Seroquel is an antipsychotic drug, but why does this drug have horror stories?
Quick Facts About Seroquel
A | B |
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Generic Name | Quetiapine |
Brand Name | Seroquel, Seroquel XR |
Manufacturer | AstraZeneca Pharmaceuticals LP |
Drug Class | Atypical antipsychotic |
Uses | Treatment of schizophrenia in adults and adolescents (ages 13 and older); treatment of bipolar disorder in adults and adolescents (ages 10 and older); manic episodes; depressive episodes; maintenance therapy |
Mechanism of Action | Blocks dopamine and serotonin receptors in the brain, primarily acting as an antagonist at dopamine D2 receptors |
Dosage Form | Oral tablet, extended-release oral tablet |
Available Strength | Oral tablet (25 mg; 50 mg; 100 mg; 150 mg; 200 mg; 300 mg; 400 mg), Oral tablet, extended release (50 mg; 150 mg; 200 mg; 300 mg; 400 mg) |
Age For Use | Schizophrenia treatment in adults and children at least 13 years old; bipolar disorder treatment in children at least 10 years old |
Dosage | Varies based on condition and patient response |
Controlled Substance Classification | Not a controlled substance |
Common Side Effects | Drowsiness, agitation, constipation, weight gain, dry mouth, blurred vision |
Serious Side Effects | Movement disorders, uncontrolled muscle movements, signs of infection, severe nervous system reaction |
Warnings | Increased risk of death in seniors with dementia-related psychosis; should not be used with certain medications due to increased bleeding risk; Increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults |
Interactions | CNS depressants (e.g., alcohol, benzodiazepines) may enhance sedation; Antidepressants, antihypertensive, and anticholinergic drugs may interact; Strong inhibitors or inducers of CYP3A4 may affect quetiapine metabolism; Use caution with drugs that prolong the QT interval or increase quetiapine levels (e.g., ketoconazole, ritonavir) |
Administration | Typically taken orally, with or without food |
Availability | Prescription only |
Storage | Store at room temperature in a dry place. Keep out of reach of children and pets |
Pregnancy Category | Category C: Potential benefits may warrant use despite potential risks, especially in severe cases |
Lactation | Excreted in breast milk; caution advised; potential risks to the infant |
Seroquel horror stories - What does this really mean? Like why are there horror stories for Seroquel? Sounds unfathomable or weird right?
Today Healthsoothe brings to you the horrifying experiences people have passed through due to using Seroquel.
What is really horrid about Seroquel? Why do we have Seroquel horror stories? Are the side effects of this drug really that devastating? What is the FDA saying about Seroquel?
Find the answer to all these questions and other facts that you have to know or nobody is saying about Seroquel in this article.
Read on.
Firstly, what do you know about Seroquel?
Firstly, before we go further I have to go a little in-depth into Seroquel so that you will have to really know what Seroquel is and we have Seroquel horror stories.
Seroquel is an antipsychotic medication that falls under the category of atypical antipsychotics.
Seroquel is a brand name (trade name) for quetiapine, which may be used to bring calmness and reduce psychotic thoughts.
Seroquel (quetiapine) is known to operate on multiple receptors in the brain; however, some experts think its mood-calming effects may be due to the antagonism of dopamine and serotonin receptors.
Seroquel may also alter histamine receptors (which are important for sedation) and adrenergic alpha1 receptors (responsible for the fall in blood pressure when standing).
Seroquel is available in generic form as quetiapine.
Uses of Seroquel
- Seroquel is a medication that may be used to treat schizophrenia in adults and children over the age of 13.
- Seroquel is also approved for the treatment of bipolar disorder in adults and children over the age of ten.
- Because of its capacity to soothe and induce sleep, it may be used in conjunction with antidepressants or to treat other diseases (off-label uses include anxiety disorder).
Side effects of Seroquel
So, what exactly are the Seroquel side effects that might lead to Seroquel horror stories? Continue reading.
If you are between the ages of 18 and 60, do not take any other medications, and have no other medical issues, you are more likely to have the following negative effects:
- Confusion, headache, tiredness, anxiety, constipation, weight gain, dry mouth, and impaired vision are all possible side effects.
- Sedation might impair your ability to drive or operate machines. Stay away from alcohol.
- May induce a drop in blood pressure, which is especially visible when rising from a seated posture and may increase the risk of falling. Seroquel may also cause an elevation in blood pressure in certain persons.
- It should not be used in seniors suffering from dementia-related psychosis since it raises the chance of mortality.
- Serotonin syndrome may result from a drug interaction or overdosage (symptoms include mental status changes [such as agitation, hallucinations, coma, delirium], fast heart rate, dizziness, flushing, muscle tremor or rigidity, and stomach symptoms [including nausea, vomiting, diarrhea]). Another hazardous illness known as Neuroleptic Malignant Syndrome (NMS) has also been described; symptoms include high body temperature, muscular stiffness, and mental abnormalities; if signs of NMS occur, quit Seroquel immediately and seek urgent medical attention.
- May raise the risk of bleeding, particularly when used with other medications that increase the risk of bleeding.
- Anxiety, anxiousness, or sleeplessness may also occur. All antipsychotics, including Seroquel, have the risk of tardive dyskinesia (uncontrollable, repetitive facial movements).
- Significant weight reduction has been recorded, while some persons may gain weight.
- In persons with undiagnosed bipolar illness, it may trigger a manic episode.
- May result in a decrease in total body sodium (hyponatremia); older patients, those using diuretics, or those who are already dehydrated may be particularly vulnerable.
- If suddenly discontinued, it may produce discontinuation syndrome, which includes irritation, poor mood, dizziness, electric shock feelings, headache, and disorientation.
- High blood sugar levels, which may lead to diabetes, as well as increases in cholesterol or triglyceride levels, have been documented. Seroquel usage may potentially result in hypothyroidism (low thyroid levels).
- Seroquel, like related drugs, may raise the risk of suicide thoughts or actions in young people; the risk is greatest in those under the age of 25.
- Seroquel extended-release should not be administered to anybody under the age of 18.
Note: In general, elderly and children, persons with specific medical disorders (such as liver or kidney issues, heart illness, diabetes, seizures), or those who take other drugs are more likely to suffer severe diabetes, pancreatitis, tardive dyskinesia, and even death.
What will happen if you miss significant doses of Seroquel and what do I do?
Nothing much will happen. Just that if you have missed significant doses of the drug, it will not be effective or potent enough to treat you for the ailment you took it for.
Do the following if you have missed significant doses;
- If you forget to take one or more doses: take your next dose at the usual time and in the average amount. Do not take anymore than your doctor prescribed
- If you miss one dose, skip it and continue with
- your normal schedule.
- Do not increase the dosage to catch up with the missed doses
- You should consult your doctor on what to do if you don’t know what to do.
What will happen if you overdose on Seroquel and what do I do?
Overdosage may result in serotonin syndrome (symptoms include mental status changes [such as agitation, hallucinations, coma, delirium], fast heart rate, dizziness, flushing, muscle tremor or rigidity, and stomach symptoms [including nausea, vomiting, diarrhea]).
Another serious syndrome known as Neuroleptic Malignant Syndrome (NMS) has also been reported; symptoms include high body temperature, muscle rigidity, and mental disturbances; discontinue Seroquel immediately and seek immediate medical attention if any of these symptoms, particularly those of NMS, occur.
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Seroquel Horror stories
Here, I will drop some experiences of people who used Seroquel and have gone through its devastating side effects, making them have one or two Seroquel horror stories to tell.
Seroquel horror stories;
- The first one is from Kathleen A. Shea MA, MPH: At first, it was a love story. It was the winter of 2004. After more than three years of getting a minuscule amount of broken sleep every night and trying every insomnia remedy possible – from herbal and nutritional supplements to Ayurvedic medicine to prescription drugs known to be sedating, such as the antidepressant Remeron (mirtazapine) – a VA psychiatrist decided to prescribe me, off-label, the atypical antipsychotic Seroquel (quetiapine). A specialist in psychopharmacology, he quickly titrated me up to 400 mg and informed me that this was the highest effective dose for insomnia. The results were miraculous. Sleep became easy; I slept a solid eight hours every night and I thought that would be the simple, joyful end of my quest for sleep. As with most love stories, the magic did not last. The Seroquel became less effective and by 2006, I was also seeking the help of a civilian sleep-disorders specialist. He added more drugs to my nightly Seroquel, prescribing Xyrem off-label, which is a highly-controlled chemical cousin of the date-rape drug GHB. Then my sleep disorders specialist added 20 mg of Ambien to the mix. I dutifully followed my doctors’ orders. But after eight months with no appetite and a substantial weight loss off my already slim frame, both doctors decided it would be in my best interest to discontinue Xyrem. By 2009, I had a new VA psychiatrist and was taking a new sleep cocktail consisting of 600 mg of Seroquel, 20 mg of Zyprexa (olanzapine), and 30 mg Restoril (temazepam). Though I had remembered what my previous psychiatrist had told me about not taking above 400 mg for insomnia, I thought maybe this new doctor knew something that the other one didn’t, and I just wanted to feel rested. Soon after, he prescribed 800 mg of Seroquel in addition to the other drugs. Fast forward eight years to the summer of 2017. My VA doctor, who had clearly overmedicated me, finally realized that fact. He had me reduce my dose of Seroquel from 800 mg to 400 mg over four months’ time. Luckily, I didn’t experience any difficulties or worsening of my broken sleep patterns. Recognizing that I was still overmedicated, this doctor then wanted me to withdraw from Zyprexa over two months. I managed to do it in four. I had no problems whatsoever and didn’t notice any worsening of my non-restorative sleep. By this time, however, I’d acquired a myriad of side-effects I’d learned were brought on by Seroquel, including hypothyroidism, supraventricular tachycardia (SVT), and low blood pressure, all of which needed to be controlled by other medications. In June 2018, I mentioned to my psychiatrist that my optical nerve had a suspicious appearance suggesting glaucoma. Since glaucoma is another potential side effect of Seroquel use, this was the last straw for him. He said, “You have no psychiatric illness. You just can’t sleep.” He wanted me to cease my 14-year experience with Seroquel within two weeks’ time. Apparently, he had never looked at my history. Years ago, I had battled Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD). Though I did not follow his advice, a cascade of events happened to fundamentally change my life forever. What my doctor told me would be a quick, two-week affair turned into a 14-month nightmare that I chronicled in my recently published book, Catastrophic Withdrawal: An Insomniac’s Attempt to Withdraw from Seroquel and How It Dramatically Altered Her Life. During my harrowing journey, I ended up spending three months in a psychiatric drug withdrawal clinic with a holistic slant. They claimed they could help me completely withdraw from Seroquel. The clinic was extremely expensive. But with no other options in sight, I decided to attempt their eight-week program. I ended up extending my stay to 11 weeks, and yet, I left the clinic so much worse than when I got there. And I was nowhere near withdrawn from the drug, still taking a 200 mg dose. I was considered one of the most difficult cases of attempted withdrawal from any psychotropic drug they had ever seen. At the beginning of my stay, the medical director, a psychiatrist, was concerned and seemed compassionate. But by my second month there, he and the entire staff did not believe I was on Seroquel just for insomnia. They thought I must certainly have severe mental illness. What else could explain the litany of bizarre effects I experienced during my attempted withdrawal, from partial paralysis to time distortion to days lost to amnesia? I couldn’t do the simplest things to pass the time. I was so cognitively impaired that I did not know how to take a shower, I had no understanding of television, and couldn’t comprehend pamphlets or books. One good thing (if you can call it that) did happen at that clinic. The day after I got there, in October 2018, I was diagnosed with orofacial tardive dyskinesia (TD). I thought back to July 1, at a family birthday celebration, when a very close friend asked me why my mouth, especially my lips and tongue, were moving involuntarily in a strange way that I wasn’t aware of. These movements occurred two weeks after I began my descent from 400 mg of Seroquel, though I didn’t make the connection at the time. I had no idea how important TD would become to what I see now as my purpose in life. Initially, the clinic psychiatrist prescribed amantadine to treat my TD, stating that if it worked, it would work quickly, with a low side-effect profile. But after three weeks on it, my TD persisted, so the naturopathic doctor prescribed high-dose chelated manganese, an alternative treatment based on some small studies conducted decades ago. After six weeks, my involuntary movements were completely gone. I was overjoyed! But a week later, on Christmas Day 2018, something even more frightening took their place. I began to have intermittent difficulties with walking. I had only a week left at the clinic. At the time, no one at the clinic realized that manganese taken at a high dose for TD could accumulate in the movement center of the brain, causing Parkinson’s-like tremors and disturbances with gait and other neurological effects. The medical team just told me I needed leg-strengthening exercises. On New Year’s Eve, I walked out of the clinic on my own two feet, normally. I was dependent on a reliable friend who knew it would be impossible for me to try to navigate the long trip home from Arizona back home to Florida when I was still having difficulty following a simple conversation and had only slept about four hours total in three weeks due to my still-present insomnia. At this point, I wouldn’t have understood how to traverse an airport by myself. There was no way I would have been able to manage my luggage or get through security or make it to the right gate. My friend had made all the arrangements – from booking our flight to renting and driving a car. My friend had planned every part of our itinerary but had no way of knowing that at the first rest stop after leaving the clinic I would be completely unable to walk without assistance. Thankfully, he was a strong, 6’3” man who could manage the situation rather than my 80-year-old mother, who had initially planned to make the trip with me After we made it to the plane, we settled into the roomy first row of seats of the coach section. Thankfully, he thought of this little detail because we are both taller than the average traveler. But now the extra space was crucial because I had intermittent upper-body tremors. After I got settled in for the flight, though my cognition was severely impaired, I picked up and looked at a test of my neurotransmitters that the clinic had conducted. A section heading, “Low Dopamine,” jumped out at me. My eyes were drawn to the last sentence of the paragraph below, which stated, “Manganese excess may … produce Parkinson’s-like symptoms.” That morning, before leaving the clinic, I took my last dose of manganese. Several days after stopping it, my involuntary orofacial movements fully returned. It took three months after returning home from the clinic for my cognition to return. It happened suddenly over a week. My ability to speak without stuttering lasted about three months as well. However, I walked with a cane for eight months. And the TD continued. It was life-changing to live with these disabilities.
- This one is from Cassandra Bartlett: Seroquel was prescribed to me for sleep. I have PTSD and at first i loved it, it would just completely knock me out. It works so good that i couldnt sleep with out it. Years down the road Im still on it but at the moment im tapering off of it. The drug no longer helps me and has become quite harmful to. First of all, they physical effects are quite dangerous. I do not recommend cooking or anything requiring movement at all. I found myself having to sit down on the floor any time i was going in the kitchen or another room as i was about to faint, and fall completely down. Very dangerous. This drug also has become harmful to me psychologically. Every time i take it, about 30 minutes after i start having serious PTSD, like so bad it over takes me to the point where im helpless, crying and met with feelings and images that devastate me. I know every single time i take it, this will happen. I literally have had to call people to talk me thru the torment. I officially am taking my life, my mind, and my well being back. Tapering off because once before i had ran out of it from over taking it and IS THE WORST WITH DRAWAL. I would imagine herion withdrawal to be very similar to the withdrawal symptoms of seroquel. I believe the drug can be helpful in some cases but as a patient progresses through depression and ptsd, maybe think about decreasing dosage or talking to doctor about a safer alternative.
- Jim Cooper: I took seroquel for ten years not for psychiatric reasons but for insomnia worked better than other sleep drugs 25 mg knocked me out but ofcourse the dosage went up by the end I was at 250 and lost my sanity I didn’t know it was from seroquel but it actually killed me last year put my heart into to at prolongation I passed out at 9:30pm no one found me until 11:50 the next day died in the ambulance they resuscitated me and then at the hospital put me in a coma for 3 days this drug is criminal and the makers should be made to take it for a year.
- From Michelle: Both of my elderly in laws were placed under Sereguel after getting sick, then showing signs of dementia.Within a week my father in law turned into a zombie. My husband insisted the medication be stopped immediately. He passed away shortly after that. Years later, today, I am in the hospital with my mother in law who was recuperating from a stomach flu that left her dehydrated. She did mention wanting to go home and said the doctors would end up killing her. She was given Seraquel and fell into what looks like a coma. I am in the process of gathering information but I don’t understand how this garbage that cures nothing can be on the market. She should have been treated at home with an IV and vitamins.
- Stacey’s experience: You are so right about Serequol. Looking back now I feel as though I was a guinea pig but how were they to really understand at the time? I just decided after only a month of taking it or a little longer, that I just didn’t need this drug. I hated it. Made me feel worse. So with my doctor’s blessings he took me off. (He didn’t prescribe it to me to begin with). This particular Doctor was pretty good to me. But yes I am still taking meds but never again with antipsychotics. If they even mention a name in that category I immediately say no. But my Dr. in Tampa was great. But then a life changing event happened to move me out of there. So then I became alive again and alert. I had no choice about that. Also I would like to mention that yes I have known a couple of people who have been on them when I lived in Tampa. One guy, I warned him to get off that crap. He ended up in a nursing home. The other person used it help her sleep at night and someone else that I know of does the same thing. Me, personally I believe this drug Seroquel should be taken off the market.
- Susan: I started Seroquel for racing thoughts. But it made me almost fall asleep during the day. As it happens I tried everything under the sun to help me sleep and nothing worked until Seroquel. I take 50 mg each night and I sleep great. However, I have twitches and weight gain (which I know is in part attributed to menopause). My new psychiatrist who did not prescribe it told me it’s very bad for the body. I tried natural sleep agents he sells throgh his office, but didn’t work. The associate practioner whom I see instesd of him tried to give me a controlled substance, but I read was highly addictive, so I threw the script away and to this day I am still taking seroquel. We’ll see what she says next month.
- From E: I’m speaking from my own experience from living with a girl who needed specific medication for a specific condition….I have looked at other forums that say Seroquel is a bad drug. Here is a short story of my experience. My girlfriend was on a variety of meds, and was switched around meds during a 3-6 month time, during which, I eventually got involved with her Dr. visits. Anti-Depressants, Anti-Anxiety, and other meds for her diagnosed Bi-Polar disorder when she was 18. I met her at 29 and I was not aware of her condition when I met her, since she was “self medicating” herself, and seemed “normal” to me (I don’t take medication, don’t use any illicit drugs). Little did I know, it wasn’t Dr. prescribed medicine, but “street” prescriptions that she was medicating herself with. After numerous break-ups she “came clean” and told me about her addiction. She started seeing a Dr. and a nurse practitioner and they started their trial and error with medication. During this time we broke up a couple more times, the last one being her calling the police on me in a state of paranoia. Within these 3 months, she was committed to the hospital twice, once by the Dr. office and once by her family. This was not the first time her family had gone through this with her(also, not disclosed to me). Like I said, she was diagnosed as Bi-Polar at 18, and her family had tried to help her….at this point they all turned their back on her. Finally, her Dr. took her OFF all meds, and prescribed to her Seroquel. There was about a 2-3 week period that was both horrific and completely entertaining for me when I look back at it. I guess it took about 3 weeks for the Seroquel to kick in. Since that time we have had a wonderful time together. She is a 100% different person. Before, while she was getting switched around meds, she got fired from 2 separate jobs due to her behavior. Now she is acting great, holding a good job, and interacting socially well with the public on a daily and hourly basis. Seroquel has definitely helped this girl out in a good way, and helped us out too. Now…the side effects that I see….
- About 20 minutes after she takes it, she gets hungry, usually for “sweet” food, i.e. ice cream, cereal, or…ice cream, lol.
- Weight gain due to the increased appetite..(although this was a good thing in my case).
- About 20 minutes after she takes it, she gets sleepy. Many nights of me carrying her to bed from the couch.
- Grumpy as hell in the morning. This could be from being groggy from the Seroquel from the night before. If you love someone, you will stick by them during their hard times. I knew nothing of this horrible condition before I met this woman. I have since been trying to get educated about it and will probably never stop learning about it. I do want to say that I don’t disagree with anyone else on this post, or any other post on other websites. This post is my own personal experience with Seroquel.
- Jacquie says: Wow, Seroquel? I was on 700mg (Yes, u heard right) for about a year and a half and basically I was so stoned I missed all that time and didn't function at all! Slept and watched TV. Against (or unbeknownced) to my doctor I cut myself down to 50 mg a day and what a HUGE difference. My life is already fucked up with irratic sleeping patterns – up all night-sleep all day- so I don't need more sleeping issues added on. Is it working for me? who knows? what would I be like without it completely? What i DO know is it turns me into a catatonic couch potatoe. Taking myself off the meds was dangerous and i don't recommend it but I'm so glad i did. I got such a hassle from my doctor when i suggested cutting down my dosage that i just did it behind his back. Now, If I can only deal with my sleeping timetable now. Does anyone else feel like they're sleeping their life away? Ain't mental illness grand?????
- Anonymous: I was given Seroquel in 2006 during my last psych IP when I had been 10 weeks with only 3-4 hours of disturbed sleep per night (if I had sleep). The doc prescribed 25mg and it knocked me out worse than any mickey or minnie. While taking the medication; I would wake up in a complete mental fog. I could not put words together coherently for much of the day. All I wanted to do is sleep and oddly, eat sugary items… the more high in sugar the absolute better. In the 2 months I was on it, I gained 15 lbs. I actually gained 25 but I added the other 10 due to Lithium that I was taking at the exact same time. Within 2 months of starting both meds.. I gained 25 pounds. I was already obese at 185 lbs to start, before the meds. The reason I was finally taken off the Seroquel was because I suddenly developed stiffness in my neck, pain in my lower calve muscles, and a low grade temperature of 100.2 for 4 days. My doctor said this was an adverse reaction and had it removed. I know of folks, whose psychiatrist's, prescribe 900mg per night or more. I know this because I worked in a call center pre-certifying medications for a leading health insurance company just this past winter. I was aghast at such high dosages and one in particular was being prescribed 1200mg per night. The nurse, when asked for the reason for the dosage, said "patient is freaking bipolar and needs it cause otherwise she is just freaking crazy I guess. In fact (and giggled) she was on a much higher dose than this and this is actually reduced." — T
- From mom232012: “I have had a negative experience on Seroquel. I do not want this to deter anyone from taking it, as everyone's reaction and experience on this medicine is subjective; I just want to put this out there for anyone who might be experiencing similar symptoms and reactions and may be hesitant to say it and to just relate my own experience. I am Bipolar 2 and have untreated ADHD due to the ADHD medicines causing manic episodes. I started Seroquel 2 months ago when I was having a bout of insomnia. I should state that I was on Wellbutrin, Lamictal, and Paxil, and was feeling good. I was productive during the day and upbeat. I was prescribed Seroquel for the insomnia and taken off all the other except Lamictal. I am now a "zombie", depressed, sleepy 24/7.”
- Anonymous: “I really noticed a negative difference when comparing the XR version to the regular Seroquel. It took longer to kick in and made me so drowsy at work that I felt like I was drunk. I think I was taking 100-200 mg. When I went back to regular Seroquel, 100-200 mg put me to sleep fast and made a difference in stabilizing my mood without me feeling too drowsy to function the next day.”
Now, what is so terrifying about Seroquel that we have Seroquel horror stories?
Why do we have Seroquel horror stories? What is so horrid about this drug? If you have read through this article to this point, then you will have already discerned why we have Seroquel horror stories.
Right from the various sub-headings above, in which I have dropped info on the side effects of Seroquel and the various bad experiences that people have experienced on using Seroquel, you should know why Seroquel is considered horrid.
But if you haven’t gotten why we have Seroquel horror stories on reading to this point or because you just skimmed the article to this point without taking time to read through, then I will analyze and bring each point here that makes Seroquel to be termed a bad medication and also why we have Seroquel horror stories.
Read on.
Now, the first warning on Seroquel came a dozen years ago, when the Food and Drug Administration accused the drug company AstraZeneca of “false or misleading” information about health risks in the marketing material for its blockbuster medication Seroquel, an antipsychotic developed to treat schizophrenia but increasingly prescribed “off label” for insomnia.
What followed was an onslaught of litigation by state attorneys general, who charged AstraZeneca with fraudulently promoting Seroquel for unapproved uses, and by individual patients, who claimed that it had failed to alert consumers about some of the drug’s most pernicious side effects.
Although the company never admitted wrongdoing, by the end of 2011 it had paid out more than $1 billion to settle many of the cases.
Another product might have been derailed, but not Seroquel. Despite generic competition and lingering lawsuits, AstraZeneca’s annual reports show Seroquel remained a blockbuster, with $3.6 billion in sales from 2014 to 2016.
In the drug’s titanic success and its strong link to off-label prescribing lies a cautionary tale — about the sometimes conflicting forces within health care, the relationship between medications and marketing, and the limits of regulatory protections.
These days, the powerful antipsychotic is used for an expansive array of ills, including insomnia, post-traumatic stress disorder, and agitation in patients with dementia.
Many of the doctors who turn to it for off-label uses are physicians with minimal training in psychiatry and, medical experts say, too little understanding of the potential downsides.
And while the FDA is responsible for oversight of safety issues, it lacks a mandatory reporting system for adverse events that could reveal a more complete picture of problems with a drug.
Adding to the agency’s constraints are recent court rulings that pharmaceutical companies have a First Amendment right to commercial free speech — rulings that raise questions about how much authority the FDA has to regulate off-label marketing of medications.
FDA Commissioner Scott Gottlieb, who has led the agency since May, previously advocated allowing manufacturers to promote uses of their products that the agency had not approved.
Spokeswoman Stephanie Caccomo did not respond to questions about Gottlieb’s current position or concerns he might have about the off-label use of antipsychotics such as Seroquel.
Nor would she say when the FDA will finish reviewing its policies and regulations for “manufacturer communications” about unapproved uses of approved medical products.
The review began during the Obama administration; a public comment period 1https://www.federalregister.gov/documents/2017/01/19/2017-01013/manufacturer-communications-regarding-unapproved-uses-of-approved-or-cleared-medical-products was reopened for three months last year.
“The FDA continues to examine our rules and policies . . . as part of our efforts to make sure our authorities and policies best protect and promote the public health and are informed by ongoing scientific and legal developments,” Caccomo said in an email.
In the meantime, a pill that medical experts say can cause diabetes, heart arrhythmia, and potentially irreversible movement disorders continue to be prescribed to many Americans who are only seeking a good night’s sleep or less anxiety by day.
Many are probably not aware that it is a drug originally aimed at the delusions and paranoia of schizophrenia.
“The range of problems it causes in terms of deteriorating quality of life makes it not worth it,” said David Healy, a British psychiatrist who has written books on psychopharmacology.
Healy says he prescribes Seroquel only for his most seriously ill patients “to be able to function.”
A Washington Post analysis of more than four years of the most recent data from the FDA’s Adverse Event Reporting System 2https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm070093.htm — through the first quarter of 2017 — found about 20,000 cases where Seroquel or its generic equivalent, quetiapine, was listed as the primary or secondary suspect in an adverse event.
That included 1,754 deaths in which they were the primary suspect plus 2,309 deaths in which they were a secondary suspect. Overall, 93 percent were apparently the result of off-label prescribing of the drug.
Earlier data, analyzed by the nonprofit Institute for Safe Medication Practices, looked at adverse events by category of quetiapine use and found that off-label prescribing accounted for more than a quarter of 5,657 cases from 2004 through September 2010.
More than half of the off-label cases were for insomnia and sleep disorders.
The numbers could actually be a significant undercount, too, although that’s impossible to determine because the FDA’s voluntary system depends on someone notifying the agency of a complication or death.
A drug manufacturer is required to alert the FDA only when a healthcare professional or consumer reports an injury directly to the company.
Paul Pennock, a New York City lawyer whose practice focuses on defective drugs and devices, has spoken with dozens of people who alleged their lives were harmed by Seroquel.
Along with a group of other lawyers, he represented 2,200 plaintiffs who were diagnosed with Type 2 diabetes and other related disorders, and who became part of a nationwide, $520 million civil settlement 3https://www.justice.gov/opa/pr/pharmaceutical-giant-astrazeneca-pay-520-million-label-drug-marketing joined by the federal government.
The case involved allegations of illegal marketing and payments to doctors; AstraZeneca denied any improper actions 4http://www.washingtonpost.com/wp-dyn/content/article/2010/04/27/AR2010042703624.html?itid=lk_inline_manual_22.
“Off-label use was the mountain where the billions were made,” Pennock said. “That was the problem with Seroquel.”
Some lawsuits are still pending. The Texas attorney general filed suit 5http://freepdfhosting.com/812e573fad.pdf in 2014, alleging that AstraZeneca defrauded the state’s Medicaid program by having its sales team urge doctors to prescribe the drug for unapproved uses, especially among children.
Bloomberg News reported last November that the state and the company were in settlement talks and quoted an AstraZeneca spokeswoman as saying the allegations were “without merit” and that “all applicable laws were followed.”
illustration of a section of a press release from the Justice Department about its 2010 settlement with AstraZeneca concerning the illegal use and marketing of Seroquel
AstraZeneca declined an interview request. Nearly a decade after that initial FDA warning prompted the drugmaker to revise Seroquel’s warning label 6https://www.law360.com/articles/89176/astrazeneca-to-make-seroquel-label-changes, a company statement stressed that it “is committed to acting responsibly and sharing information about the safety and efficacy of its medicines.”
Both Seroquel and its extended-release version, Seroquel XR, “have been studied and granted several approved indications by the FDA,” the statement continued.
“AstraZeneca provided appropriate clinical trial information to the FDA to support those approvals.
These are important medicines to help people suffering from medical conditions such as schizophrenia and bipolar disorder, which are serious mental illnesses that can take devastating tolls on the lives of individuals and families.”
David Conley, 43, wasn’t thinking about any possible harm when his primary-care doctor suggested in 2013 that he take Seroquel.
Seroquel works like an antihistamine at low doses, with mild sedation as a side effect. That sounded good to Conley, who couldn’t remember when he’d last had a full night’s sleep.
In fact, insomnia had been a constant nearly all his life, as far back as his childhood in the Midwest.
Restless, his mind always “on,” he slept a fitful couple of hours a night, every night, through his college years when he played linebacker on a Division 1 football team.
Conley was proud of maintaining his fitness after graduating and visited the gym almost daily. But lack of sleep made him increasingly miserable.
An internist first prescribed 100 milligrams of Seroquel, a moderate dose to be taken at bedtime. Conley says the doctor never told him it was an antipsychotic drug.
The pill “knocked me out,” he recounted from his home in the Phoenix area, where he works in human resources for a local nonprofit.
“I’d never slept like that.” Yet within weeks, he began gaining weight and his blood-sugar level started to climb. “My hands were swelling at night. . . . I’m taking 200 milligrams two years in, and I notice heart palpitations, pools of sweat at night, stabbing pain in my feet and arms.”
Despite working out, Conley gained 40 pounds. He became pre-diabetic and began taking blood-pressure medication.
He was also seeing more doctors, including a cardiologist for an irregular heartbeat that once frightened him so much he called 911 from a gas station.
“I knew I had to get off this drug,” he said.
As he tried to slowly taper his dosage, however, the symptoms sometimes seemed to worsen. “They say it’s not addictive, but your whole body gets used to it,” Conley said.
“I was back and forth to the hospital . . . 25, 30 times with anxiety attacks and heart palpitations.”
When he asked the internist in 2015 why he had prescribed the drug given all the side effects, he remembers being told, “Because you needed to sleep.”
Even with physicians’ greater awareness of the side effects, they wrote nearly 9 million prescriptions of Seroquel and its generic versions in 2015, the latest year for which data are available through the federal Medical Expenditure Panel Survey.
Many doctors turned to the drug for reasons other than its FDA-approved uses, which have expanded to bipolar disorder and as an adjunct to the treatment of major depression.
A Post review of data provided last year by SERMO, a social network for physicians, found that of 764 non-psychiatrists who said they had prescribed Seroquel or quetiapine, 84 percent did so for off-label uses.
Insomnia was one of the top reasons cited, despite the lack of clinical studies on its efficacy 7http://www.ndshp.org/Resources/Documents/Quetiapine.pdf.
Other reasons doctors cited for giving patients Seroquel ran the gamut: obsessive-compulsive disorder and autism, nausea and poor appetite, and even erectile dysfunction.
illustration of a section of the lawsuit filed by the State of Texas against AstraZenecaconcerning Seroquel in 2014.
Critics such as Aaron Kesselheim of Harvard Medical School, an expert on pharmaceutical development and policy, raise a host of concerns about the proliferation of off-label use generally and about the issues surrounding Seroquel specifically.
“It has to do with pharmaceutical promotion, not enough data, not enough research into the comparative effectiveness of the drugs already approved,” Kesselheim said of Seroquel’s popularity.
“I think there are physicians who are cavalier about products they can use. And there are patients who are demanding and expecting medication.”
Initially, Seroquel seemed to have few side effects or complications, making it appealing as an alternative to the highly addictive benzodiazepines approved for insomnia and anxiety, among other conditions. But expert opinion has shifted.
“The risks are far greater than I think has been represented,” said Mark Olfson, a research psychiatrist at Columbia University and the New York State Psychiatric Institute.
Facebook, Instagram, message boards, and blogs are replete with warnings from people who described serious side effects after they started taking Seroquel or its generic equivalent.
And though the website askapatient.com rates the average patient opinion of Seroquel 8https://www.askapatient.com/searchresults.asp?searchField=seroquel as “satisfied” across a range of FDA-approved and nonapproved uses — “This is the only medication that has ever truly helped me sleep,” a 42-year-old woman posted in 2016 — many other comments reveal distress sometimes bordering on despair.
- From a 58-year-old man, after taking Seroquel for four months for insomnia: “Severe ringing in the ears, raised cholesterol, blood pressure, heart rate, and sugar levels. Serious memory loss.”
- From a 29-year-old woman, after taking Seroquel for one year for anxiety: “Memory loss, shortness of breath, unbeatable fatigue, twitches.”
- From a 36-year-old man, after taking Seroquel for 10 years for insomnia and anxiety: “Was told by psychiatrists for 10 years that 100 mg Seroquel would never cause tardive dyskinesia [a severe movement disorder.] . . . Well, I’m walking around smacking my lips, puckering my lips like a fish and repetitively licking my lower lip.”
Off-label uses of medication carry an inherently higher risk of adverse reactions.
A 2016 study 9https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2467782 by researchers at Canada’s McGill University, Brigham and Women’s Hospital in Boston, and the Massachusetts College of Pharmacy and Health Sciences found a 50 percent higher incidence than for FDA-approved uses.
Yet it’s impossible to know exactly how big a problem adverse events present — for Seroquel or any other drug — since the FDA’s reporting system is voluntary for healthcare professionals.
And while the system is accessible to the public, it includes only raw data that is difficult to navigate.
In a statement to the Post, the FDA said it was “aware that there is substantial variation in the completeness and quality of adverse event reports” and that it “wants to ensure that it is broadly aware of public concerns about the safety of the drugs and biologics it regulates.”
The agency continues “to actively monitor the safety” of antipsychotics such as Seroquel and to update product labeling and medication guides as new information is learned, its spokeswoman noted via email.
“The agency promotes and protects the public health by helping to ensure that these products are safe and effective for their intended uses.”
At the same time, the statement acknowledged the FDA’s “perspective” that once a drug is approved, “health care providers generally may prescribe or use it for unapproved uses when they judge that the unapproved use is medically appropriate for an individual patient.”
In Arizona, Conley keeps trying to rid himself of Seroquel. After he began reducing the dosage, it took him a year to go from 200 milligrams to 25. He held firm even when insomnia returned.
“Coming off, you’re seriously worse. I was struggling through, day by day,” he said. “You’re throwing up, shaking, cold sweats, itching all over my body.”
The man who once took pride in being fit long after his college football career now despairs getting his health back.
Every time he gave in and took a pill — to steal a few hours of sleep — he knew he’d wake in the morning with his heart pounding.
And on the nights he didn’t take Seroquel, he would lie in bed and try to force his body to release, praying for a slumber that rarely came.
Reading through all that above, do I need to go further? You can see throughout the years what Seroquel had done, and the reason we have Seroquel horror stories.
Several lawsuits have been filed against AstraZeneca, the company that produced Seroquel due to the horrific side effects of Seroquel which have even resulted in death.
How can you recover from the horrifying side effects of Seroquel?
As soon as you start observing severe side effects of Seroquel, stop taking Seroquel and consult your doctor immediately. Alternative treatments are available.
If you have already gone far on Seroquel, and the side effects have overwhelmed you, find anyway you can to contact your healthcare provider or your doctor.
It’s never too late. There are various treatments and therapies available for people who have gone too far on Seroquel and it seems there’s nowhere back for them.
All you gotta do is call out for help as soon as you can when you start seeing or observing these side effects.
Timing is also key here, because the more you delay, the more damage is done to your body system, and then often these damages are untreatable and deadly.
Don’t wait to have your own Seroquel horror stories.
Do not be afraid of the various Seroquel horror stories I have written here, but rather I did that for you to know what others are passing through with this drug, and learn from their experience, instead of adding to Seroquel horror stories.
Take control of your life now.
Other tips to note:
- Immediate-release pills may be taken with or without meals. Extensive-release pills should be taken in the evening, either without food or after a small meal. Do not crush or chew the extended-release pills.
- Lower doses are first given. These are progressively raised as required so that tolerance to side effects like sleepiness or low blood pressure develops.
- When rising from sleeping or sitting posture to a standing one, take your time.
- Seroquel may be taken once or many times each day, depending on your doctor's advice and the kind of pill used (for example, immediate vs extended-release).
- If Seroquel makes you tired, do not drive, use equipment, or do dangerous duties.
- Speak with your doctor if you believe your mood is deteriorating, you are agitated, or you are having suicidal thoughts.
- Keep hydrated and avoid drinking while taking Seroquel. Avoid overtraining.
- Inform your doctor if you see any unusual facial movements.
Summarizing on Seroquel horror stories by Healthsoothe
Maybe there were a lot of things you wanted to know about Seroquel but were afraid or shy to ask.
Dear reader, anything concerning your health, never be afraid, shy, or reluctant to speak up and ask questions till you are satisfied, so as to know what you are signing up for, and also not have Seroquel horror stories of your own.
There is so much to know about Seroquel, and really, you’re so right to be afraid.
I’ve done this to make a point to let you know what you’re getting into bed with and in the case of Seroquel, you’re getting into bed with a very dangerous substance.
And whenever you take a (psychotropic, psychiatric) medication it’s worth knowing the risks. Seriously. Like, really worth it. And the risks of taking medication are laid out in black and white in the prescribing information.
And just to be clear, I’m not attacking Seroquel here. Seroquel just happens to be the highest-grossing psychotropic medication and that’s why I picked it.
Prescribing information and all its nastiness is available for any drug. I do think though, particularly everyone on an antipsychotic should look at its full prescribing information.
I’m not suggesting these are bad medications, but what I am suggesting is that they are very dangerous and you need to be made aware of what you need to know about them before you stay on them for years so that you will not regret them later on in the end or have Seroquel horror stories to tell.
Additional resources and citations
- 1https://www.federalregister.gov/documents/2017/01/19/2017-01013/manufacturer-communications-regarding-unapproved-uses-of-approved-or-cleared-medical-products
- 2https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm070093.htm
- 3https://www.justice.gov/opa/pr/pharmaceutical-giant-astrazeneca-pay-520-million-label-drug-marketing
- 4http://www.washingtonpost.com/wp-dyn/content/article/2010/04/27/AR2010042703624.html?itid=lk_inline_manual_22
- 5http://freepdfhosting.com/812e573fad.pdf
- 6https://www.law360.com/articles/89176/astrazeneca-to-make-seroquel-label-changes
- 7http://www.ndshp.org/Resources/Documents/Quetiapine.pdf
- 8https://www.askapatient.com/searchresults.asp?searchField=seroquel
- 9https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2467782
The content is intended to augment, not replace, information provided by your clinician. It is not intended nor implied to be a substitute for professional medical advice. Reading this information does not create or replace a doctor-patient relationship or consultation. If required, please contact your doctor or other health care provider to assist you in interpreting any of this information, or in applying the information to your individual needs.