Posts Tagged ‘Paxil’

Treatment for PTSD may be killing veterans

Wednesday, September 1st, 2010

War in Context

by News Source on August 31, 2010

Associated Press reports:

Andrew White returned from a nine-month tour in Iraq beset with signs of post-traumatic stress disorder: insomnia, nightmares, constant restlessness. Doctors tried to ease his symptoms using three psychiatric drugs, including a potent anti-psychotic called Seroquel.

Thousands of soldiers suffering from PTSD have received the same medication over the last nine years, helping to make Seroquel one of the Veteran Affairs Department’s top drug expenditures and the No. 5 best-selling drug in the nation.

Several soldiers and veterans have died while taking the pills, raising concerns among some military families that the government is not being up front about the drug’s risks. They want Congress to investigate.

In White’s case, the nightmares persisted. So doctors recommended progressively larger doses of Seroquel. At one point, the 23-year-old Marine corporal was prescribed more than 1,600 milligrams per day — more than double the maximum dose recommended for schizophrenia patients.

A short time later, White died in his sleep.

“He was told if he had trouble sleeping he could take another (Seroquel) pill,” said his father, Stan White, a retired high school principal.

Activist, Vince Boehm, communicated with the Whites and told Beyond Meds:

Stan and Shirley White lost two sons to war. Robert White, a staff sergeant, was killed in Afghanistan in 2005, when his Humvee was hit by a rocket-propelled grenade. But the death of Robert’s younger brother Andrew, who survived Iraq only to succumb to a different battle, is in some ways “harder to accept” says his father.

Struggling with PTSD compounded by grief over the death of his brother, Andrew sought help from VA doctors. Their first line of defense was to prescribe him 20 mg of Paxil, 4 mg of Klonopin and 50 mg of Seroquel. These medications helped at first, but later proved ineffective. Instead of changing the course of treatment, the doctors responded by continually increasing his dosage until the Seroquel alone reached a whopping 1600 mg per day. Within weeks of Andrew’s death, three more young West Virginia veterans died while being treated for PTSD with the same drugs, prompting Stan and Shirley White to begin a mission to find out what the deaths have in common.

Earlier this year, Martha Rosenberg reported on the same deadly cocktail being used to treat PTSD:

Sgt. Eric Layne’s death was not pretty.

A few months after starting a drug regimen combining the antidepressant Paxil, the mood stabilizer Klonopin and a controversial anti-psychotic drug manufactured by pharmaceutical giant AstraZeneca, Seroquel, the Iraq war veteran was “suffering from incontinence, severe depression [and] continuous headaches,” according to his widow, Janette Layne.

Soon he had tremors. ” … [H]is breathing was labored [and] he had developed sleep apnea,” Layne said.

Janette Layne, who served in the National Guard during Operation Iraqi Freedom along with her husband, told the story of his decline last year, at official FDA hearings on new approvals for Seroquel. On the last day of his life, she testified, Eric stayed in the bathroom nearly all night battling acute urinary retention (an inability to urinate). He died while his family slept.

Sgt. Layne had just returned from a seven-week inpatient program at the VA Medical Center in Cincinnati where he was being treated for post-traumatic stress disorder (PTSD). A video shot during that time, played by his wife at the FDA hearings, shows a dangerously sedated figure barely able to talk.

Sgt. Layne was not the first veteran to die after being prescribed medical cocktails including Seroquel for PTSD.

Read the rest of this article here: http://warincontext.org/2010/08/31/treatment-for-ptsd-may-be-killing-veterans/

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The Over-Prescribing of Psychoactive Drugs to Children: A Scourge of Our Times

Wednesday, September 1st, 2010

The Huffington Post

September 1, 2010

by Dr. Ronald Ricker and Dr. Venus Nicolino

Today, the administration of psychoactive drugs to children (6-17) is all too common and growing at an alarming rate. These drugs often cause the opposite of the intended effect, often condemning children to a life of misery and ill health. The prescription of these drugs is said to treat “chemical imbalances” which were said to cause ADHD, Depression and Bi-polar disorder. It turns out, however, that what we were calling “disease-causing chemical imbalances,” is simply incorrect . The sad irony is, the inappropriate use of these medications is in fact creating different chemical imbalances, which do cause mental disorders, many of which are both life-long and debilitating.

Furthermore, it is now clear that often we are diagnosing ordinary childhood and adolescent behavior as mental disorders (Wait, children are supposed to be bursting with energy? It’s normal for a teenager to be moody and aloof?). This diagnosing is not only based on this idea of “chemical imbalances,” but also a general and pervasive notion that every non-acceptable behavior is due to a mental illness. And last, but certainly not least, the prescribing of these medications by doctors is based on the disinformation provided them by the FDA, drug manufactures and often fraudulent studies, all in the name of making money, on the backs of our children.

In a recent lecture, respected journalist, writer and Nobel Prize Nominee, Robert Whitaker (PBS, Boston, June 15, 2010) highlighted not only the appallingly unscientific methodology used in the development, prescription and use of psychotropic drugs in school-aged children, but also how hopelessly corrupt and failed the systems that should be regulating the safety of medicines are in this country.

Unfortunately, many drug companies exist for one reason: to make money. As such, the people who run these companies have developed a worldview bereft of any more notion of ethics or morality than British Petroleum. Some drug companies’ success is not based on a drug’s usefulness or the safety of its products, but whether it makes money. The path to more money is simple: find new uses for their old drugs, invent new drugs and find new markets for both new and old drugs. Unfortunately, children are today’s newest market.

The FDA requires a “Successful Drug Trial” to approve new medications. “Trial” is often a misnomer, as the word implies some notion of impartiality and unknown outcome. These “trials” often are more like kangaroo courts. In one “trial,” in this case to prove the usefulness of Prozac, corruption and dishonesty were the rule. Children who responded to placebos were removed from the data, as were negative responders to the actual drug. This meant that the only children who were left in the study group were so-called “positive responders.” And, even then, the researchers and doctors, whose “research” funding was provided by the makers of Prozac, were the very ones to decide which subjects, if any, actually did respond “positively” to the drug. This, of course, is a massive conflict of interest. The doctors, researchers and drug companies all want the same thing — FDA approval and to make more money.

In a 2004 article published in perhaps the most prestigious British medical journal, Lancet, said the trial studies used to provide proof of the usefulness of anti-depressant drugs in children, were “nothing but fraudulent.” Following that assessment, all anti-depressants but Prozac were banned in the UK for use on children. (The fact that Prozac was not banned was based on very dubious, some say dishonest, research as documented above).

The true damage caused by the use of anti-depressant drugs like Paxil, Zoloft, Prozac, etc. (AKA of SSRI’s: Selective serotonin reuptake inhibitors) by school-aged children is only found by legitimate, longer studies, like those that continued from 17 months to six years. In one study, 25 percent of children who had been on SSRI’s for three years were re-diagnosed with the much more serious disorder of Bi-polar disease. This number increased to 50 percent after six years of SSRI use. Long-term use of new anti-psychotics may lead to even greater problems than the initial disease. Diabetes, morbid obesity and early death have all been linked to the use of these drugs. And, as written by us in a previous blog both short and long term use of stimulant drugs such as Adderall), have numerous serious side effects.

Read the rest of this article here: http://www.huffingtonpost.com/dr-ronald-ricker-and-dr-venus-nicolino/the-prescribing-of-psycho_b_665838.html

Note: To view all international drug regulatory warnings and studies on psychiatric drugs including those issued specifically for children,visit CCHR’s psychiatric drug search engine here: http://www.cchrint.org/psychdrugdangers/drug_warnings.php

Also see this video – Drugging Our Children: Side Effects – http://www.cchrint.org/videos/

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Psychiatrist pleads guilty to 15 counts of fraud in Paxil clinical trials for kids

Friday, August 20th, 2010

CNBC

Associated Press

NEW ORLEANS – A 58-year-old psychiatrist involved in two clinical trials evaluating the drug Paxil’s safety and effectiveness in children and adolescents has pleaded guilty to 15 federal counts of failing to prepare and maintain records, with intent to defraud and mislead, in connection with those clinical trials.

Dr. Maria Carmen Palazzo was a clinical investigator for SmithKline Beecham doing business as GlaxoSmithKline. Prosecutors say that during those studies she included psychiatric diagnoses inconsistent with patients’ psychiatric histories; prepared multiple psychiatric evaluations on study patients which contained different diagnoses and reported symptoms she knew the study subject did not demonstrate.

Read the rest of this article here:  http://www.cnbc.com/id/38783181

Read more about Maria Carmen Palazzo here: http://medicaresmostwanted.blogspot.com/2007/06/dr-maria-carmen-palazzo-has-been.html

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Glaxo Still Haunted by Faked Paxil Studies in Kids; Crooked psychiatrist expected to plead guilty to criminal charges today

Thursday, August 19th, 2010

“The use of Paxil in children became extremely controversial after it emerged that GSK knew for 15 years, but didn’t tell anyone until 2006, that the drug may carry a risk for suicide. The drug now carries a black-box warning for suicide risk in children.”

BNET
By Jim Edwards
August 19, 2010

A crooked doctor who faked data in a GlaxoSmithKline (GSK) study of the antidepressant Paxil in children pled guilty to criminal charges today, causing groans among GSK’s senior management as the company hopes to fend off a different criminal investigation into whether it manipulated clinical data on its diabetes drug, Avandia. She was sentenced to 13 months in prison.

The two cases are technically completely separate, but they’re both about data manipulation. GSK has been accused of sitting on data showing risks on both drugs; and the FDA previously shut down one of GSK’s factories where both drugs were made.

Thus, the expected guilty plea of Dr. Maria Carmen Palazzo today is a reminder to managers everywhere that cutting ethical corners can cause unwanted chickens to return to their roosts, even years later.

Palazzo was indicted in 2007 on 40 counts of defrauding Medicare and Medicaid at her New Orleans clinic, and 15 counts of conducting fraudulent clinical trials. The charges followed an FDA accusation that she had enrolled 26 children in studies of Paxil for obsessive-compulsive disorder and major depressive disorder. She included children in the trial — which was given the cutesey nickname “Kiddie-Sads-Present and Lifetime” — who did not have the diagnoses being studied. GSK gave her more than $5,000 for each child she enrolled.

At trial, Palazzo was convicted on 39 counts of healthcare fraud and was sentenced to 87 months in prison and forfeiture of $655,000. The clinical trial fraud charges were thrown out, but prosecutors appealed and won a ruling this year reinstating those charges. That appears to be the reason Palazzo is reappearing in court to make a plea.

The use of Paxil in children became extremely controversial after it emerged that GSK knew for 15 years, but didn’t tell anyone until 2006, that the drug may carry a risk for suicide. The drug now carries a black-box warning for suicide risk in children.

Read entire article here:  http://www.bnet.com/blog/drug-business/10-years-later-glaxo-still-haunted-by-faked-studies-of-paxil-in-kids/5545

Read more about Palazzo here:
http://medicaresmostwanted.blogspot.com/2007/06/dr-maria-carmen-palazzo-has-been.html

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Glaxo To Pay $1Billion To Settle Paxil Birth Defect Cases

Wednesday, July 21st, 2010

Pharmalot
By Ed Silverman
July 21, 2010

In an effort to get its arms around massive litigation, GlaxoSmithKline has agreed to settle yet another wad of product-liability lawsuits involving one of its popular meds. The latest deal involves an agreement to pay more than $1 billion to settle some 800 cases alleging its Paxil antidepressant caused birth defects in children borne to women who took the drug, Bloomberg News writes.

The move comes after a Pennsylvania state court jury last October awarded a woman $2.5 million in damages for failing to properly warn docs and pregnant women about the risks of the antidepressant. This case, which was filed by the family of a three-year-old boy who was born with heart defects his mother blamed on the drug. It was the first of 600 such lawsuits and was seen as a test of Glaxo’s vulnerability (background).

Last week, Glaxo disclosed plans to take a $2.4 billion charge in its second quarter to settle product-liability lawsuits over its Avandia diabetes pill, litigation involving the Paxil antidepressant and a US government investigation into its manufacturing site at Cidra, Puerto Rico.

The Paxil deal, which would provide an average payout of more than $1.2 million to families of the affected children, leaves more than 100 similar cases pending. The birth-defect settlements bring to more than $2 billion the amount Glaxo has agreed to pay to resolve a variety of Paxil-related suits, including claims the pill caused suicides or attempted suicides and addiction problems, Bloomberg writes.

Read the entire article here:  http://www.pharmalot.com/2010/07/glaxo-to-pay-1b-to-settle-paxil-birth-defect-cases/

See all international studies/warnings on Paxil: http://www.cchrint.org/psychdrugdangers/drug_warnings.php

See what doctors, pharmacists, health care providers and others have reported to the US FDA on Paxil side effects (such as birth defects): http://www.cchrint.org/psychdrugdangers/medwatch_psych_drug_adverse_reactions.php

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Psychiatric Meds 101: A Surprising Discovery

Tuesday, July 20th, 2010

By Shane “The People’s Chemist” Ellison
Author, Over-The-Counter Natural Cures

I may be a perfect candidate for psychiatry.

I ask questions with period marks to shorten conversations. I avoid eye contact with strangers in fear (maybe it’s anxiety) that I might learn too much about them. I secretly think that Metallica would be making better music if they went back to bludgeoning themselves with party drugs and alcohol, instead of “therapy.” I’m trying to master the Law of Un-attraction to shield myself from a “real job,” small homes and junky cars.  And, I’m constantly giving my children advice, only to give it to myself.

Psychiatry, can your drugs help me?

Perhaps these questions are what motivated me to pursue a career as a drug design chemist, winning multiple awards for my work. Nothing gets me more excited than drugs and how they affect the body (except my wife’s abs). I’ve studied their molecular anatomy, risked life and limb to mix and match explosive chemicals in a round bottom flask, and even sold my soul to Big Pharma in exchange for a lab bench and chemical hood.

During this time, I’ve made some surprising discoveries about psychiatric meds, which include antidepressants, antipsychotics, stimulants, and anti-anxiety drugs. Understanding what I’ve learned will protect you from the flood of side effects that are now being discovered at breakneck speeds, courtesy of the myriad of patients being prescribed psychiatric drugs in the name of mental health.

Your Own Personal Hell

Antidepressants strive to increase the levels of a “coping” molecule known as serotonin in the brain. It supposedly helps us find happiness when it’s covered in an avalanche of nastiness. But, it’s never been proven. Still, the drugs attempt to boost serotonin by “selectively” stopping the “reuptake” among brain cells. This is where the whole SSRI acronym came from—“selective serotonin reuptake inhibitor.” It’s a slick name, but a stupid idea. Nothing is selective in the body.

While trying to block the reuptake of serotonin, antidepressants can also prevent its release and that of another brain compound known as dopamine. The areas of the brain responsible for release and reuptake of these neurotransmitters are so damn similar (after all, they work on the same molecule) that an antidepressant drug isn’t smart enough to understand which one it is supposed to work on. So it does what any dumb drug would do, it blocks both. That’s why users usually carry a glassy stare in their eye. Fully under the psychiatric spell, they’ve tuned out.

Deep sadness, fear, anger and aggression can set in over time. By removing serotonin and dopamine from the brain, long-term antidepressant users can’t find or feel happiness. Instead, they may become buried in the avalanche of nastiness. And if you can’t find or feel happiness in life, what’s the point? What’s going to stop you from snapping your own neck or spraying bullets on your classmates? Not much when you live in your own personal antidepressant hell.

Think this is all opinion?

According to the FDA, antidepressants can cause suicidal thoughts and behavior, worsening depression, anxiety, panic attacks, insomnia, irritability, hostility, impulsivity, aggression, psychotic episodes and violence.  Some even cause homicidal ideation according to the manufacturers. Many long-term antidepressant users will tell you they no longer feel normal emotions—they’re numb, like zombies.

But the side effects of these drugs aren’t limited to hijacking your feelings and emotional state, causing violent and psychotic states. Physical side effects occur too and include abnormal bleeding, birth defects, heart attack, seizures and sudden death. Over one hundred and seventy drug regulatory warnings and studies have been issued on antidepressants, to sound the alarm on these side effects.

For Elephant Use Only

Psychiatrists prescribe antipsychotic meds such as Zyprexa and Seroquel, for anything from schizophrenia, bipolar disorder, delusional disorder, psychotic depression, autism or anything else they can think of, even “pervasive developmental disorder,” which is perfect for boosting sales because it targets children who suffer from irritability, aggression, and agitation. It’s a shame ‘cause these drugs are good for nothing but sedating irate elephants, not curing psychiatric disease.

According to a study published in Psychological Medicine, antipsychotic drugs cause brains to shrink – they lessen brain matter and volume. Originally designed for those deemed “schizophrenic,” the drug companies came up with a brilliant marketing campaign to sell these drugs to a much wider market—unsatisfied antidepressant users. You’ve probably seen the ads—if your “depression medication” isn’t working, then don’t blame the drug; you may just have bipolar disorder!

Once swallowed, antipsychotics sail through the blood stream where they’re carried to the brain. Like a giant oil spill, antipsychotics cover the brain in a medicinal slick, where brain wave transmission is blocked. Users become devoid of normal brain activity. Motivation, drive and feelings of reward are shunted. If psychiatry considers this a “treatment,” they’re the crazy ones.

If you’ve ever seen someone who has suffered from the “spill” courtesy of following doctors orders, you can’t mistake one of the most common side effects, it’s called Akathisia. Involuntary movements, tics, jerks in the face and the entire body can become permanent side effects for antipsychotic users.

Antipsychotics also cause obesity, diabetes, stroke, cardiac events, respiratory problems, delusional thinking and psychosis. Drug regulators from the U.S., Canada, United Kingdom, Ireland, Australia, New Zealand and South Africa warn that they can also lead to death. I wouldn’t be surprised if psychiatrists considered this a cure…

Use This to Jump The Grand Canyon

If you’re going to attempt to jump your scooter over the Grand Canyon, or ride your snowboard off Kilimanjaro, stimulants are great. They flood the brain with dopamine and trigger an inhuman surge of adrenaline, responsible for making you believe life is grand, despite eminent death. Outside of that, you’re either a speed freak, a college student trying to learn an entire semester of Biology 101 in 4 hours, or a fifth grader “following doctor’s orders.”

Top stimulants being prescribed today are nothing more than a mix of amphetamines packaged into trade names like Adderall, Dexedrine and Ritalin.  Street thugs sell it as meth, poor man’s cocaine, crystal, ice, glass and speed. It’s no wonder kids are now abusing Ritalin, Adderall and these drugs more than street drugs, they’re cheaper to get and they’re “legal,” hence the term kiddie cocaine.

Even the U.S. Drug Enforcement Administration (DEA) categorizes Ritalin in the Schedule ll category, meaning a high potential for abuse—just like cocaine and morphine. All of them have the same effects regardless of how they’re named: Central nervous system overload leading to heart attack and/or heart failure. And kids are dropping faster than Meth Heads at Raves…

I’m not exaggerating.

Eleven international drug regulatory agencies and our own FDA has issued warnings that stimulants like Ritalin cause addiction, depression, insomnia, drug dependence, mania, psychosis, heart problems, stroke and sudden death.

Bash Your Head in with Anti-Anxiety Drugs

If you’re not man enough for a drug that could sedate an elephant like antipsychotics, then psychiatrists will prescribe anti-anxiety meds, particularly benzodiazepines. Choosing between the two is akin to deciding whether or not you should be hit in the head with an aluminum bat or a wooden one; anti-anxiety meds being the latter.

Discovered in the stinky chemistry labs of Hoffman La Roche in 1955, anti-anxiety meds aim to trigger sleep receptors in the brain, just slightly. So, rather than being riddled with anxiety, you are put to sleep, halfway. It’s “treatment,” and psychiatrists have been “practicing it for decades.” But, it has yet to work, because drugging your problems away is more dangerous than anxiety. The use of anti-anxiety meds is coupled with a host of nasty side effects such as seizures, aggression and violence once the drug wears off. Hallucinations, delusional thinking, confusion, abnormal behavior, hostility, agitation, irritability, depression and suicidal thinking are all possible outcomes according to Big Pharma’s heavily guarded research papers.

Getting off the drugs could be harder than abandoning a heroin addiction. Some have described withdrawal from “benzos” being akin to pulling hundreds of fish hooks out of their skin, without anesthesia. If you doubt their addictive nature, go to Google search and type in a few of the leading anti-anxiety drugs like Klonopin or Xanax and here is what you’ll find:

“Klonopin withdrawal” 1,860,000 results

“Xanax withdrawal” 1,980,000 results

Exposing Psychiatry: How to Get The Truth

In total, the side effects of psychiatric meds spread far and wide. And most are hidden from patients and doctors alike. Fortunately, Citizens Commission on Human Rights has solved this problem with a state-of-the-art database that allows people to search through the adverse reaction reports sent to the FDA on psychiatric drugs. It also provides international drug regulatory agency warnings and studies published on the side effects of the drugs.

So, can psychiatry help me? No. And that’s surprising because psychiatric meds are some of the biggest selling drugs, poised to seal the hopes and dreams of millions.  Regardless of what mental state I might be in (or anyone else for that matter), there is not a single drug that cures, treats or solves the perceived problems of mental health.

While people can suffer miserably from emotional or mental duress that can hinder their lifestyle, the pseudo-science of psychiatry has yet to solve any of these problems, and in fact only contributes to poor health as seen by the wide array of side effects. Marketing campaigns and ghostwritten medical journals are designed to obscure these facts. But the psychiatric drug side effect database courtesy of CCHR ensures that all patients have access to the truth, to the documented facts, which could save their life or that of a loved one.

About the Author

Shane Ellison holds a masters degree in organic chemistry and is the author of Over-The-Counter Natural Cures.  An award winning chemist, he has been quoted by USA Today, Shape, Woman’s World, as well as Women’s Health and appeared on Fox and NBC as a natural medicine advocate.  Sample his book free at www.thepeopleschemist.com

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GlaxoSmithKline settles case with woman who linked her use of antidepressant Paxil to the death of her infant son

Monday, July 19th, 2010

The Associated Press
By Wayne Ortman
July 19, 2010

SIOUX FALLS, S.D. — A settlement has been reached in a lawsuit filed against a pharmaceutical company by a Watertown woman who linked her prescribed use of Paxil to the death of her infant son, according to court files.

Jennifer Berg of Watertown sued SmithKline Beecham, doing business as GlaxoSmithKline, in October 2007. The complaint said Nathan Berg died in 2004 because of a heart disorder caused by her use of the antidepressant Paxil while she was pregnant.

The federal court lawsuit sought unspecified damages from the company for failing to warn of a link between the two. Letters from her attorneys to the presiding judge indicate there’s a settlement. No settlement documents have been filed in court.

Lawyers at a California firm handling the case for Berg did not immediately return a phone call Monday for comment.

GlaxoSmithKline said last week that it expects to take a $2.36 billion charge against second-quarter earnings for settlements, agreements to settle and other provisions for long-standing legal cases over Paxil, the diabetes drug Avandia and other issues. The company said settlement details would be confidential.

According to the lawsuit, Nathan Berg was born Aug. 20, 2004 at Watertown and was immediately transferred to a Minneapolis hospital where he died 58 days later of Persistent Pulmonary Hypertension of the Newborn (PPHN), a disorder which prevents proper oxygenation of the blood.

“At the time Paxil was prescribed to Ms. Berg, GSK (GlaxoSmithKline) knew or should have known through pre-market studies and post-market studies and reports that Paxil was associated with an increased risk of PPHN in babies whose mothers ingested Paxil during pregnancy,” according to the lawsuit.

Read entire article:  http://www.google.com/hostednews/ap/article/ALeqM5j7UU4otrHhelqaJFcC3ttvwj4bYgD9H29RK00

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Glaxo To Book $2.4 billion To Settle Legal Cases, Including Avandia, Paxil

Thursday, July 15th, 2010

USANewsweek
July 15, 2010

British Pharma giant GlaxoSmithKline is expected to record a legal charge of $2.4 billion for the second quarter of this fiscal year in order to settle legal cases relating to its antidepressant Paxil and controversial diabetes pill Avandia. The British company announced two days ago that the money would be used not only to cover the settlements for Avandia but also other long-standing legal cases. It is learnt that the company would use the money to settle an investigation into its former factory at Cidra in Puerto Rico as well.

The news of the hefty charge, which is around 2.5 percent of the market value of the British drug maker took the edge off an expected rally in the shares after a U.S. panel allowed the company to Avandia in stores but the panel asked Glaxo to include new warnings on heart risks. “Some people might baulk at the size of the charge but probably most will say this is putting it all behind the company, so we can now look to the continuing business and view the stock on a more rational basis,” said Deutsche Bank analyst Mark Clark.

Menwhile, Glaxo did not divulge how much it was setting aside to settle legal issues related to Avandia. The company defended its decision saying that settlement terms were confidential. Earlier, it was reported that Glaxo might have to spend a whopping $6 billion to resolve legal cases related to Avandia but the panel vote allowing the company to keep the drug in market means that the company would be able to settle the claims by paying around $1 billion.

Read entire article:  http://www.usanewsweek.com/news/Glaxo-To-Book-2-4-billion-To-Settle-Legal-Cases–Including-Avandia–Paxil-1279232979/

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Prescription Pill-Popping By Far a Leading Killer as Florida’s Drug Deaths Spike 20%

Thursday, July 1st, 2010

FlaglerLive.Com
July 1, 2010

Oxycodone, the addictive prescription pain-killer also known by its Purdue Pharma brand name OxyContin, directly caused more deaths in Florida in 2009 than cocaine, heroin and morphine combined. Prescription drugs as a whole are killing far more Floridians than illegal drugs, with some 8,600 deaths last year involving at least one prescription drug, according to an annual report released today by the Florida Medical Examiners Commission.

That’s 5 percent of all deaths in Florida in 2009, when 171,300 people died in the state.

The number of people killed by prescription drugs is a significant 20 percent increase over last year’s 6,200 deaths attributed to overdoses. Much of the increase is due to a spike in oxycodone addiction. The increase in prescription-drug addiction continues a trend that began in Florida 10 years ago, when prescription drugs overtook illegal drugs as leading causes of drug-related deaths.

Alcohol is also included in the examiners’ analysis, and it leads the way of all drug-related deaths, with 4,046.

The annual report is a stark look at the effects of legalized drug addiction and over-prescription of drugs, both of which affect a far larger segment of the population than recreational or illegal narcotics.

For the first time in 2009, the commission tracked deaths by region. In Flagler County’s district, which includes St. Johns and Putnam counties, 22 deaths were attributed to oxycodone (the fourth lowest number in the state’s 23 districts), with 13 of those deaths directly attributed to the drug, and nine cited as being present among other drugs that contributed to death.

Hydrocodone claimed 16 lives in the district. Cocaine contributed to 19 deaths in the Flagler district, though only four cases were directly attributed to the drug. In 15 cases, cocaine was present in the body in conjunction with other drugs that proved lethal. Overall in Florida, cocaine-related deaths (including the majority of cases where cocaine wasn’t directly the factor but was present in the body at the time of death), have fallen from a peak of 2,179 in 2007 to 1,462 in 2009. (Again, cocaine was the direct result of death in 529 cases out of those).

Ken Kramer, a researcher with the Citizens Commission on Human Rights of Florida, says the numbers underestimate the extent of the problem, because medical examiners do not track deaths attributed to antipsychotic drugs or to antidepressants, both of which carry black-box or black-label warnings. The warnings on antidepressants, required by the Food and Drug Administration, state that the drugs increase the risk of suicidal thinking and behavior in children, adolescents and young adults up to age 24. (Antidepressants include Paxil, Prozac, Zoloft, Effexor, Lexapro and Celexa.)

Anti-psychotic drugs carry a variety of black label warnings of increased mortality in elderly patients (including a death rate almost twice as high for people taking Risperdal, for example). Those drugs, prescribed and often overprescribed in nursing homes and assisted living facilities, include Abilify, Clozaril, Geodon, Risperdal, Seroquel and Zyprexa.

“Certainly, the actual number of prescription drug deaths is higher than the annual report states,” Kramer said. “It is unknown just how much higher because the Medical Examiners Commission does not track these classes of drugs.”

Two years ago Kramer got his concern heard by the commission following an email exchange with a commissioner in which he argued that antidepressants and anti-psychotic drugs’ contributions to mortality should be part of the annual report. He was rebuffed. One examiner vsaid he had not seen “more than the occasional death caused by these types of drugs,” according to the minutes of the Aug. 13, 2008 meeting of the commission.

Read entire article:  http://flaglerlive.com/7256/florida-prescription-drugs-deaths-oxycontin-oxycodone

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Jury recommends major reforms in drug prescribing after investigation of 18-year-old’s suicide under the influence of Paxil

Wednesday, June 30th, 2010

Pharmalot
By Ed Silverman
June 30, 2010

There have been numerous claims that a medication caused a suicide, but few lead to sweeping changes. In Canada, however, the suicide of 18-year-old Sarah Carlin, who had taken the Paxil antidepressant, is a clear exception. Following a coroner’s inquest, Canada’s provincial and federal governments were told to ensure patients are better informed about drug risks, tighten regulations on drugmakers and establish an independent agency to regulate medications.

“If these things had been in place at the time Sara was prescribed Paxil, she would be alive today,” her father, Neil Carlin, said outside court. “We consider this a great victory…We are truly confident that if these are acted upon there will be young lives saved down the road.”

For more than a year before her death, Sara had been taking Paxil, an anti-depressant, which Health Canada warns can increase the risk of suicidal events in children and adolescents under 18. The teenager hanged herself in her parents’ basement in May 2007. The inquest made numerous recommendations, which you can see if you keep reading…

Of the various recommendations, the one that is garnering the most discussion appears to be the creation of a Drug Safety Board to investigate the side effects and issue warnings to the public, doctors and hospitals. The inquest specifically recommended the new board not receive any funding from drugmakers. Drugmakers must also report all adverse events to Health Canada within 30 days.

A Glaxo spokeswoman writes to says the drugmaker “is supportive of appropriate recommendations designed to prevent similar tragedies from occurring in the future, and will give the recommendations addressed to the broader pharmaceutical industry our full attention and consideration. Sara Carlin’s death was a tragedy and we continue to express our deepest sympathies to her family.”

1. The Ministry of Health and Long-Term Care (MOHLTC) should develop a Drug Information System. This system would promote:
• Patient safety in the prescribing and dispensing of drugs.
• Collection and compilation of data in a single repository for all drugs dispensed for all Ontarians.
• Research into drug and patient safety.

2. The Drug Information System should track and monitor all drugs dispensed in Ontario regardless of who is paying for the prescription.

3. The Drug Information System should collect, compile and release data upon request to scientists such as those studying population-based health outcomes at the Institute for Clinical Evaluative Sciences.

4. The Ministry of Health and Long-Term Care should commit to developing a province-wide suicide prevention strategy as has occurred in other provinces such as Alberta.

5. The objectives of the province-wide suicide prevention strategy should include:
• Enhanced mental health and well being for Ontarians.
• The education of the public to de-stigmatize mental health disorders, including depression and substance abuse disorders.
• Improving intervention and support for Ontarians affected by depression and substance abuse.
• Improving intervention and treatment for those at risk of suicide.
• Increased efforts to reduce access to lethal means of suicide.
• Increased research activities in Ontario on suicide, suicidal behaviour and suicide prevention.
• Improved suicide and suicidal behaviour-related surveillance systems.
• Inform and educate the media into strategies when reporting deaths due to suicide to prevent ‘copy cat’ suicides from occurring.

6. Strategies in the province-wide suicide prevention strategy should be humane, effective and evidence based, respectful of community and culture-based knowledge, inclusive of research, surveillance, evaluation and reporting and reflective of evolving knowledge and practices.

7. The ministry of Health and Long-Term Care of Ontario and Government of Ontario should commit to supporting the development of a national suicide prevention strategy for all Canadians.

Read entire article:  http://www.pharmalot.com/2010/06/sara-carlin-paxil-and-drug-safety-in-canada/

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