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Common Painkillers Tied to Kidney Risks for Children: Study

Children taking the common painkillers known as nonsteroidal anti-inflammatory drugs may be at risk for acute kidney damage, particularly when the kids are dehydrated, a new study finds.

Nonsteroidal anti-inflammatory drugs (commonly called NSAIDs), such as ibuprofen (brand names Advil and Motrin), naproxen (Aleve) and ketorolac (Toradol) are used to relieve pain and fever.

“The one thing we did see that seemed to be connected to kidney damage was dehydration,” said lead researcher Dr. Jason Misurac, a nephrologist at Indiana University School of Medicine in Indianapolis.

For the study, which was published in the Jan. 25 online edition of the Journal of Pediatrics, Misurac’s team looked at the medical records of children admitted to Riley Hospital for Children in Indianapolis from 1999 through mid-2010. Over that time, they identified more than 1,000 cases of children being treated for kidney damage.

In nearly 3 percent of the cases, the damage was related to NSAIDs, the study found. Most kids were teens, but four were under 5 years old. All of them had been given NSAIDs before being hospitalized. Since many other cases involved several causes of kidney damage, it is possible some of those also were related to NSAIDs, the researchers said.

Most children who developed kidney damage had been given the recommended dose and had not been taking NSAIDs for more than a week.

In adults, taking NSAIDs regularly for several years has been tied to kidney problems, according to the U.S. National Institute of Diabetes and Digestive and Kidney Diseases. Cases involving children have previously been reported but only rarely.

Misurac noted that most of the children in the study hadn’t been drinking well and also were vomiting and had diarrhea, all of which can lead to dehydration. When someone is dehydrated the kidneys have a way of protecting themselves, which NSAIDs block, resulting in the damage, Misurac explained.

“Certainly in the way NSAIDs affect the kidneys, it’s reasonable to think that dehydration plus an NSAID has more of an effect than just an NSAID by itself,” he said.

Often the signs of kidney problems aren’t apparent, Misurac said. One sign is a decrease in urine; another is stomach pain. “But most kids who have episodes of acute kidney injury have nonspecific symptoms and there’s no one way to tell,” he said.

“If kids are dehydrated and not drinking well, then parents should think twice about using NSAIDs,” Misurac said. Tylenol (acetaminophen), which acts differently than NSAIDs, might be a better choice for children, he said.

For many of the children in the study, the kidney damage was reversed, Misurac said. The damage, however, was permanent for seven patients and they will probably need ongoing monitoring and treatment for declining kidney function, he said.

All the children under age 5 had to undergo dialysis and were more likely to be treated in an intensive-care unit, the researchers said. They also stayed in the hospital longer.

Although the study showed an association between taking NSAIDs and kidney problems in children, it didn’t establish a cause-and-effect relationship.

One expert agreed that NSAIDs can damage the kidneys.

“This is well known. Unfortunately, it is better known among doctors; the public is not as educated regarding this problem,” said Dr. Felix Ramirez-Seijas, director of pediatric nephrology at Miami Children’s Hospital.

Ramirez-Seijas said NSAIDs are “overused and abused, both by doctors and patients.”

For children, most fevers should not be treated; fever is how the body fights infection, he said. “There is a fear of fever that leads to overtreatment,” Ramirez-Seijas said.

In addition, children who take NSAIDs for aches after vigorous exercise also are at risk, because they may be dehydrated, Ramirez-Seijas said.

His advice to parents is to be sure children are well hydrated if they are going take NSAIDs. In addition, he believes that even these over-the-counter drugs should only be used with the advice of a doctor.

“Most people see taking a couple of Advil like taking a sip of water, but it’s not,” Ramirez-Seijas said.

By Steven Reinberg     HealthDay    Jan. 25
 

 

nsaids

 

Nonsteroidal Anti-inflammatory Drugs (NSAIDs)

What are NSAIDs and how do they work?

Prostaglandins are a family of chemicals that are produced by the cells of the body and have several important functions. They promote inflammation that is necessary for healing, but also results in pain, and fever; support the blood clotting function of platelets; and protect the lining of the stomach from the damaging effects of acid.

Prostaglandins are produced within the body’s cells by the enzyme cyclooxygenase (COX). There are two COX enzymes, COX-1 and COX-2. Both enzymes produce prostaglandins that promote inflammation, pain, and fever. However, only COX-1 produces prostaglandins that support platelets and protect the stomach. Nonsteroidal anti-inflammatory drugs (NSAIDs) block the COX enzymes and reduce prostaglandins throughout the body. As a consequence, ongoing inflammation, pain, and fever are reduced. Since the prostaglandins that protect the stomach and support platelets and blood clotting also are reduced, NSAIDs can cause ulcers in the stomach and promote bleeding.

What NSAIDs are approved in the United States?

The following list is an example of NSAIDs available:

  • aspirin
  • celecoxib (Celebrex)
  • diclofenac (Cambia, Cataflam, Voltaren-XR, Zipsor, Zorvolex)
  • diflunisal (Dolobid – discontinued brand)
  • etodolac (Lodine – discontinued brand)
  • ibuprofen (Motrin, Advil)
  • indomethacin (Indocin)
  • ketoprofen (Active-Ketoprofen [Orudis – discontinued brand])
  • ketorolac (Toradol – discontinued brand)
  • nabumetone (Relafen – discontinued brand)
  • naproxen (Aleve, Anaprox, Naprelan, Naprosyn)
  • oxaprozin (Daypro)
  • piroxicam (Feldene)
  • salsalate (Disalsate [Amigesic – discontinued brand])
  • sulindac (Clinoril – discontinued brand)
  • tolmetin (Tolectin – discontinued brand)

What are the side effects of NSAIDs?

NSAIDs are associated with several side effects. The frequency of side effects varies among NSAIDs.

Common side effects are

  • nausea,
  • vomiting,
  • diarrhea,
  • constipation,
  • decreased appetite,
  • rash,
  • dizziness,
  • headache, and
  • drowsiness.

Other important side effects are:

  • kidney failure (primarily with chronic use),
  • liver failure,
  • ulcers, and
  • prolonged bleeding after injury or surgery.

NSAIDs can cause fluid retention which can lead to edema, which is most commonly manifested by swelling of the ankles.

WARNING: Some individuals are allergic to NSAIDs and may develop shortness of breath when an NSAID is taken. People with asthma are at a higher risk for experiencing serious allergic reaction to NSAIDs. Individuals with a serious allergy to one NSAID are likely to experience a similar reaction to a different NSAID.

Use of aspirin in children and teenagers with chickenpox or influenza has been associated with the development of Reye’s syndrome, a serious and sometimes fatal liver disease. Therefore, aspirin and non-aspirin salicylates (for example, salsalate [Amigesic]) should not be used in children and teenagers with suspected or confirmed chickenpox or influenza.

NSAIDs increase the risk of potentially fatal, stomach and intestinal adverse reactions (for example, bleeding, ulcers, and perforation of the stomach or intestines). These events can occur at any time during treatment and without warning symptoms. Elderly patients are at greater risk for these adverse events. NSAIDs (except low dose aspirin) may increase the risk of potentially fatal heart attacks, stroke, and related conditions. This risk may increase with duration of use and in patients who have underlying risk factors for heart and blood vessel disease. Therefore, NSAIDs should not be used for the treatment of pain resulting from coronary artery bypass graft (CABG) surgery.

For what conditions are NSAIDs used?

NSAIDs are used primarily to treat inflammation, mild to moderate pain, and fever.

Specific uses include the treatment of:

  • headaches,
  • arthritis,
  • ankylosing spondylitis,
  • sports injuries, and
  • menstrual cramps.
  • Ketorolac (Toradol) is only used for short-term treatment of moderately severe acute pain that otherwise would be treated with narcotics.

Aspirin (also an NSAID) is used to inhibit the clotting of blood and prevent strokes and heart attacks in individuals at high risk for strokes and heart attacks.

NSAIDs also are included in many cold and allergy preparations.

Celecoxib (Celebrex) is used for treating familial adenomatous polyposis (FAP) to prevent the formation and growth of colon polyps.

With which drugs do NSAIDs interact?

NSAIDs reduce blood flow to the kidneys and therefore reduce the action of diuretics (“water pills”) and decrease the elimination of lithium (Eskalith, Lithobid) and methotrexate (Rheumatrex, Trexall). As a result, the blood levels of these drugs may increase as may their side effects.

NSAIDs also decrease the ability of the blood to clot and therefore increase bleeding. When used with other drugs that also increase bleeding (for example, warfarin [Coumadin]), there is an increased likelihood of serious bleeding or complications of bleeding. Therefore, individuals who are taking drugs that reduce the ability of blood to clot should avoid prolonged use of NSAIDs.

NSAIDs also may increase blood pressure in patients with hypertension (high blood pressure) and therefore antagonize the action of drugs that are used to treat hypertension.

NSAIDs increase the negative effect of cyclosporine on kidney function.

Persons who have more than three alcoholic beverages per day may be at increased risk of developing stomach ulcers when taking NSAIDs.

 

Medical and Pharmacy Editor: Jay W. Marks, MD  
Pharmacy Author: Omudhome Ogbru, PharmD 
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Common Painkillers Linked To Increased Risk Of Heart Attack, Study Says

Story highlights
A new study links common painkillers called to increased risk of heart attacks
Researchers urge doctors and patients to weight the risks and benefits
The drugs are not proved to be a a direct cause of heart attacks

(CNN)Taking even over-the-counter doses of common painkillers known as NSAIDs – nonsteroidal anti-inflammatory drugs – has been linked to an increased risk of heart attack in a new study.

The likelihood of experiencing a heart attack was calculated to increase by an average of 20% to 50%, compared with someone not taking the drugs, regardless of the dosage and amount of time the medications are taken.

The findings are observational and based on an association, however, with the drugs not proved to be a a direct cause of heart attack.

This group of drugs includes ibuprofen, diclofenac, celecoxib and naproxen, which are available over the counter or by prescription for higher doses, to relieve pain or fever resulting from a range of causes, including flu, headaches, back pain and menstrual cramps. Their range of uses also means they are often taken as needed, for short periods of time.

The level of risk increased as early as one week into the use of any drug in this category and at any dose, and the risk associated with taking higher doses was greatest within the first month.
“We found that all common NSAIDs shared a heightened risk of heart attack,” said Dr. Michèle Bally, an epidemiologist at the University of Montreal Hospital Research Center, who led the research. “There is a perception that naproxen has the lowest cardiovascular risk (among the NSAIDs), but that’s not true.”

Researchers’ overall finding was that taking any dosage of these drugs for one week, one month or longer was linked to an increased risk of a heart attack. The risk appeared to decline when these painkillers were no longer taken, with a slight decline one to 30 days after use and a greater decline, falling below 11%, between 30 days and one year after use.

Based on the paper, published Tuesday in the BMJ, Bally’s team suggests that doctors and patients weigh the potential harms and benefits before relying on the drugs as a treatment option.

“People minimize the risks because drugs are over the counter and they don’t read labels,” Bally said. “Why not consider all treatment options? … Every therapeutic decision is a balance of benefits and risk.”

Building on previous research

Cardiovascular diseases are the No. 1 cause of death globally, according to the World Health Organization, with 80% of all deaths in this category due to heart attacks and strokes. Each year, it’s estimated that 735,000 people in the United States have a heart attack. In the United Kingdom, more than 200,000 hospital visits each year are due to a heart attack.

Previous research has showed that this class of painkillers could increase the risk of having a heart attack, known as myocardial infarction. In 2015, the US Food and Drug Administration called on drugmakers to update their warnings labels to identify an increased risk of a heart attack or stroke.

But the specifics in terms of timing, dosage and treatment durations were less clear.

Bally and her team reviewed all available studies in this area from Canadian and European databases, analyzing the findings from 446,763 people, with 61,460 of them having had a heart attack. Their goal was to calculate the risk, determinants and time course of heart attacks associated with the use of NSAIDs under typical circumstances.

The team looked at very short-term use and at any dose, said Bally. “In real life, people use drugs at low doses and use them on and off,” she said, adding that this is not reflected in many clinical trials, for example, in which people have often been monitored during prolonged use of these drugs.

When using them for one week, the greatest risk was associated with rofecoxib, followed by diclofenac, ibuprofen and then celecoxib, respectively, though all except celecoxib had similar levels of risk, hovering around 50% increased odds of a heart attack, at any dose.

At higher doses, typically needing a prescription, some drugs had an even greater risk of heart attack between one week and one month of use. For example, naproxen showed a 75% increased likelihood of a heart attack within one month with doses of 1200 milligrams per day or more, and naproxen showed an 83% increased likelihood of a heart attack with doses greater than 750 milligrams per day when taken for one week to one month.

But the level of risk declined, on average, when the drugs were used for longer than one month.

“This is relative to not taking these drugs, your baseline risk,” Bally said. “The risk is not 75%. It’s an increase (maybe) from a tiny baseline risk that they have.”
Millions of these pills are sold every year, Bally said. “Therefore the risk, no matter how small or relative, is important to note from a population viewpoint.”
“We already know that these drugs increase your risk of having a heart attack,” said Dr. Mike Knapton, associate medical director at the British Heart Foundation, in a statement. “However this large-scale study worryingly highlights just how quickly you become at risk of having a heart attack after starting NSAIDs.” Knapton was not involved in the research.

Knapton further added that people must be made aware of the risk and that alternative medication or treatment should be considered where appropriate. For example, physical therapy or yoga could be used to alleviate pain from an injury.

nonsteroidal anti-inflammatory drugs
nonsteroidal anti-inflammatory drugs

Association, not causation

The researchers stress that the findings are purely observational, as they used readily available data about certain populations. Not all potentially influential factors could be taken into account, they say.

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, commented that a number of lifestyle factors, such as smoking and body mass index, are not available in the data about the study participants. “It leads to uncertainty,” he said.

Tobacco use, unhealthy diet, obesity, alcohol abuse and hypertension are just a few of many factors that can cause a heart attack.

“This is the largest study of its kind, but it is still observational data based on prescription or dispensing information, rather than whether people were actually taking their medication,” said Dr. Amitava Banerjee, senior clinical lecturer in clinical data science at UCL in the UK. “Although these data reflect real-world use of NSAIDs, it is impossible to control for all the factors which may lead to confounding or bias.”

This uncertainty combined with the overall observational nature of the findings means the cause of the increased risk shown in the analysis cannot be explained, nor can the drugs be directly stated as a cause of heart attacks.

Bally thinks a cause could be changes in blood pressure or effects on kidney function, as these areas are poorly studied. But she stresses that all five drugs studied have individual behaviors. “It will be hard to point to one factor,” she said.

Relative, not absolute risk

“The paper has good evidence that there is some risk of a heart attack for all NSAIDs and suggests that the risk starts immediately on starting them, but is only expressed in relative terms,” said Evans, who was not involved in the research. “There is no clear description of the absolute risk.”

The findings are based on the chances of a heart attack occurring in people taking these drugs, compared with those not taking them. If risk was already low in a person, a 20% to 50% increased risk is not that much cause for concern.

“The risks are relatively small, and for most people who are not at high risk of a heart attack, these findings have minimal implications,” Evans said.

It’s also possible that people taking these drugs are, on average, already at higher risk than people not taking the drugs, he said, commenting that the study did not account for these factors in their calculations. For example, the reason someone is prescribed an NSAID, such as for severe pain, may also be the reason they have a heart attack soon after. So while the study shows that risk of a heart attack increases as soon as a few days into taking NSAIDs, the links may not be as clear as suggested, Evans said.

“The most likely mechanisms for action of the drugs would be expected to show a low risk at the start and only have an effect on heart attacks after longer usage. That this wasn’t the case casts some doubt on the findings of an immediate increase in risk,” he said.
“All effective medicines have unwanted effects, and NSAIDs, although easily available, are not without some risks, but this study is no reason to induce anxiety in most users of these drugs,” he said.

But while waiting for more clarity on the true level of risk and its cause, experts still advise caution when prescribing or taking these painkillers.

“The increased risk of heart attack with NSAIDs, regardless of which one, means that both health professionals and the public should weigh up the harm and the benefit when prescribing these medications, especially for more than a day or two,” Banerjee said.
“Despite the over-the-counter availability of the traditional NSAIDs, this caution is still required. The mechanism of this increased risk of heart attack is not at all clear from existing studies.”

By Meera Senthilingam, CNN         May 9, 2017
 source: www.cnn.com