Its no wonder that so many suffer ill health or ADRs from prescription drugs....
60 Minutes Exposes the Maker of the #1 Most Fatal Drug of 2009
From Dr Mercola's site:
Drug company whistle-blower Cheryl Eckard talks about her experience trying to fix problems at GlaxoSmithKline. Her discoveries about the dangerous practices of the company made her a key figure in a federal lawsuit.
...... Due to various production line failures, powerful medications were also getting mixed up. Potent and potentially dangerous drugs were literally ending up in the wrong bottles! The antidepressant Paxil was mixed into bottles of Avandia, a diabetes drug. And Avandia was found in packages of the over-the-counter antacid Tagamet. All in all, Eckard identified nine different mix-ups of various drugs. http://tinyurl.com/4dj8nfe
Showing posts with label Drug Alerts. Show all posts
Showing posts with label Drug Alerts. Show all posts
Tuesday, January 18, 2011
Friday, January 7, 2011
Another wonder cancer drug bites the dust!! None of these have shown to be helpful.
A significant percentage of newly diagnosed patients are turning to safer modalities. Sadly, most die of side effects from toxic drugs and invasive tests rather than the primary cancer. Furthermore, many cancer patients develop new cancers caused by chemo, radiation and arsenal of unnecessary drugs.
Breaking News: Popular Cancer Drug Declared More Harmful Than Helpful
The FDA has said that the controversial drug Avastin should be phased out as a treatment for metastatic breast cancer. Recent studies show that its benefits are outweighed by dangerous side effects.
The announcement does not affect Avastin's status as a drug that can be prescribed for lung cancer, kidney cancer, colorectal cancer and brain cancer.
In 2008, the FDA granted Avastin accelerated approval for use to treat metastatic breast cancer. But studies have failed to show that patients getting Avastin lived longer than patients on standard chemotherapies.
According to CNN:
"Along with those disappointing findings, serious side effects became apparent in patients taking Avastin, including high blood pressure, internal bleeding, perforated internal organs, heart failure and heart attacks, and in some cases, even swelling of the brain."
Genentech, which makes Avastin, has a right to appeal the decision.
Folks, the best way of preventing breast cancer isn't a drug at all, and it's free! Sun exposure may be the single most effective means of reducing breast cancer, thanks to vitamin D, which forms in your body in reaction to sunlight. In a recent study, data collected over a decade from more than 67,000 women showed that women in sunny climes with high vitamin D levels were at a significantly reduced risk of breast cancer!
Sources:
CNN December 16, 2010
Cancer Epidemiology, Biomarkers and Prevention December 2, 2010
Popular Breast Cancer Drug Proven More Harmful than Helpful
Avastin, which costs about $8,000 a month and is one of the best-selling cancer drugs in the world, is now being phased out in the US due to lack of effectiveness and dangerous side effects.
As reported by CNN, the FDA has deemed the drug to be more harmful than beneficial based on recent studies, and recommends phasing it out as a treatment for metastatic breast cancer.
The drug will still maintain its status as an approved therapy for lung-, kidney-, colorectal- and brain cancer, however.
The European Medicines Agency is also altering its recommendation, but rather than withdrawing approval entirely, Avastin will now only be prescribed in combination with the drug Paclitaxel for the treatment of breast cancer in the EU.
A significant percentage of newly diagnosed patients are turning to safer modalities. Sadly, most die of side effects from toxic drugs and invasive tests rather than the primary cancer. Furthermore, many cancer patients develop new cancers caused by chemo, radiation and arsenal of unnecessary drugs.
Breaking News: Popular Cancer Drug Declared More Harmful Than Helpful
The FDA has said that the controversial drug Avastin should be phased out as a treatment for metastatic breast cancer. Recent studies show that its benefits are outweighed by dangerous side effects.
The announcement does not affect Avastin's status as a drug that can be prescribed for lung cancer, kidney cancer, colorectal cancer and brain cancer.
In 2008, the FDA granted Avastin accelerated approval for use to treat metastatic breast cancer. But studies have failed to show that patients getting Avastin lived longer than patients on standard chemotherapies.
According to CNN:
"Along with those disappointing findings, serious side effects became apparent in patients taking Avastin, including high blood pressure, internal bleeding, perforated internal organs, heart failure and heart attacks, and in some cases, even swelling of the brain."
Genentech, which makes Avastin, has a right to appeal the decision.
Folks, the best way of preventing breast cancer isn't a drug at all, and it's free! Sun exposure may be the single most effective means of reducing breast cancer, thanks to vitamin D, which forms in your body in reaction to sunlight. In a recent study, data collected over a decade from more than 67,000 women showed that women in sunny climes with high vitamin D levels were at a significantly reduced risk of breast cancer!
Sources:
CNN December 16, 2010
Cancer Epidemiology, Biomarkers and Prevention December 2, 2010
Popular Breast Cancer Drug Proven More Harmful than Helpful
Avastin, which costs about $8,000 a month and is one of the best-selling cancer drugs in the world, is now being phased out in the US due to lack of effectiveness and dangerous side effects.
As reported by CNN, the FDA has deemed the drug to be more harmful than beneficial based on recent studies, and recommends phasing it out as a treatment for metastatic breast cancer.
The drug will still maintain its status as an approved therapy for lung-, kidney-, colorectal- and brain cancer, however.
The European Medicines Agency is also altering its recommendation, but rather than withdrawing approval entirely, Avastin will now only be prescribed in combination with the drug Paclitaxel for the treatment of breast cancer in the EU.
Tuesday, December 21, 2010
Study identifies prescription drugs associated with cases of violence
By Michael C. Cohen, president of the Institute for Safe Medication Practices
The link between violence and prescription drugs has rarely been studied. However, a study published last week in the journal PLoS ONE identified 31 drugs that are disproportionally associated with reported cases of violence.
The study drew on reports of violence and aggression made to the Food and Drug Administration from 2004 through the third quarter of 2009. While far from definitive, these findings signal that more research is needed.
Leading the list in numbers of reports is the smoking cessation drug Chantix (varenicline).
Also associated with violence were psychoactive medications for depression (Prozac and Paxil), attention deficit disorder (Strattera), and sedative/hypnotic drugs.
The authors, Thomas J. Moore, a consulting senior scientist at the Institute for Safe Medication Practices, Joseph Glenmullen of Harvard Medical School, and Curt D. Furberg of Wake Forest University School of Medicine, selected cases from the ISMP QuarterWatch database, which is composed of computer extracts of all adverse drug event reports received by FDA.
A violent event was defined as any case report mentioning homicide, physical assault, physical abuse, homicidal ideation or violence-related symptom.
For the five-year study period, the authors identified 484 drugs that accounted for 780,169 serious adverse event reports of all kinds. This total included 1,937 (0.25 percent) cases that met the violence criteria.
Thirty-one drugs met study criteria for a disproportionate association with violence, accounting for 1,527 (79 percent) of the violence cases.
Included were 387 reports of actual homicide, 404 that were physical assaults, 223 cases with violence-related symptoms, and 896 homicidal ideation reports.
The prominence of Chantix was not a surprise. An association between that drug and serious psychiatric symptoms, including hostile behavior, was also a finding in a 2008 study by our group that looked at FDA adverse event reports in the fourth quarter of 2007. The authors of the present study had earlier linked Chantix to thoughts and acts of aggression/violence. The association also led FDA to require product label changes, including a boxed warning for the drug.
The authors conclude that their data "provide new evidence" that violent acts are "associated with a relatively small group of drugs" and that systematic studies "are needed to establish the incidence, confirm differences among drugs and identify additional common features."
Read more: http://www.philly.com/inquirer/magazine/20101220_Check_Up.html
By Michael C. Cohen, president of the Institute for Safe Medication Practices
The link between violence and prescription drugs has rarely been studied. However, a study published last week in the journal PLoS ONE identified 31 drugs that are disproportionally associated with reported cases of violence.
The study drew on reports of violence and aggression made to the Food and Drug Administration from 2004 through the third quarter of 2009. While far from definitive, these findings signal that more research is needed.
Leading the list in numbers of reports is the smoking cessation drug Chantix (varenicline).
Also associated with violence were psychoactive medications for depression (Prozac and Paxil), attention deficit disorder (Strattera), and sedative/hypnotic drugs.
The authors, Thomas J. Moore, a consulting senior scientist at the Institute for Safe Medication Practices, Joseph Glenmullen of Harvard Medical School, and Curt D. Furberg of Wake Forest University School of Medicine, selected cases from the ISMP QuarterWatch database, which is composed of computer extracts of all adverse drug event reports received by FDA.
A violent event was defined as any case report mentioning homicide, physical assault, physical abuse, homicidal ideation or violence-related symptom.
For the five-year study period, the authors identified 484 drugs that accounted for 780,169 serious adverse event reports of all kinds. This total included 1,937 (0.25 percent) cases that met the violence criteria.
Thirty-one drugs met study criteria for a disproportionate association with violence, accounting for 1,527 (79 percent) of the violence cases.
Included were 387 reports of actual homicide, 404 that were physical assaults, 223 cases with violence-related symptoms, and 896 homicidal ideation reports.
The prominence of Chantix was not a surprise. An association between that drug and serious psychiatric symptoms, including hostile behavior, was also a finding in a 2008 study by our group that looked at FDA adverse event reports in the fourth quarter of 2007. The authors of the present study had earlier linked Chantix to thoughts and acts of aggression/violence. The association also led FDA to require product label changes, including a boxed warning for the drug.
The authors conclude that their data "provide new evidence" that violent acts are "associated with a relatively small group of drugs" and that systematic studies "are needed to establish the incidence, confirm differences among drugs and identify additional common features."
Read more: http://www.philly.com/inquirer/magazine/20101220_Check_Up.html
Wednesday, December 15, 2010
Watch out for these drugs on the FDA monitoring list:
13 Drugs on Latest FDA List for Safety Monitoring
July 2, 2010 — A watch list of 13 drugs based on potential signs of serious risks or new safety information collected by the Adverse Event Reporting System (AERS) of the US Food and Drug Administration (FDA) during the first quarter of 2010 has been released.
The FDA is studying all of the drugs to determine the need for any regulatory action.
A drug's appearance on the watch list does not mean the agency has determined that the drug poses the health risk in question. Physicians should not stop prescribing the drug, and patients should not stop taking it, according to the FDA.
The FDA is evaluating 2 antibiotics — azithromycin (Zithromax; Pfizer) and clarithromycin (Biaxin; Abbott) — to find out whether they are associated with liver failure. Suspicions about azithromycin and liver failure are not new. The label for the antibiotic states that adverse events discovered after the drug entered the marketplace — and for which a causal relationship may not be established — include "abnormal liver function including hepatitis and cholestatic jaundice, as well as rare cases of hepatic necrosis and hepatic failure, some of which have resulted in death." During clinical trials, cholestatic jaundice was a rarely reported adverse effect.
Postmarketing adverse events for clarithromycin have included infrequent cases of sometimes severe, but usually reversible, hepatic dysfunction, including cholestatic hepatitis, with or without jaundice. There also have been rare and fatal cases of hepatic failure "associated with serious underlying diseases and/or concomitant medications," according to the drug label. Cholestatic jaundice did not emerge as an adverse effect in clinical trials.
Two other antibiotics made it on the latest watch list. AERS turned up reports of pyloric stenosis linked to azithromycin extended release 2 g (Zmax; Pfizer) and pulmonary eosinophilia and eosinophilic pneumonia linked to daptomycin (Cubicin; Cubist Pharmaceuticals).
FDA Studying Anticoagulant to Determine Whether It Causes Blood Clots
Three other medications on the watch list are in the cardiovascular camp. The anticoagulant prasugrel (Effient; Eli Lilly), is being watched on account of thrombotic thrombocytopenic purpura — a rare and life-threatening disorder that causes clots to form in small blood vessels throughout the body. The drug's label warns that this disorder emerged as an adverse effect during clinical trials. Heartwire recently reported that researchers continue to debate whether the medication increases the risk for cancer.
Another drug, dronedarone (Multaq; Sanofi-Aventis), used to treat atrial fibrillation and atrial flutter, has come under surveillance because of reports of congestive heart failure. As reported by Heartwire, clinicians have considered dronedarone a safer alternative to amiodarone (Cordarone; Wyeth-Ayerst; Pacerone; Upsher-Smith) for patients with atrial fibrillation.
The third cardiovascular drug on the watch list is ranolazine (Ranexa; Gilead), prescribed for patients with angina. Here, the FDA is investigating reports of torsades de pointes — a ventricular tachycardia that can lead to sudden death.
Two medications prescribed for narcolepsy — modafinil (Provigil; Cephalon) and sodium oxybate (Xyrem; Jazz Pharmaceuticals) — are under study for a possible association with convulsions. Physicians prescribe modafinil to counteract excessive sleepiness caused by narcolepsy, sleep apnea, or shift work. Likewise, sodium oxybate reduces daytime sleepiness, as well as the number of cataplexy attacks suffered, in patients with narcolepsy.
Perhaps the most well-known product on the watch list is the blend of estrogens marketed as Premarin (Wyeth), used to treat symptoms of menopause. It landed on the list based on reports of angioedema.
Potential Signals of Serious Risks/New Safety Information Identified by AERS, First Quarter 2010 http://www.medscape.com/viewarticle/724545?sssdmh=dm1.624895&src=nldne&uac=128675HJ
13 Drugs on Latest FDA List for Safety Monitoring
July 2, 2010 — A watch list of 13 drugs based on potential signs of serious risks or new safety information collected by the Adverse Event Reporting System (AERS) of the US Food and Drug Administration (FDA) during the first quarter of 2010 has been released.
The FDA is studying all of the drugs to determine the need for any regulatory action.
A drug's appearance on the watch list does not mean the agency has determined that the drug poses the health risk in question. Physicians should not stop prescribing the drug, and patients should not stop taking it, according to the FDA.
The FDA is evaluating 2 antibiotics — azithromycin (Zithromax; Pfizer) and clarithromycin (Biaxin; Abbott) — to find out whether they are associated with liver failure. Suspicions about azithromycin and liver failure are not new. The label for the antibiotic states that adverse events discovered after the drug entered the marketplace — and for which a causal relationship may not be established — include "abnormal liver function including hepatitis and cholestatic jaundice, as well as rare cases of hepatic necrosis and hepatic failure, some of which have resulted in death." During clinical trials, cholestatic jaundice was a rarely reported adverse effect.
Postmarketing adverse events for clarithromycin have included infrequent cases of sometimes severe, but usually reversible, hepatic dysfunction, including cholestatic hepatitis, with or without jaundice. There also have been rare and fatal cases of hepatic failure "associated with serious underlying diseases and/or concomitant medications," according to the drug label. Cholestatic jaundice did not emerge as an adverse effect in clinical trials.
Two other antibiotics made it on the latest watch list. AERS turned up reports of pyloric stenosis linked to azithromycin extended release 2 g (Zmax; Pfizer) and pulmonary eosinophilia and eosinophilic pneumonia linked to daptomycin (Cubicin; Cubist Pharmaceuticals).
FDA Studying Anticoagulant to Determine Whether It Causes Blood Clots
Three other medications on the watch list are in the cardiovascular camp. The anticoagulant prasugrel (Effient; Eli Lilly), is being watched on account of thrombotic thrombocytopenic purpura — a rare and life-threatening disorder that causes clots to form in small blood vessels throughout the body. The drug's label warns that this disorder emerged as an adverse effect during clinical trials. Heartwire recently reported that researchers continue to debate whether the medication increases the risk for cancer.
Another drug, dronedarone (Multaq; Sanofi-Aventis), used to treat atrial fibrillation and atrial flutter, has come under surveillance because of reports of congestive heart failure. As reported by Heartwire, clinicians have considered dronedarone a safer alternative to amiodarone (Cordarone; Wyeth-Ayerst; Pacerone; Upsher-Smith) for patients with atrial fibrillation.
The third cardiovascular drug on the watch list is ranolazine (Ranexa; Gilead), prescribed for patients with angina. Here, the FDA is investigating reports of torsades de pointes — a ventricular tachycardia that can lead to sudden death.
Two medications prescribed for narcolepsy — modafinil (Provigil; Cephalon) and sodium oxybate (Xyrem; Jazz Pharmaceuticals) — are under study for a possible association with convulsions. Physicians prescribe modafinil to counteract excessive sleepiness caused by narcolepsy, sleep apnea, or shift work. Likewise, sodium oxybate reduces daytime sleepiness, as well as the number of cataplexy attacks suffered, in patients with narcolepsy.
Perhaps the most well-known product on the watch list is the blend of estrogens marketed as Premarin (Wyeth), used to treat symptoms of menopause. It landed on the list based on reports of angioedema.
Potential Signals of Serious Risks/New Safety Information Identified by AERS, First Quarter 2010 http://www.medscape.com/viewarticle/724545?sssdmh=dm1.624895&src=nldne&uac=128675HJ
Corticosteroids are known to cause manic episodes, insomnia, and other CNS symptoms in many. This article concerns those who are using corticosteroids inhalers for asthma. Is it that helpful for asthma? There have been several articles warning about the dangers of beta2-agonists (LABAs) with corticosteroids. Later found to be of no benefits, (harmful), no longer advised for treating asthma. http://www.medicalnewstoday.com/articles/132495.php
Montelukast used to treat asthma has been linked to severe CNS reactions, including suicide ideation and self harm. http://www.leaderpost.com/news/Asthma+drug+linked+suicide+attempts+thoughts+self+harm/1768232/story.html
The article below, concerns inhaled corticosteroid and Diabetes Mellitus.
Inhaled Corticosteroid Use May Increase Risk for Diabetes Mellitus
Laurie Barclay, MD
December 15, 2010 — Inhaled corticosteroid use may increase the risk for diabetes mellitus, according to the results of a study reported in the November issue of the American Journal of Medicine.
"High doses of inhaled corticosteroids commonly used in patients with [chronic obstructive pulmonary disease (COPD)] are associated with an increase in the risk of requiring treatment for diabetes and of having to intensify therapy to include insulin," lead author Samy Suissa, PhD, from the Center for Clinical Epidemiology, Lady Davis Research Institute, Jewish General Hospital in Montreal, Quebec, Canada, and the Department of Epidemiology and Biostatistics and Department of Medicine, McGill University, said in a news release. "Therefore, patients instituting therapy with high doses of inhaled corticosteroids should be assessed for possible hyperglycemia and treatment with high doses of inhaled corticosteroids [should be] limited to situations where the benefit is clear."
The study authors note that although inhaled corticosteroids are recommended only for patients with the most severe COPD, current practice is that they are prescribed to more than 70% of all patients with COPD, including those with less severe disease. Because the prevalence of COPD and diabetes both increase with age, it is important to examine any possible interaction between inhaled corticosteroid use and worsened glycemic control.
Using the Quebec health insurance databases, the investigators identified a new-user cohort of patients treated from 1990 through 2005 for respiratory disease. Follow-up was through 2007, until diabetes onset, or until diabetes progression in the subcohort treated with oral hypoglycemics. To estimate the rate ratios of diabetes onset and progression associated with current use of inhaled corticosteroids, the investigators used a nested case-control analysis, with adjustment for age, sex, respiratory disease severity, and comorbid conditions.
Of 388,584 patients in the study cohort, 30,167 developed incident diabetes during 5.5 years of follow-up (incidence rate, 14.2/1000/year), and 2099 patients subsequently progressed from oral hypoglycemic therapy to insulin treatment (incidence rate, 19.8/1000/year).
Participants with current use of inhaled corticosteroids had a 34% increase in the rate of diabetes (rate ratio [RR], 1.34; 95% confidence interval [CI], 1.29 - 1.39) and in the rate of diabetes progression (RR, 1.34; 95% CI, 1.17 - 1.53).
The highest inhaled corticosteroid doses, equivalent to at least 1000 μg/day fluticasone, were associated with the greatest risk increases (RR for rate of diabetes, 1.64; 95% CI, 1.52 - 1.76; RR for diabetes progression, 1.54; 95% CI, 1.18 - 2.02).
Limitations of this study include possible residual confounding and the possible underestimation of incidence of diabetes.
"In patients with respiratory disease, inhaled corticosteroid use is associated with modest increases in the risks of diabetes onset and diabetes progression," the study authors write. "The risks are more pronounced at the higher doses currently prescribed in the treatment of [COPD]."
This research was supported by grants from the Canadian Institutes of Health Research, Boehringer-Ingelheim GmbH, and the Canadian Foundation for Innovation. Some of the study authors report various financial relationships with AstraZeneca, Boehringer-Ingelheim, GlaxoSmithKline, Merck, Pfizer, Merck Frosst Canada, Novartis, and/or Nycomed.
Am J Med. 2010;123:1001-1006. Abstract
Montelukast used to treat asthma has been linked to severe CNS reactions, including suicide ideation and self harm. http://www.leaderpost.com/news/Asthma+drug+linked+suicide+attempts+thoughts+self+harm/1768232/story.html
The article below, concerns inhaled corticosteroid and Diabetes Mellitus.
Inhaled Corticosteroid Use May Increase Risk for Diabetes Mellitus
Laurie Barclay, MD
December 15, 2010 — Inhaled corticosteroid use may increase the risk for diabetes mellitus, according to the results of a study reported in the November issue of the American Journal of Medicine.
"High doses of inhaled corticosteroids commonly used in patients with [chronic obstructive pulmonary disease (COPD)] are associated with an increase in the risk of requiring treatment for diabetes and of having to intensify therapy to include insulin," lead author Samy Suissa, PhD, from the Center for Clinical Epidemiology, Lady Davis Research Institute, Jewish General Hospital in Montreal, Quebec, Canada, and the Department of Epidemiology and Biostatistics and Department of Medicine, McGill University, said in a news release. "Therefore, patients instituting therapy with high doses of inhaled corticosteroids should be assessed for possible hyperglycemia and treatment with high doses of inhaled corticosteroids [should be] limited to situations where the benefit is clear."
The study authors note that although inhaled corticosteroids are recommended only for patients with the most severe COPD, current practice is that they are prescribed to more than 70% of all patients with COPD, including those with less severe disease. Because the prevalence of COPD and diabetes both increase with age, it is important to examine any possible interaction between inhaled corticosteroid use and worsened glycemic control.
Using the Quebec health insurance databases, the investigators identified a new-user cohort of patients treated from 1990 through 2005 for respiratory disease. Follow-up was through 2007, until diabetes onset, or until diabetes progression in the subcohort treated with oral hypoglycemics. To estimate the rate ratios of diabetes onset and progression associated with current use of inhaled corticosteroids, the investigators used a nested case-control analysis, with adjustment for age, sex, respiratory disease severity, and comorbid conditions.
Of 388,584 patients in the study cohort, 30,167 developed incident diabetes during 5.5 years of follow-up (incidence rate, 14.2/1000/year), and 2099 patients subsequently progressed from oral hypoglycemic therapy to insulin treatment (incidence rate, 19.8/1000/year).
Participants with current use of inhaled corticosteroids had a 34% increase in the rate of diabetes (rate ratio [RR], 1.34; 95% confidence interval [CI], 1.29 - 1.39) and in the rate of diabetes progression (RR, 1.34; 95% CI, 1.17 - 1.53).
The highest inhaled corticosteroid doses, equivalent to at least 1000 μg/day fluticasone, were associated with the greatest risk increases (RR for rate of diabetes, 1.64; 95% CI, 1.52 - 1.76; RR for diabetes progression, 1.54; 95% CI, 1.18 - 2.02).
Limitations of this study include possible residual confounding and the possible underestimation of incidence of diabetes.
"In patients with respiratory disease, inhaled corticosteroid use is associated with modest increases in the risks of diabetes onset and diabetes progression," the study authors write. "The risks are more pronounced at the higher doses currently prescribed in the treatment of [COPD]."
This research was supported by grants from the Canadian Institutes of Health Research, Boehringer-Ingelheim GmbH, and the Canadian Foundation for Innovation. Some of the study authors report various financial relationships with AstraZeneca, Boehringer-Ingelheim, GlaxoSmithKline, Merck, Pfizer, Merck Frosst Canada, Novartis, and/or Nycomed.
Am J Med. 2010;123:1001-1006. Abstract
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