Seroquel - more deadly side effects - another one the FDA tried to bury
Here we go again: another deadly side effect from Seroquel that was
Of course when you have the FDA in your pocket, it takes even longer for the public to become aware of the potential dangers and side effects associated with seroquel use. In Fact the FDA in April 2011 told POGO that no new warning were in the offing for seroquel. So without public fanfare the FDA releases this new warning yesterday.
From the NYTimes
Heart Warning Added to Label on Popular Antipsychotic Drug
By DUFF WILSON Published: July 18, 2011AstraZeneca is adding a new heart warning to the labels of Seroquel, its blockbuster antipsychotic drug, at the request of the Food and Drug Administration, company and agency officials said on Monday.
Warnings for Seroquel will soon recommend that the drug be avoided in combination with 12 drugs linked to arrhythmia.
The revised label, posted without fanfare last week on the F.D.A. Web site, says Seroquel and extended-release Seroquel XR “should be avoided” in combination with at least 12 other medicines linked to a heart arrhythmia that can cause sudden cardiac arrest.
Sandy Walsh, a spokeswoman for the F.D.A., said the statement was only a precaution for doctors, and should not be considered a complete ban against prescribing Seroquel with the other drugs.
Ms. Walsh said the label was changed after the F.D.A. received new information about reports of arrhythmia in 17 people who took more than the recommended doses of Seroquel. Though it should not be a problem at a normal dosage, she said, it may still be good advice to avoid using the drugs together.
The arrhythmia, known as prolongation of the QT interval, referring to two waves of the heart’s electrical rhythm, is estimated to cause several thousand deaths a year in the United States.
As AstraZeneca prepares to report its second-quarter earnings at the end of this month, it faces additional scrutiny this week. The F.D.A. is considering the London-based company’s dapagliflozin, a proposed diabetes drug with Bristol-Myers Squibb, and is expected to decide soon on Brilinta, an anticoagulant. The company is facing the loss of patents for Seroquel next year and for the heartburn drug Nexium in 2014.
Seroquel is one of the top-selling drugs in the world, at $5.3 billion last year, including $3.7 billion in the United States. Introduced in 1997, it has been approved for schizophrenia, bipolar disorder and severe depression. Seroquel has caused legal problems for AstraZeneca, including a $520 million payment in 2009 to settle government charges of illegal marketing. Thousands of lawsuits are pending over side effects like diabetes.
The previous Seroquel labels had mentioned the risk of a prolonged QT interval, but had not identified other drugs to avoid, Stephanie Andrzejewski, a spokeswoman for AstraZeneca, said Monday. The new warning also is separated from other warnings and precautions on the label, she said, “to provide some additional guidance to physicians” treating patients ”who are already at risk of QT prolongation.”
The new warning will be added to printed labels as soon as possible, Ms. Andrzejewski said.
The new label lists the other drugs to avoid as antiarrhythmic drugs like quinidine, procainamide, amiodarone and sotalel; antipsychotic drugs like ziprasidone, chlorpromazine and thioridazine; antibiotics like gatifloxacin and moxifloxacin; the anti-infective drug pentamidine; and synthetic opioids like levomethadyl acetate and methadone. The label also raises caution about use by the aged and people with heart disease.
James J. Pepper, a lawyer in Pennsylvania who is involved in drug litigation, has been arguing for months in letters to government officials that Seroquel has a potentially deadly interaction with methadone in regard to the QT interval.
“This is a huge, huge step,” Mr. Pepper said of the label change, though he said he thought it should be stronger.
Ms. Walsh said the F.D.A. action was unrelated to Mr. Pepper’s arguments.
Three months ago, Dr. Janet Woodcock, director of the F.D.A. Center for Drug Evaluation and Research, rejected those arguments in a letter to the Project on Government Oversight, a nonprofit group in Washington, which had also raised the issues. Dr. Woodcock wrote that a thorough agency review had found it “exceedingly unlikely” that patients faced an unreasonable risk from the interaction between Seroquel and methadone. The review found only one death that was probably caused by the interaction, she wrote.
Dr. Woodcock concluded that the F.D.A. would take no action to change the label. Ms. Walsh said that conclusion was still correct, because the F.D.A. had found no biological basis for a problem or unusual numbers of deaths at normal dosages.
From POGO Blog
Paging Dr. Woodcock...Dr. Janet Woodcock....Do You Have Any Clue What's Happening Inside the FDA?
By PAUL THACKER
There is confusion and then there is confused confusion--a level of incomprehensibility that defies sound, sober attempt at explanation. After confused confusion comes...the FDA.
Case in point: the FDA's dithering over changes to the label of an antipsychotic drug now widely prescribed to veterans with post-traumatic stress disorder. Last October, POGO sent a letter to FDA Commissioner Margaret Hamburg asking her to look into a potentially dangerous interaction of the drugs Seroquel (quetiapine) and methadone that may be putting veterans at risk.
Prescriptions of Seroquel and methadone are at an all-time high for veterans who are suffering extremely high rates of PTSD after combat. An investigation by the Military Times found that military spending on Seroquel almost quadrupled between 2001 and 2009. Many of these veterans are also taking methadone for pain relief and to control anxiety caused by PTSD. The Military Times found that methadone overdose has caused at least 60 deaths in the military—more than any other drug, legal or illegal.
A separate investigation by the Associated Press noted that military expenditures on Seroquel have jumped sevenfold since the beginning of the war in Afghanistan. The military spent $8.6 million on Seroquel in 2009. Physicians said that they are prescribing it to provide relief from nightmares and anxiety caused by PTSD.
The Associated Press also discovered that Seroquel has become the Department of Veterans Affairs' (VA) second biggest drug expenditure since 2007. In 2009, the VA spent $125 million on Seroquel compared to $14.4 million in 2001.
Alerting the FDA to this problem, we also sent a study published in 2007 in the Journal of Clinical Psychopharmacology. This study found that Seroquel significantly increases blood plasma levels of methadone.
How did FDA respond? In April, we received a letter signed by Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the FDA. According to Dr. Woodcock, there was nothing to worry about:
After assessment of our evaluations, we believe that a potentially dangerous interaction involving quetiapine and methadone is unlikely, and, therefore, no further Agency action is indicated regarding either a revision in labeling that would include new warnings or cautions, or targeted public and professional communications efforts.To make sure we got the point, she added:
At this point, there is agreement within CDER that an interaction between quetiapine and methadone that confers unreasonable risks to patients is exceedingly unlikely and, therefore, no further action is indicated regarding the labeling for these products or for related communication initiatives.Less than two months later, in June, the FDA approved changes to the label for Seroquel to note that the drug “should be avoided in combination with other drugs” such as methadone.
What the hell? This is exactly what we asked them to do. Exactly what Dr. Woodcock said didn’t need to be done.
Can somebody please explain this to me? Please!
Anyways, we are now sending a second letter to the FDA asking them, as we did in October, to please issue an action alert to inform patients and prescribers. There is a potential for people to die if they are on Seroquel and methadone, and it seems highly improbable that a military doctor treating veterans with PTSD has the time to read the entire 73 pages of the Seroquel label.
That’s right. It's 73 fricking pages!!!
That’s not a label, that’s a novella.
We hope the FDA agrees to send out an action alert. But maybe we’ll get a letter from Dr. Woodcock saying that everything is okay, and no further action is indicated…and there’s no need to alarm people by sending out an action alert….
And then they’ll send it anyways.
Paul Thacker is a POGO Investigator.
AstraZeneca's antipsychotic SEROQUEL: new label revision includes risk of sudden death-QT prolongationStill interested in taking the antipsychotic Seroquel for insomnia off-label? think again, know your medications, this is not a sleep aid. (and it's not an antidepressant)
Seroquel label fine print pdf click here:
• QT Prolongation: Post-marketing cases show increases in QT interval in
patients who overdosed on quetiapine, in patients with concomitant illness, and in
patients taking medicines know to cause electrolyte imbalance or increase QT
interval. Avoid use with drugs that increase the QT interval and in patients with
risk factors for prolonged QT interval.
What is QT Prolongation?
"In cardiology, the QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. In general, the QT interval represents electrical depolarization and repolarization of the left and right ventricles. A prolonged QT interval is a biomarker for ventricular tachyarrhythmias like torsades de pointes and a risk factor for sudden death."-wikipedia
The label changes listed on the info prescribing sheet
RECENT MAJOR CHANGES
Warnings and Precautions, Hyperglycemia (5.4), 1/2011
Warnings and Precautions, Hyperlipidemia (5.5), 1/2011
Warnings and Precautions, Weight Gain (5.6), 1/2011
Warnings and Precautions, QT prolongation (5.12), 6/2011
Warnings and Precautions, Hypothyroidism (5.14), 1/2011
Warnings and Precautions, Withdrawal (5.23), 05/2010
This is an antipsychotic, not an antidepressant, not a sleep aid, it was created for psychosis treatment and is now off-label used and being approved for just about everything imaginable. At what cost does AstraZeneca milk this patent? this is a potent neuroleptic and note that there are withdrawals warnings in the fine print also...
George Carlin had it right...."they got you by the balls"