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Big Weight Gain For Kids on Psych Drugs

From TIME:

Children on widely used psychiatric drugs can quickly gain an alarming amount of weight; many pack on nearly 20 pounds and become obese within just 11 weeks, a study found.

Weight gain is a known possible side effect of the anti-psychotic drugs which are prescribed for bipolar disorder and schizophrenia, but also increasingly for autism, attention deficit disorders and other behavior problems. The new study in mostly older children and teens suggests they may be more vulnerable to weight gain than adults.

The study also linked some of these drugs with worrisome increases in blood fats including cholesterol, also seen in adults. Researchers tie these changes to weight gain and worry that both may make children more prone to heart problems in adulthood.

The study authors said their results show that children on the drugs should be closely monitored for weight gain and other side effects, and that when possible, other medicines should be tried first.

The study appears in Wednesday's Journal of the American Medical Association. It involved 205 New York City-area children from 4 to 19 years old who had recently been prescribed one of the drugs; the average age was 14.

Depending on which of four study drugs children used, they gained between about 10 and 20 pounds on average in almost 11 weeks; from 10 percent to 36 percent became obese.

The drugs are Abilify, Risperdal, Seroquel and Zyprexa. Of the four, Seroquel and Zyprexa are not yet approved for children, and they had the worst effects on weight and cholesterol. However, a government advisory panel recently voted in favor of pediatric use for the two drugs, and the Food and Drug Administration often follows its advisers' recommendations.

The drugs' makers said these problems are known side effects but emphasized the drugs' benefits in helping patients cope with serious mental illness.

The four drugs have been considered safer than older anti-psychotic drugs, which can cause sometimes permanent involuntary muscle twitches and tics. That has contributed to widespread use of the newer drugs, including for less severe behavior problems, a JAMA editorial said.

The number of children using these drugs has soared to more than 2 million annually, according to one estimate.

Why these drugs cause weight gain is uncertain but there's some evidence that they increase appetite and they may affect how the body metabolizes sugar, said Jeff Bishop, a psychiatric pharmacist at the University of Illinois at Chicago. The drugs also can have a sedation effect that can make users less active.

Minn. court: Bong water can count as illegal drug

From the Associated Press:

In Minnesota, bong water can count as an illegal drug.

That decision from Minnesota's Supreme Court on Thursday raises the threat of longer sentences for drug smokers in that state who fail to dump the water out of bong — a type of water pipe often used to smoke drugs.

The court said a person can be prosecuted for a first-degree drug crime for 25 grams or more of bong water that tests positive for a controlled substance.

Lower courts had held that bong water is drug paraphernalia. Possession of that is a misdemeanor crime.

The case involved a woman whose bong had about 2 1/2 tablespoons of liquid that tested positive for methamphetamine. A narcotics officer had testified that drug users sometimes keep bong water to drink or inject later.

Experts: Key drug facts often left off FDA labels

From the Associated Press:

Did you know that Lunesta will help you fall asleep just 15 minutes faster? Or that a higher dose of the osteoporosis drug Zometa could damage a cancer patient's kidneys and raise their risk of death?

Chances are you didn't, and neither did your doctor. Much of what the Food and Drug Administration knows about a drug's safety and effectiveness is not included on the label, say two drug safety experts who are calling on the agency to make that information more accessible.

In this week's issue of the New England Journal of Medicine, researchers from Dartmouth College argue that drug labels don't reflect the nuanced decisions the FDA makes when deciding to approve a drug. The editorial from Drs. Lisa Schwartz and Steven Woloshin recommends easy-to-read fact boxes to help patients weigh the benefits and risks of medications.

If drug labels sometimes exaggerate benefits and play down drug risks, the authors say there's a very good reason: they are written by drugmakers.

While FDA must approve the final labeling, the actual language is drafted by the manufacturer, with input from FDA scientists.

The labeling is based on results from company studies, which generally compare results for patients taking the drug versus those taking placebo.

If FDA decides the drug's ability to treat or prevent a disease outweighs its side effects, the agency is obligated to approve it. But Schwartz and Woloshin point out that benefits may be slim and potential harms may not be fully understood.

In the case of Sepracor Inc.'s blockbuster sleeping pill Lunesta, it's virtually impossible to tell how well the drug works based on the labeling, which only indicates that it worked better than placebo, or a dummy pill.

Only by wading through the FDA's 403-page internal review of Lunesta do the details emerge: patients fell asleep 15 minutes faster and slept 37 minutes longer, on average.

"Lunesta patients still met criteria for insomnia and reported no clinically meaningful improvement in next-day alertness," the authors state.

Despite that lackluster finding, the drug has grown into a $600 million-a-year drug for Sepracor, helped by the company's advertisements featuring a green Lunesta moth.

FDA review documents can also hide critical safety information.

The authors point to the example of Novartis' Zometa, which was approved in 2001 to prevent skeletal fractures in cancer patients with brittle bones. The drug was approved in both 4-mg and 8-mg doses, despite FDA findings of increased kidney damage and death with the higher dose.

FDA went back and added language about kidney toxicity in 2008, but the information about death rates is still missing from the label.

While FDA reviews are posted online, they are often hundreds of pages long and written in extremely dense medical language.

Posted: 10/22/2009 10:10:00 AM

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Drug taboos may block a potential treatment for cluster headaches

From Newsweek:

Though they look like ordinary people, and could easily be your neighbors or colleagues, clusterheads (sufferers of cluster headaches—a condition some doctors call the most painful known to medical science), as they jokingly refer to one another, have excruciating and extraordinary life stories. Their condition is well documented, poorly understood—and devastatingly painful. The medications they use to treat or at least reduce the suffering are sometimes life-threatening, often physically damaging, and usually psychologically and emotionally debilitating. As a rule, they've gone mis- or undiagnosed for years, been called hysterical by general practitioners and neurologists unfamiliar with the condition, and endured countless failed attempts at a cure. Now, thanks to an active online community, and organizations like Cluster Busters, some sufferers are finding relief in an unlikely treatment: the serotonergic psychedelic drugs LSD and psilocybin, two chemicals that helped fuel the psychedelic revelry of the 1960s. Anecdotal reports of the drugs' effectiveness against cluster headaches have even begun to attract the attention of major research universities.

Nobody is certain what actually causes cluster headaches. Theories have ranged from defects in the trigeminal nerve, which branches out across the jaw, face, and forehead, to the irregular swelling of major cranial veins. Recent fMRI studies suggest that these theories are incorrect, and instead point to structural changes in the hypothamalus—the part of the brain responsible for circadian rhythms and other life-sustaining functions. Traditional treatments focus on aborting a headache that has started by self-injecting drugs like sumatriptan or dihydroergotamine, which both share chemical and biological similarities with the neurotransmitter serotonin, or preventing attacks altogether with calcium channel blockers like verapamil and steroids like prednisone. Pure oxygen is often effective at aborting an attack that has just started, but it must be administered almost immediately, and requires the correct type of oxygen mask and tank to be nearby. Unfortunately, long-term, heavy use of most traditional treatments can cause terrible side effects, including poor circulation, organ fibrosis, blood pressure and cardiac disturbances, type 2 diabetes, osteoperosis, anxiety, and other biological and psychological disorders.

Bob Wold, the president of Cluster Busters, came across an online discussion about using LSD or psilocybin to treat cluster headaches. He was hesitant, but 45 minutes after his first dose of psilocybin, he could tell that something remarkable was happening: "My head was clearer than it had felt in 20 years."

But in his quest for a treatment, Wold had also broken the law. According to the Controlled Substances Act, LSD and psilocybin fall under Schedule 1, the most restricted class of drugs in the United States. Unlike all other drugs, those in Schedule 1 cannot be prescribed for any reason, and people caught in possession of them are subject to serious jail time no matter their medical condition. (Cocaine and methamphetamine, by comparison, can be prescribed by a doctor, and are listed in Schedule 2.) These drugs are so restricted by the DEA that researchers at the country's top universities find it almost impossible to get the permission and funding necessary to study the substances in humans. LSD, which is hard to make, is particularly difficult for cluster headache sufferers to find. But a legal gray area—and a little help from mother nature—makes psilocybin much more available. That's because while "magic mushrooms" contain psilocybin, their spores do not—and the online trade in psychedelic mushroom spores is brisk, and legal, in most states. (Actually growing those spores into mushrooms is considered the illegal manufacture of a controlled substance, so the legal loophole only makes the mushrooms easier to find. Possession is still illegal.) In addition, the legality of collecting wild-grown mushrooms containing psilocybin is murky.

In the six years since he founded Cluster Busters, Wold has collected a cache of survey-based data on cluster headache sufferers who have tried LSD or psilocybin. A normal approach to the novel treatment involves taking one to three doses of either substance (Wold says LSD usually works as a single dose, whereas psilocybin often requires three doses spread over a few days) to abort a cluster headache episode that has already started, and twice-yearly maintenance doses to prevent new episodes from coming. (Users are left to figure out what a "dose" actually amounts to, since tabs of LSD vary in strength, and some batches of mushrooms have more psilocybin than others. And because they're both illegal, one doesn't get active dose information and measurements from a dealer like one would from a registered pharmacist—though Wold insists that both are usually taken in small enough amounts that the "doses" remain subpsychedelic.) Wold says that he has documented more than 500 cases of people using this approach, and that roughly 75 percent of those who have tried it have had significant reductions of their symptoms.

Self-reported treatments should always be viewed with skepticism, says Dr. John Halpern, director of the Laboratory for Integrative Psychiatry, Division of Alcohol and Drug Abuse at McLean Hospital, and assistant professor of psychiatry at Harvard Medical School, who attended the Cluster Busters conference. But the strength of Wold's anecdotal evidence warranted further investigation. So in 2006, Halpern and colleagues Andrew Sewell and Harrison Pope Jr. published an analysis of interviews with 53 subjects who had tried LSD or psilocybin for their cluster headaches. What they found was astounding: 41 percent of those who took psilocybin during a cluster episode (which can last for months) reported a decreased intensity or frequency of headaches, and an additional 52 percent said the episode ended altogether; 95 percent of those who took psilocybin between episodes said their next episode was delayed or totally averted. The study was preliminary, unblinded, and uncontrolled, but convincing enough to prompt more methodical research. McLean Hospital and Harvard Medical School are currently reviewing a prospective study using psilocybin to treat cluster headaches in a controlled environment.

With support from McLean Hospital, Harvard Medical School, and Medizinische Hoschule Hannover in Germany, Halpern and a team have begun a pilot study treating cluster headache patients with BOL (also know as 2-Bromo-LSD), a substance almost identical to LSD yet not psychedelic. Halpern presented a preliminary round of results earlier this year at the International Headache Congress, and though only a few subjects have gone through the study, each as had a strong measure of improvement.

The early success of BOL gives sufferers hope for a legal, low-side-effect therapy. But it takes years to get a new drug on the market, and there are no promises that BOL will continue to perform so well if it makes it to later-stage clinical trials. In the meantime, some clusterheads—who euphemistically refer to their writhing, rocking, hair-pulling, wall-punching, head-crushing, crying, screaming attacks as "dancing"—will do what they have to do to relieve their pain. Even if it means breaking the law.

Posted: 10/15/2009 12:30:00 PM

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Heartburn drugs deemed safe for fetuses according to Ben-Gurion University researchers

From EurekAlert!:

H2 Blocker drugs, such as Famotidine, Cimetidine and Ranitidine, approved in the U.S. for acid reflux (heartburn), pose no significant risks for the fetus according to a large collaborative cohort study by researchers at Ben-Gurion University of the Negev.

The study published in the Journal of Clinical Pharmacology provides significant reassurance for the safety of the fetus when H2 blocker drugs are given to women to relieve acid reflux during pregnancy.

H2 blockers are among the most frequently recommended drugs for acid reflux symptoms of heartburn, regurgitation and trouble swallowing, which are common in pregnant women. The findings of a large cohort study examining infants born to mothers who were exposed to H2 blockers, particularly Famotidine, during pregnancy. Usually symptoms of acid reflux are more frequent and more severe in the latter months of gestation. It has been estimated that between 30 percent to 80 percent of pregnant women are affected.

The safety of H2 blockers used during the first trimester of pregnancy was investigated by linking a database of medications dispensed over 10 years to all women registered in Clalit Health Services in the Southern District of Israel, with databases containing maternal and infant hospital records, and with therapeutic abortion records of Soroka University Medical Center, during the same period. In the study, 1,148 (or 1.4 percent) were exposed to H2 blockers during the first trimester of pregnancy of the 84,823 infants born to mothers during the study period.

The rate of major congenital malformations identified in the group that was exposed to H2 blockers during the first trimester was 5.7 percent (65 of 1,148 infants), as compared with a rate of 5.3 percent (4,400 of 83,675 infants) in the unexposed group.

According to principal investigator epidemiologist Dr. Amalia Levy of the BGU Faculty of Health Sciences, and chairwoman of the BeMORE collaboration, "Exposure to H2 blockers among this group was not associated with significantly increased risks of major congenital malformations. The results were unchanged when therapeutic abortions of exposed fetuses were included in the analysis. Also, infants exposed in utero had no increased risk of perinatal mortality, low birth weight or premature birth".

Posted: 10/7/2009 10:52:00 AM

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Vaccine for cocaine habit? May be coming soon

From msnbc.com:

A simple shot could be the latest tool in curbing cocaine abusers' habits, says new research. The vaccine-like shot not only kept them from getting high but also helped them fight their addiction, showed the first successful rigorous study of this approach to treating illicit drug use.

The shots didn't work perfectly, but the researchers say their limited success is promising enough to suggest the intriguing vaccine approach could be widely used to treat addiction within several years.

"It is such an important study. It clearly demonstrates ... that it is possible to generate vaccine that could interfere with cocaine actions in the brain," said Dr. Nora Volkow, director of the National Institute on Drug Abuse, which funded the study.

The results come just days after that government agency announced plans for the first late-stage study of an experimental nicotine vaccine designed to help people quit smoking. The NicVAX vaccine has been fast-tracked by the Food and Drug Administration, and the research will be paid for with federal stimulus money.

The cocaine and nicotine vaccines both use the same approach, stimulating the immune system to produce antibodies that attach to molecules of the drugs and block them from reaching the brain.

In the new study, cocaine-fighting antibodies helped prevent users from getting a euphoric high and led nearly 40 percent of them to substantially cut back or stop cocaine use at least temporarily.

With more than 2 million cocaine abusers nationwide and no federally approved treatment, the results "are good enough — better than having nothing," said lead author Dr. Thomas Kosten of Baylor College of Medicine in Houston. He developed the vaccine used in the study.

The study appears in October's Archives of General Psychiatry, released Monday.

Posted: 10/6/2009 12:18:00 PM

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In 16 states, drug deaths overtake traffic fatals

From SeattlePI.com:

In 16 states and counting, drugs now kill more people than auto accidents do, the government said Wednesday.

Experts said the startling shift reflects two opposite trends: Driving is becoming safer, and the legal and illegal use of powerful prescription painkillers is on the rise.

For decades, traffic accidents have been the biggest cause of injury-related death in the U.S., and they are still No. 1. But drug overdoses are pulling ahead in one state after another.

The drug-related death rate roughly doubled from the late 1990s to 2006, according to the most recent CDC data.

The number of states in which drug-related deaths have overtaken traffic fatalities has gone from eight in 2003 to 12 in 2005, and 16 in 2006. They are: Massachusetts, New Hampshire, Rhode Island, Connecticut, New York, New Jersey, Maryland, Pennsylvania, Ohio, Michigan, Illinois, Colorado, Utah, Nevada, Oregon and Washington.

While cocaine and heroin continue to be significant killers, most of the increase is attributed to prescription opiates such as the painkillers methadone, Oxycontin and Vicodin.

From 1999 to 2006, death rates for such medications climbed for every age group. Deaths from methadone (from msnbc.com) alone increased sevenfold, according to the CDC.

It's not all black market stuff, either.

About half of the opiate medication deaths in King County, Wash., which includes Seattle, involved people who got their drugs through legal prescriptions, said Caleb Banta-Green, a University of Washington research scientist.

"There has been a dramatic change in how doctors prescribe opiates," Banta-Green said.

In the 1990s, he said, doctors began recognizing that chronic pain was undertreated. The prescribing of painkillers escalated after that. Today, about one in five U.S. adults and one in 10 adolescents are prescribed an opiate each year, he said.

Using death certificate data, CDC researchers counted more than 45,000 U.S. deaths nationwide from traffic accidents in 2006, and about 39,000 from drug-induced causes.

About 90 percent of those drug fatalities are sudden deaths from overdoses, but the count includes people who died from organ damage from long-term drug use or abuse.

In Massachusetts, there were more than 1,000 drug-related deaths in 2006, double the number of traffic deaths, according to the CDC. Michigan had about 500 more drug deaths than vehicle fatalities, and New York had 350 more.

Nationally, the death rate from traffic accidents fell by about 6.5 percent from 1999 through 2006 - from 15.3 deaths per 100,000 people to 14.3 per 100,000, according to the National Highway Traffic Safety Administration.