What is ibuprofen?
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.
Ibuprofen is used to reduce fever and treat pain or inflammation caused by many conditions such as headache, toothache, back pain, arthritis, menstrual cramps, or minor injury.
Ibuprofen is used in adults and children who are at least 6 months old.
Ibuprofen has a negative impact on the testicles of young men, a study published Monday in the journal Proceedings of the National Academy of Sciences found. When taking ibuprofen in doses commonly used by athletes, a small sample of young men developed a hormonal condition that typically begins, if at all, during middle age. This condition is linked to reduced fertility.
Advil and Motrin are two brand names for ibuprofen, an over-the-counter pain reliever. CNN has contacted Pfizer and Johnson & Johnson, the makers of both brands, for comment.
The Consumer Healthcare Products Association, a trade group that represents manufacturers of over-the-counter medications and supplements, “supports and encourages continued research and promotes ongoing consumer education to help ensure safe use of OTC medicines,” said Mike Tringale, a spokesman for the association. “The safety and efficacy of active ingredients in these products has been well documented and supported by decades of scientific study and real-world use.”
The new study is a continuation of research that began with pregnant women, explained Bernard Jégou, co-author and director of the Institute of Research in Environmental and Occupational Health in France.
Jégou and a team of French and Danish researchers had been exploring the health effects when a mother-to-be took any one of three mild pain relievers found in medicine chests around the globe: aspirin, acetaminophen (also known as paracetamol and sold under the brand name Tylenol) and ibuprofen.
Their early experiments, published in several papers, showed that when taken during pregnancy, all three of these mild medicines affected the testicles of male babies.
Testicles and testosterone
Testicles not only produce sperm, they secrete testosterone, the primary male sex hormone.
All three drugs then are “anti-androgenic,” meaning they disrupt male hormones, explained David M. Kristensen, study co-author and a senior scientist in the Department of Neurology at Copenhagen University Hospital.
The three drugs even increased the likelihood that male babies would be born with congenital malformations, Kristensen noted.
Tringale noted that pregnant and nursing women should always ask a health professional before using medicines.
Knowing this, “we wondered what would happen in the adult,” he said. They focused their investigation on ibuprofen, which had the strongest effects.
A non-steroidal anti-inflammatory drug, ibuprofen is often taken by athletes, including Olympians and professional soccer players for example, before an event to prevent pain, Jégou said. Are there health consequences for the athletes who routinely use this NSAID?
The research team recruited 31 male volunteers between the ages of 18 and 35. Of these, 14 were given a daily dosage of ibuprofen that many professional and amateur athletes take: 600 milligrams twice a day, explained Jégou. (This 1200-mg-per-day dose is the maximum limit as directed by the labels of generic ibuprofen products.) The remaining 17 volunteers were given a placebo.
For the men taking ibuprofen, within 14 days, their luteinizing hormones — which are secreted by the pituitary gland and stimulate the testicles to produce testosterone — became coordinated with the level of ibuprofen circulating in their blood. At the same time, the ratio of testosterone to luteinizing hormones decreased, a sign of dysfunctional testicles.
This hormonal imbalance produced compensated hypogonadism, a condition associated with impaired fertility, depression and increased risk for cardiovascular events, including heart failure and stroke.
For the small group of young study participants who used ibuprofen for only a short time, “it is sure that these effects are reversible,” Jégou said. However, it’s unknown whether the health effects of long-term ibuprofen use are reversible, he said.
After this randomized, controlled clinical trial, the research team experimented with “little bits of human testes” provided by organ donors and then conducted test tube experiments on the endocrine cells, called Leydig and Sertoli cells, which produce testosterone, explained Jégou.
The point was to articulate “in vivo, ex vivo and in vitro” — in the living body, outside the living body and in the test tube — that ibuprofen has a direct effect on the testicles and so testosterone.
“We wanted to understand what happened after exposure (to ibuprofen) going from the global human physiology over to the specific organ (the testis) down to the endocrine cells producing testosterone,” Kristensen said.
More than idle curiosity prompted such an extensive investigation.
Questions around male fertility
The World Health Organization estimates that one in every four couples of reproductive age in developing countries experiences childlessness despite five years of attempting pregnancy.
A separate study estimated that more than 45 million couples, or about 15% of all couples worldwide, were infertile in 2010, while another unrelated study suggested that men were solely responsible for up to 30% and contribute up to 50% of cases overall.
Meanwhile, a recent analysis published in the journal Human Reproduction Update found that sperm counts of men in North America, Europe, Australia and New Zealand are plunging. Researchers recorded a 52% decline in sperm concentration and a 59% decline in total sperm count over a nearly 40-year period ending in 2011.
Erma Z. Drobnis, an associate professional practice professor of reproductive medicine and fertility at the University of Missouri, Columbia, noted that most drugs are not evaluated for their effects on human male fertility before marketing. Drobnis, who was not involved in the new study, has done extensive research into sperm biology and fertility.
“There is evidence that some medications are particularly harmful to the male reproductive system, including testosterone, opioids, antidepressants, antipsychotics, immune modulators and even the over-the-counter antacid cimetidine (Tagamet),” she said. “However, prescribing providers rarely mention these adverse effects with patients when prescribing these medications.
She believes the new study, though small, is “important” because ibuprofen is among the most commonly used medications.
Though the new research indicates that ibuprofen disrupts the reproductive hormones in healthy young men, she thinks it’s possible there’s an even greater negative effect in men with low fertility. The other OTC drugs concerning for potential fathers are cimetidine and acetaminophen. She recommends that men who are planning to father a child avoid drugs for several months.
“Larger clinical trials are warranted,” she said. “This is timely work that should raise awareness of medication effects on men and potentially their offspring.”
Jégou agrees that more study is needed to answer many questions, including whether ibuprofen’s effects on male hormones are seen at low doses and whether long-term effects are reversible.
“But the alarm has been raised now,” he said. “if this serves to remind people that we are really dealing with medical drugs — not with things which are not dangerous — this would be a good thing.”
“We need to remember that it is a pharmaceutical compound that helps a lot of people worldwide,” Kristensen said. He noted, though, that of the three mild analgesics examined, ibuprofen had “the broadest endocrine-disturbing properties identified so far in men.
Important information
Ibuprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using ibuprofen, especially in older adults.
Do not take more than your recommended dose. An ibuprofen overdose can damage your stomach or intestines. Use only the smallest amount of medication needed to get relief from your pain, swelling, or fever.
Before taking this medicine
Ibuprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.
Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using ibuprofen, especially in older adults.
You should not use ibuprofen if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:
- heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
- a history of heart attack, stroke, or blood clot;
- a history of stomach ulcers or bleeding;
- asthma;
- liver or kidney disease;
- fluid retention; or
- a connective tissue disease such as Marfan syndrome, Sjogren's syndrome, or lupus.
Taking ibuprofen during the last 3 months of pregnancy may harm the unborn baby.Do not use this medicine without a doctor's advice if you are pregnant.
It is not known whether ibuprofen passes into breast milk or if it could affect a nursing baby. Ask a doctor before using this medicine if you are breast-feeding.
Do not give ibuprofen to a child younger than 2 years old without the advice of a doctor.
How should I take ibuprofen?
Use ibuprofen exactly as directed on the label, or as prescribed by your doctor. Do not use in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.
Do not take more than your recommended dose. An ibuprofen overdose can damage your stomach or intestines. The maximum amount of ibuprofen for adults is 800 milligrams per dose or 3200 mg per day (4 maximum doses). Use only the smallest amount needed to get relief from your pain, swelling, or fever.
A child's dose of ibuprofen is based on the age and weight of the child. Carefully follow the dosing instructions provided with your child's medicine for the age and weight of your child. Ask a doctor or pharmacist if you have questions.
Take ibuprofen with food or milk to lessen stomach upset.
Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.
The ibuprofen chewable tablet must be chewed before you swallow it.
If you use this medicine long-term, you may need frequent medical tests.
Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
What happens if I miss a dose?
Since ibuprofen is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.
What should I avoid while taking ibuprofen?
Avoid drinking alcohol. It may increase your risk of stomach bleeding.
Avoid taking aspirin while you are taking ibuprofen.
Avoid taking ibuprofen if you are taking aspirin to prevent stroke or heart attack. Ibuprofen can make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form).
Ask a doctor or pharmacist before using any cold, allergy, or pain medicine. Many medicines available over the counter contain aspirin or other medicines similar to ibuprofen. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.
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