Atypical Antipsychotics: Patient Safety Information

These documents are all in PDF form. You will need Adobe Acrobat Reader to view them. Download Adobe Acrobat here.

If you prefer, you can view the Patient Safety Information in HTML at the official Food & Drug Administration website.

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Study shows atypical antipsychotics pose a higher risk for cardiac arrest

The New York Times has reported that a recent study found atypical antipsychotics, which include the friendly family of Clozaril, Abilify, Risperdal, Zyprexa, and Seroquel (maybe Saphris soon), can increase a patient’s risk of dying from cardiac arrest twofold.

The study published in The New England Journal of Medicine also concluded that the risk of death from the psychotropic medications isn’t high. However, an editorial also published in the same issue “urged doctors to limit their prescribing of antipsychotic drugs, especially to children and elderly patients, who can be highly susceptible to the drugs’ side effects.”

A U.S. News & World Report article linked to the FDA’s atypical antipsychotics page for further patient information. If you’re on an atypical, I’d recommend reading each word in the patient safety info that applies to you. Proofreaders like me shouldn’t be the only ones tortured with reading all the fine print. *winks*

FDA: No link between Singulair and suicidal behavior

On Tuesday, the FDA announced that an investigation into Merck’s clinical trial data did not discover a link between Singulair (montelukast) and suicidal behavior. The investigation, which began 9 months ago, was prompted by a number of reported suicides, especially that of 15-year-old Cody Miller who took the drug and appeared to have no history of mood or behavioral problems. (It is worth noting here that Singulair “is the top-selling drug for people under 17 years old” and Merck’s biggest seller with annual sales of close to $4.5 billion.)

In attempt to assess Merck’s data better, the FDA also investigated AstraZeneca’s Accolate (zafirlukast) and Cornerstone Therapeutics’s Zyflo (zileuton). Although the FDA did imply that “the data were inadequate to draw a firm conclusion” and said that the clinical trials were not set up to observe any psychiatric behavior. Here are the data the FDA discovered during their review of these trials:

SingulairSingulair: 41 placebo-controlled trials that included 9,929 patients

  • Reports of suicidal thoughts: 1 (treated with Singulair)
  • Attempted suicides: None reported
  • Completed suicides: None reported

AccolateAccolate: 45 placebo-controlled trials that included 7,540 patients

  • Reports of suicidal thoughts: 1 (placebo group)
  • Attempted suicides: 1 (placebo group)
  • Completed suicides: None reported

ZyfloZyflo: 11 placebo-controlled trials (number of patients unknown)

  • Reports of suicidal thoughts: None reported
  • Attempted suicides: None reported
  • Completed suicides: None reported

Forgive me for being cynical but the data sounds fishy. I can’t pinpoint why but it does. The suicide numbers and patient involvement data seem to deviate some from the numbers listed in Merck’s PR issued last March. (I’m seeing 11,000+ patients vs. 9,929 patients.) Regardless of the clinical trial data, it appears that the FDA as of yet have not reviewed post-marketing data.

Scott Korn, a senior safety surveillance executive for Merck said in an article for Reuters:

“‘At the time we did not believe, and we still don’t think a link has been established’ between Singulair and the suicides.”

In the same article, Sanford Berstein analyst Tim Anderson had this to say about the possibility of the FDA finding a link:

“If the… safety review leads to a stern warning about behavioral changes in the Singulair label, this could frighten users of the drug or their parents and give Merck’s competitors ammunition to attack the brand.”

The Washington Post has Dr. David Weldon, director of the Allergy and Pulmonary Lab Services at Scott & White in College Station, Texas, on record saying that he had not “seen any increase in psychiatric problems with the drug but that some patients had complained of nightmares after starting on Singulair.” (Note: It appears that the closest conflict of interest Weldon would have here is that he served as a consultant and is honoraria for AstraZeneca.)

Dr. Rauno Joks, head of the SUNY Downstate division of allergy and immunology, made an interesting point in the Washington Post article:

“The physician really needs to review whether there are symptoms that have developed since patients started taking the medication, if there’s an underlying depression that was there before medication started.

Also, seasonal allergies in and of themselves can cause fatigue and lethargy, which makes it harder to assess, because those are some of the symptoms you have with depression.”

The FDA says they’ve completed analyses of submitted clinical trial data but their “safety review will continue” for several more months before they come to a concrete conclusion. For customer testimonials, check out medications.com that has over 2,300 people reporting side effects and askapatient.com that has an average 2.3 rating from 524 reviewers. The most commonly reported mood-related side effect on both of the sites is irritability.

FDA: Doctors don't disclose conflicts of interest? We don't really care

According to a NYTimes article, government investigators have reported that the FDA doesn’t seem to care much about the financial disclosure of doctors who participated in clinical trials of medication and diagnostic devices. Then get this:

Moreover, the investigators say, agency officials told them that trying to protect patients from such conflicts was not worth the effort. (Despite the fact that the FDA’s rules require it.)

Doctor making moneyThe article goes on to say that in 42 percent of clinical trials, the FDA did not receive financial disclosure forms that might report conflicts of interest and never followed up on them. In 31 percent of the trials in which the forms were received, “agency reviewers did not document that they looked at the information.” And then, in 20 percent of the cases in which doctors disclosed significant financial conflicts—”neither the FDA nor the sponsoring companies took any action to deal with the conflicts.”

Apparently, the NIH has been investigated for the same thing and government investigators came to the same conclusion as in the FDA case.

Loose Screws Mental Health News

The mastermind behind Stavzor is Noven Pharmaceuticals (in conjunction with Banner Pharmacaps Inc.). The new “small, easy-to-swallow soft gel capsule” is available in three strengths: 125, 250, and 500 mgs. The pills are are “up to 40% smaller than han Depakote® and Depakote ER® tablets at the 500 mg dosage strength.” From Noven’s PR:

Stavzor is approved for the treatment of manic episodes associated with bipolar disorder, as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures, and for prophylaxis of migraine headaches.

The drug will hit the market in mid to late August.

The hotline receives an average 250 calls each day from veterans that have fought in Iraq, Vietnam, and Afghanistan.

The issue of soldiers with mental illness has recently come to light with studies showing that 1 in 5 soldiers returning from Iraq and Afghanistan have shown symptoms of post-traumatic stress disorder. The issue of the high suicides rate has been a high priority of the VA since mental health director Ira Katz tried to hide the significant number of suicides committed by veterans.

The National Suicide Prevention Lifeline is available 24 hours a day by calling 800-273-TALK (8255); veterans should press “1” after being connected.

“We have seen a 60 per cent increase in demand for our child anxiety classes in the past six months,” said [Dr. Kimberley O’Brien, of the Quirky Kids Clinic at Woollahra in Sydney].

It sounds more like the article is speaking of children who are exposed to constant physical and emotional abuse. If that’s the case, shouldn’t there rather be an increase in parenting properly classes?

John Grohol interviews Wyeth's VP of Medical Affairs on Pristiq

Dr. Grohol interviewed Dr. Phil Ninan, Wyeth’s VP of Medical Affairs on Pristiq, its efficacy, and surrounding issues. It was quite an interesting interview (and long) but here are some highlights that I chose to comment on. I’ll be making some comments in between Dr. Ninan’s answers due to the extensive length. Some parts of the answers have been truncated.

Read the rest of this entry »

Pittman, Zoloft, and akathisia revisited

Christopher PittmanI’ve written about Christopher Pittman, now 19, who confessed to shooting and killing his grandparents when he was on psych meds at the age of 12. He appealed for a Supreme Court hearing but was denied, CNN reported today. He — and his defenders — appealed on the grounds that his 30-year sentence was “excessive for someone that age” and that the dosage of his antidepressants at the time (200 mg) “sent his mind spinning out of control.” Pittman was tried as an adult and, his lawyers argue, “no other inmate in the United States is serving so severe a sentence for a crime committed at such an early age.”

In previous posts here and here, I’ve questioned the link between Zoloft and violence/rage. Pittman, in 2001, had been switched to Zoloft a few days before the murder of his grandparents. However, it sounds like there had been some emotional problems in Pittman’s life that may have given prosecutors a solid case:

At the time of the crime, the boy had bounced around homes for years, experiencing a half dozen family splits and divorces after his mother had twice abandoned him as a child. She has not been in Pittman’s life for years.

Joe Pittman, the boy’s father, raised Christopher Pittman and his sister for much of their lives, but the relationship between father and son deteriorated. A state psychologist later testified this was a “young man who’d had difficulty with the adults in his life.”

On November 28, 2001, Pittman was sent home early for fighting in school and sent to bed by the grandparents. The boy claimed his “Pop-Pop” also beat him with a belt as punishment.

South Carolina prosecutors may easily have set Pittman up as a disturbed young man, which he very well may have been. But there are indications that this disturbance transcended his emotional state into his mental health:

After threatening to harm himself and suffering other emotional incidents, the boy was diagnosed as clinically depressed. His lawyers said Pittman was then given Paxil, a mild antidepressant no longer recommended for those under 18.

Just days before [shooting his grandparents], a doctor had begun prescribing Zoloft, another antidepressant. The family contends the abrupt substitution of drugs caused a bad chemical reaction, triggering violent outbursts.

At trial, a parade of psychiatrists offered conflicting testimony on whether the boy’s emotional problems excused his criminal behavior. Prosecutors called the Zoloft defense a “smokescreen.”

Juror Steven Platt later told CNN the crime appeared deliberate. “It always seemed like the defense was grasping at straws,” he said. “Just because you take prescription medicine doesn’t mean you can’t be held accountable for your actions.”

Read the rest of this entry »

Brief update on Singulair-suicide link

Merck issued a press release today responding to the FDA’s investigation. Along with the standard "we didn’t know about this problem until after it the market" disclaimer, the PR mentioned:

In a cumulative analysis recently provided to the FDA of Merck’s randomized, double-blind, placebo-controlled clinical trials, which included over 11,000 adults and children in over 40 studies who were treated with SINGULAIR, there were no reports of suicidal thoughts or actions and no completed suicides in the patients who received SINGULAIR.

Additionally, in a cumulative analysis recently provided to the FDA of Merck’s randomized, double-blind, clinical trials that compared SINGULAIR with other active agents to treat asthma (which included over 3,900 adults and children who were treated with SINGULAIR and over 3,400 who were treated with other asthma therapies), there was 1 patient who attempted suicide who received SINGULAIR, and there were 3 patients who attempted suicide who received other asthma therapies (including inhaled corticosteroids and long-acting beta-agonists).  These studies were not designed to compare the rate of suicide in patients taking SINGULAIR with the rate of suicide in patients taking these other asthma agents.

Did Merck report that one suicidal attempt when compared to "other active agents to treat asthma"? It doesn’t say anything in their patient safety or prescribing information when I checked. Perhaps someone can find out whether they reported this in their clinical trials?

In the meantime, the Singulair section of medications.com is ablaze with parents who are now expressing concern over their children’s well-being on the drug. Apparently, issues have cropped up with the drug even before the FDA announced their investigation.

Singulair and Suicidal Behavior

SingulairIn a particularly odd link, the FDA is looking into Singulair, the asthma and allergy drug and its correlation with suicidal behavior. I’ve taken Singulair in the past and not once did it ever occur to me to think about an allergy medication being linked to suicidal behavior. The FDA also says that it could cause mood and behavior changes. The situation that alerted the FDA to this possibility is the story of 15-year-old Cody Miller who killed himself 17 days after switching from allergy medication Allegra to Singulair. Miller’s mother, Kate, approached his medication switch with extreme caution and informed herself of the possible side effects:

She checked the Merck website and the information sheet she got from the pharmacist on Singulair and found no red flags, so they were stumped when Cody started acting out of character.

I have to hand it to Merck: Once the Millers reported Cody’s death, they immediately updated Singulair’s warnings to include suicidal thoughts and actions. However, Cody died on August 4, 2007. Merck updated their information two months later. As of February 29, 2008, the FDA still hadn’t taken any action. Despite the updated warnings, however, doctors and pharmacists were unaware of the new information.

The Singulair website carries the updated side effects, but you have to search it out in the patient information PDF on the fourth of five pages.

If you check with the FDA, you’ll find nothing. That’s because they admit they haven’t updated their website on Singulair since 2001.

According to the FDA’s MedWatch safety information, they have only begun their investigation today. They say it will take 9 months for them to “complete their investigation.” We may not hear of the FDA’s conclusions until early 2009. If this is a single, isolated incident, the FDA may just say the results are inconclusive and allow Merck rip the warning off their patient safety information. It is also important to note, however, that Singulair has also been linked to depression and anxiety.

Read the rest of this entry »

Generic drugs are not exactly like brand names

Gianna at Bipolar Blast stumbled upon an article at the LA Times that outlines the FDA’s standard for generics:

In almost all cases, the FDA permits a generic drug to release 80% to
125% of an active ingredient into the bloodstream, compared to that
released in a single dose of the original medication.

Gianna makes a good point for tapering down on brand-name meds then switching to generics:

And definately too broad when I’ve been cutting down my only 10% at a
time. If the drug is 80% of what I’m taking that is a 20% cut without
intending a reduction. It of course can work the other way and make
coming off the drug a longer task and more difficult if it’s actually
125% of the brand name.

eek – that’s something to think about.

Loose Screws Mental Health News

I recently wrote about the MOTHERS Act and the unnecessary scare tactics surrounding it. A Dallas-Fort Worth TV station picked up on the story and provided a short one-sided view of the issue, continuing to purport that the bill is solely about drugging new moms. I don’t discount Ms. Philo’s terrible experience with her medication. In fact, I’d be against the act if its sole purpose was to force treatment on pregnant women – medicated or not. Again, I’d like to reiterate that the bill’s purpose is to educate moms about postpartum depression and postpartum psychosis – not to shove unnecessary pills down women’s throats.

If you have sleep apnea, your CPAP (Continuous Positive Airway Pressure) machine may alleviate depression symptoms. My husband has sleep apnea and hasn’t been able to use the CPAP machine because of sinus problems. When he doesn’t use it (he hasn’t for a while), he’s noticeably moodier and prone to depressive symptoms. But then again, anyone who doesn’t get good sleep for several days is pretty moody.

Seroquel XRAstraZeneca (AZ) is going after Teva Pharmaceutical Industries and Novartis AG’s Sandoz unit after the two companies applied to make cheaper version of Seroquel available. AZ’s patent on Seroquel expires in 2011. The trial date for patent litigation is August 11. In the meantime, according to the Bloomberg report, the FDA is considering approval of Seroquel XR for bipolar depression and bipolar mania.

What is it about the U.K. that they seem to take pharma’s power more seriously than the U.S.? The UK Medicines and Healthcare products Regulatory Agency (MHRA) charged GlaxoSmithKline (GSK), the maker of Seroxat (Paxil in the U.S.), with not fully disclosing their clinical trial data that downplayed serious side effects such as increasing suicidal tendencies among those 18 years and younger. The MHRA also asserts that Seroxat didn’t alleviate depression as much as GSK’s initial data showed. GSK, of course, denied manipulating the data to show favorable results:

GSK denies withholding data, claiming the risks did not come to light until the results of nine studies were pooled.

The UK minister of public health, Dawn Primarilo, promised to address the issue of Big Pharma hiding negative clinical trial data.

“Notwithstanding the limitations that may exist in the law, pharmaceutical companies should disclose any information they have that would have a bearing on the protection of health,” she says.

In other news, I shouldn’t be a successful writer or novelist. The correlation between creative writers and suicide is ridiculously high. More than 70 well-known writers and poets have successfully committed suicide. How much more “unknown” writers and poets have as well?

(Image from Monthly Prescribing Reference)

I hate to brag, but…

I hate to brag, but…

February 28, 2007
Pristiq's FDA Chances: Depression – Yea; Menopause – Nay

It wouldn't surprise me if they said yea to antidepressant use and nay to vasomotor use because of lack of evidence in improved symptoms.

April 19, 2007
Wyeth looking for Pristiq's FDA approval in 2008

I'll follow Pristiq as the information continues to trickle out but don't expect to hear much about it until next year when Wyeth becomes the proud papa of a brand new (and approved) product.

This is one of the few times I can actually say I was right. (Teenage-like "squee!" goes here.)

More recent posts from:

Loose Screws Mental Health News

Let’s start off small and build up, shall we?

A blog I came upon, Providentia, has a post on the suicide rate in Kentucky over a 10-year period. Male schizophrenics have the highest rate of suicide. The leading methods of suicide in the state are firearm use, overdose, and hanging.


Mary WinklerMary Winkler, the preacher’s wife who killed her husband, has been moved from jail to a mental health facility, where she will serve the remainder of her three-year sentence.


East meadow, a poster on the drugs.com message board, asks about Lexapro’s correlation to suicide. Her sister committed suicide while on Lexapro and questions whether the Lexapro might have affected her in that way. As a former Lexapro user, I can empathize with the change in her sister’s behavior.


The Depression Calculator: see how much depression is costing your company and see if treatment is worth your while. I went through it for kicks and basically, I walked away feeling like it cost too much to hire someone with depression, especially if I were running a small business. Blah.


Apparently, bipolar disorder is covered under the Americans with Disabilities Act (ADA). Starbucks is settling an $85,000 lawsuit with Christine Drake, a former Starbucks employee who suffers from bipolar disorder. It seems that Drake’s first manager was willing to work with her “psychiatric impairment” and allow her to gain “extra training and support.” Then, get this:

“But, during her third year, new management told her she was “not Starbucks material,” refused to continue the accommodation and ultimately fired her for discriminatory reasons, the agency alleged.”

Starbucks probably put up one helluva fight, but in the end, they’ve tried to put a good face and good spin on the situation:

Starbucks agreed to pay Drake $75,000 and donate another $10,000 to the Disability Rights Legal Center, which provides legal representation for low-income people with disabilities facing discrimination, as part of the settlement.

“The facts of this case illustrate how relatively minor accommodations are often all that disabled people need to be productive members of the work force,” said the EEOC’s San Francisco district office director, Joan Ehrlich. “It is important that all of Starbucks’ managers understand their legal duties regarding disabled employees and provide them with the tools necessary to succeed. This is in everyone’s best interest.”

Ms. Drake, who seems to be more than capable of handling a job well, has probably eeked out several years of a barista’s salary from the Starbucks suit.


I’m amused, but it’s not necessarily a good thing.

RisperdalJohnson & Johnson is gearing up to put Risperdal for children on the market. I’m sure other blogs have beat me to the punch on this, but I just came across this info and found it absolutely retarded. (But what do drug companies care?)

The FDA has approved “expanded use” for Risperdal in teenagers who suffer from schizophrenia and the short-term treatment of bipolar mania in kids ages 10-17. I’m leery enough about antidepressants in kids let alone antipsychotics.

“J&J said the agency has not requested the company perform any additional studies, implying that it need only agree with the FDA on acceptable labeling for the expanded uses in order to gain final approval.”

I wasn’t sure what “expanded use” was so I looked it up. This was the best I could come up with:

“Applications for a new or expanded use, often representing important new treatment options, are formally called “efficacy supplements” to the original new drug application.”

Well, I didn’t know what efficacy supplements were so I looked that up too:

“The legislative history indicates that this provision was directed at certain types of efficacy supplements (i.e., supplemental applications proposing to add a new use of an approved drug to the product labeling).”

So – correct me if I’m wrong – it sounds like the studies performed that led up to this “expanded use” are not as rigorously evaluated by the FDA as the initial studies that allowed the drug to be released on the market in the first place. It just seems like a company and the FDA simply need to agree on “acceptable labeling.” So if we’re following the theory that I’m still correct, the FDA doesn’t follow up on the clinical trials performed on these children, they just agree with J&J on the “acceptable labeling.” Doesn’t that thought make you feel all warm and fuzzy inside about your health?


Christopher PittmanOn the subject of children and psychotropic medications, 12-year-old Christopher Pittman shot and killed his grandparents and then set their house on fire in November 2001 all while on an adult dosage of Zoloft. It looks like the drama is still playing out in June 2007.

According to CourtTV.com, Pittman suffered from hallucinations while on the 200 mg dose and while in jail, displayed symptoms of mania.

“Three years after the killings, Pittman was tried in adult court and convicted of murder. He was sentenced to 30 years in prison. He was then 15 years of age.”

No doubt Pittman should be held responsible for what occurred, especially if he admitted to the killings (which he did). However, the situation raises a few questions. First of all, why was he on 200 mg of Zoloft when he was TWELVE? Why wasn’t he considered mentally ill and placed in a mental health facility? I could go on and on. While Pittman “did the crime and needs to do the time,” why isn’t the doctor who prescribed this not present in any of the reported stories? If this incident was 2001, it can only be worse for antidepressants and other psych meds today.

Women & Antidepressants

Pink, a magazine for business women, has an article in its April/May 2007 issue titled, “The Magic Pill.” (The only way to read this article is to get a hard-copy of the mag.) No, this isn’t about birth control. The subhead: “Antidepressants are now used for everything from migraines to menopause. But are women getting an overdose?”

Good question. The article, well-written by Mary Anne Dunkin, does a nice job of trying to present both sides of the coin. One subject, Pam Gilchrist, takes tricyclic antidepressants to relieve her fibromyalgia symptoms. “One of the [antidepressants] that allows her to keep going” is Effexor (venlafaxine). God forbid the woman should ever have to come off of that one. (It works well when you’re on it, but withdrawal is sheer hell.)

The other subject mentioned in the article, Billie Wickstrom, suffers from bipolar disorder, but had a therapist who diagnosed her with obsessive-compulsive disorder. The psychiatrist she was referred to promptly put her on Anafranil (clomipramine). We all know what antidepressants tend to do for those with bipolar disorder. Wickstrom blanked out at an interview that she says she normally would have aced. In another incident, she veered off-course after leaving town and spent the night on the side of the road with her daughter. “Search parties in three states” were out looking for them.

“Three years and three hospitalizations later, Wickstrom is finally free of clomipramine and has a job she loves as PR director for a $300 million family of companies. She says she’s happy, she’s focused and she feels great – consistently.”

Dunkin’s article uncovers a large, problematic use – by my standards, anyway – of off-label usage by doctors.

“Gilchrist… is one of the estimated one in 10 American women taking some type of antidepressant medication. And a considerable percentage of these prescriptions, particularly those for tricyclic antidepressants, are not used to treat depression at all.

A growing number of doctors today prescribe antidepressants for a wide range of problems, including anxiety, chronic pain, insomnia, migraines, high blood pressure, irritable bowel syndrome, premenstrual syndrome, menopausal hot flashes and smoking cessation.”

I’m sure the list goes on, but magazines have but oh so much space.

Melissa McNeilDr. Melissa McNeil at the University of Pittsburgh points out three things:

  1. Since depression is a prevalent (see common) condition, doctors are better detecting it.
  2. Since antidepressants have proven their safety and efficacy, primary care physicians have no reservations prescribing them.
  3. Clinical studies are finding that antidepressants can aid a number of medical issues apart from depression.

My take on McNeil’s points (I’ll try to keep them brief):

  • Depression is way too common to be abnormal. If a woman has a rough patch in life for 2 weeks or more, she’s got depression. As for doctors being better at detecting depression? Studies consistently show that doctors are great at overlooking depression in men.
  • Antidepressants haven’t proven jack squat. Placebos have proven more safety and efficacy than antidepressants. PCPs have no reservations prescribing them because they only know about the positive facts that pharma reps tell them instead of researching the potential side effects.
  • Clinical studies aren’t finding all those things out. Seroquel has FDA-approval to treat psychiatric symptoms (psychosis, for one). As far as I know, Seroquel is not FDA-approved to treat insomnia or crappy sleeping patterns. There are no specific clinical studies to see if Seroquel can treat insomnia. Seroquel is prescribed to treat insomnia/restless sleep because doctors have found that a major side effect of the drug is somnolence. If this is the case, Effexor should be prescribed for weight loss. It’d be the new Fen-Phen.

Dunkin cites two widely used antidepressants for nonpsychiatric uses: Wellbutrin (bupropion) and Prozac (fluoxetine). Zyban, used for smoking cessation is, well, bupropion. Sarafem, used to treat PMS symptoms is – you guessed it – fluoxetine.

Viktor BouquetteDr. Viktor Bouquette of Progressive Medical Group thankfully takes a more cautious approach:

“The widespread use – mostly misuse – by physicians of antidepressants to treat women for far-ranging symptoms from insomnia, chronic fatigue and irritability to PMS and menopause is merely another unfortunate example of the pharmaceutical industry’s tremendous influence on the practice of modern medicine. Take enough antidepressants and you may likely still have the symptoms, but you won’t care.”

Kudos to Dunkin for landing that quote. Since Bouquette is part of an alternative medicine group, he’s got a good motive for slamming pharma companies.

McNeil goes on to sound anti-d happy in the article. Not that it matters, but she is also a section editor for the Journal of Women’s Health, which has several corporate associates representing pharmaceutical companies. (She is also the only source in the article who sings anti-d’s praises.) Dunkin tracked down Dr. Scott Haltzman, a clinical professor at the Brown University Department of Psychiatry, who advocated patient responsibility.

“Just because antidepressants work for depression does not mean they should always be used. People need to learn skills to manage their depressive symptoms instead of depending on medication. When you take medicine for every complaint, you lose the opportunity to learn how to regulate your mood on your own.”

Oh, for more doctors like Haltzman and Bouquette.

UPDATE: Uh, alleged fraud suit pending against Progressive Medical Group. Bouquette is now part of Progressive Medical Centers of America.

Loose Screws Mental Health News

In one of the scariest articles I’ve read in a while, Ms . Jane Brody in the NYT explains the symptoms and results of an illness called serotonin syndrome. And yes, too much of it can be fatal. Key symptoms to watch out for:

  • Cognitive-behavioral symptoms like confusion, disorientation, agitation, irritability, unresponsiveness and anxiety.
  • Neuromuscular symptoms like muscle spasms, exaggerated reflexes, muscular rigidity, tremors, loss of coordination and shivering.
  • Autonomic nervous system symptoms like fever, profuse sweating, rapid heart rate, raised blood pressure and dilated pupils.

(link attribution: Furious Seasons)

doggieIn another story that I find appalling, the FDA has approved a drug for carsick dogs. Yes, that’s right. Carsick dogs. soulful sepulcher first wrote about it and linked to the original story. How long before kids start taking this stuff to get high or something? You know something’s wrong when dogs can die from serotonin syndrome and feel better off of FDA-approved drugs. *shakes head* He’s cute, but he’ll just have to throw up.

Clinical Trial Phases: Handy to Know

Some of my readers may not have any clue about the difference between Phase I, II, or III of clinical trials, except that they’re, uh, different. Here’s info courtesy ClinicalTrials.gov:

"Study Phase
Most clinical trials are designated as phase I, II, or III, based on the type of questions that study is seeking to answer:

    * In Phase I clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
    * In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
    * In Phase III
studies, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
    * In Phase IV studies, the post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations."

I’m sure a pharma blog will pick up on Pristiq soon enough.

Pristiq's FDA Chances: Depression – Yea; Menopause – Nay

As more info on Pristiq continues to roll out, I'll do my best to track them quite closely.

While Wyeth scrambles to resolve issues in its Puerto Rico plant to meet FDA standards, Ms. Kathleen Kerr of Newsday recently reported on Pristiq's potential to be approved for use in depression and hot flashes resulting from menopause. I was so excited to see some decent reporting on a mental health issue in a paper other than the NYT. It was also nice to see that it didn't end with "Shares of Wyeth fell 38 cents Friday to close at $51.50 on the New York Stock Exchange."

"If Pristiq wins Food and Drug Administration approval, it will be the first antidepressant and only non-hormonal remedy marketed specifically for hot flashes. But Pristiq isn't without problems – it poses rare suicide risks in young people."

Read the rest of this entry »

Pristiq gains ground with FDA

FDA approval for Pristiq (I'll refer to it as Pq occasionally) is contingent upon Wyeth's handling of "quality control problems… made to the satisfaction of federal inspectors." As I'd previously mentioned before, Wyeth has built an amazingly similar medication based on Effexor. Wyeth is trying to market Pristiq as an antidepressant and treatment for vasomotor symptoms (hot flashes during menopause). Wyeth is significantly banking on Pristiq since their $3.5 billion Effexor XR will lose its patent in a few years, allowing other companies to make venlafaxine generics.

Some of the "quality control" problems Wyeth is experiencing:

  • unclear whether Pq keeps depressive episodes at bay
  • efficacy at low doses and in young kids
  • severe nausea in 50 percent of patients in the clinical trials

Reuters' article notes this, though:

"But the studies do not need to be completed prior to approval of the new depression pill."

While Wyeth has admitted that Pq is "structurally related" to Effexor, it "has not yet disclosed if Pristiq has any advantages over Effexor XR, other than to say it would be an alternative to existing treatments."

But it has acknowledged the newer drug caused nausea in about one-half of patients in clinical trials.

Wyeth is banking on patients sticking out the nausea for one week (it supposedly subsides after that) or a 50 mg pill that would be more effective than the whopping 400 mg they used in earlier phases of the clinical trials.

"The company said it will not launch Pristiq until it obtains results from the low-dose trials. Moreover, Wyeth said the timing of the launch also will depend on progress of the FDA's ongoing review of Pristiq as a possible non-hormonal treatment for hot flashes. The FDA is scheduled to decide on the hot flashes indication in April."

Wyeth wants to be absolutely sure they can cover all of their bases in an effort not to lose a single portion on their market share — from those who can tolerate low doses at 50 mg to those who need to go 400 mg and up.

"A G Edwards analyst Joseph Tooley has predicted Pristiq will garner annual sales of $1.4 billion by 2011 — about $1 billion from use against depression and the remainder for menopausal symptoms."

Getting not only psychiatrists to prescribe the drug, but also OB/GYNs is a clever move on their part.

Loose Screws Mental Health News

Yay for the New York Times! Alex Berenson, doggedly keeping up on the Zyprexa story, has written an article about how state prosecutors in Vermont and Illinois are now demanding that Eli Lilly submits documents to them about their marketing practices of Zyprexa. Something I didn’t know:

“Federal prosecutors in Philadelphia have also recently accelerated their own investigation into Lilly’s marketing of Zyprexa.”

My residence in the Philly area has prompted me to follow this closely now. More juicy information:

“In a statement yesterday, Lilly said it would cooperate with the investigations and had done nothing wrong. ‘We intend to cooperate with the Illinois attorney general’s civil investigative demand relating to Zyprexa,’ the company said.

While the investigation being led by Illinois is civil, other investigations into Lilly’s conduct are both civil and criminal. [emphasis mine] Attorneys general in California and Florida may seek to recover Medicaid payments that the states made for Zyprexa. Any fine or cost recovery could be sizable, because Zyprexa has been a commercial success.”

Because investigators need to search through more than 10,000 documents relating to Zyprexa and its marketing and talk to former and current employees about the matter, it could take years for anything to happen. Berenson’s last paragraph at the end brought my excitement to a quick halt:

“As long as drug makers comply with federal requirements to provide data about their products to the Food and Drug Administration, companies have a relatively strong defense against criminal prosecution, according to lawyers who are experts in drug marketing.”

Great. So as long as Lilly complies with the FDA and state and federal prosecutors, they can escape criminal prosecution. Please don’t tell families who have loved ones who died over this medication. Lilly’s settlements are nice and all, but money is never restitution for someone’s death. I’ll soon have a post up about how Pfizer had this issue with Neurontin from 2002-2004. They, too, had to pay more than $430 million to settle lawsuits on civil and criminal charges. Pfizer plead guilty; let’s see if Eli Lilly follow suit (no pun intended).

Andre WatersI’ve been a little late on the bus with this, but I’ve previously written about Andre Waters who killed himself in November. Despite theories of depression surrounding his suicide, a neurologist has claimed that Waters sustained brain damage from playing football which triggered his depression and led to his death. Dr. Bennet Omalu, an expert in forensic pathology, says that Water’s brain tissue “had degenerated into that of an 85-year-old man with similar characteristics as those of early-stage Alzheimer’s victims.” Omalu gets pretty grim though:

“If [Waters] had lived, within 10 or 15 years ‘Andre Waters would have been fully incapacitated.'”

The NFL has no comment.

doggieAs I’ve been trying to tell my husband recently, pets can relieve symptoms of depression. Come on, who can be sad when you’ve got an happy little dog wagging its tail at you with bundles of love? (I’m thinking cute little Yorkies or friendly Golden Retrievers.) Owning a pet can have great mental health benefits:

  • Can reduce anxiety
  • Induce social contact
  • Promote a better quality of life
  • Help kids develop higher self-esteem and lower levels of fear

The only downside: animals can cause stress. But it seems like the stressors can be addressed, i.e. animal training, neutering. (source: The Trouble With Spikol)

Also linked to by Liz Spikol, another interesting mental illness combatant: sports therapy. It seems that it can help those suffering from PTSD, abuse, amnesia, and shyness. Italian doctors, however, a testing to see if soccer can treat illnesses like depression and schizophrenia. This should be interesting.

Oh, and NOTHING to do with mental illness, but I found this NYT article on weight loss and maintaining it quite interesting.

Loose Screws Mental Health News

Starting off with some crazy (npi) mental health news, psychotherapists are now beginning to diagnose depression and anxiety in infants. Yes, infants. Before you know it, newborns will begin suffering from post-traumatic stress disorder after enduring complications during delivery. Fetuses will suffer from depression due to lack of exposure to light.

I’m all for diagnosing mental illness in children, but infant depression? Unless it’s mistreated, the concept is ridiculous.

“He says he doesn’t put babies on the couch. Instead, he observed Jayda through a one way mirror. He was looking for clues on why she wouldn’t bond with her mother, Kari Garza.”

What?

“Psychologist Douglas Goldsmith says ‘even by the first birthday, some of the research is saying we should be able to start to see signs of more serious social disorders.’

There are some warning signs to look out for, such as a lack interest in sights and sounds. Others include of lack of desire to interact; listlessness; or excessive crying.”

I can’t help but think it’s rooted in a physical rather than a mental problem. I excessively cried for six months as an infant; no knew that I’d developed eczema and the itching was unbearable because I wasn’t able scratch.

“Figuring out what’s depression versus normal behavior is hard, according Pediatrician Linda Nelson of the Franciscan Children’s Hospital, because ‘the crankiness and all of that, teasing that out from true depression, it’s very difficult.'”

Josh of “We Worrywrites:

“I may be way off the mark on this one, but if I’m not mistaken, an infant’s cognitive abilities are incredibly limited and, for the most part, are dictated entirely by instinctual behaviors. It seems that it would be impossible to determine if an infant had depression or anxiety because it’s impossible to ask them.”

Nope, not off the mark at all.


Want to know what dealing with a bipolar is like? The following is dead on:

“Bipolar is a hell of a disease, and I wonder if patients [at my community health center job] knew how devastating it is, whether they’d choose to label themselves that way.

Bipolar used to be called manic-depression. People with bipolar disorder are constantly on a roller coast ride between severe depression and mania. On the depressed end, this can include feelings of worthlessness, excessive guilt, changes in eating (over- or under-), changes in sleep patterns (can’t go to sleep or can’t wake up), and recurrent thoughts of death.

On the manic end, bipolar people experience feelings of grandiosity, believing they’re capable of things nobody can do. At this end of the spectrum they often sleep very little, their thoughts race, and they can’t stop talking. They tend to get involved in risky activities, such as unrestrained buying sprees, sexual indiscretions, or foolish business investments. Some feel more angry than expansive in their manic phase, or when they’re on their way up or down.”

Congrats. You get the gold star. You’ve just learned something today (if you’re not bipolar).


I recently read Graham’s Blog and among a list of meds, I saw “Zispin.”

Whaa?

It’s trademarked as Remeron in the U.S. and Zispin in Great Britain. The generic name is mirtazapine. Sounds like a name for a German lady €“ Fraulein Mirtazapine.

According to the wonderful wikipedia, mirta treats “mild to severe” depression.” That’s a wide spectrum of patients to cover. Mirta is as effective for people with mild depression as it is for those who are dang near suicidal everyday? I’m not convinced.

Of course, since it’s a med, it’s used off-label for panic disorder, GAC, OCD, and PTSD among other health problems.

If you’re you suffer from bipolar and get a prescription for this stuff, get another doctor quick: mania is a side effect.

I won’t get into the fine details of how mirta works, but it appears that it enhances neurotransmitter actions rather than affect serotonin levels directly.

There’s my new medication lesson of the day.


I’m late on the bandwagon, here. I’m sure Furious Seasons, CL Psych, and other blogs have railed on the injustice of Judge Weinstein’s stupid yes, it is stupid decision to uphold his gag order (he imposed it so why would he change it?) that keeps blogs from “dissemination” Eli Lilly’s leaked documents. Basically, the judge wants to block wiki Zyprexa Kills from showing this info. Any other blog that has the documents, links to it, or publishes it is — well — subject to a gag order as well. *gag*

I have a personal opinion on the matter and since you’re reading this blog, you’ll be subjected to it.

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Catching up…

After a hectic week between work and excessive blogging, I've finally caught up to the latest NYTimes articles on Eli Lilly's troubles with Zyprexa.  I also read the NYT's editorial on the issue. The last paragraph caught my eye:

"Lilly contends that it has never promoted Zyprexa for unapproved uses and has always shown its marketing materials to the Food and Drug Administration, as required by law. Both claims ought to be tested in Congressional hearings that should focus on how well the industry complies with existing laws and how effectively the F.D.A. regulates the industry’s marketing materials."

Furious Seasons and CL Psych beat me to the punch on the skepticism. Congressional hearings would do nothing and I am even more skeptical of the FDA. Pharma companies like Lilly probably slip Dr. Andrew C. von Eschenbach some money to get their stuff approved. But I'm merely speculating because I'm tired and haven't done more research on this at the moment.

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Loose Screws Mental Health News

VNSCyberonics has its vagus nerve stimulator (VNS) while Neurontics is attempting to promote its Neurostar. The Food and Drug Administration will consider whether Neurontics’ device will be able to compete with Cyberonics’ device on Jan. 26. The VNS, according to FDA standards, is the only device that has been proven to show efficacy in depression treatment for those who do not respond to drug treatment. While the VNS is surgically implanted in the chest and stimulates nerves in the neck to alleviate depression, Neurontics claims that Neurostar is not surgically implanted and uses magnetic pulses over the course of three to six weeks to stimulate a patient’s brain.

In the most shocking news ever, the Australian Mental Health Council has found that marijuana can induce mental illness. [sarcasm] Former Federal Police commissioner Mick Palmer has noted three significant conclusions from the MHC report: Cannabis use can:

  • increase the risk of mental illness in young adults, namely with those who have a family history of psychosis
  • make any current mental illness worse
  • induce poor education and employment outcomes

This report once again reminds us, kids, that we must always say no to drugs. Especially if you’re mentally ill.

Girl, InterruptedAn article from the UK Guardian points out that Hollywood’s depiction of mental illness is NOT what people experience on a normal basis. Tim Lott states the reality of mental illness quite well:

“Genuinely accurate depictions of mental illness are still rare in all the art forms. Why? For the very good reason that real mental illness is boring. Depressives are toxic and dull. Manic depressives are irritating. People with schizophrenia or autism are largely indecipherable.”

Just in case you didn’t know, depression can be a problem during the holidays. Oh and p.s. from the article: those who abuse anti-depressants are more likely to commit suicide. You know… just in case you were wondering. Amy Alkon at the Advice Goddess Blog rightly shoots down the holiday-suicide increase myth.

NBC5 in Chicago has reported that “brain music” can help fight depression. Brain waves are recorded through an EEG (electroencephalogram) and then the recordings are turned into a music CD containing two files. According to Dr. Galina Mindlin, who introduced the therapy to the U.S. from Russia, says one file helps a patient relax and the other file helps increase “concentration, performance and productivity.” Mindlin adds that the “relax” music helps decrease anxiety levels in a patient and helps the patient fall asleep and stay asleep. The treatment, according to NBC5, has been used in Europe for the past 15 years, but is not widely available in the U.S. BUT if you’re itching to try it, you’d better have some dough in your pocket: it’s not covered by insurance and costs $550.

FDA expands black-box warning on antidepressants

Black Box Warning

Muy importante:

“A Food and Drug Administration advisory panel on Wednesday agreed with the agency’s proposal that the labels on antidepressants should be expanded to include the risk of increasing suicidal thoughts and behaviors in young adults.”

This FDA expansion ruling is significant because it expands the black-box warning from children and adolescents (up to 18 years old) to young adults (up to 25 years old). However, what about the gap between those 25-34 years old? And then 34-65 years old? Studies consistently show that teens and the elderly are at the highest risk for suicide attempts. Why isn’t there also a black-box warning for those 65 and older?

My recommendation? The FDA needs to slap a general black-box warning on all antidepressants saying that it “can increase the risk of suicidal thoughts and behaviors.” Period.

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