 |
|
|
| 5/8/2009 8:04:00 AM | Email this article • Print this article | Northwoods' woman says risperidone killed her father
Case study: Bowman dies after showing classic Risperdal side effects
Risperdal kills.
That's the very simple, straightforward message one Northwoods' woman wants to spread to the world, and especially to Wisconsin residents: Risperdal kills, and Rhinelander resident Lisa MaKarrall says she knows because it killed her father.
One of the world's best-selling drugs, Risperdal, a highly controversial antipsychotic medication manufactured by Janssen Pharmaceutica, and its generic formulation have for years been popular among the medical establishment, used not only for FDA-approved treatments of schizophrenia, bipolar disorder and irritability associated with autism in children but for a broad array of "off-label" diagnoses such as deficit-hyperactivity disorder (ADHD), depression, anxiety, mood disorder, and aggression associated with late-onset dementia.
Especially in Wisconsin, doctors and nursing homes have continued to dispense the drug and other so-called atypical antipsychotics like it despite a 2003 FDA warning it could increase risks for diabetes and strokes, despite a 2005 FDA black-box warning that it could cause increased morbidity in elderly patients with dementia, despite a 2009 government report linking atypical antipsychotics such as Risperdal to an increased risk of cardiac death, and despite other studies showing the drugs to be no more effective and causing no fewer side effects than older atypical antipsychotics.
In 2005, FDA whistleblower Dr. David Graham estimated that off-label use of atypicals could cause as many as 62,000 excess deaths a year.
That's 170 deaths a day, and Rhinelander resident Lisa MaKarrall firmly believes that on June 19, 2008, her father, Bruce Bowman, became one of those casualties.
Cause of death?
The story starts about seven months earlier, in the early fall of 2007, when Bowman fell at home and was admitted to Taylor Park Nursing Home in Rhinelander for rehabilitation. The stay was short, though, and he returned home, only to fall again in early November of that year.
That landed him back in Taylor Park on Nov. 5, 2007, where he fell once more three days after arriving.
Even though those falls had occurred, and he had suffered a seizure in October, no one attending Bowman upon his admission to Taylor Park thought he had any potentially fatal condition. In assessments given Nov. 8, 2007, Dec. 15, 2007, Jan. 7, 2008, Jan. 29, 2008, Feb. 20, 2008, April 24, 2008, May 11, 2008, and May 15, 2008, assessors answered 'no' to the question: Does the patient have an end-stage disease with six or fewer months to live?
Yet, five weeks to the day after the May 15, 2008, assessment, Bowman was dead.
How did it happen? What killed him?
To the doctor signing the death certificate, Dr. John Frost, it was Marchiafava-Bignami, a rare disease associated with chronic alcoholism. But only several hundred cases have ever been diagnosed worldwide, and MaKarrall says her father wasn't an alcoholic and hadn't even had a beer in 10 years.
Bowman's records show conflicting reports about past known alcohol use, but even if he had the syndrome, it is certainly debatable whether that was the immediate cause of death. Bowman was in fact being treated with thiamine, a therapy that, with vitamin B-12, has proven to be effective in boosting recovery in those diagnosed with the syndrome.
Indeed, others viewed the immediate cause of death as that of MRSA pneumonia, possibly having progressed from aspiration pneumonia, which is caused by inhaling foreign material such as food, liquids, and secretions from the mouth into the lungs.
MRSA pneumonia was in fact the documented cause of Bowman's last admission to the hospital from Taylor Park Nursing Home.
That's important because increased deaths due to pneumonia in patients taking risperidone - the drug has been linked to aspiration pneumonia due to the swallowing difficulties it can induce - was one of the reasons the federal Food and Drug Administration issued its 2005 black-box warning about the risks of using atypical antipsychotics to treat elderly patients with dementia.
To MaKarrall, that just about says it all: Risperdal killed her father, she says, and she further points to documented physical symptoms her father suffered during the months he took risperidone as further evidence that his is a textbook case of risperidone death.
Whatever the accuracy of that claim, there is no doubt Bruce Bowman's physical symptoms, as documented in his medical records, are identical to the side effects that multiple studies have confirmed in others taking risperidone.
What's more, Bowman's records clearly indicate that risperidone was not fulfilling its prescribed purpose - controlling his aggression - and several medical personnel raised concerns about the effects of the drug on his health.
In the end, though, while prescribers periodically reduced the dosage or withdrew the drug for short stints, after which Bowman inevitably improved, time and again the medical community returned him to the medicine, and in ever-increasing doses.
Bowman timeline
In the months after Bowman entered the nursing home in November 2007, there's no question he became increasingly agitated. The question was why.
MaKarrall says one of the reasons for his distress, apart from being away from home, was his roommate, whom she described as "babbling nonstop," and the people Bowman ate with in the dining room, whom MaKarrall says also "babbled, cried and yelled."
As his anxiety grew, so did his aggression, and on Dec. 12, 2007, the nursing home started him on Risperdal. The next day, they also moved Bowman into his own room in an attempt to ameliorate one of the environmental, or nonpharmacologic, factors associated with his agitation.
On the face of it, those orders - a simultaneous effort to remedy the agitation with medication and with environmental solutions - would violate federal nursing home guidelines for administering antipsychotics for dementia, which call for environmental solutions to be exhausted before trying the drugs.
Risperdal and other atypicals are supposed to be drugs of last resort, in other words, not of first resort.
The Omnibus Budget Reconciliation Act (OBRA) of 1987 limited the use of psychotropic medications in residents of long-term care facilities, requiring that medical, environmental and psychosocial causes of behavioral problems must be ruled out, and nonpharmacologic management must be attempted, before psychotropic drugs are prescribed to nursing home residents, federal guidelines state.
For dementia, those guidelines call for the facility to first identify or rule out environmental or psychosocial stressors, to try medical or environmental solutions, and, if those fail, to give the drug - but only if it is needed to maintain functionality.
The nursing home should have been well aware of those guidelines. The February 2005 newsletter of the Wisconsin Association of Medical Directors, an association of nursing home directors, laid out them out explicitly.
"Before giving antipsychotic medication for disruptive behavior, CMS guidelines say facilities should try nonpharmacological management, which may include identifying other possible causes, such as boredom or pain; adjusting schedules to residents' behavior patterns, such as allowing a farmer to rise early; and offering activities specific to residents' abilities and needs," the newsletter states.
The newsletter cautioned that some behaviors, either those that were not persistent or caused by preventable reasons, did not qualify for antipsychotic treatment.
"If a behavior causes danger to the resident or others, or if uncontrolled crying, yelling screaming, and/or pacing impairs functional capacity, the use of antipsychotics may be appropriate," the newsletter stated. "By themselves, the following are inappropriate target behaviors: wandering, insomnia, poor self-care, unsociability, restlessness, indifference to surroundings, impaired memory, fidgeting, anxiety, nervousness, depression (without psychosis), uncooperativeness, and agitation not a danger to self or others."
Bowman's case: Justified or not?
At first glance, the nurse's notes from early December would seem to indicate a justified use of Risperdal.
In a Dec. 12 report, nurse practitioner Pam Thul-Immler reported that, five minutes into lunch, Bowman was focused "on peer," restless and moving away from the table. But she also reported that he had kicked his roommate in the calf, unprovoked, according to a nursing home staff member named Eddie.
All in all, to Thul-Immler, it seemed the right time for risperidone.
"New physical aggression to peers, generally frustrated and angry," she wrote in her assessment. "His risk for dangerousness is significant - both to self and peers. He has demonstrated anger toward roommate."
Thul-Immler recommended risperidone at .25 mg daily "for physical aggression to peers in context of dementia," and she said she had discussed that recommendation with Dr. John Frost, who had called in the order.
Interestingly, though, six days later, officials were looking at the kicking incident in an entirely different light. Now it was believed that Bowman had kicked his roommate accidentally after starting risperidone.
"The gentleman was believed to have kicked a peer one week ago," she wrote in her Dec. 18 assessment. "After investigation, nursing manager believes involuntary movements may have been the cause of Mr. Bowman's kicking out. Risperidone had been started 12/12."
So, in other words, if the follow-up investigation was true, the drug given to Bowman to control his aggression - risperidone can cause involuntary movements - was prescribed before officials perceived any danger of physical aggression, and was in fact the cause of it.
Indeed, the Dec. 18 chart review showed "no evidence of [physical aggression to peers] overall."
Nonetheless, that did not cause Thul-Immler to back away from the risperidone recommendation. She advised continuing the drug for four to six weeks while "the team" monitored whether it should be discontinued.
In actuality, the staff continued to increase the risperidone. After speaking with Thul-Immler, a nurse asked Frost in a Dec. 21, 2007, physician's communication if he would up the dosage because of Bowman's agitation toward a peer, which turned out to be his roommate, Bowman having been moved back into the nonprivate room that staff considered one of the causes of the aggression in the first place.
Frost did, to .25 BID (that is, twice a day rather than once a day), as well as "prn" (when necessary).
That apparently did the trick. The agitation subsided, but by Jan. 15, 2008, according Thul-Immler, Bowman was restless.
"His physical aggression has not recurred, but he has daily marked restlessness and yelling that respond variably to meeting his needs and redirection," Immler wrote in her consultation report Jan. 15.
So, even though the physical aggression that might not have been physical aggression in the first place but a risperidone side effect was absent, and though the patient had been responding in part to environmental solutions, and though risperidone is not considered an appropriate drug with which to target restless behavior, that's exactly what Thul-Immler's report states she did.
In fact, she recommended ramping up the dosage even more. The physician order sheet for that day shows an increase to .5 BID for dementia and physical aggression.
"Advance risperidone to .25 mg tid (from bid)," she wrote in the recommendations section of the report, meaning to three times a day. "In 1 week, if still restless and no significant orthastosis may increase risperidone to .5 bid."
By Jan. 29, however, Thul-Immler concluded, the risperidone wasn't working very well, and she began to tie Bowman's outbursts to an anti-seizure drug, Keppra, which he had been taking since suffering a seizure in October 2007.
"Mr. Bowman has responded poorly overall to risperidone for his physical aggression/outbursts secondary to dementia," Thul-Immler wrote in her Jan. 29 report.
She then noted that Bowman "may well be having neuro/cognitive agitation to Keppra (literature cites greater than 10 percent of cases)," even though the drug had kept him seizure-free.
In fact, the percentage is 13 percent, and that number sent Thul-Immler back to the doctors to discuss the possibility of an alternative anti-seizure medication that might also stabilize Bowman's mood.
She repeated her concerns on Feb. 5, 2008: "I remain concerned that his Keppra 500 mg bid may be contributing to agitation, outbursts and recent physical aggression," she wrote. She again mentioned that a "call had been place to Dr. Pallagi" to discuss an alternative medication.
Thul-Immler also suggested that changing Bowman's environment might help.
"I support a smaller supervised environment for meals as this is the setting where a number of intrusive behaviors have occurred," she wrote.
That same day Bowman was put in the so-called Diner's Club, a small lounge with two other people. By the end of March, Thul-Immler reported, the Diner's Club switch was helping.
In her March 5 report, Thul-Immler stated that she had finally discussed an alternative seizure medication with a doctor on Feb. 14, and he had in fact approved an alternative drug. Overall, she wrote, Bowman appeared physically healthy.
"Mr. Bowman continues with occasional unpredictable explosive episodes on Keppra with no evidence for medical illness, slight weight loss," she wrote.
Meanwhile, the risperidone flowed on at the higher dosage level of .5 bid.
Risperidone side effects?
If Bowman's aggression was improving, he physical abilities were not. He began to have trouble walking and swallowing. He fell in late February, and tore the skin on his hand in March, and, then, on April 24, he choked on a cheese sandwich, suffering severe aspiration.
Bowman was rushed to the emergency room.
The inability to swallow and aspiration are classic side effects of risperidone, and that did not go unnoticed on April 24. In addition, the nurses' notes of that incident state that Bowman was unable to chew or speak.
"He was making chewing movements with no speech or air exchange," the notes state, and an evaluation of the incident signed May 2 cited Bowman's tongue pumping - all classic and acknowledged side effects of risperidone.
That risperidone could be the culprit also did not go unnoticed in the emergency room on April 24. After returning him to Taylor Park, doctors discontinued the drug.
Without Risperdal, Bowman's physical improvement was immediate, MaKarrall says.
"We - his family - noticed a big improvement in his ability to talk, his hands straightened out, he was alert, happy, laughing and smiling," she says. "He also ate and drank with no problems swallowing and was able to hold his own drinks."
The nurses noticed improvement, too. Over the next several days, off the Risperdal and on a pureed diet, the nurses' notes indicate a palpable change for the better. His coughing stopped. He wasn't choking.
By April 30, he started to regain his speech. The notes don't say that explicitly but they do acknowledge he was talking again: "Stated he doesn't like the texture of his food," the notes state.
Thul-Immler noticed improvement, too.
"Since (discontinuing risperidone), no recurrence of aspiration, and level of alertness, interaction have improved," she wrote in her April 29 health consultant recommendations.
At the time, doctors were planning to reduce Keppra and replace it with Lamictal to deal with the reactive aggression, but, in the meantime, she asserted in her April 29, 2008, report, "if recurring agitation/aggression occur, consider advancing memantine (a relatively new Alzheimer's drug)."
Nowhere in the April 29 recommendations does Thul-Immler recommend restarting risperidone. In fact, she stated, the goal was exactly the opposite, which she hoped would be possible with Keppra's replacement.
"Goal of psychotropic med treatment was/is reduction of antipsychotic after Keppra," she wrote.
The slide goes on
Unfortunately for Bowman, though his physical and mental condition might have improved without risperidone, his emotional distress was on the increase: The nurse's notes during this period indicate "increased agitation" and aggression toward staff.
On May 3, 2008, he was screaming profanity in demanding that he be removed from the noisy dining room, where staff had apparently returned him. On May 4, personnel moved him again to the quieter lounge area, where, as he had before, he "ate well and had no agitation."
Then, on May 8, 2008, doctors OK'd a restart of Risperdal "as long as it is a small dose," the nurses' notes state.
"He was sent to the Emergency Room, came back with his Risperdal discontinued," writes nurse Beth Ann Walton of her nursing home visit May 8. "He seemed to perk up a bit, was a bit more interactive with the staff, but now in the past week, he has become more agitated and in the last day or so, he has started to exhibit some physical aggression toward staff, as well as targeting his roommate."
The plan would be, she said, to restart Risperdal at a lower dose - .25 mg daily, with an additional .125 dose available as needed in a 24-hour period for agitation and aggression - and, on May 12, to begin decreasing the Keppra.
As soon as Bowman was back on the Risperdal, MaKarrall said, her father's physical condition deteriorated immediately, and he again began to exhibit classic symptoms of risperidone side effects.
"Shortly after starting back on the Risperdal, dad started having a hard time again swallowing, talking, his hands went into claw-like positions, he was zombie-like, drooling and coughing all the time," MaKarrall says.
Meanwhile, the smaller Risperdal dose appeared not to work. Nurse notes indicate Bowman continued to show aggression on May 11, May 12, May 13, and May 14. Staff apparently tried to manage the increased aggression by increasing both Lamictal and Keppra.
As the days ticked by into late May, Bowman now had other problems. Following the Risperdal restart, he began to fall. He fell on May 11, and he fell again on May 15 after attempting to self-transfer from his bed. Later that same day, he was found lying on the floor, and a wheelchair alert was issued.
He was again found on the floor the next day.
In late May, as nurses noted Bowman's aggression, they also maintained risperidone dosage. On May 28, 2008, for example .25 risperidone was given prn (when necessary).
Just three weeks after Walton had ordered risperidone restarted, she returned for another visit, on May 29, and found Bowman had rapidly deteriorated and now was experiencing a possible dystonic reaction, which is an adverse motor effect that often occurs shortly after narcoleptic drug therapy and is characterized by intermittent spasmodic or sustained involuntary contractions of muscles in the face, neck, trunk, pelvis, and extremities.
The most common causes of drug-induced dystonic reactions are antipsychotics and antidepressants. At the time, Bowman was not taking any anti-depressants.
"He was showing some upper body rigidity Tuesday, but yesterday and today it has become more pronounced," Walton wrote. "Staff has asked me to see him. He is able to swallow by taking in very small amounts. His upper body is rigid with his neck thrown back in a rigid sort of movement."
Walton contacted Frost, she reports, "as this is a fairly significant change in his condition, wondering if this is related to his neurological illness or a possible medication reaction. I did not see via the literature that the Keppra or Lamictal would cause reactions."
Just the opposite, in fact. Keppra is an anti-Parkinson's agent that has been used in some cases to treat dystonic reactions. Even so, Walton reports, after talking with Frost, they decided to decrease the Keppra. She does not mention decreasing risperidone.
Ultimately that day, she dispatched Bowman to the emergency room. There, though, doctors refused to admit him. Instead, in consultation, they determined him to be "terminal" and ordered Bowman returned to the nursing home "with care, comfort, dignity and respect," according to the emergency room report that day by the attending physician, Dr. Peter Zenti.
Likely role
Not everyone missed risperidone's likely role in Bowman's dystonic distress.
On the following day, May 30, Frost ordered all risperidone stopped and Bowman's primary care team acknowledged the drug's probable part in Bowman's deteriorating situation.
"Mr. Bowman has developed an acute dystonia, likely multi-factorial - underlying disease and sensitivity to dopamine blockade of risperidone," Thul-Immler wrote of Frost's and Walton's May 30 assessment.
What no one mentioned was the fact that Bowman probably had something else - aspiration pneumonia, an acknowledged side effect of risperidone.
After he was returned to Taylor Park, Bowman's family visited, and MaKarrall says they were shocked at what they found two days later, on May 31.
"Upon coming in, we saw dad lying flat in bed, pants around his knees, door wide open, no privacy screen and burning up with fever," MaKarrall said. She insisted he be admitted to the hospital.
Personnel again returned Bowman to the emergency room, and this time Dr. Christopher Koeppl found an infectious disease.
"He has had further difficulty with swallowing and swallowing study revealed aspiration, his diet has been adjusted accordingly," Koeppl wrote in his emergency room report of May 31, 2008.
His first diagnostic impression? Right upper lobe pneumonia, "possibly aspiration type." Koeppl started Bowman on Class IV antibiotics and admitted him to the hospital. Further testing revealed MRSA pneumonia.
Bowman remained in the hospital for six days before returning to Taylor Park with a diagnosis of pneumonia and a prognosis of death. There are conflicting records of what medications Bowman received in the two weeks he had left to live, but officially he was off the Risperdal.
But the pneumonia did not improve, and Bowman continued to weaken.
On June 19, 2008, doctors pronounced Bruce Bowman dead. Written on the form releasing his body to a funeral home was a specific malady: MRSA pneumonia.
Did Marchiafava-Bignami kill Bruce Bowman, as his death certificate states? Did MRSA pneumonia kill him? Did the MRSA stem from risperidone-induced aspiration or aspiration pneumonia? Those are obviously debatable questions. What's not debatable are the timeline and symptoms Bruce Bowman's record reveals.
To MaKarrall, who is still seeking to have the cause of death changed on the death certificate, the record is convincing enough that her father suffered a risperidone overdose.
"Let's just say that a doctor in Rhinelander was right diagnosing my dad as the 151st person in the world with Marchiafava-Bignami," she says. "That doesn't cause trouble swallowing or rigidity. Only Risperdal does. That's why the FDA does not approve its use on dementia patients."
Next: The state's medical consent forms - what Bruce Bowman's family was told - and wasn't.
|
Reader Comments
Posted: Thursday, February 18, 2010
Article comment by:
julie sione
We are in the investigation stages of a class action lawsuit involving non FDA approved Risperdal/Risperidone use in elderly patients with dementia. Any information provided is extremely helpful. In CA, OR and/or AZ right now but may branch out to other states.
Posted: Tuesday, July 21, 2009
Article comment by:
Jake Kurt
About 10 year's ago in Edmundston been given to me dose of 1mg.That day I came home,I diden't took 1mg that day(I break madication in to 4 pieces and iI took smallest.It reacts quick,You freez,rapid hart beep,can't swallow,bonne dry mouth(need to drink water,8 glasses between dry to flushed untill in the morning)-About 10 yrs.later here in Fredericton hospital whithout my consent been mixed in to my apple juice & I only sipped 5ml.I HAD SAME SYMPTONS.Key point is i only tooked Apo Lorazapem last 10 years only one ocassion Risperidon.Yes Risperidon will kill you if you dont have the sikness & wrongfully given to you.Regards.Now Im working on with gv. to remouve that entry from my madical history which can leed my deaths.
Posted: Wednesday, June 03, 2009
Article comment by:
Lisa MaKarrall
Anyone who would like to contact me regarding similar reactions to Risperdal...especially in the elderly, my email address is lmakarrall@yahoo.com
Lisa MaKarrall
Posted: Thursday, May 28, 2009
Article comment by:
Susan Hatzel
I am in New York.
I don't know what to say after reading this article - my father died on Saturday a few weeks after starting on Risperdal. He stopped eating and drinking (not swallowing) and became non responsive. I raised all the concerns with the doctors who said that risperdal was used all the time and the warnings only applied to long term use.
I am not sure if risperdal killed my father. He was hallucinating before he started on it, though the later neurologists involved said they thought Alzheimers was a misdiagnosis since the onset was so sudden and severe, and their diagnosis was toxic delirium. After risperdal, he seemed like he was dying. It is a long story, two hospitals, one nursing home, many doctors. Later he was changed from risperdal to seroquel, which I believe is in the same class and has the same warnings about the elderly. Klonopin and ativan were also used. He had never been on those type of meds before.
What can I do? Can I get in contact with this family member you mention in the article? Are there action groups?
It is a terrible feeling that even though we advocated so hard for him the doctors still did as they wanted and maybe that's what killed him.
Posted: Wednesday, May 27, 2009
Article comment by:
justin
hi, i was taking risperidone and i think i got type 2 diabetes from it i was wondering if there was a way of starting a lawsuit or if you already have, could you in some way help me.
|
|
Comment on this story
|
|
|
|
