January 8, 2013 at 11:16 am (Antipsychotics, Bipolar Disorder, Depression, Loose Screws Mental Health News, Mental Health/Illness, Schizophrenia)
Tags: Adasuve, agitation, Alexza Pharmaceuticals, asthma, Bipolar Disorder, Books, bronchospasm, C-reactive protein, COPD, CRP, Depression, I'd Like to Apologize to Every Teacher I Ever Had, Japan, Loose Screws Mental Health News, loxapine, marijuana, Medscape, mental health, mental illness, NICS, pot, psychosis, public school teachers, reading, Schizophrenia, teens, Tony Danza
An antipsychotic inhalation powder has been approved by the FDA for the treatment of agitation in adults with schizophrenia or bipolar I disorder. While loxapine (brand name: Adasuve) by Alexza Pharmaceuticals acts rapidly, the side effects include “bronchospasm and increased mortality in elderly patients with dementia-related psychosis,” according to Medscape. In case you don’t know, bronchospasm can lead to acute respiratory problems in people with lung disease, asthma, or COPD (chronic obstructive pulmonary disease).
Plans are for the drug to only be accessible through a medical facility with the ability to treat bronchospasms.
In related and somewhat interesting news, the Medscape article also notes that 3.2 million people in the U.S. are being treated for schizophrenia or bipolar I. “Of these, approximately 90% will develop agitation during the course of their illness.”
That’s an incredibly high number of people who develop agitation. Just sayin’.
According to an article in U.S. News & World Report, patients in a study dealing with depression seemed to have high levels of C-reactive protein (CRP), a marker for increased risk of heart and inflammatory disease. The lead researcher notes that “people with increased CRP have a two- to threefold risk of depression.” It is not clear whether CRP causes depression or is simply a sign of it. Increased levels of CRP tend to be seen in obese patients and those with chronic diseases.
“More than 21 million Americans suffer from depression, a leading cause of disability, according to Mental Health America.”
Note: the 2011 estimate of those residing in the U.S. stands at more than 311 million.
Depression is increasing among Japan’s public school teachers.
“A report by the Ministry of Education, Sports, Culture, Science and Technology shows that in 2011, around 5,200 public school teachers had to go on sick leave due to various mental illnesses, including severe depression.”
The Japan Daily Press article also notes:
“The study also highlights the fact that the main reason for the increasing depression is a school environment that puts too much workload and pressure on the teachers that they cannot have a healthy work-life balance anymore, much less deal with students, their guardians and the paper work that comes with all of these. (emphasis mine)”
I recently finished a book by actor Tony Danza called I’d Like to Apologize to Every Teacher I Ever Had in which he chronicles his yearlong stint in Philadelphia’s inner city public school system. He echoes some of these sentiments as well. After trying to teach his students, he notes that it is difficult not to get involved in their personal lives as well. In the Epilogue, Danza writes:
“…I can only do so much. Where does teaching stop, and start? Where should it? I don’t really know. To engage my students, I found that I had to become engaged in their lives, their problems, and their futures. That connection was what made the job the most rewarding. Yet it was also the intensity of that involvement that, by the end of the year, had made the job of teaching so much tougher than I’d ever expected.”
It seems that Japan’s public school teachers are no different from American public school teachers.
Although 38 states require mental health background checks, only a quarter of states actually report their statistics to the federal NICS (National Instant Criminal Background Check System).
And surprise, according to a recent study, pot could lead to psychosis in teens or teens who smoke pot can later develop psychosis. I find it interesting that teens were actually evaluated after smoking pot.
January 15, 2009 at 8:30 am (Medicine/Meds, News, Suicide)
Tags: Accolate, allergy, allergy medication, anxiety, asthma, AstraZeneca, clinical trials, Cornerstone Therapeutics, data, Depression, drug, drugs, FDA, inhaler, investigation, medication, medications.com, meds, Merck, montelukast, mood changes, night terrors, nightmares, paroniria, patient information, patient safety, Patient Safety Information, patients, PR, prescribing information, press release, safety information, safety review, Singulair, suicidal, suicidal actions, suicidal attempts, suicidal behavior, suicidal ideation, suicidal thoughts, Suicide, terrors, zafirlukast, zileuton, Zyflo
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:
Singulair: 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
Accolate: 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
Zyflo: 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.
March 27, 2008 at 4:27 pm (Medicine/Meds, Suicide)
Tags: allergy, allergy medication, asthma, clinical trials, drug, drugs, FDA, inhaler, investigation, medication, medications.com, meds, Merck, montelukast, patient safety, Patient Safety Information, patients, PR, prescribing information, press release, Singulair, suicidal, suicidal actions, suicidal attempts, suicidal behavior, suicidal thoughts, Suicide
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.