A study of the adverse effects of 4 second-generation antipsychotics in children and adolescents documented substantial weight gain during 11 weeks of treatment with each agent, with the increased abdominal fat that has been associated with development of metabolic syndrome in adults. Metabolic abnormalities emerged with 3 of the 4 agents, differing in type and severity with the agent and, in some cases, with the dose.
In this analysis from the Second-Generation Antipsychotic Treatment Indications, Effectiveness and Tolerability in Youth (SATIETY) study, 10% to 36% of 272 patients between 4 and 19 years of age (mean, 13.9 years) who had not previously received antipsychotic medication became overweight or obese. There was minimal weight change in a comparison group of patients who had refused the agent, or who discontinued it within 4 weeks.1
Christoph Correll, MD, Zucker Hillside Hospital, Glen Oaks, NY, and colleagues conducted this observational cohort study as the largest to date of adverse experiences with second-generation antipsychotics in antipsychotic treatment–naive children. The researchers noted that there has been increasing use of these agents in younger patients for psychotic and bipolar disorders as well as nonpsychotic disorders, despite little available age-specific data on adverse reactions.
READ MORE @ PSYCHIATRIC TIMES
Showing posts with label Adverse drug effects. Show all posts
Showing posts with label Adverse drug effects. Show all posts
Thursday, December 31, 2009
Sunday, December 20, 2009
Not All Drugs Are the Same After All
LET me start by saying I’m a fan of generic drugs. They save Americans billions of dollars each year and give us access to wonderful drugs at affordable prices. I’ve recommended generics in this column many times and use them myself when possible.
But there is a gnawing concern among some doctors and researchers that certain prescription generic drugs may not work as well as their brand-name counterparts. The problem is not pervasive, but it’s something consumers should be aware of — especially now that more insurers insist that patients take generic medications when they are available.
Let me also prepare the groundwork for what I hope will be full and frank reader comments, by acknowledging that this issue is controversial.
Joe Graedon, who has been writing about pharmaceuticals for three decades and runs a consumer advocacy Web site, the People’s Pharmacy (peoplespharmacy.com), was 100 percent behind generics for many years.
“We were the country’s leading generic enthusiasts,” he told me recently. But over the last eight or nine years, Mr. Graedon began hearing about “misadventures” from people who read his syndicated newspaper column, also called The People’s Pharmacy.
READ MORE @ NY TIMES
But there is a gnawing concern among some doctors and researchers that certain prescription generic drugs may not work as well as their brand-name counterparts. The problem is not pervasive, but it’s something consumers should be aware of — especially now that more insurers insist that patients take generic medications when they are available.
Let me also prepare the groundwork for what I hope will be full and frank reader comments, by acknowledging that this issue is controversial.
Joe Graedon, who has been writing about pharmaceuticals for three decades and runs a consumer advocacy Web site, the People’s Pharmacy (peoplespharmacy.com), was 100 percent behind generics for many years.
“We were the country’s leading generic enthusiasts,” he told me recently. But over the last eight or nine years, Mr. Graedon began hearing about “misadventures” from people who read his syndicated newspaper column, also called The People’s Pharmacy.
READ MORE @ NY TIMES
Thursday, December 3, 2009
New Safety Concern Related to Antipsychotic Treatment
Overall, antipsychotic medications are reasonably effective, and fairly well tolerated treatments for mood and psychotic disorders. However, treatment with a number of antipsychotic medications is associated with weight gain, and for some, hyperglycemia and hyperlipidemia. In the current issue of Biological Psychiatry, published by Elsevier, researchers discuss this cluster of metabolic side effects and how it may contribute to the risk for diabetes, hypertension, and other medical disorders associated with heart disease. This is of particular concern because there is a higher cardiovascular mortality among the severely mentally ill compared to the general population.
Researchers already know that differences exist between antipsychotics in their effect on clinical measures associated with cardiovascular risk, namely weight, lipids and glucose. Systemic inflammation has recently emerged as an important marker of cardiovascular risk, but the effects of antipsychotics on inflammatory markers in the blood have not been extensively studied until now.
READ MORE @ SCIENCE DAILY
Researchers already know that differences exist between antipsychotics in their effect on clinical measures associated with cardiovascular risk, namely weight, lipids and glucose. Systemic inflammation has recently emerged as an important marker of cardiovascular risk, but the effects of antipsychotics on inflammatory markers in the blood have not been extensively studied until now.
READ MORE @ SCIENCE DAILY
Thursday, October 29, 2009
Weight Gain Associated With Antipsychotic Drugs
Young children and adolescents who take the newest generation of antipsychotic medications risk rapid weight gain and metabolic changes that could lead to diabetes, hypertension and other illnesses, according to the biggest study yet of first-time users of the drugs.
The study, to be published Wednesday in The Journal of the American Medical Association, found that 257 young children and adolescents in New York City and on Long Island added 8 to 15 percent to their weight after taking the pills for less than 12 weeks.
The patients, ages 4 to 19, added an average of one to one-and-a-half pounds a week.
“The degree of weight gain is alarming,” said Dr. Wayne K. Goodman, head of a Food and Drug Administration advisory panel on the drugs last summer and chairman of psychiatry at Mount Sinai School of Medicine in Manhattan. “The magnitude is stunning,” he said.
Although the drugs’ influence on weight and metabolism had been previously detected, Dr. Goodman, who was not involved in the study, said the speed and magnitude of the effects found in the study were greater than previously reported — findings he said were made possible by looking exclusively at new patients.
READ MORE @ NY TIMES
The study, to be published Wednesday in The Journal of the American Medical Association, found that 257 young children and adolescents in New York City and on Long Island added 8 to 15 percent to their weight after taking the pills for less than 12 weeks.
The patients, ages 4 to 19, added an average of one to one-and-a-half pounds a week.
“The degree of weight gain is alarming,” said Dr. Wayne K. Goodman, head of a Food and Drug Administration advisory panel on the drugs last summer and chairman of psychiatry at Mount Sinai School of Medicine in Manhattan. “The magnitude is stunning,” he said.
Although the drugs’ influence on weight and metabolism had been previously detected, Dr. Goodman, who was not involved in the study, said the speed and magnitude of the effects found in the study were greater than previously reported — findings he said were made possible by looking exclusively at new patients.
READ MORE @ NY TIMES
Tuesday, October 6, 2009
Depression Is a Dilemma for Women in Pregnancy
When Sherean Malekzadeh Allen of Marietta, Ga., learned she was pregnant, she was 43, had been married for two years, had gone through two miscarriages and had all but given up hope of having a baby.
But instead of being overjoyed, Ms. Allen was immobilized: panic-ridden, nauseated, listless and thoroughly depressed. She could not rouse herself to go to work in the marketing business she founded and ran, or even get through the newspaper.
And she faced the pregnant woman’s quintessential dilemma: take drugs that might pose a risk to the developing baby, or struggle through an anguishing pregnancy that could harm the baby in other ways?
“Every single thing you put in your body when you’re pregnant, you wonder, ‘Oh, my God, am I growing my baby an extra finger?’ ” Ms. Allen said. “I was worried that I would hurt the baby if I took the pills, and I was worried I would hurt the baby if I didn’t.”
READ MORE @ NY TIMES
But instead of being overjoyed, Ms. Allen was immobilized: panic-ridden, nauseated, listless and thoroughly depressed. She could not rouse herself to go to work in the marketing business she founded and ran, or even get through the newspaper.
And she faced the pregnant woman’s quintessential dilemma: take drugs that might pose a risk to the developing baby, or struggle through an anguishing pregnancy that could harm the baby in other ways?
“Every single thing you put in your body when you’re pregnant, you wonder, ‘Oh, my God, am I growing my baby an extra finger?’ ” Ms. Allen said. “I was worried that I would hurt the baby if I took the pills, and I was worried I would hurt the baby if I didn’t.”
READ MORE @ NY TIMES
Thursday, October 1, 2009
CORRECTED - US family doctors prescribe most mental health drugs
(Corrects final paragraph to show the FDA did not approve Seoquel's use in children, but an FDA advisory panel)
* Most mental health drugs prescribed by family doctors
* Doctors' role raises concerns about quality of care
Fifty-nine percent of U.S. mental health drug prescriptions are written by family doctors, not psychiatrists, raising concerns about the quality of some treatments, according to a study released on Wednesday.
Researchers from Thomson Reuters (TRI.TO) and the U.S. Substance Abuse and Mental Health Services Administration examined 472 million prescriptions written for psychotropic drugs from August 2006 and July 2007.
They found that general practitioners prescribed the bulk of prescriptions in two main categories -- 62 percent of antidepressants and 52 percent of stimulants.
The stimulants were mainly drugs for treating attention deficit hyperactivity disorder, or ADHD. About 25 percent of all stimulant prescriptions examined were written by pediatricians, they reported in the journal Psychiatric Services.
READ MORE @ REUTERS
* Most mental health drugs prescribed by family doctors
* Doctors' role raises concerns about quality of care
Fifty-nine percent of U.S. mental health drug prescriptions are written by family doctors, not psychiatrists, raising concerns about the quality of some treatments, according to a study released on Wednesday.
Researchers from Thomson Reuters (TRI.TO) and the U.S. Substance Abuse and Mental Health Services Administration examined 472 million prescriptions written for psychotropic drugs from August 2006 and July 2007.
They found that general practitioners prescribed the bulk of prescriptions in two main categories -- 62 percent of antidepressants and 52 percent of stimulants.
The stimulants were mainly drugs for treating attention deficit hyperactivity disorder, or ADHD. About 25 percent of all stimulant prescriptions examined were written by pediatricians, they reported in the journal Psychiatric Services.
READ MORE @ REUTERS
Wednesday, September 30, 2009
Prescriptions now biggest cause of fatal drug overdoses
Debra Jones didn't begin taking painkillers to get high.
Jones, 50, was trying to relieve chronic pain caused by rheumatoid arthritis.
Yet after taking the painkiller Percocet safely for 10 years, the stay-at-home mother of three became addicted after a friend suggested that crushing her pills could bring faster relief. It worked. The rush of medication also gave her more energy. Over time, she began to rely on that energy boost to get through the day. She began taking six or seven pills a day instead of the three to four a day as prescribed.
"I wasn't trying to abuse it," says Jones, from Holly Springs, N.C., who has since recovered from her battle with addiction. "But after 10 years, I couldn't help what it did to my body or my brain. It was hard to work without it."
Addiction to prescription painkillers — which kill thousands of Americans a year — has become a largely unrecognized epidemic, experts say. In fact, prescription drugs cause most of the more than 26,000 fatal overdoses each year, says Leonard Paulozzi of the Centers for Disease Control and Prevention.
READ MORE @ USA TODAY
Jones, 50, was trying to relieve chronic pain caused by rheumatoid arthritis.
Yet after taking the painkiller Percocet safely for 10 years, the stay-at-home mother of three became addicted after a friend suggested that crushing her pills could bring faster relief. It worked. The rush of medication also gave her more energy. Over time, she began to rely on that energy boost to get through the day. She began taking six or seven pills a day instead of the three to four a day as prescribed.
"I wasn't trying to abuse it," says Jones, from Holly Springs, N.C., who has since recovered from her battle with addiction. "But after 10 years, I couldn't help what it did to my body or my brain. It was hard to work without it."
Addiction to prescription painkillers — which kill thousands of Americans a year — has become a largely unrecognized epidemic, experts say. In fact, prescription drugs cause most of the more than 26,000 fatal overdoses each year, says Leonard Paulozzi of the Centers for Disease Control and Prevention.
READ MORE @ USA TODAY
Monday, September 28, 2009
Many Kids Suffer Medication Side Effects: Study
More than half a million kids a year are treated for medication side effects in American outpatient clinics and emergency rooms, according to new data.
Researchers at Children's Hospital Boston analyzed National Center for Health Statistics outpatient data between 1995 and 2005. Among children up to age 18, there were 585,922 visits a year for adverse drug events (ADEs). Most visits were to outpatient clinics, but 22 percent were to hospital emergency departments.
"We found that there are as many as 13 outpatient visits for adverse drug events per 1,000 children, indicating that they are a common complication of pediatric care," study leader Dr. Florence Bourgeois, of Children's division of emergency medicine, said in a news release.
The majority of visits were by children 4 and younger (43 percent), followed by youngsters aged 15 to 18 (23 percent). Skin-related (45 percent) and gastrointestinal (16.5 percent) were the most common types of side effects, and 52 percent of the children had symptoms that suggested an allergic reaction.
READ MORE @ ATLANTA JOURNAL CONSTITUTION
Researchers at Children's Hospital Boston analyzed National Center for Health Statistics outpatient data between 1995 and 2005. Among children up to age 18, there were 585,922 visits a year for adverse drug events (ADEs). Most visits were to outpatient clinics, but 22 percent were to hospital emergency departments.
"We found that there are as many as 13 outpatient visits for adverse drug events per 1,000 children, indicating that they are a common complication of pediatric care," study leader Dr. Florence Bourgeois, of Children's division of emergency medicine, said in a news release.
The majority of visits were by children 4 and younger (43 percent), followed by youngsters aged 15 to 18 (23 percent). Skin-related (45 percent) and gastrointestinal (16.5 percent) were the most common types of side effects, and 52 percent of the children had symptoms that suggested an allergic reaction.
READ MORE @ ATLANTA JOURNAL CONSTITUTION
Monday, September 21, 2009
Dueling Intimidation Allegations Filed in Neurontin Litigation
The continuing litigation about whether Pfizer’s anti-seizure medication Neurontin is linked to suicidal behavior in some patients has been marred by allegations filed by attorneys on both sides accusing the other of using intimidation and strong-arm tactics.
Neurontin, known chemically as gabapentin, is an anti-epileptic medication (also called an anticonvulsant) taken by patients to reduce or eliminate seizures in adults and children as young as 12. The drug has been associated with serious side effects, most notably suicide.
Pfizer
Attorneys representing victims of Neurontin recently accused Pfizer’s counsel of trying to intimidate a potential key witness in the case. Pfizer’s attorneys then returned fire with a similar complaint against David Egilman, an expert witness for the plaintiffs.
READ MORE AT ATTORNEYATLAW.COM
Neurontin, known chemically as gabapentin, is an anti-epileptic medication (also called an anticonvulsant) taken by patients to reduce or eliminate seizures in adults and children as young as 12. The drug has been associated with serious side effects, most notably suicide.
Pfizer
Attorneys representing victims of Neurontin recently accused Pfizer’s counsel of trying to intimidate a potential key witness in the case. Pfizer’s attorneys then returned fire with a similar complaint against David Egilman, an expert witness for the plaintiffs.
READ MORE AT ATTORNEYATLAW.COM
Tuesday, September 15, 2009
Glaxo Executive’s Memo Suggested Burying Drug Studies (Update4)
An executive of GlaxoSmithKline Plc, the world’s second-biggest drugmaker, talked about burying negative studies linking its antidepressant drug Paxil to birth defects, according to a company memo introduced at a trial.
“If neg, results can bury,” Glaxo executive Bonnie Rossello wrote in a 1997 memo on what the company would do if forced to conduct animal studies on the drug. The memo was read during opening statements in the trial of a lawsuit brought by the family of a child born with heart defects.
The Philadelphia trial is the first of more than 600 cases alleging that London-based Glaxo knew Paxil caused birth defects and hid those risks to pump up profits. The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, 2.1 percent of Glaxo’s total revenue.
The family of Lyam Kilker claims Glaxo withheld information from consumers and regulators about the risk of birth defects and failed to properly test Paxil. Kilker’s mother, Michelle David, blames Paxil for causing life-threatening heart defects in her 3-year-old son.
Glaxo officials urged scientists to withhold information about Paxil’s risks from a paper laying out the company’s “core safety philosophy” for the drug, said Sean Tracey, a lawyer for Kilker and David, in his opening statement in the trial.
READ MORE @ BLOOMBERG
“If neg, results can bury,” Glaxo executive Bonnie Rossello wrote in a 1997 memo on what the company would do if forced to conduct animal studies on the drug. The memo was read during opening statements in the trial of a lawsuit brought by the family of a child born with heart defects.
The Philadelphia trial is the first of more than 600 cases alleging that London-based Glaxo knew Paxil caused birth defects and hid those risks to pump up profits. The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, 2.1 percent of Glaxo’s total revenue.
The family of Lyam Kilker claims Glaxo withheld information from consumers and regulators about the risk of birth defects and failed to properly test Paxil. Kilker’s mother, Michelle David, blames Paxil for causing life-threatening heart defects in her 3-year-old son.
Glaxo officials urged scientists to withhold information about Paxil’s risks from a paper laying out the company’s “core safety philosophy” for the drug, said Sean Tracey, a lawyer for Kilker and David, in his opening statement in the trial.
READ MORE @ BLOOMBERG
Sunday, September 13, 2009
SSRI Use May Correlate With Lower Bone Mineral Density in Middle-Aged Women: Presented at ASBMR
A study presented at the 31st Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) found that use of some antidepressants may have a correlation with reduced bone mineral density (BMD) in women.
While data have been circulated since the late 1990s associating the use of selective serotonin reuptake inhibitors (SSRIs) with an increased risk of hip fractures, the studies have been in elderly women.
"They were based on database studies and were not able to control for important variables such as bone density and other health conditions," said Susan Diem, MD, University of Minnesota, Minneapolis, Minnesota, on September 12. "Basic science data in the last few years have also found that serotonin transcriptors may exist on bone cells. SSRIs, which block serotonin transcription, might then have an effect on bone density."
READ MORE @ DOCTOR'S GUIDE
While data have been circulated since the late 1990s associating the use of selective serotonin reuptake inhibitors (SSRIs) with an increased risk of hip fractures, the studies have been in elderly women.
"They were based on database studies and were not able to control for important variables such as bone density and other health conditions," said Susan Diem, MD, University of Minnesota, Minneapolis, Minnesota, on September 12. "Basic science data in the last few years have also found that serotonin transcriptors may exist on bone cells. SSRIs, which block serotonin transcription, might then have an effect on bone density."
READ MORE @ DOCTOR'S GUIDE
Saturday, September 12, 2009
GlaxoSmithKline to Defend Paxil in Birth-Defect Case (Update1)
GlaxoSmithKline Plc, the world’s second-biggest drugmaker, begins a trial in Philadelphia next week in what may be a test case for more than 600 lawsuits over claims its antidepressant drug Paxil causes birth defects.
Patients and their parents claim internal company documents produced for trial show Glaxo failed to warn about the risks of Paxil until forced to do so in 2005 by the U.S. Food and Drug Administration. In a trial set for Sept. 14, Michelle David blames the drug for causing life-threatening heart defects in her son Lyam Kilker, 3.
The London-based company faces two more such trials a month from October through January in state court in Philadelphia. The first group will show both sides how the rest of the lawsuits may fare, said David Logan, dean and professor of law at Roger Williams University in Bristol, Rhode Island.
“These cases are sort of like the canary in the coal mine,” Logan said in a phone interview. “The early cases set the parameters for any global settlement negotiations.”
Paxil, approved by the FDA in 1992, generated about $942 million in sales last year, 2.1 percent of the total for the company. Glaxo has settled other Paxil-related cases, including a suit brought by the New York Attorney General’s office accusing the company of withholding safety data about the antidepressant.
READ MORE @ BLOOMBERG
Patients and their parents claim internal company documents produced for trial show Glaxo failed to warn about the risks of Paxil until forced to do so in 2005 by the U.S. Food and Drug Administration. In a trial set for Sept. 14, Michelle David blames the drug for causing life-threatening heart defects in her son Lyam Kilker, 3.
The London-based company faces two more such trials a month from October through January in state court in Philadelphia. The first group will show both sides how the rest of the lawsuits may fare, said David Logan, dean and professor of law at Roger Williams University in Bristol, Rhode Island.
“These cases are sort of like the canary in the coal mine,” Logan said in a phone interview. “The early cases set the parameters for any global settlement negotiations.”
Paxil, approved by the FDA in 1992, generated about $942 million in sales last year, 2.1 percent of the total for the company. Glaxo has settled other Paxil-related cases, including a suit brought by the New York Attorney General’s office accusing the company of withholding safety data about the antidepressant.
READ MORE @ BLOOMBERG
Monday, August 10, 2009
Certain drugs may increase risk of falling
In elderly men and women, certain medications can increase the risk of falling, new research shows.
Findings from a 4-year study conducted in France suggest the risk of falling is 1.4 times greater among elderly men and women taking a long-acting benzodiazepine, compared with age-matched men and women not using this type of anti-anxiety medication.
Dr. Annick Alperovitch, at INSERM in Paris, and colleagues also found a moderately increased risk of falling among elderly men and women who regularly used mood- and behavior-altering "psychotropic" medications.
Their findings, reported in the journal BMC Geriatrics, identified similar risk among elderly individuals reporting regular use of tranquilizers, muscle relaxants and anti-spasmodics, and some antihistamines that block nerve responses (so-called "anticholinergics").
READ MORE @ REUTERS
Findings from a 4-year study conducted in France suggest the risk of falling is 1.4 times greater among elderly men and women taking a long-acting benzodiazepine, compared with age-matched men and women not using this type of anti-anxiety medication.
Dr. Annick Alperovitch, at INSERM in Paris, and colleagues also found a moderately increased risk of falling among elderly men and women who regularly used mood- and behavior-altering "psychotropic" medications.
Their findings, reported in the journal BMC Geriatrics, identified similar risk among elderly individuals reporting regular use of tranquilizers, muscle relaxants and anti-spasmodics, and some antihistamines that block nerve responses (so-called "anticholinergics").
READ MORE @ REUTERS
Wednesday, August 5, 2009
CCHRINT Announces FDA Reported Psychiatric Drug Side Effects Search Engine
Citizens Commission on Human Rights International Announces FDA Reported Psychiatric Drug Side Effects Search Engine: Decrypted FDA reports reveal 4,260 suicides, 2,452 additional deaths, 195 homicides from 2004-2006 alone.
For the first time the side effects of psychiatric drugs that have been reported to the U.S. Food and Drug Administration (FDA) by doctors, pharmacists, other health care providers and consumers have been decrypted from the FDA's MedWatch reporting system and been made available to the public in an easy to search psychiatric drug side effects database and search engine. The database is provided as a free public service by the mental health watchdog, Citizens Commission on Human Rights International (CCHR).
The report totals reveal that between 2004-2008 the FDA's MedWatch system received pregnancy-related psychiatric drug adverse reaction reports which included 2,442 babies born with heart disease, 3,372 other birth defects, as well as 1,072 miscarriages, abortions and other deaths.
The database also reveals that, between 2004-2008 there were reports submitted to MedWatch including 4,895 suicides, 3,908 cases of aggression, 309 homicides and 6,945 cases of diabetes from people taking psychiatric drugs. These numbers reflect only a small percentage of the actual side effects occurring in the consumer market, as the FDA has admitted that only 1-10% of side effects are ever reported to the FDA.
The database is searchable by individual reports (for the 2004-2006 period), type of drug, age of patient, the side effect reported (suicide, homicide, heart attack, stroke, mania, etc.), and whether the drug in question carries a black box warning (the agency's strongest warning--short of banning a drug).
It is searchable by drug name and age group and includes who reported the psychiatric drug reaction (doctor, pharmacist, consumer, etc.). It also includes the top 20 reported adverse reactions to all psychiatric drugs to the FDA and combined summaries of all psychiatric drug reactions for the years 2004-2006 and 2004-2008.
READ MORE @ PR WEB
For the first time the side effects of psychiatric drugs that have been reported to the U.S. Food and Drug Administration (FDA) by doctors, pharmacists, other health care providers and consumers have been decrypted from the FDA's MedWatch reporting system and been made available to the public in an easy to search psychiatric drug side effects database and search engine. The database is provided as a free public service by the mental health watchdog, Citizens Commission on Human Rights International (CCHR).
The report totals reveal that between 2004-2008 the FDA's MedWatch system received pregnancy-related psychiatric drug adverse reaction reports which included 2,442 babies born with heart disease, 3,372 other birth defects, as well as 1,072 miscarriages, abortions and other deaths.
The database also reveals that, between 2004-2008 there were reports submitted to MedWatch including 4,895 suicides, 3,908 cases of aggression, 309 homicides and 6,945 cases of diabetes from people taking psychiatric drugs. These numbers reflect only a small percentage of the actual side effects occurring in the consumer market, as the FDA has admitted that only 1-10% of side effects are ever reported to the FDA.
The database is searchable by individual reports (for the 2004-2006 period), type of drug, age of patient, the side effect reported (suicide, homicide, heart attack, stroke, mania, etc.), and whether the drug in question carries a black box warning (the agency's strongest warning--short of banning a drug).
It is searchable by drug name and age group and includes who reported the psychiatric drug reaction (doctor, pharmacist, consumer, etc.). It also includes the top 20 reported adverse reactions to all psychiatric drugs to the FDA and combined summaries of all psychiatric drug reactions for the years 2004-2006 and 2004-2008.
READ MORE @ PR WEB
Friday, July 10, 2009
Elderly patients boost sales of dangerous antipsychotics
Bill Wiggins believes a powerful antipsychotic medication helped save his wife, Kathye.
Helen Shields believes one of these drugs helped kill her mother, Helen Marciniszyn.
Two families, two drugs, two stories that capture the extremes of a debate about using these medicines to treat the diseases of aging when there are no other effective alternatives.
Kathye Wiggins took Johnson & Johnson's Risperdal. Marciniszyn took AstraZeneca's Seroquel. Both drugs are atypical antipsychotics, a category of psychotropic drugs that also includes Zyprexa from Eli Lilly & Co., Abilify by Bristol-Myers Squibb Co., and Pfizer Inc.'s Geodon.
The federal government approved atypicals in the 1990s to treat schizophrenia and bipolar disorder. Since then, they have become popular for treating disorders including autism and Alzheimer's, despite mixed evidence that they help and ample evidence that they hurt.
Doctors prescribe atypicals for these illnesses because they may calm people and help them sleep. Also, patients with Alzheimer's and dementia can lose touch with reality, as schizophrenics do, so, in theory, atypicals could help.
Sales of atypicals rose to $14.36 billion in 2008 from $8.4 billion in 2003, according to data provider IMS Health.
Elderly patients have been a major source of that growth. Studies suggest that 20 percent to 30 percent of nursing-home residents take an atypical, despite not having a psychosis diagnosis.
READ MORE @ PHILADELPHIA INQUIRER
Helen Shields believes one of these drugs helped kill her mother, Helen Marciniszyn.
Two families, two drugs, two stories that capture the extremes of a debate about using these medicines to treat the diseases of aging when there are no other effective alternatives.
Kathye Wiggins took Johnson & Johnson's Risperdal. Marciniszyn took AstraZeneca's Seroquel. Both drugs are atypical antipsychotics, a category of psychotropic drugs that also includes Zyprexa from Eli Lilly & Co., Abilify by Bristol-Myers Squibb Co., and Pfizer Inc.'s Geodon.
The federal government approved atypicals in the 1990s to treat schizophrenia and bipolar disorder. Since then, they have become popular for treating disorders including autism and Alzheimer's, despite mixed evidence that they help and ample evidence that they hurt.
Doctors prescribe atypicals for these illnesses because they may calm people and help them sleep. Also, patients with Alzheimer's and dementia can lose touch with reality, as schizophrenics do, so, in theory, atypicals could help.
Sales of atypicals rose to $14.36 billion in 2008 from $8.4 billion in 2003, according to data provider IMS Health.
Elderly patients have been a major source of that growth. Studies suggest that 20 percent to 30 percent of nursing-home residents take an atypical, despite not having a psychosis diagnosis.
READ MORE @ PHILADELPHIA INQUIRER
Monday, June 15, 2009
Study Shows Possible Link Between Deaths and ADHD Drugs
Children taking stimulant drugs such as Ritalin to treat attention-deficit hyperactivity disorder are several times as likely to suffer sudden, unexplained death as children who are not taking such drugs, according to a study published yesterday that was funded by the Food and Drug Administration and the National Institute of Mental Health.
While the numbers involved in the study were very small and researchers stopped short of suggesting a cause and effect, the study is the first to rigorously demonstrate a rare but worrisome connection between ADHD drugs and sudden death among children. In doing so, the research adds to the evolving puzzle parents and doctors face in deciding whether to treat children with medication.
Doctors have speculated about such a connection in the past because stimulants increase heart rate and have other cardiovascular effects. Physicians are currently advised to evaluate patients for cardiac risks before prescribing the drugs, and FDA officials said yesterday that those guidelines do not need strengthening in light of the new study. About 2.5 million children in the United States take ADHD medications such as Ritalin and Adderall.
READ MORE @ WASHINGTON POST
While the numbers involved in the study were very small and researchers stopped short of suggesting a cause and effect, the study is the first to rigorously demonstrate a rare but worrisome connection between ADHD drugs and sudden death among children. In doing so, the research adds to the evolving puzzle parents and doctors face in deciding whether to treat children with medication.
Doctors have speculated about such a connection in the past because stimulants increase heart rate and have other cardiovascular effects. Physicians are currently advised to evaluate patients for cardiac risks before prescribing the drugs, and FDA officials said yesterday that those guidelines do not need strengthening in light of the new study. About 2.5 million children in the United States take ADHD medications such as Ritalin and Adderall.
READ MORE @ WASHINGTON POST
Saturday, May 23, 2009
Results of phase III study on Labopharm's novel antidepressant published in Psychiatry (Edgemont) Journal
Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced the publication of Extended Release Trazodone in Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Study in the May 2009 issue of the journal Psychiatry (Edgemont) (Volume 6, Number 5) (www.psychiatrymmc.com). The results of this Phase III clinical trial (study 04ACL3-001), which were originally reported by the Company in February 2008, demonstrate clear benefits for Labopharm's novel antidepressant.
More than 120 million people around the world suffer from depression. Treatment is often challenging because response to antidepressant drug therapy can vary significantly. Clinically depressed patients are typically treated with two different types of drug therapy: selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)). However, some 40 to 50% of patients being treated for depression stop taking these antidepressant drugs within the first 12 months of treatment. Frequently cited reasons for discontinuing therapy include suboptimal efficacy on depression symptoms, exacerbation of sleep disturbance, increased agitation, slow onset of action, sexual dysfunction and weight gain.
Labopharm's novel formulation of the antidepressant trazodone is designed to optimize the efficacy of trazodone, and address the major challenges in treating depression.
Summary of Results of Labopharm's Phase III Clinical Trial on Trazodone
READ MORE @ PR NEWSWEIRE
More than 120 million people around the world suffer from depression. Treatment is often challenging because response to antidepressant drug therapy can vary significantly. Clinically depressed patients are typically treated with two different types of drug therapy: selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)). However, some 40 to 50% of patients being treated for depression stop taking these antidepressant drugs within the first 12 months of treatment. Frequently cited reasons for discontinuing therapy include suboptimal efficacy on depression symptoms, exacerbation of sleep disturbance, increased agitation, slow onset of action, sexual dysfunction and weight gain.
Labopharm's novel formulation of the antidepressant trazodone is designed to optimize the efficacy of trazodone, and address the major challenges in treating depression.
Summary of Results of Labopharm's Phase III Clinical Trial on Trazodone
READ MORE @ PR NEWSWEIRE
Wednesday, April 8, 2009
FDA Review Questions Cardiac, Suicide Risks for Investigational Antipsychotic
Investigational antipsychotic drug sertindole (Serdolect) is effective at treating schizophrenia, but it may lead to sudden cardiac death, according to an FDA review.
The agency released its review in advance of Tuesday's meeting of the Psychopharmacologic Drugs Advisory Committee, which will decide if the drug's cardiovascular risk is an obstacle to FDA approval.
The advisory panel will also consider the sponsor's suicide prevention claim, and whether to recommend to the FDA that the drug is safe and effective. The vote will effectively amount to a recommendation of approval or denial.
Sertindole is already used in other countries to treat schizophrenia.
According to the FDA review, led by psychiatrist Phillip Kronstein, M.D., sertindole is effective in treating schizophrenia, but concerns remain about the drug's potential to prolong the heart's QT interval, which can lead to sudden cardiac death. That same cardiac risk has been seen in other antipsychotic drugs similar to sertindole.
Sertindole is a so-called atypical antipsychotic drug, Its specific mechanism appears to be to inhibit spontaneously active dopamine neurons in the mesolimbic ventral tegmental area without affecting dopamine neurons in the substantial nigra compacta.
READ MORE @ MADPAGE TODAY
The agency released its review in advance of Tuesday's meeting of the Psychopharmacologic Drugs Advisory Committee, which will decide if the drug's cardiovascular risk is an obstacle to FDA approval.
The advisory panel will also consider the sponsor's suicide prevention claim, and whether to recommend to the FDA that the drug is safe and effective. The vote will effectively amount to a recommendation of approval or denial.
Sertindole is already used in other countries to treat schizophrenia.
According to the FDA review, led by psychiatrist Phillip Kronstein, M.D., sertindole is effective in treating schizophrenia, but concerns remain about the drug's potential to prolong the heart's QT interval, which can lead to sudden cardiac death. That same cardiac risk has been seen in other antipsychotic drugs similar to sertindole.
Sertindole is a so-called atypical antipsychotic drug, Its specific mechanism appears to be to inhibit spontaneously active dopamine neurons in the mesolimbic ventral tegmental area without affecting dopamine neurons in the substantial nigra compacta.
READ MORE @ MADPAGE TODAY
Monday, April 6, 2009
Does Antipsychotic Treatment Impact Pediatric Health Care Costs?
Declining health care costs in pediatric patients treated with antipsychotic agents are being offset by the health care costs associated with the development of adverse events related to these medications.
Using retrospective data from South Carolina's Medicaid medical and pharmacy claims between January, 1996 and December, 2005, researchers Jeanette Jerrell, Ph.D., and Roger McIntyre, M.D., identified 4140 children and adolescents prescribed antipsychotic medications, and a random sample of 4500 children not treated with psychotropic medications. Their main outcome measures were total health care costs and emergency, inpatient, and outpatient services use over time, but they included pre-existing medical conditions, receipt of multiple psychotropic medications, and individual risk factor differences for gender, age group, and ethnicity in the analyses.
READ MORE @ MEDICAL NEWS TODAY
Using retrospective data from South Carolina's Medicaid medical and pharmacy claims between January, 1996 and December, 2005, researchers Jeanette Jerrell, Ph.D., and Roger McIntyre, M.D., identified 4140 children and adolescents prescribed antipsychotic medications, and a random sample of 4500 children not treated with psychotropic medications. Their main outcome measures were total health care costs and emergency, inpatient, and outpatient services use over time, but they included pre-existing medical conditions, receipt of multiple psychotropic medications, and individual risk factor differences for gender, age group, and ethnicity in the analyses.
READ MORE @ MEDICAL NEWS TODAY
Monday, March 16, 2009
Antidepressants Linked to Sudden Cardiac Death in Women
A new study has concluded that women with no history of cardiac problems but who use antidepressants are at an increased risk for sudden cardiac death (SCD). HealthDay ,News reports that the reason for the link remains unknown, according to the researchers whose findings were published in the Journal of the American College of Cardiology.
“We suspect that their use is a marker for people with worse depression,” explained the study’s lead author Dr. William Whang, an assistant professor of clinical medicine at Columbia University Medical Center in Manhattan. “The elevated risk seems more specific for antidepressant use, but that use may well be a marker of more severe symptoms,” quoted HealthDay News. Whang noted that the link seemed to be physiological saying, “We found that women who had worse depressive symptoms had higher rates of risk factors such as hypertension, diabetes, and smoking.” As a matter-of-fact, the report indicated, said HealthDay News, women with clinical depression were at a two-fold risk of experiencing SCD.
READ MORE @ NEWS INFERNO
“We suspect that their use is a marker for people with worse depression,” explained the study’s lead author Dr. William Whang, an assistant professor of clinical medicine at Columbia University Medical Center in Manhattan. “The elevated risk seems more specific for antidepressant use, but that use may well be a marker of more severe symptoms,” quoted HealthDay News. Whang noted that the link seemed to be physiological saying, “We found that women who had worse depressive symptoms had higher rates of risk factors such as hypertension, diabetes, and smoking.” As a matter-of-fact, the report indicated, said HealthDay News, women with clinical depression were at a two-fold risk of experiencing SCD.
READ MORE @ NEWS INFERNO
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