Posts Tagged ‘Cardiac arrest’

Record Breaking $327 Million Verdict Upheld Against Manufacturer of Antipsychotic Risperdal—Request for New Trial Denied

Wednesday, December 21st, 2011

PR Newswire – December 21, 2011

(Click image for international warnings on antipsychotic drugs) The "dear doctor" letter, sent to more than 7,000 doctors across South Carolina, and the package insert were found to be misleading about the safety and effectiveness of the antipsychotic drug Risperdal.

The jury verdict in the case of State of South Carolina versus Ortho-McNeil-Janssen Pharmaceuticals and Johnson & Johnson, Inc. has been upheld and requests for a new trial denied, affirming groundbreaking $327 million in civil penalties against the manufacturers of the drug Risperdal.

Circuit Court Judge Roger Couch announced the rulings on December 20 through two written orders. One order denies the defendant’s motion for judgment notwithstanding the verdict or, in the alternative, for a new trial; the second order denies the defendant’s motion to alter or amend the judgment and/or for a new trial. John B. White, Jr. and Donald C. Coggins, Jr. of Harrison, White, Smith & Coggins, P.C., a Spartanburg-based law firm, along with John Simmons of the Simmons Law Firm, a Columbia-based law firm, and Bailey Perrin Bailey, a Texas based law firm represented South Carolina in the case.

“We are obviously very pleased with Judge Couch’s decision and his careful consideration of this matter,” stated John B. White, Jr. one of the attorneys representing the state in the case. “The verdict handed down by the jury is just and speaks the truth. The damages awarded further substantiated the level of deception Janssen used in business practices in our state. Once again, we have sent a clear message to drug companies that deceptive business practices will not be tolerated in South Carolina.”

On March 22, 2011 a jury in the Spartanburg Court of Common Pleas found that New Jersey-based Janssen willfully violated the South Carolina Unfair Trade Practices Act by engaging in unfair or deceptive acts or practices in the conduct of any trade or commerce in the “dear doctor” letter of November 10, 2003 and the drug label (package insert). This decision represents the first jury verdict that finds the defendant violated unfair trade practices since the inception of its pharmaceutical product. The “dear doctor” letter, sent to more than 7,000 doctors across South Carolina, and the package insert were found to be misleading about the safety and effectiveness of the antipsychotic drug Risperdal. Risperdal was introduced by Janssen in 1994 and by 2005, generated annual revenues in excess of $3.5 billion.

On June 3, 2011 civil penalties amounting to $327,073,700 were ordered by Circuit Court Judge Roger Couch based upon violations found with the drug labels and “dear doctor” letters. Regarding the drug label violations, the judge ruled that 509,499 package inserts were distributed with sample boxes, and levied $300 per violation for a total drug label awarded damages of $152,849,700. Regarding the “dear doctor” letter violations, the judge ruled that 7,184 letters were mailed and 36,372 were provided during sales calls, and levied $4000 per violation for a total “dear doctor” letter awarded damages of $174,224,000.

The combination of the drug label and letter damages of $327,073,700 amounts to the highest verdict brought against Janssen for the drug Risperdal.

http://www.marketwatch.com/story/record-breaking-327-million-verdict-upheld-in-janssen-case-and-request-for-new-trial-denied-2011-12-21

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The US Military’s Drugged Troops: Survey finds at least 1 in 6 service members is on some form of psychiatric drug

Tuesday, August 31st, 2010

Pharmalot
By Ed Silverman
August 31, 2010

The widely used Seroquel antipsychotic was never approved to treat post-traumatic stress disorder or the insomnia sometimes related to the afflication, but that hasn’t stopped the drug from being prescribed for that purpose by the US Department of Veteran Affairs and, in the process, becoming one of the VA’s biggest expenditures.

Since 2001, VA spending on Seroquel jumped more than 770 percent, while the number of patients covered by the VA increased just 34 percent, the Associated Press writes. Seroquel is now the VA’s second-biggest prescription drug expenditure since 2007, behind the Plavix bloodthinner. The agency spent $125.4 million last fiscal year on Seroquel, up from $14.4 million in 2001, and the growth in spending outpaces the growth in personnel who have gone through the military during that time.

Meanwile, thousands of soldiers have taken the med, and several soldiers and veterans have died, raising concerns among some military families the government is not being forthcoming about the risks, the AP writes, noting that they want Congress to investigate. The trend, by the way, is not confined to Seroquel. An investigation earlier this year found that at least one in six service members is on some form of psychiatric drug (background).

According to the VA, Seroquel is only prescribed as a third or fourth option for patients with difficult-to-treat insomnia stemming from PTSD, the AP writes. And the US Defense Department’s deputy director for force health protection, Michael Kilpatrick, tells the news service that the government has not seen any increase in dangerous side effects from Seroquel and other drugs.

Read entire article:  http://www.pharmalot.com/2010/08/the-military-post-traumatic-stress-and-seroquel/

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Antipsychotic Drugs, U.S. Vets & Sudden Deaths: Families Call on Congress to Investigate

Monday, August 30th, 2010

Note from CCHR:  Our psychiatric drug database lists FDA advisory warnings on Seroquel causing sudden death, death, suicide, suicidal ideation, heart problems, as well as a Journal of Toxicology report dating back to 2001, warning of antipsychotic drugs causing stroke, cerebrovascular events (such as loss of brain function) seizures, toxicity, confusion and coma. Simply keyword search Seroquel here (or for a broader search, newer antipsychotics)  http://www.cchrint.org/psychdrugdangers/drug_warnings.php

Questions loom over drug given to sleepless vets

By MATTHEW PERRONE (AP) – 1 hour ago

WASHINGTON — 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.

An investigation by the Veterans Affairs Department concluded that White died from a rare drug interaction. He was also taking an antidepressant and an anti-anxiety pill, as well as a painkiller for which he did not have a prescription. Inspectors concluded he received the “standard of care” for his condition.

It’s unclear how many soldiers have died while taking Seroquel, or if the drug definitely contributed to the deaths. White has confirmed at least a half-dozen deaths among soldiers on Seroquel, and he believes there may be many others.

Spending for Seroquel by the government’s military medical systems has increased more than sevenfold since the start of the war in Afghanistan in 2001, according to documents obtained by The Associated Press under the Freedom of Information Act. That by far outpaces the growth in personnel who have gone through the system in that time.

Seroquel is approved to treat schizophrenia, bipolar disorder and depression, but it has not been endorsed by the Food and Drug Administration as a treatment for insomnia. However, psychiatrists are permitted to prescribe approved drugs for other uses in a common practice known as “off-label” prescribing.

But the drug’s potential side effects, including diabetes, weight gain and uncontrollable muscle spasms, have resulted in thousands of lawsuits. While on Seroquel, White gained 40 pounds and experienced slurred speech, disorientation and tremors — all known side effects.

Last year, researchers at Vanderbilt University published a study suggesting a new risk: sudden heart failure.

The study in the January 2009 edition of the New England Journal of Medicine found that there were three cardiac deaths per year for every 1,000 patients taking anti-psychotic drugs like Seroquel. Seroquel’s unique sedative effect sets it apart from others in its class as the top choice for treating insomnia and anxiety.

AstraZeneca PLC, maker of the drug, said it is reviewing the study. The FDA is conducting its own review, citing the limited scope of the Vanderbilt study.

According to the Veterans Affairs Department, Seroquel is only prescribed as a third or fourth option for patients with difficult-to-treat insomnia stemming from PTSD.

Marine Cpl. Chad Oligschlaeger, 21, was being treated for PTSD when he died in his sleep at Camp Pendleton, Calif., in May 2008. Oligschlaeger was taking six types of medication, including Seroquel, to deal with anxiety and nightmares that followed two tours of duty in Iraq.

The military medical examiner attributed the death to “multiple drug toxicity,” indicating that Oligschlaeger, too, died from a drug interaction. Because of the complex reactions between various drugs, medical examiners do not attribute such deaths to any one medication.

After consulting with physicians, parents Eric and Julie Oligschlaeger now believe their son died of sudden cardiac arrest caused by Seroquel.

“Right now, I’m so angry, and I believe someone needs to be held accountable,” said Julie Oligschlaeger, of Austin, Texas. “The protocol absolutely has to change.”

The Defense Department’s deputy director for force health protection, Dr. Michael Kilpatrick, said the government has not seen any increase in dangerous side effects from Seroquel and other drugs.

Physicians interviewed by the AP said they began prescribing Seroquel because it was the only drug that offered relief from the nightmares and anxiety of PTSD.

“By accident, some people were giving them Seroquel for anxiety or depression, and the veterans said, ‘This is the first time I have slept six or seven hours straight all night. Please give me more of that.’ And the word spread,” said Dr. Henry Nasrallah of the University of Cincinnati, who has treated PTSD patients for more than 25 years.

Most of the soldiers and veterans seeking treatment for PTSD do so at hospitals run by the VA or the Defense Department.

The VA’s spending on Seroquel has increased more than 770 percent since 2001. In that same time frame, the number of patients covered by the VA increased just 34 percent.

Seroquel has been the VA’s second-biggest prescription drug expenditure since 2007, behind the blood-thinner Plavix. The agency spent $125.4 million last fiscal year on Seroquel, up from $14.4 million in 2001.

Spending on Seroquel by the Department of Defense, has increased nearly 700 percent since 2001, to $8.6 million last year, according to purchase records.

Read the rest of this article here: http://www.google.com/hostednews/ap/article/ALeqM5iPPHBQ6w28w4kTXzANGm6kCzPN1gD9HTRUQ80

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Huffington Post—Adderall: The Most Abused Prescription Drug in America; can cause lasting mental defects & death

Tuesday, June 22nd, 2010

The Huffington Post
By Dr. Ronald Ricker and Dr. Venus Nicolino
June 21, 2010

Adderall is abused mostly by college students and young adults. Estimates are that somewhere between 20-30 percent of college students regularly abuse Adderall.

Adderall has the dubious distinction of being the latest addition to the rogue’s gallery of lawful drugs that have made the transition to the black market. In recent years, abuse of Adderall and its imitators has increased by nearly 200 percent. Calling it an “upper” is like calling a hydrogen bomb a grenade. It is made of pure amphetamine, it’s already picked up its share of street monikers: Speed, Beans, Black Beauties, Christmas Trees, and Double Trouble, amongst others.

What are the pluses in this wonder-drug? In ordinary people it often but not always offers increased concentration. It also keeps people awake for more studying and lots more partying. It often offers a sense of euphoria and happiness and a lot better and more frequent sex, all fun at parties.

Between the glut of pop-psychology theories (often fraudulent) and the never-ending blitz of promotion by Big Pharma, people now believe they can diagnose themselves with something like ADHD as easily as ascertaining if they have a head cold and believe they have the ability to determine the correct medication for their condition. Sometimes they’re grandiosely right. Most of the time, however, they’re wrong on both counts. Even more of the time, diagnosis is irrelevant. The relevant question is where’s the “connection?” Sadly, that’s where many of us physicians fit in. We certainly don’t intend to, but often serve as the ‘connection’. Then, of course, there are those ‘patients’ and doctors that inhabit the bottom of the barrel: lying ‘patients’ and immoral doctors. Scripts can and are sold, for lots of money. Never mind the human cost, there’s money to be made and drugs to be copped. Take that prescription to the pharmacy. Or, take your money to a nearby local University. You’ll pay $30 to $40 dollars per pill for a very small amount of Adderall, usually sold to you by a student. Sales are usually student to student although the numbers of genuine drug dealers are growing rapidly in numbers, bringing with them all the problems of low-life, criminal drug dealers. Dealers recognize good business opportunities. Imagining little Johnny, having just finished Geography 1A, dealing with a real dealer chills the mind.

Illicit Adderall is taken in many ways. Most obviously, a pill can be swallowed. Pills can also be chewed, ground up and snorted, and ground up and injected (the most dangerous way of administration, by far). And then there’s ‘Stuffing’. This is accomplished by ‘stuffing’ Adderall in any orifice with a mucous membrane (anus, vagina, penis, mouth, etc.). Shooting gets the most immediate and strongest effect. Snorting is second, chewing third, and stuffing fourth. What ‘stuffing’ lacks in immediate ‘oomph’ and the loss of whatever dignity the person may retain, is made up by the length of effect and allows for the greatest amount of Adderall to be used at one time. The anus and vagina are big places and can hold a great deal of Adderall.

Sadly, there’s no free lunch.

1) Side effects are numerous. Some are minor, some serious, and some very serious. Most users have no clue as to negative side effects and usually don’t care. Ignorance, we suppose, is bliss. The most important and most negative side-effect is the Overdose. Overdose with Adderall is nasty. Results include Cardiac and/or pulmonary arrest, death, severe and lasting mental effects/defects. Which one happens to you is a matter of chance. If you’re in an Emergency Room and still alive your chances are relatively good. If you overdose at your apartment and are alone, the chance of your living is slim. If you Over Dose at a party, maybe a Frat Party, you’ve probably bought it. Drunken, high Frat boys are not known for their medical skills or even a modicum of clear thinking. Minor side effects include anxiety, and transient depression. More serious effects include heart palpitations, elevation of blood pressure, Tourette’s syndrome, seizures, stroke, and psychotic episodes or plain old psychosis.

Read entire article:  http://www.huffingtonpost.com/dr-ronald-ricker-and-dr-venus-nicolino/adderall-the-most-abused_b_619549.html

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