihydropyridine calcium channel blockers.

To find out how often these medicines are prescribed, Hripcsak’s team tracked data on nearly 5 million patients across four countries — Germany, Japan, South Korea and the United States.

All of the patients began treatment for high blood pressure by using a single drug.

In nearly half (48% ) of cases, ACE inhibitors were the first drug prescribed, compared with 17% of patients who were first prescribed thiazide diuretics, the team found.

But the study suggests that ACE inhibitors might not always be the best choice.

Patients who were prescribed thiazide diuretics ended up having 15% fewer heart attacks, strokes and hospitalizations for heart failure, as well as lower rates of 19 side effects, compared to those who had been prescribed ACE inhibitors.

Crunching the numbers, the Columbia team calculated that about 3,100 major cardiovascular events among the patients who first took ACE inhibitors could have been prevented if they’d first been treated with a thiazide diuretic.

They reported their findings Oct. 24 in The Lancet journal.

The researchers also found that another class of blood pressure meds, non-dihydropyridine calcium channel blockers, were less effective than all of the other first-line classes of blood pressure drugs.

Continued

Right now, there’s a real lack of research aimed at helping doctors choose which drug class a patient should start on, Hripcsak believes.

He noted that the current literature has data from randomized, controlled clinical trials that included a total of just 31,000 patients, and none of those patients were just beginning treatment for high blood pressure.

“Randomized clinical trials demonstrate a drug’s effectiveness and safety in a highly defined patient population,” Hripcsak explained in a university news release. “But they’re not good at making comparisons among multiple drug classes in a diverse group of patients that you would encounter in the real world.”

With the new study, Hripcsak believes that “we have found a way to fill in the gaps left by randomized, controlled trials.

Two cardiologists who weren’t involved in the new study took different stances on the results — suggesting that debate on this topic is far from over.

Dr. Satjit Bhusri said the study “is statistically very powerful and can have profound changes in medical practice.” But he added that decisions around which anti-hypertensive drug to choose should still be made on a case-by-case basis.

“I would suggest that the choice of first-line blood pressure therapy be specific to the patient, especially in those with heart disease or at an elevated risk of heart disease.,” Bhusri advised. But, for patients “treated for high blood pressure without an elevated cardiac risk, thiazide medication should be the first-line [choice],” he said.

However, cardiologist Dr. Benjamin Hirsh took issue with the Columbia study’s methodology.

The researchers’ conclusion that “use of thiazide diuretics over ACE inhibitors causes ‘15% fewer cardiovascular effects’ is a conclusion that is highly subject to bias,” he noted.

“ACE Inhibitors are used to treat patients with higher cardiovascular risk, such as those with advanced heart failure and kidney disease,” Hirsh explained.”So, these patients are at higher risk for heart disease in general.”

According to Hirsh, it stands to reason that patients on ACE inhibitors would have worse outcomes than those on thiazide diuretics, because they were sicker to begin with.

And he noted that “thiazide diuretics also must be used carefully with other drugs.” Those include newer diabetes medications such as Jardiance, because the concurrent use of a thiazide diuretic might trigger too-low blood pressure, Hirsh explained.

WebMD News from HealthDay

Sources

SOURCES: Satjit Bhusri, M.D., cardiologist, Lenox Hill Hospital, New York City; Benjamin Hirsh, M.D., director, preventive cardiology, Northwell Health Sandra Atlas Bass Heart Hospital, Manhasset; NY; Columbia University, news release, Oct. 24, 2019

Copyright © 2013-2018 HealthDay. All rights reserved.

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Aspirin, Antihistamines: Kids Often Use OTC Drugs in Suicide Attempts

By Serena Gordon
HealthDay Reporter

MONDAY, Oct. 7, 2019 (HealthDay News) — More teens are attempting suicide by overdosing on drugs, and new research suggests they are often turning to over-the-counter (OTC) medications like ibuprofen and aspirin in their efforts.

Antidepressants, antipsychotics and antihistamines were also common choices, the researchers added.

“What we were seeing was youth increasing suicide attempts using medications readily available in the home,” said study author John Ackerman, suicide prevention coordinator at the Center for Suicide Prevention and Research at Nationwide Children’s Hospital in Columbus, Ohio.

“People think that youth are thinking deeply about which medicine to take, but when someone is in crisis, it’s what’s in the medicine cabinet. These drugs are having very serious medical outcomes for young people,” Ackerman added.

Girls were much more likely than boys to attempt suicide by what is known as “self-poisoning,” and suicide attempts by self-poisoning in children and teens were higher in rural communities. These types of suicide attempts occurred more often during the school year, the study found.

When people survive a self-poisoning suicide attempt, they may have heart problems or seizures afterwards. Ackerman said that the drugs may have an impact on brain function as well.

“This paper is a call to action for parents to increase their safe storage practices and talk to kids about their mental health concerns,” he added. “Ask your kids how they’re doing.”

Parents may think it’s impossible to keep kids away from all medicines. “But, if you’re adding barriers — like a lock box or safe, and counting medication — those seemingly simple tasks can help. They can be a bridge to a child or teen seeing other options,” Ackerman explained.

From 2000 to 2018, more than 1.6 million young people between the ages of 10 and 25 attempted suicide by self-poisoning. The rates of these suicide attempts in young people aged 10 to 18 started to increase in 2011, the study found.

Almost one-quarter of those attempts resulted in a serious medical outcome. The drugs most used in these attempts were OTC pain relievers, antidepressants, antihistamines and antipsychotics. Opioids were only involved in 7% of cases with a serious medical outcome.

Continued

ADHD medications were more commonly used in the younger group — 10- to 15-year-olds.

Less densely-populated states were more likely to have reported cases ending in serious medical outcomes.

“Rural communities are more at risk. It might be social isolation, lack of access to mental health care and economic factors,” Ackerman suggested.

In kids 18 and younger, suicide attempts by self-poisoning occurred more during the school months of September through May. This pattern wasn’t seen in the 19- to 21-year-old age group. The 22- to 25-year-old group had an increase in the summer months.

“Younger people seem to be more vulnerable during the school year,” Ackerman said. Although the study didn’t look at causes behind the findings, he said that school stress, peer behaviors, bullying and social media likely play a role.

Daniel Reidenberg, executive director of Suicide Awareness Voices of Education, reviewed the study and said, “In an acute suicidal crisis, people turn to the quickest, most easily available means.”

He said there are usually signs before someone reaches a crisis level. “People might be struggling with sleep; their appetite might be off; they might talk about aches and have other complaints about physical problems. They don’t want to go to school. They don’t want to interact with their friends,” Reidenberg said.

Of even greater concern is when someone talks about being a burden or says they have no hope for the future. They might start to look for ways to die or talk about suicide.

Reidenberg said a huge red flag is if someone just can’t sleep for a few days. “Anxiety and agitation become worse as someone gets sicker. It’s very, very important that anyone who might be at risk of suicide be monitored for sleep. It can be hard to notice disrupted sleep patterns in teens, but if there’s one, two or three days without sleep, you need to have a conversation, and hopefully get some professional help.”

Reidenberg added that connections are crucial: “The more connections that people have, the better off they are. A sense of aloneness increases the sense of distress and the risk of suicide.”

Continued

If you find your child has attempted self-poisoning, Ackerman said it’s important to get them to the ER immediately. The sooner they get help, the better the chances for a good outcome.

The findings were published Oct. 7 in Clinical Toxicology.

WebMD News from HealthDay

Sources

SOURCES: John Ackerman, Ph.D., suicide prevention coordinator, Center for Suicide Prevention and Research, Nationwide Children’s Hospital, Columbus, Ohio; Daniel J. Reidenberg, Psy.D., executive director, Suicide Awareness Voices of Education, and managing director, National Council for Suicide Prevention, and general secretary, International Association for Suicide Prevention; Oct. 7, 2019,Clinical Toxicology

Copyright © 2013-2018 HealthDay. All rights reserved.

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FDA Warns of Problems for Some Taking Hep C Drugs

By Robert Preidt        
       HealthDay Reporter

THURSDAY, Aug. 29, 2019 (HealthDay News) — Taking the hepatitis C drugs Mavyret, Zepatier or Vosevi can trigger rare cases of severe liver problems or liver failure in patients who already have moderate-to-severe liver impairment, the U.S. Food and Drug Administration warned Wednesday.

The agency has identified 63 cases of worsening liver function, some resulting in liver failure or death, among patients taking the drugs.

While the medicines are safe and effective in patients with no or mild liver impairment, the same cannot be said for those with moderate-to-severe liver impairment, the FDA said.

“Hepatitis C virus remains a significant public health issue, but effective therapeutic options have helped patients to receive important curative treatments,” said Dr. Debra Birnkrant, director of the FDA’s Division of Antiviral Products at the Center for Drug Evaluation and Research.

Chronic hepatitis C, or HCV, is a viral disease that causes inflammation of the liver that can lead to serious liver problems if left untreated. Hepatitis C medicines reduce the amount of HCV in the body by preventing it from multiplying and eventually curing a patient of HCV,” Birnkrant explained in an agency news release.

Health care providers should continue to prescribe Mavyret, Zepatier or Vosevi as indicated, but should not give these medicines to patients with signs and symptoms of worsening liver function, the agency advised.

Dr. David Bernstein, chief of hepatology at Northwell Health in Manhasset, N.Y., noted that these medications “are safe and effective when properly prescribed.”

Bernstein said that “most hepatitis C patients do not have impaired liver function, so these therapies should be safe.”

And he added that other hepatitis drugs such as Harvoni and Epclusa are safe for patients with impaired liver function because they do not contain the agent that can threaten liver function.

Patients should not stop taking these medicines without first talking to a health care professional, and those with liver disease should talk with a health care professional about the benefits and risks of the medicines, the FDA said.

In many of the 63 cases, liver failure occurred in patients who should not have been prescribed these medicines, according to the FDA news release.

In some cases, patients had no cirrhosis (liver scarring) or cirrhosis with mild liver impairment, but did have indications of advanced liver disease or risk factors for liver impairment. In most of the patients, symptoms improved after they stopped taking the potent medicines.

WebMD News from HealthDay

Sources

SOURCES: David Bernstein, M.D., chief, hepatology, Northwell Health, Manhasset, N.Y.; U.S. Food and Drug Administration, news release, Aug. 28, 2019

Copyright © 2013-2018 HealthDay. All rights reserved.

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WebMD Health

What Are Nootropics or “Smart Drugs” or Cognitive Enhancers?

SOURCES:

BMJ: “The Billion Dollar Business of Being Smart.”

Chris D’Adamo, PhD, director of research and education, Center for Integrative Medicine, University of Maryland School of Medicine.

Cochrane Database of Systemic Reviews: “Cytidinediphosphocholine (CDP?choline) for Cognitive and Behavioural Disturbances Associated With Chronic Cerebral Disorders in the Elderly,” “Huperzine A for Mild Cognitive Impairment,” “Vinpocetine for Cognitive Impairment and Dementia.”

European Neuropsychopharmacology: Modafinil for Cognitive Neuroenhancement in Healthy Non-Sleep-Deprived Subjects: A Systematic Review.”

Evidence-Based Complimentary and Alternative Medicine: “Establishing Natural Nootropics: Recent Molecular Enhancement Influenced by Natural Nootropic.”

Experimental Gerontology: “Effects of Creatine Supplementation on Cognitive Function of Healthy Individuals: A Systematic Review of Randomized Controlled Trials.”

Barry Gordon, MD, PhD, director, Cognitive Neurology/Neuropsychology Division, Johns Hopkins Medicine.

Harvard Business Review: “Like It or Not, Smart Drugs Are Coming to the Office.”

Journal of Ethnopharmacology: “Meta-Analysis of Randomized Controlled Trials on Cognitive Effects of Bacopa Monnieri Extract.”

National Center for Health Research: ” ‘Study Drug’ Abuse by College Students: What You Need to Know.”

Nutritional Neuroscience: “The Combined Effects of L-theanine and Caffeine on Cognitive Performance and Mood.”

FDA: “Spilling the Beans: How Much Caffeine is Too Much?” “Pure and Highly Concentrated Caffeine.”

WebMD Health

New Cholesterol Drugs’ Cost Put Patients at Risk

By Dennis Thompson
HealthDay Reporter

TUESDAY, July 23, 2019 (HealthDay News) — Heart attacks, strokes and other heart problems are more likely in high-risk patients denied access to cutting-edge cholesterol-busting drugs called PCSK9 inhibitors, a new study reports.

Patients are 16% more likely to have a heart-related health crisis if their PCSK9 prescription is rejected than if it is covered and filled for a year, according to researchers.

Patients who have a prescription but don’t fill it — probably because they can’t afford the copay — have a 21% greater risk of a heart-related emergency, the researchers added.

“We should be a little up in arms that we have the tools to help people, and we aren’t helping them,” said study co-author Katherine Wilemon, founder and CEO of the FH Foundation, a research and advocacy group for patients with familial hypercholesterolemia, high cholesterol related to their genetics.

PCSK9 inhibitors entered the U.S. market in 2015, but remain costly compared with first-line statin therapy, researchers said. The new drugs work by boosting the liver’s ability to remove excess cholesterol from the bloodstream.

The drugs cost about $ 14,000 a year during the time covered by this study, 2015 to 2017, researchers said. Manufacturers last year announced price cuts to the two leading PCSK9 inhibitors — Praluent (alirocumab) and Repatha (evolocumab) — but the cost is still $ 4,500 to $ 8,000 a year.

For this study, researchers reviewed medical records and pharmacy claims of about 139,000 high-risk adults after PCSK9 inhibitors became available in 2015. On average, patients were tracked for about a year after their prescription date.

Patients were considered at high risk if they had familial hypercholesterolemia or had suffered heart problems related to clogged arteries.

“This group was at extremely high risk in total,” said lead researcher Kelly Myers, chief technology officer for the FH Foundation. “The annual rate of cardiovascular events in this group was about 3.5%. The annual rate for the entire adult U.S. population is less than half a percent.”

The researchers specifically looked at access to the new cholesterol drugs, and whether it influenced patients’ risk for heart-related health events such as heart attacks, unstable angina, angioplasty, coronary bypass surgery, cardiac arrest, and heart disease or stroke caused by congested arteries.

Continued

Insurance companies rejected about two-thirds of PCSK9 prescriptions among high-risk patients, researchers found.

Even after the 2018 price cuts, rejection rates have remained high, Myers said.

“We haven’t seen a lot of evidence in the data that there’s been a compelling change yet,” he said. “There’s general improvement, but over 50% of individuals in a lot of plans are still being rejected therapy.”

In addition, about 15% of people with an approved prescription didn’t have it filled, probably because they couldn’t afford it, Myers added.

Two-thirds of patients who didn’t fill their PCSK9 inhibitor prescription are on Medicare, which doesn’t allow for copay assistance, Myers said. Their average copay for the drugs is $ 200 a month, compared to $ 100 month for people with private prescription insurance.

“They’re probably abandoning their therapy because of extremely high copay costs,” Myers said.

Lack of access to these drugs had an immediate impact on their risk of heart attack, stroke and other heart problems, researchers found.

“People whose cholesterol-lowering drug prescriptions are rejected or abandoned are more likely to have heart events than those whose prescriptions are covered,” said Dr. Donald Lloyd-Jones, chairman of preventive medicine at Northwestern University Feinberg School of Medicine in Chicago and a American Heart Association (AHA) spokesman.

The researchers also found that a prescription was more likely to be rejected if a patient is female, black or Hispanic.

“The study clearly shows how disparities in access to PCSK9 inhibitor prescriptions affect cardiovascular outcomes and the need to improve health equity,” Lloyd-Jones added. “So as we continue to make inroads to prevent and treat heart disease — the world’s leading killer — we must capitalize on data from this study and others that quantify ways we can make a difference.”

The AHA changed its cholesterol guidelines in 2018 to promote the use of PCSK9 inhibitors among high-risk people who are already taking the largest dose of statins they can tolerate.

The findings were published July 23 in the journal Circulation: Cardiovascular Quality and Outcomes.

WebMD News from HealthDay

Sources

SOURCES: Katherine Wilemon, founder and CEO, FH Foundation, Pasadena, Calif.; Kelly Myers, chief technology officer, FH Foundation; Donald Lloyd-Jones, M.D., Sc.M., senior associate dean, clinical and translational research, and chairman, Department of Preventive Medicine, Northwestern University, Feinberg School of Medicine, Chicago, and spokesman, American Heart Association;Circulation: Cardiovascular Quality and Outcomes, July 23, 2019

Copyright © 2013-2018 HealthDay. All rights reserved.

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Higher Cost of New Cholesterol Drugs Putting Patients at Risk: Study

TUESDAY, July 23, 2019 — Heart attacks, strokes and other heart problems are more likely in high-risk patients denied access to cutting-edge cholesterol-busting drugs called PCSK9 inhibitors, a new study reports.

Patients are 16% more likely to have a heart-related health crisis if their PCSK9 prescription is rejected than if it is covered and filled for a year, according to researchers.

Patients who have a prescription but don’t fill it — probably because they can’t afford the copay — have a 21% greater risk of a heart-related emergency, the researchers added.

“We should be a little up in arms that we have the tools to help people, and we aren’t helping them,” said study co-author Katherine Wilemon, founder and CEO of the FH Foundation, a research and advocacy group for patients with familial hypercholesterolemia, high cholesterol related to their genetics.

PCSK9 inhibitors entered the U.S. market in 2015, but remain costly compared with first-line statin therapy, researchers said. The new drugs work by boosting the liver’s ability to remove excess cholesterol from the bloodstream.

The drugs cost about $ 14,000 a year during the time covered by this study, 2015 to 2017, researchers said. Manufacturers last year announced price cuts to the two leading PCSK9 inhibitors — Praluent (alirocumab) and Repatha (evolocumab) — but the cost is still $ 4,500 to $ 8,000 a year.

For this study, researchers reviewed medical records and pharmacy claims of about 139,000 high-risk adults after PCSK9 inhibitors became available in 2015. On average, patients were tracked for about a year after their prescription date.

Patients were considered at high risk if they had familial hypercholesterolemia or had suffered heart problems related to clogged arteries.

“This group was at extremely high risk in total,” said lead researcher Kelly Myers, chief technology officer for the FH Foundation. “The annual rate of cardiovascular events in this group was about 3.5%. The annual rate for the entire adult U.S. population is less than half a percent.”

The researchers specifically looked at access to the new cholesterol drugs, and whether it influenced patients’ risk for heart-related health events such as heart attacks, unstable angina, angioplasty, coronary bypass surgery, cardiac arrest, and heart disease or stroke caused by congested arteries.

Insurance companies rejected about two-thirds of PCSK9 prescriptions among high-risk patients, researchers found.

Even after the 2018 price cuts, rejection rates have remained high, Myers said.

“We haven’t seen a lot of evidence in the data that there’s been a compelling change yet,” he said. “There’s general improvement, but over 50% of individuals in a lot of plans are still being rejected therapy.”

In addition, about 15% of people with an approved prescription didn’t have it filled, probably because they couldn’t afford it, Myers added.

Two-thirds of patients who didn’t fill their PCSK9 inhibitor prescription are on Medicare, which doesn’t allow for copay assistance, Myers said. Their average copay for the drugs is $ 200 a month, compared to $ 100 month for people with private prescription insurance.

“They’re probably abandoning their therapy because of extremely high copay costs,” Myers said.

Lack of access to these drugs had an immediate impact on their risk of heart attack, stroke and other heart problems, researchers found.

“People whose cholesterol-lowering drug prescriptions are rejected or abandoned are more likely to have heart events than those whose prescriptions are covered,” said Dr. Donald Lloyd-Jones, chairman of preventive medicine at Northwestern University Feinberg School of Medicine in Chicago and a American Heart Association (AHA) spokesman.

The researchers also found that a prescription was more likely to be rejected if a patient is female, black or Hispanic.

“The study clearly shows how disparities in access to PCSK9 inhibitor prescriptions affect cardiovascular outcomes and the need to improve health equity,” Lloyd-Jones added. “So as we continue to make inroads to prevent and treat heart disease — the world’s leading killer — we must capitalize on data from this study and others that quantify ways we can make a difference.”

The AHA changed its cholesterol guidelines in 2018 to promote the use of PCSK9 inhibitors among high-risk people who are already taking the largest dose of statins they can tolerate.

The findings were published July 23 in the journal Circulation: Cardiovascular Quality and Outcomes.

More information

The FH Foundation has more about insurance coverage for cholesterol drugs.

© 2019 HealthDay. All rights reserved.

Posted: July 2019

Drugs.com – Daily MedNews

Heartburn Drugs Again Tied to Fatal Risks

THURSDAY, June 6, 2019 — People who use common heartburn drugs for months to years may face heightened risks of dying from heart disease, kidney failure or stomach cancer, a new study suggests.

The study included more than 200,000 U.S. veterans. It’s the latest to raise concerns over drugs called proton pump inhibitors (PPIs). They include prescription and over-the-counter drugs like Prilosec (omeprazole), Prevacid (lansoprazole) and Nexium (esomeprazole). And they rank among the top-selling medications in the United States.

Research in recent years has linked prolonged PPI use to increased risks of various diseases and premature death.

These latest findings point to the specific causes of death tied to the drugs, said lead researcher Dr. Ziyad Al-Aly.

He stressed that the excess risks were relatively small. For example, over 10 years, 13% of PPI users died of a cardiovascular condition, including heart disease or stroke. That compared with just over 11% of people who used H2 blockers, another class of heartburn drug.

When the researchers weighed other factors — such as patients’ age and chronic health conditions — PPI use was tied to a roughly 18% higher risk of cardiovascular death.

However, based on patients’ medical records, many of those with PPI prescriptions had no documented need for one.

“That’s unsettling,” said Al-Aly, an assistant professor at Washington University School of Medicine in St. Louis.

“It suggests a lot of people were using a PPI without actually needing one,” he said. “They could be taking a risk without deriving any benefit.”

But an expert not involved in the study said it’s unclear whether PPIs, themselves, are responsible for the higher death rates.

Dr. Lawrence Kim is a member of the American Gastroenterological Association’s governing board. He said the current study, like others before it, is “observational” — that is, it used medical records to track patients’ outcomes.

Those types of studies cannot prove cause and effect, Kim said. There may be other explanations for the higher risks seen among PPI users.

In 2017, Kim said, the gastroenterological association published a review of the research into the issue.

“The report concluded that the evidence supporting all of these risks was low- to very-low quality,” he said. “Therefore, there’s insufficient evidence to conclude that these adverse outcomes are likely to be an effect of the PPI therapy.”

PPIs work by blocking the enzyme system that creates stomach acid. They are commonly prescribed for gastroesophageal reflux disease (GERD), where stomach acid chronically escapes into the esophagus (the tube connecting the mouth and stomach).

Many people with GERD can take a PPI for just a short time, Al-Aly said. That allows damaged tissue in the esophagus to heal. Then patients can switch to a different treatment, like an H2 blocker. Those medications include drugs such as Tagamet (cimetidine), Pepcid (famotidine) and Zantac (ranitidine).

“Most people don’t need to be on a PPI for months or years,” Al-Aly said.

In this study, the risks linked to PPIs rose with prolonged use. The odds of death over 10 years were 63% to 71% higher among patients who’d used the drugs for at least a year, versus those who’d used them for a few months.

However, some GERD patients do need long-term PPI treatment, Al-Aly and Kim said. That includes people with recurrent stomach ulcers or Barrett’s esophagus — serious damage to the esophageal lining that can raise the risk of cancer.

Before you start a PPI, Al-Aly said, be sure you actually need one. The drugs are available over the counter, but they should not be used for more than a couple weeks without talking to a doctor, he said.

If you’ve used a PPI for a long time, Kim said, talk to your doctor about whether you need to continue.

According to the study, more than 15 million Americans have PPI prescriptions. And millions more buy them over the counter without a doctor’s knowledge.

The findings were published recently in the journal BMJ. The veterans in the study — mostly older men — started on a PPI or H2 blocker between 2002 and 2004.

Over the next 10 years, 38% of PPI users died, as did nearly 36% of those on H2 blockers.

If PPIs contribute to deaths, it’s unclear why. According to Al-Aly, lab research has hinted the drugs may cause dysfunction in the lining of the blood vessels, or disrupt the gut’s immune function and normal bacterial makeup.

More information

The U.S. National Institute on Diabetes and Digestive and Kidney Diseases has more on treating GERD.

© 2019 HealthDay. All rights reserved.

Posted: June 2019

Drugs.com – Daily MedNews

Could 2 Prostate Cancer Drugs Fight Disease in Earlier Stages?

SUNDAY, June 2, 2019 — Cutting-edge prostate cancer drugs that help extend life in the toughest cases might also be useful in fighting less aggressive tumors, two new clinical trials suggest.

Two drugs that interfere with cancer’s ability to use testosterone for fuel, apalutamide (Erleada) and enzalutamide (Xtandi), are already approved for use against more advanced prostate tumors that don’t respond to regular therapy.

But these trials show that the drugs also can improve survival and slow progression in prostate cancers that do respond to regular therapy, which typically involves medication that halts production of testosterone.

Both clinical trials involved patients with prostate cancer that had spread to other parts of their body but who still responded to androgen-deprivation therapy.

“We’re slowly starting to see a migration of drugs traditionally saved for advanced stages of disease, where we’re incorporating them into earlier stages of disease,” said Dr. Bobby Liaw, medical director of the Blavatnik Family Chelsea Medical Center at Mount Sinai, in New York City. He was not involved in the trials.

Apalutamide combined with androgen-deprivation therapy caused a 33% reduction in overall risk of death, compared against patients who received a placebo alongside their androgen-deprivation therapy, said the lead researcher of that clinical trial, Dr. Kim Chi.

Apalutamide also delayed progression of the cancer by 52%, and the length of time before patients required chemotherapy by 61%, said Chi, medical director of the Clinical Trials Unit at the BC Cancer Agency-Vancouver Prostate Center in Canada.

Adding the hormone blocker significantly improved patients’ outcomes with few side effects, Chi said.

“It’s well-tolerated, both from a side-effect profile and from a quality-of-life perspective,” Chi said, noting that side effects differ little from a placebo.

The second trial involved adding enzalutamide to androgen-deprivation therapy, and again positive results were found.

About 80% of men treated with enzalutamide were alive after three years, compared with 72% of men who received standard treatment, the researchers said.

Study co-chair Ian Davis is a professor at Monash University in Australia. “The actual result in patients starting hormonal therapy — noting patients had a 60% improvement in the time it takes to detect the cancer growing again along with a 33% increase chance of survival — was far higher than we expected,” he said in a news release.

In that trial, 1,125 men were randomly assigned to receive either enzalutamide or placebo, the study authors said.

The next step for researchers will be head-to-head comparisons that will help doctors decide which drugs would work best for specific patients, Liaw said.

“We don’t yet have any data to compare these drugs side-to-side. That’s where we’re going to start to see a bit of debate over which one is arguably the best drug to start with first,” Liaw said. “We’ve never had a lot of satisfying data to help us figure out what is the proper sequence, is there an optimal sequence, should we be combining certain drugs to get a better effect?”

Cost will also be an issue in using these new drugs to fight prostate cancer. “These are really expensive drugs,” Liaw said. “These are drugs that cost thousands for a month’s supply.”

Regardless, it is good for doctors to have more drugs on hand to help patients battle prostate cancer, he concluded.

“We’re certainly hoping to have their disease controlled, not just now but for the long haul, and that’s what these drugs are showing they have the capability of doing,” Liaw said.

Both trials were to be presented at the American Society for Clinical Oncology’s annual meeting, in Chicago, this weekend, and they will also be published in the New England Journal of Medicine.

More information

The American Cancer Society has more about treating prostate cancer.

© 2019 HealthDay. All rights reserved.

Posted: June 2019

Drugs.com – Daily MedNews

UK prison guards smell a rat and find rodents stuffed with drugs

Items found inside dead rats at HMP Guys Marsh in Dorset, Britain, are seen in this picture handout obtained March 25, 2019. Ministry of Justice via REUTERS

LONDON (Reuters) – Suspected organized criminals have been stuffing the bodies of dead rats with drugs, phones and cash and throwing them over the walls of a British prison to get contraband to inmates, the government said on Monday.

Guards at Guys Marsh prison in Dorset, southwest England, grew suspicious when they found the bodies of three rats with long stitches along their stomachs, officials said.

They discovered the animals had been disemboweled and filled with five mobile phones and chargers, three SIM cards, cigarette papers and a large amount of drugs including cannabis and a synthetic substitute as well as tobacco, they added.

“This find shows the extraordinary lengths to which criminals will go to smuggle drugs into prison, and underlines why our work to improve security is so important,” Britain’s prisons minister, Rory Stewart, said.

The government did not say when the rats were found.

Seizures of drugs, mobile phones and SIM cards rose by 23, 15 and 13 percent in the 12 months to March 2018 when just over 20 percent of tests of inmates were positive for drugs, including new psychoactive substances.

Criminals have in the past tried to use tennis balls, pigeons and drones to bring contraband into prisons.

Reporting by Rachel Cordery; Editing by Andrew Heavens

Reuters: Oddly Enough

Are ‘Inactive’ Ingredients in Your Drugs Really So Harmless?

WEDNESDAY, March 13, 2019 — More than 90 percent of the medications that Americans take contain an inactive ingredient that could cause an allergic reaction, a new study suggests.

Lactose, peanut oil, gluten and chemical dyes are added to drugs to improve taste, prolong shelf life, improve absorption or make the drug tamper-proof, researchers explained. But they can also spell trouble for patients who are allergic to those ingredients.

“About 75 percent of most pills are taken up by inactive ingredients, only 25 percent is taken up by the drug,” said lead author Dr. C. Giovanni Traverso, a gastroenterologist at Brigham and Women’s Hospital in Boston.

On average, each pill or capsule has more than eight different inactive ingredients and sometimes as many as 38, he added. Reports of patients who have had severe allergic reactions to an inactive ingredient are not uncommon.

Traverso said that when doctors prescribe a drug, they are prescribing the active ingredient only. Inactive ingredients aren’t expected to have an effect.

Doctors and patients need to be aware of the inactive ingredients in drugs, Traverso said. The full list of ingredients is often found in the brochure that goes along with the drug and can also be found in databases of the U.S. National Library of Medicine, he said.

Doctors should always ask patients about allergies not only to medications, but to the inactive ingredients they contain, Traverso added.

Moreover, doctors need to be aware of the inactive ingredients in the medications they prescribe. “There is more to a pill than just the drug,” Traverso said.

For the study, Traverso and his colleagues looked at the inactive ingredients in more than 42,000 medications. These pills and capsules contained nearly 360,000 inactive ingredients.

Analysts found 38 inactive ingredients that can cause allergic reactions after they’ve been ingested. Moreover, nearly 93 percent of the drugs the researchers studied had at least one of these ingredients.

Traverso’s team found that about 45 percent of drugs contained lactose; 33 percent contained food dye; and slightly less that 1 percent contained peanut oil.

Often, formulations of drugs that don’t contain these ingredients are available. But some medications, including progesterone, which contains peanut oil, have few alternatives.

Inactive ingredients can cause allergic reactions like hives, difficulty breathing or gastrointestinal symptoms, Traverso said.

It is not clear how much of an ingredient triggers a reaction. The amount of the ingredient — like lactose, for example — may be too low to cause a reaction in patients, except those who are severely lactose-intolerant or people taking a number of drugs that contain lactose, the researchers said.

The findings were published online March 13 in the journal Science Translational Medicine.

“We better be more careful, especially in a time of growing allergies,” said Dr. Marc Siegel, a professor of medicine at NYU Langone Medical Center in New York City.

Siegel, who wasn’t involved with the study, noted that as lactose intolerance becomes more common, and since so many drugs contain lactose, it could turn into an even bigger problem.

Also, people who say they are allergic to a drug may really be allergic to one of the ingredients, he added.

“What you thought was an allergy to your blood pressure pill was actually an allergy to lactose,” Siegel said. “We may be saying people are allergic to things [to which] they are actually not.”

More information

Visit the American Academy of Allergy, Asthma and Immunology for more on allergies.

© 2019 HealthDay. All rights reserved.

Posted: March 2019

Drugs.com – Daily MedNews

Eight Cannabis Strains Named After Other Drugs

The strain name game is a fun, complicated mess of cannabis genetics, nomenclature and overzealous salespeople. You can find strains named after celebrities, candy, presidents, mountain ranges and everything in between.

Since they’re dealing with a psychoactive substance, it’s not surprising that strain breeders and pot dealers have named a few strains after other drugs that give off similar effects — luckily for tokers, not that similar. From Acid to Opium, here are eight strains named after drugs of much more serious consequence.

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Opium
Given its calming and sedating qualities, Opium’s name is well-deserved. The high is soothing for the body and mind, relieving stress, pressures and pain — or making you forget about them, at the very least. Although heavily used for medical purposes, Opium is also great for a night in, as its relaxing and visual effects keep the senses stimulated for a good amount of time before you slip into the inevitable doze.

Herijuana
Shouldn’t be hard to figure out what inspired this strain’s name. Bred from an Afghani cut from Northern California, Petrolia Headstash, and a mystery hybrid from Kentucky, this heavy indica is known for its pain-relief and sleep-inducing qualities, as well as an old-school flavor profile comprising notes of wood, hash, fruit, zest and soil. If you can’t find Herijuana, look for its citrus daughter, Orange Herijuana. 

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Blue Magic
Jay Z fans or anyone who’s seen American Gangster will get the reference, but for those who don’t: Blue magic was the name of the infamous heroin sold by New York drug trafficker Frank Lucas. The cannabis strain bearing its name is believed to be a phenotype of Blue Dream, carrying a quick burst of euphoric energy before bringing users down and relaxing their bodies.

Novacaine
Named after Novocaine, the painkiller made popular at the dentist office, this cross of Sensi Star, San Fernando Valley OG Kush and Jacks Cleaner 2 is a sativa-dominant strain known for a piney, earthy taste. We’ve seen it at Good Chemistry and around town in concentrate form by Green Dot Labs.

Does this look like LSD?

Does this look like LSD?

Herbert Fuego

LSD
The name speaks for itself: LSD produces one helluva body high, melting away aches and stress — or just making users forget about them. An intense cerebral uplift can leave users spacey, with a tendency to zone in on whatever is directly in front of them. The head high will transform into a body melt within an hour or so, though, so get your pajamas on ASAP.

Acid
This phenotype of New York City Diesel is a take on the legendary sativa from Dutch breeder Paradise Seeds. The mental euphoria can be intense and uplifting, nearing the point of “narcotic sensations,” according to Acid’s breeder. Those strong effects and the strain’s metallic, gassy flavor led to the strain’s name.

White Girl
No, not Christina Aguilera, but rather a hybrid of Berry White and Girl Scout Cookies — two strains known for thick coats of resin glands and stiff THC percentages. If you have the tolerance to handle this more-than-basic bitch, it can be a pretty even high, taking you to space before slowly dragging you down into lethargy.

DMT
An in-house creation from Green Dot Labs, this strain is named after dimethyltryptamine, or DMT, an intense psychedelic drug found at music festivals and in wook pipes across the country. With Sour Bubble genetics, expect GBL’s extracts to carry an indica heavy on the visuals, with fruity, Diesel flavors.


Toke of the Town

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