The harmful effects of supplements that can be sent to the emergency room

For many people, a healthy lifestyle means more than eating a good diet and exercise - vitamins, nutritional supplements and complementary products are also part of the plan. But although there is much publicity about its potential benefits, there is less awareness of their potential adverse effects.

In fact, the use of these products can land in the emergency department.

A study published today in the New England Journal of Medicine found that the adverse effects of the supplements were responsible for an average of about 23,000 emergency department (ED) visits per year. That's a lot of something that is supposed to be good for you.

In this 10-year study, researchers analyzed data from 63 monitoring of hospital emergency departments to estimate the annual number of visits to emergency rooms related to the adverse effects of dietary supplements. The authors define 'food supplements' as herbal products or amino acids and micronutrients complementary or vitamin.  

Patients who visit the ED for symptoms related to supplement use were on average 32 years, and women account for over half of all visits. Just over 10% of these visits resulted in hospital admission, especially in adults over 65 years.

Weight loss products accounted for one quarter of all visits for a single product and women disproportionately affected, while men were more likely to suffer the adverse effects of products advertised for sexual enhancement and bodybuilding. Energy products increased up to another 10% of these visits.

Young adults are not the only ones affected. Many children under 4 years old have suffered allergic reactions or digestive symptoms (nausea, vomiting, abdominal pain) of unsupervised ingestion, accidental vitamins. Patients over 65 were more likely to have difficulty swallowing after taking vitamins or trace large pill.

Although study results are based on visits to emergency rooms annually estimated at a relatively small number of hospitals, reflecting the increased use of food supplements and micronutrients. These products are widely available without a prescription and are advertised as alternatives or supplements to pharmaceutical drugs prescribed in therapeutics. Consequently, dietary supplements or herbal are widely perceived as natural and safe. The latest figures indicate that more than 55,000 of these products available in the United States.

What you need to know before taking a supplement 
Although the Food and Drug Administration (FDA) is responsible for the supervision of food supplements, no safety testing or FDA approval required before a new supplement hits the market. In addition, it is not only the potential effects of the requirements of the list of undesirable packing dietary supplements nor are there rules for the maximum size of the pill (a clear risk to the elderly). 

Health care providers may also neglect to ask patients about using over-the-counter or herbal dietary supplements. Without this information, they can not recognize all the signs and symptoms of their patients may experience may be related to these products.

No doubt some dietary supplements can be beneficial. This is because these products contain active ingredients - interacting molecules on receptors in the body and cause physiological changes. However, because they contain active ingredients, they can also cause side effects such as high blood pressure, racing or irregular heartbeat, headache, dizziness, or gastrointestinal symptoms.

What is the safest approach to the use of these supplements? Staying healthy requires a multidimensional approach to self-care. You become aware and informed all supplements, if they are advertised as natural, herbal or no drugs - is part of that care.

If you take vitamins, supplements or herbal products, always read the safety labels included with the package. Ask a pharmacist, your doctor or nurse to check everything you need to make sure that the supplements will not cause damage, either alone or in combination with regularly prescribed or over-the-counter medicines. If you develop symptoms after taking a food supplement, stop and call your doctor.

By: Susan Farrell, MD.

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To what extent calcium intake really protect your bones?

Ask someone how to prevent bone fractures and are likely to respond, "Get more calcium." Medical experts have tended to agree. For example, the Institute of Medicine recommends a calcium intake of 1 000 to 1 200 milligrams (mg) per day for most adults.  

But in the last five years we have also learned that calcium - at least in the form of supplements - is not without risk. An intake of 1000 mg of supplements was associated with an increased risk of heart attack, stroke, kidney stones, and gastrointestinal symptoms.

Now an analysis of reams of research concludes that calcium intake at this level to reduce fractures in people over 50 years and a related analysis indicates that increasing calcium intake has only a modest effect on bone density people of this age. Both were published online this week in the medical journal BMJ.

These results may seem surprising, but they are not a surprise to Dr. David Slovik, associate professor of medicine at Harvard Medical School professor and author of our health Osteoporosis Special Report: A Guide to Prevention and Treatment. "I do not think we ever thought that calcium reduced fractures in itself, it is part of a bigger picture," he said. You can not really say "enough calcium and you'll be fine."

What the analysis revealed 
The analyzes were performed by a team of researchers led by Mark Bolland Zealanders, who first identified the cardiovascular risk associated with calcium supplements. For the first analysis, which evaluated more than 70 studies on the effects of calcium supplements and dietary calcium in preventing fractures. 

In his view, the two randomized clinical trials and observational studies and studies vary considerably in terms of number of participants, the consumption of calcium, vitamin D, and how fractures were reported. The researchers found that, in particular calcium or calcium dietary supplements have been associated with fracture reduction.

In the second analysis, the researchers examined 59 randomized controlled clinical trials evaluating calcium intake and bone density. Fifteen of these studies included dietary calcium and calcium supplements 44 looked. Especially, to obtain at least 800 mg of calcium daily diet or take at least 1000 mg of calcium increase in bone density of an additional day. But bone density increased by only 0.6% to 1.8% - a too low to affect the risk of fracture.

Importantly, these studies included very few men. (Many people think that osteoporosis only affects women, but men can also develop osteoporosis.)

The study that started it all? 
Bolland and colleagues noted that a study they think may be responsible for calcium recommendations today. This study was a randomized controlled trial in 3800 French elderly women (average age 84) in assisted living. The women initially had low calcium intake (500 mg daily), low levels of vitamin D, and low bone density.  

Those who received 1200 mg of calcium and 800 international units (IU) of vitamin D a day for three years had a risk 23% lower hip fracture, and risk 17% lower fractures in particular those taking placebos . Women who took calcium builds bones also, while the placebo continued to lose. These findings - published in 1992 and 1994 - are often cited by the experts in the development of calcium recommendations for the general population. But Bolland argued that in healthy people, assets that have calcium deficiency and vitamin D are not subject to the same protection by taking lots of calcium.

What to do?
"The key is that you should not take calcium with the idea that this will prevent bone fractures," says Dr. Slovik. However, he noted that sufficient vitamin D and calcium is essential for bone health. A deficiency of either may increase the risk of diseases such as rickets and osteomalacia.

It is impossible to determine the amount of calcium each of us must do individually. Try to get as much calcium as possible food. If your doctor told you to get between 1,000 and 1,200 mg of calcium daily, you can add safely a daily calcium supplement of 500 mg or 600 without increasing the risk of heart attack or kidney stones. And do not forget vitamin D. No one disputes the recommendation for vitamin D - 600-800 IU per day, or from foods or supplements.
By: Beverly Merz

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What use "off-label" of a drug really is, and why you need to know about it

When your doctor prescribes a medication for you, you assume probably - and rightly - which is an FDA approved treatment for your condition.

This may or may not be the case.On average, one in five prescriptions are written for "off-label" use of a drug. This means that your doctor thinks that the drug will help you, even if it has not been specifically approved for illness or symptoms.

Prescription medications off label is legal and common, and can be beneficial for patients. For example, beta blockers (drugs approved for lowering blood pressure and treating heart disease) may also help some people with migraines or anxiety. Tricyclic antidepressants are not FDA approved to treat nerve pain, but many doctors do a good drug of choice for this disease in question.

When the off-label use is supported by strong evidence presented to the FDA, which can lead to FDA approval for that use. Most people know of botulinum toxin type A (Botox or) as a way to remove wrinkles, but originally won approval from the FDA for the treatment of a number of different conditions, sweating Excessive use of muscle spasms.

While some off-label uses for drugs are well studied and have been a part of medical practice routine for years, many off-label uses not. When a drug has not been tested for an individual or a group of people in particular state, it could have unexpected and dangerous effects. For example, doctors prescribe antipsychotic drugs such as haloperidol, off-label to manage behavior problems in people with dementia. Now we have evidence that the administration of these drugs to people with dementia is associated with a higher mortality rate.

Advertising off-label and courtsThe application can not become particularly difficult when it comes to drug advertising. Historically, the FDA has prevented most pharmaceutical companies advertise proactive off-label uses for their products. But that could soon change, thanks to two recent judgments that federal courts have cleared the way for the promotion of unapproved uses for prescription drugs. These decisions and their implications are discussed in New England Journal of Medicine.

The first case occurred in 2012 and involved the drug Xyrem (FDA approved to treat a rare disorder called narcolepsy sleep). In this case, a representative of drug sales, Alfred Caronia, facing a lawsuit after suggesting to physicians who use the drug as a treatment for other conditions such as insomnia, fibromyalgia and Parkinson's disease, despite lack of evidence that the drug worked with these health problems.

As Dr. Ameet Sarpatwari, a lawyer and an epidemiologist at Brigham and Women's Hospital and Harvard Medical School, explains that "the government has not indicated that the off-label promotion of Caronia was false or misleading. Rather He argued that the restriction on off-label promotional moved directly its real interest in protecting patients from unsafe and ineffective drugs, and therefore the constitutional requirement to intervene in the protected commercial speech met. "A federal court It divided appeals disagreed, however, noting that the Government has failed to demonstrate that less restrictive measures of speech, that the exemptions would not have achieved the same goal.

A more recent case is that of a fish oil pill called Vascepa ordinance approved by the FDA to reduce high triglyceride levels. The manufacturer, Amarin, sought approval from the FDA to promote its use in patients with moderately elevated triglyceride levels - use of the indications that the FDA considered, but not adopted.  

When the FDA said no, Amarin sued, alleging that - as in the case Caronia - off-label promotion Vascepa was protected by the First Amendment. The court ruled in his favor. Dr. Aaron Kesselheim, director of the Division of Law Programme and the therapeutic Pharmacoepidemiology and Pharmacoeconomics settlement at Brigham and Women's Hospital and associate professor of medicine at Harvard Medical School professor, said the impact of the case could Amarin be substantial: "The decision on the case Amarin is a new setback for the FDA to try to maintain their level of off-label marketing If these cases become the law of the land, there would be no motivation for companies submit. its evidence to the FDA for approval of additional indications. "

The courts have decided that pharmaceutical companies have the right to provide, and consumers have the right to receive accurate and not misleading drugs about which can help them to information. However, Dr. Sarpatwari advises that patients should also be aware that the quality and objectivity of the information is at risk. "Off-label claims do not have full and impartial review of the promoted FDA has determined safe and effective use," he said. "However, companies that make these claims have financial incentives to encourage more prescription drugs."

What this means for you
You will need to work ever more closely with your doctor to assess the risks and benefits of any medication recommended for you to off-label use. When your doctor prescribes a new medication, ask if it is approved by the FDA for your condition. If not, ask what is already known (and unknown) to use for your health, and if there are drugs that are just as good for what approved. 
By: Gregory Curfman, MD,

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The DTCA drugs - beyond what you see on TV

Twenty years ago, I probably would not have been able to name one of many prescription drugs available to you, let alone think about asking your doctor for an individual by name. Today the (even in perfect health) average consumer is bombarded by hundreds, if not thousands, of "direct to consumer" advertising of prescription drugs.

In 1997, the FDA has set specific guidelines for the dissemination of advertising related to prescription drugs. Since then, drug companies have seized this opportunity to promote their drugs for a wide range of conditions, from Alzheimer's disease at a low sperm globules due to cancer treatment - not to mention the myriad over- the- ads counter products.

Direct ads with consumers must, by law, include information about the risks of a drug and the side effects and benefits. This often comes in the form of a list of potential problems quickly recited. But because it is difficult if not impossible to cover all potential risks in a TV commercial short, these ads should also target consumers more complete information in a print ad or web page. This information is usually a very long and technical text developed by pharmaceutical companies - often the same text that give doctors and pharmacies.

Consumers have complained that information about side effects is so confusing and difficult to read than just annoying. In response, the FDA asked for a Drug Facts box that summarizes the most important risks of each drug, using simple language, color combinations and types of easily readable.

This change is a step towards giving consumers better before you decide to try a new drug "informed consent". However, critics say that the FDA has left much of what is included in the box to the safety of medicines to pharmaceutical companies. In addition to the warnings "black box" and "contra" (situations in which a person should certainly not take the drug), the only guideline is that the case must list the effects "most serious and most common" side. This could still leave out a lot of valuable information.

Inform consumers about new potentially useful drugs is not a bad thing. However, a truly informed consumer should not rely solely on direct-to-consumer ads by drug before deciding to try a new one. Buyer beware: A new drug may be more expensive than older drugs that can do the job as well.If you see an advertisement for a drug you think you can help or be an improvement on the medication you are already taking, check with your doctor.  

Make sure that you understand the potential risks and side effects, both short and long term (and be aware that they are not as well understood in the new brand-name drugs). If your doctor says "no" be willing to listen to him. Regardless of the innovative way could be a new drug, it may not be good for you. And if you are still interested after a while, you can always return to the issue in the future.
By: Nancy Ferrari
 

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It is not a "pink Viagra"

Many of my patients, colleagues, friends and even neighbors ask me about the new drug flibanserin (brand name Addyi). Just last Tuesday, the FDA approved the drug for the treatment of hypoactive sexual desire in women.

Flibanserin generated more questions, comments and questions from the media for me that I have never experienced in my 20 year career as an obstetrician / gynecologist. Although there are several drugs that enhance sexual function in men (including Viagra, the most famous), flibanserin is the first drug approved by the FDA to improve sexual function in women. Here are what I consider the relevant facts and data on flibanserin and the advice I give to my patients.

First, it is not a "pink Viagra." Viagra (sildenafil) for erectile dysfunction in men, improving blood flow to the penis by inhibiting nitric oxide synthase enzyme. However, it is estimated that the acts of FLIBANSERIN by increasing the release of dopamine and norepinephrine hormones neurotransmitters, while decreasing the release of serotonin in the brain area regulating sexuality. Viagra is taken just before sex, while flibanserin must be taken every day. Flibanserin is approved for pre-menopausal women. It has been shown that slightly improved sexual satisfaction in some women (some more than others).

Possible side effects include low blood pressure, nausea and fainting. Women should not drink alcohol or birth control use while taking as it may aggravate side effects. Of course, some women may decide these requirements and side effects are not worth it, because it can be pretty big inconvenience for a drug intended to improve the sex lives of premenopausal women.

In my practice, women of all ages have questions and concerns about sex and sexuality. Most women who see an obstetrician / gynecologist do. These questions often come right after a woman has a baby, during perimenopause, and later in life too. Women's sexuality is very complex and is affected by brain chemistry, mood, relationships, drugs and health status (torque).  

As a doctor, if a woman comes to my attention their concerns to sexuality, I begin by assessing their physical and mental health (depression is a common cause of loss of interest in sex), and then check to see if she takes medication that may influence the interest in sex. Guilty of common drugs are birth control pills, pills for high blood pressure and antidepressants. I then asked about their relationship. If all this seems to be going well, so I looked in your stress level and your schedule.

I often find that couples who are struggling with sexuality have not neglected any time and energy to your relationship. I ask, "If you and your partner were alone on a tropical island, and he had no concerns or schedules, would you be interested in sex?" If the answer is yes, we are working on strategies to prioritize and time to build the relationship. If the answer is no, then I prefer disorder diagnosis of hypoactive sexual desire disorder (also known as DSH).  

I often try to send these couples to sex therapists, but these experts are rare, and are often expensive. In addition, many couples are too embarrassed to go ahead. This subgroup of women with hypoactive sexual desire was confusing to me mostly because I have not been able to help. They are generally in a healthy relationship, and not have the desire, sexual desire, or the answer to sexuality. I try to explore all options with these women; However, to date there has not been a medical option. Flibanserin is to this group of women.

The approval of flibanserin took many years, and after two previous rejections by the FDA because he thought that the side effects were stronger than the modest profit in sexual function. In the latest revision of the FDA, the sponsor of the drug provides additional safety data that showed the absence of impaired driving following day, a comparison of side effects of flibanserin, and other products that have already approved by the FDA, and the analysis confirms that the side effects were more pronounced when flibanserin is taken with alcohol. The controversy arose because only two of the 25 volunteers for the study of alcohol were women. To add to the controversy, an advocacy group that wanted flibanserin approved, called "equalize" he suggested was sexism in the process of FDA review.

A major concern that many people, including myself, is the potential of flibanserin to be used off-label, which means it could be used in a larger population of women for whom it was not approved. For example, this population could include older women, people with medical problems, and combining the use of birth control pills or alcohol.  

The use of flibanserin for women in any of these categories can increase the risk and severity of side effects. Another concern is whether the modest improvement in sexual function worth the potential risk of side effects. I plan to discuss with women who might benefit, and let them decide. Who am I to be the final arbiter of what is important to the quality of life of a woman? A doctor-patient relationship in good health should allow this type of discussion and joint decision making.

I welcome these discussions and controversy. Female sexual dysfunction is a significant unmet medical need and deserve research and treatment options. The problem of hypoactive sexual desire and excitement, particularly for women, is real. Either flibanserin help the subset of women for whom it is appropriate, and the extent to which improves sexual function, remains to be seen.  

I suspect that the effect is low, and the group that can be safely applied is limited, but at least it is a step in the right direction. My advice is to proceed with caution and follow the FDA's advice to the letter in this case. Explore all non-pharmacological options that can help create a fulfilling sex life - reduce stress, take care of your health, talk to your doctor about medications and health status, and to give priority in their relationship.
By: Hope Ricciotti

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Is treating "low T" really safe and effective

A pharmaceutical marketing blitz during treatment promises "low T" with a boost testosterone prescription daily are men with age-related decline of this hormone are more alert, energetic, mentally strong, and fully functioning the bedroom. 

But in an article published this week in the New England Journal of Medicine Perspectives section, an FDA scientific panel reiterated its concern over the widespread use of testosterone supplements in light of the unresolved controversies about its effectiveness and the long-term security.

Is a testosterone replacement therapy (TRT) delivering what these people expect? Dr. Christine P. Nguyen, one of the authors of the article, said that just do not know yet. "The benefits of testosterone therapy has not been confirmed for the treatment of men with low testosterone levels due to aging, even if the symptoms appear to be related to low testosterone," she said.

The increase in testosterone 
While the debate on Smolders safety and efficiency, the company is thriving even testosterone. In 2013, 2.2 million American men were on testosterone drugs, and 80% of them were between 40 and 74. Some suffer from verifiable health problems that cause testosterone levels to drop, as the testicles poor operation or tumors of the pituitary gland. No one disputes that these cases warrant testosterone therapy "classic hypogonadism" (especially if it begins to lose hair and hot flashes).

However, for most men in TRT, this is not the case. "The vast majority of men receiving testosterone requirements are now middle-aged men with higher levels of testosterone in the lower end of the normal range, or slightly below the lower end of the normal" says Dr. Shalender Bhasin, a leading testosterone researcher at Harvard-affiliated Brigham and Women's Hospital. "It is for people who have no clear evidence of benefit or safety."

Security Issues 
Concerns about whether testosterone supplements are safe for the heart recently moved to the FDA to require stronger warning labels on these products. But overall, long-term risks proof elements is mixed. Some studies have shown that men on testosterone have fewer heart attacks, strokes and death from heart disease. Other studies have found a higher risk of heart disease.

Frustratingly, there have been no studies to date designed to respond conclusively to this fundamental question. "It is an indication that [men] may have an increased cardiovascular risk, but are not conclusive by any means," says Dr Bhasin.

Bridging the gap 
To explore the issue of security in the typical users of TRT, Mr. Bhasin and his colleagues studied a group of 300 men, ages 60 and older, whose testosterone levels were either in the lower end of normal or healthy slightly below the male range adult. The men were randomly assigned to each rub testosterone gel or placebo gel daily. The team published its findings August 11 in the Journal of the American Medical Association.
 During and after the study, the researchers used several tests to screen men of atherosclerosis or hardening of the arteries - a common cause of heart attacks and other cardiovascular problems. Over three years of using TRT, the arteries of men showed no worsening of atherosclerosis. In addition, the researchers used surveys to whether men thought their sexual function or quality of life in general improved in TRT. Polls showed no improvement.

Dr Bhasin stresses that this study does not prove that the TRT is safe for the heart; this would require a broader and more study. But at least in this group of typical users of TRT, boost testosterone did not produce some of the major benefits promised to men.

What do men?
It is particularly important for men with possible signs of testosterone deficiency for a complete evaluation before opting for a fee. The guidelines of the American Society of Endocrinology for the use of testosterone, Dr. Bhasin helped create, design the basics of good practice.

The guidelines, published in 2010, showed a number of "red flags" clear of hypogonadism, including decreased libido, erectile dysfunction, low sperm count, loss of hair and hot flashes. Other signs that might suggest a wider deficit of the hormone are lack of concentration and memory; feeling sad or blue; insomnia; decreased energy, motivation, initiative and self-confidence; decrease in muscle mass and increased body fat; and a decrease in physical performance or work.

However, most of these signs of testosterone deficiency is also common in older men who have normal testosterone levels, so "low T" can not be diagnosed based on symptoms alone. You should also check if your testosterone is low. But the tests themselves can be unreliable and difficult to interpret, so the blood levels of testosterone should be carefully evaluated, tested more than a day, and to test the levels of other hormones related to testosterone. "The record is not that expensive," says Dr Bhasin. "It's not like it costs thousands of dollars. However, testosterone prescribed somewhat blind. "

In fact, a study in the September 2015 issue of the journal Medical Care found worrying signs of inappropriate testosterone prescriptions in the VA medical system. Of the nearly 112,000 new prescriptions for testosterone given to men between 2009 and 2012 VA outpatient clinics, 16.5% of men testosterone is no measurement at all. Worse, some men have testosterone requirements, even if they had a medical condition such as prostate cancer, which usually stand in the use of hormone supplements.

"Men want a thoughtful discussion of the risks and benefits, and doctors can guide correctly on the basis of the guidelines" says Dr Bhasin. "Patients come to you for help with their symptoms, but did never had a situation where they went because I refused to give them testosterone. "
By: Daniel Pendick

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