Atypical Antipsychotics: Patient Safety Information

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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*

An inhalation drug for schizophrenia and bipolar disorder???

Oh no they didn’t. From Alexza Pharmaceuticals’ recent PR:

Staccato system-inhalationAlexza Pharmaceuticals, Inc. announced today that it has initiated its second Phase 3 clinical trial with AZ-004 (Staccato(R) loxapine). AZ-004 is an inhalation product candidate being developed for the treatment of acute agitation in patients with schizophrenia or bipolar disorder. Alexza believes the novel, non-invasive nature and rapid pharmacokinetic (PK) properties resulting from inhaled loxapine administration via the Staccato system (click on the photo to the right to see an enlargelarement) have the potential to make AZ-004 a viable product to treat acute agitation.

The supposed benefits:

  1. Rapid onset
  2. Ease of use
  3. Consistent dose and particle size
  4. Broad applicability

Is this pharmaceutical company really developing a product to treat schizophrenic and bipolar disorder symptoms by inhaling? I thought the injectable Risperdal was bad. Check out how the Staccato system works. It blows my mind that psych drugs are being developed for injection and inhalation.

Light posting again

POSTING
Posting may be light through Friday as I’m proofing an ENTIRE website — medication-related, actually — and making all the web copy is correct, the links work, and that the design/layout isn’t funky. Since it’s a website, it’s a huge job and it may take me until Friday. Here’s an example (not the real site I’m working on) of the monstrosity of the kind of work I’m doing.  I’m proofing every single piece of text on every page.  Funny thing is, I don’t mind. I love what I do.

PSYCHIATRIST APPOINTMENT
I have my psychiatrist appointment at 3:30 pm so I might be able to get a quick post in to let you know what happens. He’ll probably be concerned that I didn’t take my Abilify, but I just stopped taking fexofenadine (Allegra’s generic equivalent) and have begun to drop weight. I don’t need Abilify to help me pack it back on it again. I can do it quite easily with the help of the amazing bakery across the street.

COUNSELING
I had counseling last night but will be going again next week. I usually go once every two weeks, but my counselor is concerned since I’m having a consistent reoccurrence of suicidal thoughts. Even when I’m in a good mood, I still think of finding a way to kill myself. That’s not depression so much as it is my negative way of thinking. However, it’s still cause for concern considering that dwelling on the idea could actually lead to another attempt.

RISPERDAL WITHDRAWAL
I’ve read a few blogs in which people are enduring Risperdal withdrawal. I have a friend who’s currently coming off of Risperdal because her blood sugar is so high. She’s been on it for years. That’s one of the reasons why I don’t want to take an antipsychotic. Doctors put patients on it for long-term maintenance when most of the clinical trials have only studied short-term effects.

LAYOUT
I’ve become dissatisfied with how narrow the layout is on my blog so it’s possible that if you visit the site, it’ll look funky every now and then as I play around with it and decide on one I like. I’m not an expert with CSS so I tinker with it until I’m satisfied. I’d like my text area wide enough to post YouTube videos and pictures without them getting cut off. Just letting you know so you don’t wonder what happened to your browser.

FURIOUS SEASONS
Last but not least, if you like this blog, then please go to this one and donate $1, $2, or $5. If you know me in person, please donate as well. (I made a plea about this last week.) That blog provides me with inspiration to keep on going.  You can donate to Philip Dawdy via PayPal, check, or money order. (I guess you could send cash too but that’s never recommended.) Philip’s blog, Furious Seasons, has helped many people in the mental health community including myself.

Pharma's "me-too" drugs face skeptical docs and health insurers

As patents expire on a variety of drugmakers’ moneymakers, pharma companies have gone to great lengths to structurally reinvent the successful drugs then tout the benefits that differ from their predecessors.

InvegaCase in point — Johnson & Johnson’s Invega. Invega is the successor to the popular antipsychotic drug, Risperdal, and competitor to AstraZeneca’s widely used antipsychotic Seroquel. Scott Hensley at The Wall Street Journal’s Health Blog (WSJ) reports that Risperdal is going generic in June. Gianna at Beyond Meds recently said it will not. According to the Dow Jones Newswires (DJN), these “junior” drugs face skepticism from health insurers and doctors. California-based Kaiser Permanente and Minneapolis-based UnitedHealth Group Inc. (UNH) are example of companies that have somewhat discouraged use of the drug. Kaiser doesn’t cover Invega at all, and members of UNH are required to pay higher copays for the brand name. The wire reports New York-based psychiatrist Jeffrey Lieberman wasn’t “buying it” the difference between Invega and Risperdal.

Invega is “basically a me-too drug, and the company hasn’t done the studies that would be required to really distinguish it,” Lieberman, chairman of the psychiatry department at Columbia University’s medical school told Peter Loftus of Dow Jones Newswires.

Ouch.

The blog also quotes Daniel Carlat from the The Carlat Psychiatry Report.

Dan Carlat, a psychiatrist and a tough critic of Invega, wrote that J&J’s “marketing team apparently missed the fact that the word in the English language that sounds most like “Invega” is “inveigle,” meaning “to entice, lure, or ensnare by flattery or artful talk or inducements.’ ” He asked doctors: “Will you be doing your patients a favor by taking the plunge? Or will you simply be giving them the same wine in a fancier bottle?”

Even J&J’s Group Chairman of Pharmaceuticals, David Norton, admitted that Invega is a tough sell.

“We need to do a better job at drawing a differentiation in a difficult-to-treat population.

So far, Invega sales have been incredibly disappointing compared to the Risperdal blockbuster.

Wyeth (antidepressant Effexor XR cum Pristiq) and Shire (ADHD drug Adderall XR cum Vyvanse) face the same uphill battle. Wyeth’s Effexor faces generic competition from Teva Pharmaceuticals despite efforts to halt generic sales of the drug and the patent on Shire’s Adderall is set to expire next year.

Hensley, in his analysis, raises a question in which the answer remains to be seen:

Cheap generics abound to treat a broad assortment of illnesses these days. What’s the point, the critics ask, of paying more for drugs that are at best only slight improvements over tried and true medicines available at bargain prices?

It’s something that I’ve questioned myself.

In an attempt to have the “me-too” drugs compete with its derivative, both Wyeth and Shire are slashing their prices, or as the DJN reported, “emphasizing improved dosing for the newer drugs.” Although Pristiq’s efficacy comes at higher doses, it’s being priced 20 percent lower than Effexor.

[Deutsche Bank pharmaceutical analyst Barbara Ryan] thinks the odds of
Pristiq’s success are slim because it appears to offer few benefits
beyond those of Effexor.

That remains to be seen. So far, a few patients have commented on my blog that Pristiq has already begun to help them. I haven’t seen any DTC ads for Pristiq so I can only assume that drug reps are doing a fine marketing job at selling the different benefits of the drug to doctors.

Vyvanse, on the other hand, is looking promising for Shire, already having 7 percent of U.S. ADHD drug prescriptions. Chief Executive Matthew Emmens says the drug is chemically different from Adderall (aren’t they all?) and has better pricing. Shire expects to beat Adderall’s 26 percent peak market share. Seems like a lofty goal to me.

As for Invega, J&J is currently seeking FDA approval to use the drug for bipolar disorder and not just treatment for schizophrenia. It is also l0oking to get approval for an injectable Invega XR.

(Invega logo from Janssen.com)

Response to "Mental Health Blogs Going Bye-Bye?"

From one of Furious Seasons’s latest posts:

Mental Health Blogs Going Bye-Bye?

As I noted earlier, there’s a spate of mental health blogs that are going on hiatus of some kind. Now, it’s my sad duty to report that Gianna Kali’s Bipolar Blast blog is going on an indefinite hiatus as well. You can read her post "Quitting?" for the details. Bottom line: all those years of very high doses of psych meds seem to have injured her body. I cannot even begin to send her enough good wishes. I cannot even begin to express my disgust with some of the bad doctors she ran into over the years.

Also, the Psych Survivor blog, written by a man I only know as Mark, was taken down a few weeks ago, and from what I gather he is in the hospital with heart problems. His was/is a good and strident voice on these issues we all care about and his work is missed.

All of this kind of makes me feel glum, since the two people above had been at the blogging game for well over a year and I sensed that they’d both be around long-term. These are people I care about and it sucks that they won’t be the presence they once were.

Why is it that mental health blogs are so difficult to do and keep going? Why is it so hard for them to find the substantial audiences they deserve? The Internet is crowded with blogs about politics, technology, gadgets, gossip and parenting and many of these seem to do quite well and have huge audiences and long lives, despite the fact that many of them are merely echoes of one another. Are readers of blogs that simple-minded that all they need is the latest news and opinion on Apple’s or Microsoft’s latest bit of software or Obama’s or Hillary’s latest gaffe?

You’d think in a country where 10 percent of the population is on anti-depressants and another 5 percent to 10 percent is likely on some other psych med that there would be a substantial audience for these issues (regardless of what one makes of the dominant mental health paradigm), especially given how wildly popular neuroscience is on the Net. It makes me wonder if we all–and here I include myself–have done something wrong in how we analyze these issues (are we too contrarian?) or if we all simply haven’t been crowded out of the big search engines (that’s how most people find mental health information online) because the Net is so over-populated with pharma sites and allied pro-pharma health websites. I can certainly say that the mainstream media–which usually loves writing about characters on the Net who push against life’s many intellectual tides–has given very little attention to sites like this one, despite the fact that sites like mine have been a very real service to many in the media.

Or maybe the mainstream approach to mental health care is right and the public is just trying to tell us something.

What do you think?

I’ll tell you what I think.

Read the rest of this entry »

Loose Screws Mental Health News

If the state gets its way, hundreds of children could be put in foster homes, in what could be a wrenching cultural adjustment that may require intensive counseling.

Wow. That's all I can say. How do you place 400 different children in foster homes and ensure they'll get proper care? You can't.

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.

Johnson & Johnson subpoenaed

RisperdalI was reading the business section of my Metro paper this morning and noticed that Johnson & Johnson was subpoenaed in Boston, San Francisco, and Philly. According to the Associated Press, it is in relation to “sales and marketing of three drugs.”  The drugs? Risperdal, Topamax and Natrecor. Risperdal is used for schizophrenia and bipolar mania, Topamax is an epilepsy drug (if not approved for bipolar use, probably used off-label for that purpose), and Natrecor is used for patients with heart disease.

The latest subpoenas seek information about the corporate supervision and oversight of J&J’s Janssen, Ortho-McNeil and Scios subsidiaries, which sell the drugs, J&J said.

J&J posted Risperdal sales of $4.18 billion last year, an 18 per cent increase from 2005. In November 2005, Janssen received a subpoena from the U.S. Attorney’s Office in Philadelphia seeking information about Risperdal marketing and adverse reactions to the drug.

Topamax sales were $2.03 billion last year, a 21 per cent increase from 2005. Ortho-McNeil received a subpoena from the U.S. Attorney’s Office in Boston in December 2003 seeking documents relating to the drug’s marketing, including alleged “off-label” marketing, J&J said in the SEC filing. Doctors often prescribe drugs for uses not described on U.S. Food and Drug Administration-approved labels, but pharmaceutical companies cannot market products for off-label usage.

Do we have another Zyprexa case on our hands?

Between the Risperdal investigations, the Zyprexa lawsuits, the Seroquel lawsuits, BMS’s recent mysterious settlement with the US Attorney in New Jersey (it’s not clear if that was related to Abilify, but I bet it was), plus the pending Congressional investigation of Zyprexa and Seroquel, it looks like the wonder drugs are in a world of trouble. In my adult life, I cannot recall a class of drugs that have ended up in such a pickle before. Nor have I seen such a class of drugs that were once touted as cures turn into such duds. The whole thing is just weird.

The wonder drugs are probably in trouble, but they won’t get pulled off the market and I doubt they’ll get more coverage than how the situation affects the company’s stocks. (This is one area where I’d like to be wrong.) But I agree with Dawdy’s assessment that a class of drugs have never been more criticized than atypicals. There have been individual instances of investigations within a class of drugs, but not a whole slew of them. What leads companies to shady practices in this area when it comes to mental health? Perhaps it’s because the drugs have not been conclusively proven to be the savior they are touted as. Or maybe it’s because the hypotheses – that’s really what the explanations of how these drugs work are – have enough of an effect from clinical trials to market and make a substantial profit. I’d venture to say that psych drugs are the only class of drugs that are marketed based on hypothesis only and not conclusive evidence.

Read more at Furious Seasons.

Loose Screws Mental Health News

NAMI is touting a new atypical… in the press release for Johnson & Johnson. Michael J. Fitzpatrick, executive director of NAMI lent a statement  in J&J’s pr about Risperdal’s sibling, Invega. *sniff, sniff* Something smells fishy about this. Makes me wonder if these non-profits bag money from Big Pharma under the table… (source: Furious Seasons)
An electronic ping sent from Sprint to the police helped save the life of a college student who tried to commit suicide, according to Newsday. A ping also helped save the lives of James Kim’s wife and children after getting stuck in the mountains of Oregon. This ping thing is interesting. Especially since Newsday needs to put quotes around it because ping isn’t a real vocabulary word… yet.

Merry Christmas to all and to all a good night.

ADDENDUM: Oooh, ooh, ooh – just found out: Any family that has a minor who may have consumed Paxil or Paxil CR is eligible for a stake in a $63.8 million settlement with GlaxoSmithKline. More info about the settlement at paxilpediatricsettlement.com. Apparently, it seems as though GSK covered up information about the medications’ safety and efficacy. This is one I’d like to learn more about considering I’ve been on Paxil. Not as a minor but the settlement raises questions  regarding GSK withholding information about Paxil’s safety and efficacy regarding adults.

Is it now fashionable to sue pharma companies for not making all of their information public?