‘The Pill’ May Reduce Asthma Symptoms

Women with asthma may notice that their asthma symptoms get worse at certain times of the month. Now, a new study confirms that fluctuating female hormone levels appear to affect airway inflammation, but oral contraceptives might help ease those changes.

In women who were not using birth control pills, the study found that increased levels of estrogen were associated with decreased levels of exhaled nitric oxide — indicating decreased airway inflammation. In these same women, increased levels of progesterone were associated with increased levels of exhaled nitric oxide, indicating increased airway inflammation.

However, birth control pills lessen dramatic hormone fluctuations, and researchers didn’t find differences in asthma symptoms throughout the month for women who took them.

“This study is a first step in looking at the relationship between hormones and asthma,” said the study’s lead author, Dr. Piush Mandhane, an assistant professor of pediatric pulmonology at the University of Alberta in Canada. The findings might be of use in managing asthma among premenopausal women, the researchers said.

“Among women not on oral contraceptives, we did have changes in exhaled nitric oxide that were related to estrogen and progesterone levels. We didn’t have an association with estrogen and progesterone in women on oral contraceptives,” said Mandhane.

Results of the study are published in the November issue of the journal Chest.

Mandhane said that because many women report a change in asthma symptoms related to menstrual cycles, it’s often assumed that there is an association. But, he said, the relationship between hormonal fluctuations and asthma symptoms hasn’t been well-studied.

The current study included 17 women. Eight were on birth control pills that contained estrogen and progesterone. The average age of the women using oral contraceptives was 25.5, while the average age of the women not taking birth control pills was 37.5.

Three of the women in the group not on birth control reported experiencing menstrual-cycle related asthma prior to the study, while just one woman in the birth control group did.

The researchers gathered daily information about symptoms and conducted blood tests to measure estrogen and progesterone levels, performed spirometry (a lung function test) and took measurements of exhaled nitric oxide. They also conducted allergy tests, via skin pricks every other day.

They found that women who didn’t take birth control pills had an average exhaled nitric oxide level of 48.2 parts per billion (ppb), while those on oral contraceptives had an average level of 27 ppb. In women who weren’t taking oral contraceptives, each increase in estrogen levels was associated with a decrease in exhaled nitric oxide, while each increase in progesterone was associated with an increase in exhaled nitric oxide. That means when progesterone levels are elevated (before menstruation), asthma symptoms are likely to be worse.

Progesterone increases also aggravated allergy symptoms, with more severe allergic reactions evident on skin prick tests when progesterone levels were elevated.

The researchers didn’t find any statistically significant differences in allergic reactions during the month for women on birth control pills.

Mandhane said that “birth control works by flattening out the fluctuations in hormone levels,” and that’s likely why there weren’t many differences in asthma symptoms for women taking birth control pills.

“Hormones do play a role,” said Mandhane, “and women need to be aware that there’s a potential relationship between their asthma symptoms and their menstrual cycles.”

Dr. Jennifer Appleyard, chief of allergy and immunology at St. John Hospital and Medical Center in Detroit, said that this study “lends credence to the fact that asthma is affected by hormones. This is definitely not something women should just write off. It’s not just all in their minds.”

But she also pointed out that this was a small study, and that the women in each group were very different from each other. “There were a lot of older women in one group who took more asthma medication. It’s not really comparing apples to apples,” she said.

Because birth control pills can have some serious side effects, Appleyard said she would not advise someone to go on oral contraceptives just to help their asthma. However, if a woman notices a difference in her symptoms throughout her menstrual cycle, she may want to talk to her doctor about increasing her asthma medications during that particular time in her cycle, she said.

 

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Dementia drug use linked to UK patient deaths

LONDON (AFP) – British health professionals have called for a change in the treatment of dementia patients after an official report warned that wrongly prescribed anti-psychotic medicines are causing the deaths of an estimated 1,800 each year.

As many as 144,000 out of an estimated 180,000 people suffering from the disease are unnecessarily given powerful “chemical cosh” drugs, the Department of Health-ordered review revealed.

The report also linked a significant number of strokes among elderly patients due to over prescription of the medication.

“We need to be sure that only the people who benefit from these drugs get them, and they get them at the lowest possible dose for the shortest period of time,” Sube Banerjee, the report’s author and professor of mental health at King?s College London Institute of Psychiatry, said in the report.

“It is clear that these medications are being prescribed to deal with behaviour and psychological symptoms in dementia rather than just for psychosis,” he added.

Banerjee urged social care services to develop a “different mindset” in tackling the issue.

There are presently 700,000 people in the country with the condition, but the numbers are expected to rise to one million in the next decade because of an ageing population.

“We know there are situations where anti-psychotic drug use is necessary - we’re not calling for a ban, but we do want to see a significant reduction in use,” said care services minister Phil Hope.

Neil Hunt, chief executive of Britain’s Alzheimer’s Society, welcomed the review saying the recognition of the scale of the problem was long overdue.

“This goes beyond quality of care. It is a fundamental rights issue. Our members tell us of enormous worry and distress over what is happening to their loved ones,” he added.

 

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Reports on Pfizer drug studies misleading

Analysis of a dozen published studies testing possible new uses for a Pfizer Inc. epilepsy drug found that reporting of the results was often misleading, indicating the medicine worked better than internal company documents showed.

According to the report, when a company-funded study’s primary finding wasn’t favorable, that result was usually buried and something else positive was highlighted, without disclosing the switch.

The documents used in the review were obtained by lawyers suing Pfizer for refunds on prescriptions paid for by insurers and consumers. The lawyers, who are seeking class action status for the cases, claim Pfizer concealed evidence the epilepsy drug Neurontin didn’t work for those unapproved uses, including nerve pain, migraines and bipolar disorder.

One of the report’s authors is an expert witness for the plaintiffs; another has received fees from the lawyers.

Pfizer disputes the report’s conclusions, saying the company never “attempted to mislead the medical community about the effectiveness” of the drug for certain uses.

“We believe the review suffers from significant bias, insufficient data, poor methodology, and cannot pass the threshold of credible scientific research,” Pfizer said in a statement.

The report, by researchers at the University of California at San Francisco and the Johns Hopkins Bloomberg School of Public Health, comes two months after Pfizer was fined a record $2.3 billion — including an unprecedented $1.2 billion criminal fine — for illegally marketing other blockbuster drugs.

The report appears in Thursday’s New England Journal of Medicine.

Dr. Sidney Wolfe, head of health research at consumer group Public Citizen, called it the first comprehensive look “at studies in which a company and people working for it so maliciously manipulated the data to make a drug look more effective than it actually was.”

“In every instance, the published article made the drug look better than it would have,” said Wolfe, a member of the Food and Drug Administration’s drug safety advisory committee. “This results in harm.”

Neurontin was approved by the FDA a decade ago for treating seizures and later for pain caused by shingles — but not for other conditions. Its potential side effects include suicidal tendencies and depression.

While doctors can prescribe drugs for unapproved, or off-label uses, drug companies are legally barred from promoting their products for such uses. Drugmakers often test drugs for additional conditions and publicize the results. But they don’t always seek approval for those new uses, particularly if the new findings aren’t convincing.

Experts believe most Neurontin sales were for off-label uses — the ones in the reviewed studies. Sales peaked at $2.7 billion in 2004, when Pfizer paid $430 million in government fines to settle allegations it improperly marketed the epilepsy drug for unapproved uses. By last year, Neurontin sales fell to $387 million due to cheaper generic versions sold as gabapentin.

For the new review, the researchers examined 20 patient studies funded by New York-based Pfizer and its Parke-Davis unit on use of Neurontin for preventing migraines or treating nerve pain or bipolar disorder. The studies were published in medical journals or presented at conferences, mostly over the last decade.

In eight of the 12 published studies, the main outcome listed in internal documents differs from the one later given in the published report. In half the cases, a new primary outcome was substituted and in others, the original main outcome was instead reported as a secondary measure or wasn’t disclosed at all.

The authors cited some limitations to their review, including not knowing who made the changes.

“We cannot be certain that selective reporting was a decision made by employees of Pfizer and Parke-Davis, since the authors of the published reports included nonemployees,” the researchers wrote.

Arthur Caplan, director of the University of Pennsylvania’s Center for Bioethics, called the report “one of the most ethically disturbing papers I’ve read in some time” and “an indication that people have been playing fast and loose with studies,” particularly industry ones.

Caplan said the FDA should have the power to audit industry drug studies. Wolfe said there should be bigger fines and jail terms for manipulating study data, plus tougher rules for studies being published in journals.

Medical journals in recent years have required that studies be listed on a federal Web site, http://www.clinicaltrials.gov, to be eligible for publication. That move was made partly to make it harder for industry to hide studies on products that don’t pan out and only publish those with good results. The study descriptions also list their primary and secondary outcomes.

Pfizer said it now has 1,245 company-sponsored studies listed on the Web site.

 

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Moderate exercise may decrease prostate cancer risk

Men who regularly get moderate exercise may have a lower risk of developing prostate cancer — including aggressive, fast-growing tumors, a new study finds.

Researchers found that among 190 men who underwent biopsies for possible prostate cancer, those who exercised moderately — the equivalent of three to six hours of walking per week — were less likely to be diagnosed with the disease.

Compared with their sedentary counterparts, these men were two-thirds less likely to have a biopsy positive for prostate cancer. In addition, men who got the equivalent of one to three hours of walking each week had an 86 percent lower chance of having an aggressive form of the cancer.

The findings, which appear in the current issue of the Journal of Urology, do not prove that exercise helps prevent prostate cancer. But they could offer men yet more incentive to get active.

“If you need one more reason to exercise, this could be one,” said senior researcher Dr. Stephen J. Freedland, of the Duke University Prostate Center and the VA Medical Center in Durham, North Carolina.

A number of studies have looked at the relationship between exercise and prostate cancer, and while most have pointed to a protective effect, about one-third have found no association, Freedland told Reuters Health.

One question has been whether the positive findings reflect a greater tendency of health-conscious exercisers to get screened for prostate cancer. This study avoided that issue, Freedland said, by focusing on men who were sent for biopsies after concerning findings from prostate specific antigen (PSA) testing or a digital rectal exam.

He and his colleagues found that among the 111 sedentary men in the study, half were diagnosed with cancer after biopsy. That compared with 27 percent of those men who got the equivalent of three to six hours of walking each week.

And among men diagnosed with prostate cancer, 51 percent of sedentary patients had more-aggressive cancer, versus 22 percent of those who had been mildly active — getting the equivalent of one to three hours of moderate walking per week.

Exercise itself remained linked to a lower risk of prostate cancer after the researchers accounted for a number of other factors, like age, weight and race.

Along with studies finding a relationship between exercise habits and lower prostate cancer risk, there is also research showing that the connection is biologically plausible, Freedland said.

For one, he noted, exercise has been shown to lower blood levels of testosterone and other hormones that may stimulate prostate tumor growth. Exercise is also believed to stimulate the immune system and the body’s natural antioxidant mechanisms, both of which may help prevent the development of prostate cancer.

SOURCE: Journal of Urology, November 2009.

 

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‘All-natural’ sex pill contains Viagra chemical

The US food and drug safety watchdog warned Thursday that an over-the-counter men’s sex aid, labeled as all-natural, contains a chemical similar to the active ingredient in Viagra and could be dangerous.

“‘Stiff Nights’, a product marketed as a dietary supplement for sexual enhancement, contains an ingredient that can dangerously lower blood pressure and is illegal,” the Food and Drug Administration (FDA) said in a statement.

The FDA began probing Stiff Nights after receiving a customer complaint about the product. The agency did not reveal the nature of the complaint.

The investigation found that rather than being all-natural, Stiff Nights contains sulfoaildenafil, a chemical similar to the ingredient in Viagra.

“Because this product is labeled as an all-natural dietary supplement, consumers may assume it is harmless and poses no health risk,” said Deborah Autor, director of the FDA?s Center for Drug Evaluation and Research Office of Compliance.

“In fact, this product is illegally marketed and can cause serious complications,” she said.

Sulfoaildenafil could interact with prescription drugs known as nitrates and cause dangerously low blood pressure.

Stiff Nights is sold online and at retail stores in bottles or blister packs containing red capsules.

A bottle of 12 Stiff Nights capsules was being offered Thursday on Amazon for around 27 dollars.

Another website — mystiffnights.com — said the product is made with “only the finest herbs and greens.”

 

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Cialis in a new daily dose for treating erectile dysfunction

Cialis is an oral prescription drug taken by men for treating their erectile dysfunction problems. It has become popular with millions of men who have erectile dysfunction. The popularity of Cialis is largely due to its long lasting effects.

There are many causes of erectile dysfunction in men. Some men may suffer erectile dysfunction due to physical factors and some due to psychological factors. Some men may also have erectile dysfunction problems due to excess intake of medicines for treating medical conditions like high blood pressure or diabetes. These medical conditions can also cause erectile dysfunction in men.

Cialis that was originally available in a need based form, has now been approved in a new lower strength daily dose that can be used as a regular medicine for treating this condition.

Cialis for treating erectile dysfunction

The small daily Cialis dose has been approved by the FDA for men who have erectile dysfunction and expect frequent sexual intercourse with their sex partners. They can have sexual intercourse at least twice a week at any time between the doses. The on demand doses of Cialis are effective only within a narrow time period and so limit the time for sexual activity.

Cialis strengths

The doses of on demand Cialis are 5mg, 10mg and 20mg. But now the small dose of 2.5mg has been approved for daily use. It can be extended to 5mg dose by the physician after examining the medical condition of the patient.

Effects of Cialis

The effects of daily Cialis doses are positive and users do not have to worry about their effectiveness. They can have regular sexual intercourse with their partners. The once daily Cialis dose can be taken without regard to timing of sexual intercourse.

The use of daily Cialis dose helps strengthen erection in men who have erectile dysfunction problems. It blocks an enzyme that slows the process of blood regulation in the penis. It breaks down more slowly than other erectile dysfunction treatment drugs in the body. This is the main reason for its longer lasting effect in the body.

Side effects of Cialis

Men can experience some mild side effects after taking Cialis doses. Some of these include headache, indigestion, muscle aches, nasal congestion, and facial flushing. These side effects may also occur after taking daily doses of Cialis. You should consult a physician if any major complications arise.

Cialis regular and the daily dose are not suitable for men who take any kind of nitrate drugs. This combination can result in drop in blood pressure levels in the body and can be fatal.

Availability of Cialis

Since Cialis is a prescription drug, so it is not available without obtaining a prescription. You need to consult a physician who examines your medical condition and then issues a prescription that allows you to buy once a day Cialis from a pharmacy. It is also available online. But it requires you to do an online consultation from a licensed online clinic to obtain a prescription. You should select a reliable online source whenever you buy Cialis online.

 

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Cialis Can Cure Health Disorders Related to ED

Cialis, the trademark drug of Lilly Icos can be beneficial to human beings in ways other than curing erectile dysfunction. Clinical researches have found out that tadalafil, the main component of Cialis can help people in reducing their blood pressure, keep a widespread prostrate condition under control and deal with an impending lung disorder. These additional benefits of Cialis have made the future of Lilly Icos brighter.

David Goodkin, the Senior Vice President at Icos stated in a press release that the company is constantly working towards development of the drug for any other potential benefits. Even tadalafil, the active ingredient in Cialis, was earlier developed as angina drug years before its impotency curing properties were realized.

Icos announced that it would utilize the mechanism of Cialis for the effective treatment of hypertension or chronic high blood pressure. Goodkin said there are around 50 million people with hypertension in the United States alone. Though many drugs to cure chronic high blood pressure are available, none of them are free of major side effects. Cialis may prove to be the dream drug, with negligible side effects.

Lilly Icos went ahead with a phase 2 study of Cialis to investigate the effects of tadalafil on persons with hypertension. The result of the study was clinically meaningful. It established that tadalafil showed compatible effects to the other drugs in the market. The only difference came up in the form of side effects. All the other drugs impeded sex, whereas Cialis gave an altogether opposite effect.

Tadalafil can also treat the symptoms of Benign Prostatic Hyperplasia, a common prostate problem. A patient with this problem administered with a dose of tadalafil showed a statistically remarkable improvement. A thorough medical assessment of the patient demonstrated that Cialis can be an effective drug for men with benign prostatic hyperplasia.

Pulmonary arterial hypertension is a rare problem of the lungs, which is characterized by an increased pressure in the arteries of the lungs. People diagnosed with this condition rarely survive for more than three years. It normally occurs in people who are under 30 years of age, generally causing fatigue, shortness of breath and heart failure. The drugs to treat pulmonary arterial hypertension have an adverse effect on the liver. The FDA has already approved sildenafil as a potential drug for this condition without the risk of the harmful side effects. This has heightened the possibilities of tadalafil as a treatment.

Goodkin and other medical scientists in Icos said that many of the erectile dysfunction patients have other health problems that can be cured by Cialis. Biotechnologists are of the opinion that Cialis is one of those few wonder drugs that have multi-beneficial properties. This is certainly good news for Lilly Icos.

 

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Medicines cause most accidental poisonings in kids

Medication overdoses send one in every 180 US 2-year-olds to the emergency department every year, researchers from the Centers for Disease Control and Prevention report. Such overdoses are responsible for more than two-thirds of all childhood poisonings.

Most of the time, these cases occur when a child finds a medicine and eats or drinks it without adult supervision, Dr. Daniel S. Budnitz, who directs the Medication Safety Program at the CDC’s Division of Healthcare Quality and Promotion and led the study, told Reuters Health.

“Although there have been some great stride in preventing deaths from overdoses with the traditional child-resistant caps…it might be time to kind of take the next step,” Budnitz said. He said the CDC is working with manufacturers and other agencies to come up with innovative packaging that reduces the likelihood that a child can take too much of a medication.

While the number of calls to poison control centers nationwide is declining, Budnitz and his team note in the American Journal of Preventive Medicine, the percentage of those calls that involve medicines rather than household products such as cleaners and pesticides jumped from 34% to 44% from 2002 to 2006.

It’s not clear why, Budnitz said in an interview, but the fact that people are simply taking more medicines these days could be a factor.

To better understand how to prevent unintentional medication overdoses in children, the researchers looked at data from the National Electronic Injury Surveillance System for 2004-2005 on visits to emergency departments for unintentional poisoning by patients 18 and under.

Medication accounted for 68.9% of these visits, or an estimated 71,224 visits every year, Budnitz and his team found. Over-the-counter products were responsible for a third of the medication-related poisonings.

The most common medications involved were acetaminophen (Tylenol), representing 9.3% of cases; cough and cold medicines, 7.3%; antidepressants, 6.1%; and non-steroidal anti-inflammatory drugs such as ibuprofen (Advil), 5.3%.

Four out of five visits were due to children ingesting medications on their own, while 14.3% involved misuse of medications, for example a child being given too large a dose by an adult, or being dosed too frequently.

The youngest children were most at risk, with kids 5 and under accounting for 81.3% of the medication-related poisonings. As children got older their likelihood of unintentional medication overdose decreased, but rose again during adolescence, possibly because parents were allowing them to take medications on their own, Budnitz and his team note.

“These are not teens who are trying to get high or kill themselves,” Budnitz noted, but who simply may not understand how to use medicines. “Really you can only take medicines as directed. If the bottle says take two for pain it doesn’t mean that taking eight will be even better.”

Parents should know, he added, that teens may still need guidance in using medications properly.

And it’s also crucial for parents to tightly close the caps of medicine bottles and put them up out of the reach of children, he added. Putting medicines in a place that’s “convenient” for parents, he said, may also mean that it’s easy for kids to reach too.

 

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Antidepressant Use in U.S. Has Almost Doubled

Antidepressant use among U.S. residents almost doubled between 1996 and 2005, along with a concurrent rise in the use of other psychotropic medications, a new report shows.

The increase seemed to span virtually all demographic groups.

“Over 10 percent of people over the age of 6 were receiving anti-depression medication. That strikes me as significant,” said study author Dr. Mark Olfson, a professor of clinical psychiatry at Columbia University/New York State Psychiatric Institute in New York City.

According to background information in the study, antidepressants are now the most widely prescribed class of drugs in the United States. The expansion in use dates back to the 1980s, with the introduction of the antidepressant Prozac (fluoxetine).

The study found that 5.84 percent of U.S. residents aged 6 and over were using antidepressants in 1996, compared with 10.12 percent in 2005. That’s 13.3 million people, up to 27 million people.

“This is a 20-year trend and it’s very powerful,” remarked Dr. Eric Caine, chair of the department of psychiatry and co-director of the Center for the Study of Prevention of Suicide at the University of Rochester Medical Center.

This happened despite a “black box” warning mandated for many antidepressant medications by the U.S. Food and Drug Administration in 2004, the study authors noted.

Lower rates of increases in antidepressant use were seen in blacks (3.61 percent in 1996 versus 4.51 percent in 2005) and in Hispanics (3.72 percent versus 5.21 percent in 2005), the researchers found.

Still, about the same number of people were being treated for depression (26.25 percent in 1996 versus 26.85 percent in 2005), indicating that the drugs were being used to treat other diagnoses, such as anxiety and other mood disorders.

At the same time, those receiving antipsychotic drugs increased from 5.46 percent to 8.86 percent, and the proportion of people using psychotherapy dropped from 31.5 percent to 19.87 percent.

“The reasons [for the growth] are unclear but they may include the introduction of new antidepressants over the last 10 to 12 years or so and a broadening in the clinical indications of antidepressant treatment. Years ago, these drugs were largely focused on depression. Today, more different conditions are treated with antidepressants,” Olfson said. “There’s also been an increase in direct-to-consumer advertising and a lessening of the stigma associated with seeking mental health care.”

Indeed, a study released last week found that roughly five of six Americans now have a positive opinion on psychiatric medications, a marked increase from about a decade ago.

Depression may also be more common in the population, or at least more people may be acknowledging it and seeking help, the authors suggested.

“It is encouraging that there is apparently an increased awareness and increased willingness to seek assistance for emotional distress . . . and that is a big step forward,” said Dr. Kathryn J. Kotrla, chairwoman and associate professor of psychiatry and behavioral science at Texas A&M Health Science Center College of Medicine.

“I think part of the increased rate is increased awareness, as well as national depression screening all over the country,” added Dr. M. Beatriz Currier, an associate professor of clinical psychiatry at the University of Miami Miller School of Medicine. “Education and screening decrease stigma.”

Of concern, however, was the finding that the majority of Americans taking antidepressants were not receiving care from a psychiatrist.

Also troubling was not knowing what the prescriptions were being written for exactly.

“One wonders if the medication is being used as a possible panacea for a number of psychosocial issues which might be better served by counseling,” Kotrla said.

“Who’s really taking these medications?” Caine said. “It’s not clear that it makes anyone healthier. That’s a fundamental issue that we don’t know. We don’t have any way of telling if this made people’s lives better.”

A second study in the same issue of the journal followed 306 preschoolers aged 3 to 6 years for 24 months and found that depression in this group tends not to just go away as the child gets older, but can linger as a chronic condition.

“This is exciting because it gives us an opportunity for early intervention,” Kotrla said.

 

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Breast Cancer Drug May Beat Fungal Infection

A drug used to help prevent recurring breast cancer appears to hold promise as a treatment for deadly fungal infections, new research has found.

University of Rochester Medical Center researchers found that tamoxifen kills yeast in mice with Candida infections, which can be fatal to people with compromised immune systems, including people with cancer or HIV and those taking immunosuppressants for chronic conditions.

At extremely high levels, tamoxifen slashed yeast levels by 150-fold, causing most fungus cells to break up and die while halting surviving cells from progressing into a disease-causing state, their study found.

“It’s still early, but if tamoxifen, or molecules like it, turns out to be an effective treatment against serious fungal infections, it’ll be a welcome addition to our arsenal,” Dr. Damian Krysan, an assistant professor of pediatrics at the university and an author of the study, said in a university news release.

The results are published in the August issue of Antimicrobial Agents and Chemotherapy.

Available antifungal medications pose some issues for people who need them the most, according to background information in the news release. The only new class of antifungals approved for use in the past two decades is generally effective, but they can only be taken intravenously, which poses logistic and other problems for some patients. And the most common oral antifungal medication only slows fungus cell growth, making it difficult for immune-compromised patients to completely shake their infections.

“We don’t have vaccines against fungal infections, and the few drugs we do have aren’t always effective,” Krysan said. “We’ve got a lot more work to do to figure out whether tamoxifen could be used in high doses or whether it could be used in combination with other treatments, but we’re excited about the possibility of giving doctors another way to help these critically ill patients.”

 

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