Craig, a public relations specialist who works at Columbia University in New York City, knew that Roger’s medications could cause weight gain. But she had never been told that the drugs he was taking might be harming his heart.

“We were never counseled by his psychiatrist or his primary care provider to watch for symptoms of heart disease or any risk of sudden death at all,” Craig says. There’s no evidence that Roger’s medications caused his death, but his family might have been able to get him help sooner if they had known about the risks, Craig explains.

New research published Wednesday in the New England Journal of Medicine shows that antipsychotic drugs are not risk free, and the study’s authors are urging much more caution in their use. The drugs are associated with a risk of sudden cardiac death, particularly at higher doses. Health.com 10 best foods for your heart

Craig’s brother was taking haloperidol, which belongs to an older class of drugs called typical antipsychotics, which have long been known to increase the risk of sudden death due to cardiac causes. He was also on risperidone, a member of a newer class of drugs called atypical antipsychotics, which had been considered safer.

Doctors prescribe these newer medications, originally developed to treat schizophrenia, for a wide variety of problems — from conduct disorder in kids to aggressive behavior in Alzheimer’s patients. In fact, they’ve become so popular that three of them — olanzapine, risperidone, and quetiapine — are among the 10 top-selling drugs worldwide, with $14.5 billion in sales in 2007.

The new study suggests that among patients taking high doses of atypical antipsychotics, there are about 3.3 cases of sudden cardiac death per 1,000 patients per year, which an editorial characterizes as a risk that’s “between ‘moderate’ and ‘low,’ but not ‘rare.’” Health.com: Heart drug may be a cancer fighter

About 325,000 people in the United States each year die of sudden cardiac death, which has an incidence of 0.1 to 0.2 percent per year in adults.

“[The drugs] have potentially very serious side effects,” says Wayne A. Ray, Ph.D., the director of the division of pharmacoepidemiology at Vanderbilt University School of Medicine, in Nashville. “So whenever a decision is made to use one, consideration of potential side effects needs to be made.” Ray and his colleagues found that atypical antipsychotics doubled the risk of sudden death from heart-related causes, most likely by causing disturbances in heart rhythms.

First introduced in the mid-nineties, atypical antipsychotics were praised for having none of the troublesome side effects of their predecessors, including frequent, involuntary movements of the face and mouth that were in some cases irreversible.

But the new study shows that the increased risk of sudden cardiac death seen with the older drugs is nearly identical to that of the newer medications. There had been suspicions that the drugs were risky, especially when used in older patients, but the current study is the first to systematically investigate their association with sudden cardiac death.

Ray and his colleagues reviewed data on Tennessee Medicaid patients, comparing 44,218 people using older typical antipsychotics and 46,089 taking the newer atypical antipsychotics to 186,600 people who had never used the drugs. People with schizophrenia may have a higher rate of cardiac problems, due to smoking and other factors. To account for this, researchers also compared antipsychotic drug users without schizophrenia to non-drug users who had characteristics (in most cases, mood disorders) that made them likely candidates for the drugs.

Overall, people taking typical antipsychotics were at 1.99-times greater risk of sudden cardiac death, while the risk for those on atypical antipsychotics was increased 2.26 times. The increased risk was greater for people on higher doses of the drugs. People who had used the drugs in the past but stopped weren’t at greater risk of sudden cardiac death.

“The drugs are still very effective for conditions that there’s proven evidence for,” says Jeffrey A. Lieberman, M.D., a professor and chair of psychiatry at Columbia University, in New York City, and the director of the New York State Psychiatric Institute, who was not involved with Ray’s research. “They clearly need to still be able to be used. I think this [study] really underscores the need to be very judicious about how these medications are used and whom they’re given to.”

While atypical antipsychotics have been used to ease aggressive behavior for patients with Alzheimer’s disease, for example, they are not approved for this purpose by the U.S. Food and Drug Administration; in fact, in 2005, the FDA issued a warning that these drugs increased the risk of death among elderly people, extending the warning to all antipsychotic drugs last year, notes Sebastian Schneeweiss, M.D., Sc.D., an associate professor of medicine at Harvard Medical School, in Boston, who coauthored an editorial accompanying the current study. Health.com: How is depression in the elderly different from dementia?

Given the lack of better alternatives, these drugs are still widely used in patients with dementia despite the warnings, he adds. But while there’s anecdotal evidence that they will “cool these patients down” and reduce their aggressive behaviors, there’s no scientific evidence that they really help patients or their caregivers, Dr. Schneeweiss says.

In his editorial, Dr. Schneeweiss and coauthor Jerry Avorn, M.D., also of Harvard, call for patients to undergo an electrocardiogram before and shortly after being placed on atypical antipsychotics, to determine if the drugs are causing any heart rhythm disturbances.

For people who must be on these medications, Ray says, it’s essential for their doctors to treat any other conditions, such as high blood pressure, that can harm the heart. “Sudden cardiac death usually occurs when multiple risk factors are present,” he explains. “When you add one, it’s kind of like the straw that broke the camel’s back.”

“Absolutely the lowest dose that works should be used, because we found a strong dose response,” Ray says.

Jamaison Schuler, a spokesperson for Eli Lilly and Company, the maker of Zyprexa, says, “Although the study appears to have important limitations, it provides additional information for practicing physicians to consider as they decide how to treat very complex diseases such as schizophrenia and bipolar disorder.”

The FDA has approved atypical antipsychotics for treating bipolar disorder, Ray adds. But the researcher recommends that physicians first try safer alternatives, such as the mood stabilizer lithium. “That’s a very serious illness, and it has important consequences for patients’ quality of life and relationships,” Ray notes. “If the mood stabilizer doesn’t work, I think it’s very reasonable to consider an antipsychotic, but…other drugs should be considered first.”

Finally, he says, a patient should never stop taking any drug without consulting his or her physician. Nevertheless, anyone taking an atypical antipsychotic for a non-FDA-approved use should consult his physician. “I think off-label use should be undertaken very cautiously, and its frequency should be much less than it is currently,” Ray says. Health.com: Superfoods that can save your health

For Susan Craig, the new research makes it clear that treating serious mental illness must go far beyond just prescribing pills. “We need to be supporting these people in a better, more systematic way,” she says. “There’s no magic pill. It’s treating the whole person.”

Antipsychotic Drugs Linked to Sudden Cardiac Death – CNN.com

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The warning — which won’t be a “black box” warning — applies to all antiepileptic medications, including those used to treat psychiatric disorders, migraines, and other conditions, as well as epilepsy.

Here is a list of the medications required to add the warning:

* Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
* Clonazepam (marketed as Klonopin)
* Clorazepate (marketed as Tranxene)
* Divalproex sodium (marketed as Depakote, Depakote ER, Depakene)
* Ethosuximide (marketed as Zarontin)
* Ethotoin (marketed as Peganone)
* Felbamate (marketed as Felbatol)
* Gabapentin (marketed as Neurontin)
* Lamotrigine (marketed as Lamictal)
* Lacosamide (marketed as Vimpat)
* Levetiracetam (marketed as Keppra)
* Mephenytoin (marketed as Mesantoin)
* Methosuximide (marketed as Celontin)
* Oxcarbazepine (marketed as Trileptal)
* Phenytoin (marketed as Dilantin Suspension)
* Pregabalin (marketed as Lyrica)
* Primidone (marketed as Mysoline)
* Tiagabine (marketed as Gabitril)
* Topiramate (marketed as Topamax)
* Trimethadione (marketed as Tridione)
* Zonisamide (marketed as Zonegran)

Some of those drugs are also sold generically.
Monitor Patients

“Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior,” Russell Katz, MD, says in an FDA news release.

Katz, who directs the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, says that “patients who are currently taking an antiepileptic medicine should not make any treatment changes without talking to their health care professional.”

The FDA also issued a public health alert about the risk and asked health care professionals to notify patients, their families, and caregivers about the risk, so that patients may be closely observed. And the FDA has ordered epilepsy drugmakers to create a risk evaluation and management strategy, including a medication guide for patients, addressing the risk.
Epilepsy Drugs and the FDA

Today’s FDA actions are based on the agency’s review of 199 clinical trials of 11 epilepsy drugs. The review, which the FDA released in January, showed that patients taking those drugs had almost twice the risk of suicidal behavior or thoughts than patients taking a placebo.

That difference was about one additional case of suicidal thoughts or behaviors for every 500 patients treated with antiepileptic drugs instead of placebo.

Four patients who were randomly assigned to take one of the epilepsy drugs committed suicide. There were no suicides in the placebo group. But the results weren’t sufficient to make conclusions about drugs’ effects on completed suicides.

The biological reasons for the increased risk of suicidal thoughts and behavior observed in patients being treated with antiepileptic drugs are unknown, notes the FDA.

In July, the FDA held a public meeting of an independent committee of experts who reviewed the data. The committee agreed with the FDA about the increased risk of suicidality and recommended warning about that risk in the drugs’ labels and in medication guides, rather than requiring a “black box” warning, which is the FDA’s sternest warning.

FDA Orders Suicide Risk Warning for Epilepsy Drugs

Evidence of asthma-related deaths and serious complications led the panel of experts to warn against continued use of Glaxo’s Serevent and Novartis AG’s (NOVN.VX: Quote, Profile, Research, Stock Buzz) Foradil for adults, adolescents and children with asthma.

AstraZeneca Plc’s (AZN.L: Quote, Profile, Research, Stock Buzz) Symbicort also was deemed safe alongside Advair.

All of the inhaled drugs contain long-acting beta agonists, but Advair and Symbicort add a steroid, which the panel felt made the medicines less risky.

“It looks like use of LABAs alone is more dangerous,” said consumer advocate Sidney Wolfe, director of Public Citizen’s Health Research Group.

The U.S. Food and Drug Administration will consider the recommendations as officials decide if the drugs should continue to be approved for treating asthma.

Patients should not stop taking any of their asthma medications without consulting a doctor, John Jenkins, head of the FDA’s Office of New Drugs, advised after the meeting.

Glaxo shares rose 1.8 percent after the panel vote to close at $36.08 on the New York Stock Exchange.

Advair is Glaxo’s best-selling drug with $5.6 billion in worldwide sales through the first nine months of the year. Symbicort’s sales for the same period were $1.5 billion.

Serevent sales were much smaller at $376 million. Schering-Plough Corp (SGP.N: Quote, Profile, Research, Stock Buzz), which markets Foradil in the United States, reported sales of $76 million for that drug.

Staff within the FDA told the panel they were split on how to proceed. Drug-safety reviewers urged limits, including withdrawing the asthma approval for all of the medicines in children. Experts in another division that reviews asthma drugs said the numbers of deaths and serious complications were small and risks were manageable with appropriate warnings.

An FDA analysis found 2.8 more serious asthma-related complications, including deaths and hospitalizations, for every 1,000 patients treated with a LABA.

Asthma is marked by restricted breathing and wheezing and is often made worse by exercise, cigarette smoke and other factors. About 20 million people in the United States have asthma, according to the National Institutes of Health. Uncontrolled asthma can lead to attacks that can be fatal.

Millions of asthma patients use LABAs to help keep their airways open. Doctors on the FDA panel said the drugs offered important benefits for their patients.

Reuters

The warning pertains to the risk of acute phosphate nephropathy, which is a type of acute kidney injury.

The FDA also recommends that consumers not use over-the-counter oral sodium phosphate products, such as Fleet Phospho-soda, for bowel cleansing.

According to the FDA, over-the-counter oral sodium phosphate products, when used for bowel cleansing, pose the same kidney risk as the prescription oral sodium phosphate products. But that risk doesn’t apply to those over-the-counter products used as laxatives.
Kidney Injury Reports

The FDA has received 20 reports of kidney injury associated with OsmoPrep since OsmoPrep’s approval in 2006. Three of those cases were confirmed by biopsy. Some cases happened within hours of use; others were reported days or weeks later.

The FDA has also received reports of 19 cases of acute renal (kidney) failure, seven of which were confirmed by biopsy.

Korvik notes that one reason for the risk might be that some people may be dehydrated and not drinking enough fluid when they use oral sodium phosphate products for bowel cleansing, despite the instructions on the products.

“We don’t believe that all of the patients are at risk,” Korvik said at a news conference.

Charles Ganley, MD, who directs the FDA’s Office of Nonprescription Products, agrees, noting that “the majority” of patients who use those products “don’t run into problems.”

The FDA has asked Salix Pharmaceuticals, which makes Visicol and OsmoPrep, to do a study to learn more about the kidney risk and how to manage it.

Spokespeople for Salix Pharmaceuticals and for C.B. Fleet Company, which makes Fleet Phospho-soda, were not immediately available for comment.
No Reason to Postpone Colonoscopy

Patients 18 and older can still use Visicol and OsmoPrep for bowel cleansing before colonoscopy or other procedures.

But the FDA recommends that people use caution with those products if they are in the following risk groups:

* People older than 55
* People with dehydration, kidney disease, acute colitis, or delayed bowel emptying
* People taking certain medicines that affect kidney function, such as diuretics, ACE inhibitors, angiotensin receptor blockers, and possibly nonsteroidal anti-inflammatory drugs (NSAIDs).

The FDA’s warning doesn’t apply to Golytely, Colyte, Nulytely, Trilyte, and Halflytely, which are polyethylene glycol preparations that can be used for bowel cleansing.

Black Box Warning for Bowel Prep Drugs Visicol, OsmoPrep

Previous studies have linked moderate alcohol consumption with a decreased risk of cardiovascular disease. Hoping to find the same protective effect in the brain, Carol Ann Paul of Wellesley College in Massachusetts and colleagues conducted magnetic resonance imaging (MRI) and health exams on 1,839 adults participating in the Framingham Offspring Study between 1999 and 2001. The participants were of an average age of 60 and none had evidence of clinical dementia or had suffered a stroke. Each were asked how much alcohol they consumed each week, and were then classified as abstainers, former drinkers, or low (one to seven drinks per week), moderate (eight to 14 drinks per week) or high (more than 14 drinks per week) consumers of alcohol. Almost 38 percent of men and more than 44 percent of women fell into the “low-consumption” category.

The researchers found no protective affect on the normal, age-related shrinkage in brain volume. To the contrary, the more a person drank, the more their brain volume diminished. The participant’s brain volumes were measured as a percent of total cranial volume. After adjusting for age, body size, weight and other factors, those in the lowest drinking category had brain volumes of 78 percent of their total cranial volume, compared with 78.6 percent in abstainers. Those in the highest drinking category had brain volumes of 77.3 percent. Interestingly, although men were more likely than women to report being moderate or heavy drinkers, the link between brain volume and alcohol wasn’t as strong in men. For men, only those who were heavy drinkers had a smaller brain volume than those who consumed little or no alcohol where women, even moderate drinkers, had a smaller brain volume than abstainers or former drinkers. The researchers note this gender difference could be due to biological factors, including women’s smaller size and greater susceptibility to alcohol’s effects.

Paul says that while it is unclear why even modest amounts of alcohol may shrink the brain, alcohol is “known to dehydrate tissues, and constant dehydration can have negative effects on any sensitive tissue.” Brain volume decreases with age at an estimated rate of 1.9 percent per decade. At the same time, the brain acquires white matter lesions as it gets older. Lower brain volumes and larger white matter lesions are associated with the progression of dementia and problems with thinking, learning and memory.

“The public health effect of this study gives a clear message about the possible dangers of drinking alcohol,” the study authors concluded. “Prospective longitudinal studies are needed to confirm these results as well as to determine whether there are any functional consequences associated with increasing alcohol consumption.”

However, James Garbutt, M.D., professor of psychiatry at the University of North Carolina at Chapel Hill notes that the study did not demonstrate that the smaller brain volume actually impaired memory or mental function. In addition, the differences between brain volumes in drinkers and non-drinkers were quite small—less than 1.5 percent between abstainers and heavy drinkers. “We’re talking very small differences here,” he says. “We’re not seeing 10 to 20 percent shrinkage.” And while admitting that reduction in brain mass is an interesting finding, he says “we have a long way to go to figure out the implications of it.”

The findings are published in the October issue of the Archives of Neurology.

Medical Updates – Alcohol’s Effect on the Brain | Health News

The research, which looked at information from 2.7 million women, was published in the Journal of the National Cancer Institute.

Aspirin cut the risk by 13%, while ibuprofen lowered it by a fifth.

However, experts warned long-term use of painkillers can have serious side-effects.

There have been many studies looking at the role of painkillers in breast cancer, and the latest is a review of 38 of these, combining their results to give a more reliable picture.

Both aspirin and ibuprofen are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), and it is their ability to interfere with inflammation in the human body which appears to be key.

Two body chemicals which help produce inflammation, COX1 and 2, are thought to play roles in the development of cancer by influencing how cells divide and die, the production of new blood vessels that can “feed” tumours, and influence the body’s immune responses.

It appears NSAIDS inhibit these chemicals.

Women taking either aspirin or ibuprofen regularly had a 12% lower chance of developing breast cancer compared to those who did not use them at all, while regular ibuprofen use appeared to have the biggest effect.

Drug warning

Dr Mahyar Etminan, from the University of British Columbia, who led the research, said the results were “encouraging”, and could help scientists trying to understand the complex origins of breast cancer.

However, he warned against women adopting painkillers as part of a cancer prevention lifestyle.

“We don’t recommend the routine use of NSAIDs for breast cancer prevention until large randomised trials confirm these findings.” He said results from a trial of this type would be available next year.

The regular use of painkillers is problematic because, in some people, they can cause serious side-effects, including stomach ulcers, increased risk of stroke, asthma and heart, liver and kidney problems.

The potential benefits of reducing breast cancer risk would have to be balanced against these.

This advice was echoed by Breakthrough Breast Cancer, which urged women worried about breast cancer risk to talk to their GP rather than simply take painkillers.

Head of policy Sarah Rawlings said: “The potential of anti-inflammatory drugs, such as aspirin, to lower the chances of developing breast cancer is very interesting, but as the researchers say, large scale trials are needed to confirm these findings.

“Anti-inflammatory drugs can have potentially very serious side-effects when taken over a long period.”

BBC NEWS | Health | Painkillers ‘cut breast cancer’

Speaking at the World Economic Forum in the port of Tianjin, Wen did not announce new initiatives but he said the government would work to instill business ethics in light of the milk contamination and a string of earlier product safety disasters.

“We plan not only to revitalize the food industry and the milk powder industry, we will try to ensure that all China-made products are safe for consumers and consumers can buy with assurance,” he said.

Even before the uproar over contaminated milk, China’s manufacturing industry had been under intense scrutiny after the industrial chemical melamine and other industrial toxins were found last year in exports ranging from toothpaste to a pet food ingredient.

The milk scandal erupted this month when the public learned that melamine, which is used to make plastics and fertilizer, had been found in milk powder and was linked to kidney stones in children. Contamination has since turned up in liquid milk, yogurt and other products made with milk.

Four deaths have been blamed on the bad milk and some 54,000 children have developed kidney stones or other illnesses after drinking tainted baby formula.

Authorities say suppliers might have added melamine, which is rich in nitrogen, to watered-down milk to deceive quality tests because the chemical registers as protein.

The incident “has revealed to us that in the process of development, the government should pay more attention to business ethics and social morality,” Wen said.

He defended the handling of the crisis by the Beijing government, which has in the past been accused of being reluctant to come clean in situations that could potentially embarrass the communist leadership.

“When this kind of problem of food safety occurs, we do not cover it up,” Wen said. “We face it candidly and have taken bold moves to address it. I think this has laid a good foundation for resolving problems.”

His comments came a day after the General Administration of Quality Supervision, Inspection and Quarantine sought to reassure people by saying random samples from 296 batches of liquid milk, yogurt and other milk products from 47 brands found none tested positive for melamine.

But authorities in Hong Kong said late Saturday that melamine was detected in Chinese-made milk tablets and in cookies made by Japan’s Lotte China Foods Co. On Thursday, Macau’s Health Bureau reported that melamine in cookies made by Lotte was 24 times the safe limit.

Earlier in the week, contaminated baby cereal was discovered in Hong Kong and snack foods in Japan. Taiwan reported three children and a mother with kidney stones in the island’s first cases possibly linked to the crisis.

Health experts say ingesting a small amount of melamine poses no danger, but in larger doses the chemical can cause kidney stones and lead to kidney failure. Infants are particularly vulnerable.

American welfare group said Saturday that almost a dozen Chinese orphans were among those sickened by the tainted milk.

The children, who live in orphanages around the country, are being treated for kidney stones at hospitals after drinking Sanlu brand powdered milk, the Half the Sky Foundation said on its Web site.

“All orphanages using identified tainted brands have changed to either fresh milk or to a brand that has been identified as safe,” said Jenny Bowen, executive director of the Berkeley, Calif.-based group that provides services, supplies and work crews to 41 Chinese orphanages.

Bowen said the foundation had contacted China’s Ministry of Civil Affairs, which is working to provide guidance to institutes that house babies.

A woman who answered the telephone Saturday at the ministry said a letter had been sent a few days ago to local governments urging them to inspect orphanages. She did not have other details and gave only her surname, Zhang, as is common with Chinese officials.

Chinese leader vows better food safety, ethics on Yahoo! Health

The finding contradicts the conclusion of a pooled analysis from past studies published on Tuesday which found Spiriva raised the risk of heart attack, stroke and death from heart disease.

The results from the new four-year clinical trial, known as Uplift and involving nearly 6,000 patients, showed no such increase.

“There was no evidence of an increased risk of death during the study,” lead investigator Marc De Cramer of the University Hospitals Leuven, Belgium, said in a statement.

His comments were issued by Boehringer which, together with Pfizer, sponsored the Uplift study.

The decision to bring forward release of clinical trial marks a step-up in the fight to defend a drug which had sales of 1.8 billion euros ($2.6 billion) in 2007.

Germany’s privately held Boehringer and Pfizer had already said they strongly disagreed with the conclusions of the pooled analysis published in the Journal of the American Medical Association (JAMA).

Full safety and efficacy data on the Uplift study will be presented at the annual meeting of the European Respiratory Society in Berlin on October 5.

The highlights issued in the statement showed that 381, or 12.8 percent, of patients died in the Spiriva-treated arm of the trial against 411, or 13.7 percent, in the placebo group — a 16 percent risk reduction in favor of Spiriva.

There was also a similar risk reduction for serious cardiac adverse events.

Industry analysts had been looking to the Uplift data to clarify the safety profile of Spiriva, which is used to treat chronic bronchitis and emphysema — serious disorders typically caused by smoking.

If the safety worries over Spiriva drag on, rival drugmakers could benefit and one potential gainer could be Glaxo’s top-selling medicine Advair, according to analysts at Deutsche Bank.

The safety controversy over Spiriva, sparked by the JAMA article, has some similarities to last year’s row over GlaxoSmithKline’s diabetes pill Avandia, which was also linked to increased heart risk in a pooled analysis.

Data released early to show lung drug Spiriva safe | Health | Reuters

A study of 35 healthy men given paroxetine – sold as Paxil or Seroxat by GlaxoSmithKline – found that, on average, the proportion of sperm cells with fragmented DNA rose from 13.8 per cent before treatment to 30.3 per cent after just four weeks.

Similar levels of sperm DNA damage have been linked to problems with embryo viability in couples trying to have children.

The research by Peter Schlegel and Cigdem Tanrikut of the Cornell Medical Center in New York was reported in New Scientist magazine and is due to be presented in November at a meeting of the American Society for Reproductive Medicine.

A copy of the study abstract was made available to Reuters.

‘The fertility potential of a substantial proportion of men on paroxetine may be adversely affected by these changes in sperm DNA integrity,’ the experts concluded.

The study adds to concerns voiced by the same doctors in 2006, after finding that two men had developed low counts of healthy sperm following treatment with two different selective serotonin-reuptake inhibitors (SSRIs).

SSRIs like Paxil/Seroxat and Eli Lilly’s Prozac, both of which are now available generically, are the most commonly prescribed class of antidepressant.

Glaxo said it was reviewing the investigators’ findings, since the study was not conducted by the company.

‘These medicines remain an important option, in addition to counselling and lifestyle changes, for treatment of depression and this study should not be used to cause unnecessary concern for patients,’ a spokesman said.

‘Patients should discuss their situation with their doctor before stopping use of their medicine.’ Dr Allan Pacey, Senior Lecturer in Andrology at the University of Sheffield, said the apparent increase in sperm DNA damage was ‘alarming’, although he noted the level at which damage becomes clinically significant was open to debate.

‘It is a shame that the authors appear not to have conducted a randomised controlled trial which would be the most scientific way to investigate the drugs effects, but I agree that the results are of concern and need to be investigated further,’ he said.

SSRIs have long been known to depress libido in some men and previous research has also found that women taking the medicines are more likely to have a low birth weight baby. — REUTERS

“The caffeine content of energy drinks varies over a 10-fold range, with some containing the equivalent of 14 cans of Coca-Cola, yet the caffeine amounts are unlabeled and few include warnings about potential health risks of caffeine intoxication,” said one of the study’s authors, Roland Griffiths of Johns Hopkins Medical Institutions.

A regular 12-ounce cola drink has about 35 milligrams of caffeine. A 6-ounce cup of brewed coffee has 80 to 150 milligrams of caffeine. The Food and Drug Administration imposes limits on how much caffeine food products can contain (71 milligrams for each 12-ounce can). But energy drinks are designated as dietary supplements, not food products. Thus, manufacturers of energy drinks can load their products with caffeine. Moreover, says Chad Reissig, another of the study’s authors: “It’s notable that over-the-counter caffeine-containing products require warning labels, yet energy drinks do not.”

Caffeine intoxication is a recognized clinical syndrome. It is described as nervousness, anxiety, restlessness, insomnia, gastrointestinal upset, tremors, rapid heartbeat, restlessness and pacing. In rare cases, caffeine intoxication can cause death. See this Mayo Clinic report on caffeine side effects and this L.A. Times story on energy drinks that was written by a doctor.

The authors of the study have called for labeling on energy drinks to inform consumers of what they are getting. Advertising for energy drinks is aimed at teens and young adults and promotes the drinks as performance enhancers. Recently, however, some manufacturers have applied a harder edge to their marketing. One product is named Cocaine, and another product, a powdered energy drink sold in a vial, is named Blow. The makers of both products have received warning letters from the FDA about misleading advertising.

But occasional hand-slaps from the FDA are not enough. Besides caffeine intoxication, the use of energy drinks along with alcohol can be dangerous, the Johns Hopkins researchers say. A recent survey found that 27% of college students said they had mixed energy drinks and alcohol at least once a month. There is even some evidence, says Griffiths, that energy drinks may serve as a “gateway” product leading to more serious drug abuse.

Energy drinks can cause caffeine intoxication | Booster Shots | Los Angeles Times