Check out my recently published content on AC:
Take These Steps Before You Visit a New Doctor
Thursday, February 4, 2010
Wednesday, February 3, 2010
Definitions Related to the Use of Opioids for the Treatment of Pain
An agreement document from the American Academy of Pain Medicine, the American Pain Society, and the American Society of Addiction Medicine
Varying use of the terms addiction, dependence and tolerance, often results in misunderstandings between regulators, health care providers, patients and the general public, regarding the use of medications for the treatment of pain. Because of these misunderstandings, pain is often under-treated and individuals may be branded because of their use of opioids for medical purposes.
The Liaison Committee on Pain and Addiction (CPA) has developed definitions related to the use of medications for the treatment of pain that are consistent with current understanding of related biology of the nervous system, the study of drugs and suitable clinical practice. The ultimate goal of this project is to achieve acceptance and use of uniform definitions by clinicians, regulators and the public, both nationally and internationally, in order to promote suitable treatment of pain throughout the world. The definitions have been approved by each of the three collaborating organizations.
The Liaison Committee on Pain and Addiction is a collaborative effort of the American Academy of Pain Medicine, the American Pain Society, and the American Society of Addiction Medicine. The committee members included Seddon Savage, MD, Chair; Edward C. Covington, MD; Howard A. Heit, MD; John Hunt, MD; David Joranson, MSSW; and Sidney H. Schnoll, MD PhD. To read the rest of this article, Please go to this link http://www.ampainsoc.org
Varying use of the terms addiction, dependence and tolerance, often results in misunderstandings between regulators, health care providers, patients and the general public, regarding the use of medications for the treatment of pain. Because of these misunderstandings, pain is often under-treated and individuals may be branded because of their use of opioids for medical purposes.
The Liaison Committee on Pain and Addiction (CPA) has developed definitions related to the use of medications for the treatment of pain that are consistent with current understanding of related biology of the nervous system, the study of drugs and suitable clinical practice. The ultimate goal of this project is to achieve acceptance and use of uniform definitions by clinicians, regulators and the public, both nationally and internationally, in order to promote suitable treatment of pain throughout the world. The definitions have been approved by each of the three collaborating organizations.
The Liaison Committee on Pain and Addiction is a collaborative effort of the American Academy of Pain Medicine, the American Pain Society, and the American Society of Addiction Medicine. The committee members included Seddon Savage, MD, Chair; Edward C. Covington, MD; Howard A. Heit, MD; John Hunt, MD; David Joranson, MSSW; and Sidney H. Schnoll, MD PhD. To read the rest of this article, Please go to this link http://www.ampainsoc.org
Opioids: Addiction vs. Dependence
ChronicPainConnection.com
See all of our health sites at http://www.HealthCentral.com
by Karen Lee Richards, ChronicPainConnection Expert
One of the greatest obstacles chronic pain patients face in their quest for adequate pain relief is the widespread misunderstanding of the difference between physical dependence on a drug and addiction. Many patients, the general public, and sadly even some physicians fear that anyone taking opioid medications on a long-term basis will become addicted. As a result, pain patients are often labeled as “drug seekers” and stigmatized for their use of opioid medications. Worst of all, their pain frequently remains under-treated.
Read more: http://www.ChronicPainConnection.com
My reason for adding these articles on Opioid is that I was accused of being an addict because I took Tramadol for my arthritis and fibromyalgia pain. A local rehab center had told someone I know that I was an addict and that hanging out with me would not help him in his recovery. So please understand that I know everyone has their opinions when it comes to what is considered addictive and what is not. There are many who are experts in the field of addiction that say that the rehab center is right and we who suffer from pain day in and day out, taking medication for our pain so that we can experience some sort of normalcy, are wrong. Unless you have experienced the levels of pain we experience, it's my opinion, that we are not addicts. We depend on our medications for some normalcy, so we can carry out our daily activities like vacuuming, doing dishes, doing laundry. Thant's all.
See all of our health sites at http://www.HealthCentral.com
by Karen Lee Richards, ChronicPainConnection Expert
One of the greatest obstacles chronic pain patients face in their quest for adequate pain relief is the widespread misunderstanding of the difference between physical dependence on a drug and addiction. Many patients, the general public, and sadly even some physicians fear that anyone taking opioid medications on a long-term basis will become addicted. As a result, pain patients are often labeled as “drug seekers” and stigmatized for their use of opioid medications. Worst of all, their pain frequently remains under-treated.
Read more: http://www.ChronicPainConnection.com
My reason for adding these articles on Opioid is that I was accused of being an addict because I took Tramadol for my arthritis and fibromyalgia pain. A local rehab center had told someone I know that I was an addict and that hanging out with me would not help him in his recovery. So please understand that I know everyone has their opinions when it comes to what is considered addictive and what is not. There are many who are experts in the field of addiction that say that the rehab center is right and we who suffer from pain day in and day out, taking medication for our pain so that we can experience some sort of normalcy, are wrong. Unless you have experienced the levels of pain we experience, it's my opinion, that we are not addicts. We depend on our medications for some normalcy, so we can carry out our daily activities like vacuuming, doing dishes, doing laundry. Thant's all.
Fish oil supplements prevent mental illness; safe and effective alternative to antipsychotic drugs
by Mike Adams, the Health Ranger, NaturalNews Editor
(NaturalNews) An important new study published in the Archives of General Psychiatry reveals that fish oil supplements beat mental illness. The study involved 81 people deemed to be at high risk for psychosis. The randomized, placebo-controlled study provided fish oil supplements to half the study subjects for just 12 weeks (the other half received placebo supplements). The results? While 11 people in the placebo group developed a psychotic disorder, only 2 in the fish oil group did.
Although the study was relatively small, it helps demonstrate the wide-ranging benefits of omega-3 fatty acids, which are thought to be the key nutritional factor in fish oils. We already know that omega-3 fatty acids / polyunsaturated fatty acids (PUFAs) help protect people against cardiovascular disease. We also know they can play a role in preventing diabetes and cancer. It's little surprise that they also protect against mental illness, given the importance of healthy fatty acids for the functioning of the nervous system.
As the BBC reports, Alison Cobb, from the mental health charity Mind, said in response to this study: "If young people can be treated successfully with fish oils, this is hugely preferable to treating them with antipsychotics, which come with a range of problems from weight gain to sexual dysfunction, whereas omega-3s are actually beneficial to their general state of health."
She's exactly right: Antipsychotic drugs actually cause diabetes. They promote blood sugar disorders and weight gain, among other problems. Some psychiatric drugs have also been linked to school shootings and violent outbursts (suicides, murders, etc.). They're also expensive and they pose an environmental hazard, since many of the chemicals used in those drugs pass right through the body and end up in waters downstream.
Fish oils have none of these negative side effects. In fact, they have positive effects throughout the body. That's why fish oils are such a remarkable solution to replace antipsychotic drugs: They're safer, cheaper and they work better!
You're supposed to keep taking drugs, says Big Pharma
The drug companies, of course, are terrified that people might learn this truth. They want to keep patients on expensive, patented antipsychotic drugs while discrediting "natural remedies" like fish oils or nutritional supplements. The entire war being waged against nutrition and supplements is, of course, nothing more than the pharmaceutical industry trying to protect its own turf by destroying the competition.
Because, let's face it: For (virtually) every popular pharmaceutical on the market, there's a nutritional supplement that works better (and that's also safer and more affordable). Antipsychotic drugs can be replaced with fish oils. Cholesterol drugs can be replaced with B vitamins. Anti-cancer drugs can be replaced with vitamin D and medicinal mushrooms. Diabetes drugs can be replaced with a healthy plant-based diet and targeted supplements. The list goes on and on...
Nutrition works so well that in this study, subjects experienced a protective effect from fish oils for an entire year even though they only took those fish oils for 12 weeks! Imagine how much better the outcome might have been if they continued on the fish oils for the entire year...
Get quality fish oils
Of course, when it comes to fish oils, don't settle for just any cheap fish oil supplement. Many of the cheaper store-bought brands are largely made of olive oil filler combined with a tiny amount of fish oil extract. Search out quality supplements or oils from companies like Moxxor, Nordic Naturals or Carlson Labs.
Make sure your supplements are free from heavy metals, pesticides and other residues. Make sure they are harvested in a truly sustainable way, and make sure you can trust the source to provide consistent quality.
Fish oils can provide astonishing health benefits. If the medical industry were truly honest about researching what works for patients rather than what makes money for drug companies, they would have openly prescribed fish oils long ago (and abandoned many of the antipsychotic drugs they still push).
But as you already know, the pharmaceutical industry isn't interested in what works for people unless it's something they can sell at monopoly prices. They don't want people to know about natural remedies, nutritional cures or healing foods. They would much rather see people stay ignorant about those things while pumping their minds full of advertisements and propaganda that ridiculously suggests the human brain is somehow deficient in Big Pharma's patented chemicals and that the only way you'll ever be truly healthy, happy or sane is to keep swallowing their pills for the rest of your life.
The real insanity in the world is not in the minds of mental patients; it's in the evil plans of the FDA, the WHO and the pharmaceutical cartel -- all of whom conspire to peddle dangerous medications when far safer, more natural and more effective alternatives are readily available.
Abstract of study from the Archives of General Psychiatry
Long-Chain Omega-3 Fatty Acids for Indicated Prevention of Psychotic Disorders
http://archpsyc.ama-assn.org/cgi/co...
A Randomized, Placebo-Controlled Trial
G. Paul Amminger, MD; Miriam R. Schäfer, MD; Konstantinos Papageorgiou, MD; Claudia M. Klier, MD; Sue M. Cotton, PhD; Susan M. Harrigan, MSc; Andrew Mackinnon, PhD; Patrick D. McGorry, MD, PhD; Gregor E. Berger, MD
Arch Gen Psychiatry. 2010;67(2):146-154.
Context: The use of antipsychotic medication for the prevention of psychotic disorders is controversial. Long-chain omega-3 (omega-3) polyunsaturated fatty acids (PUFAs) may be beneficial in a range of psychiatric conditions, including schizophrenia. Given that omega-3 PUFAs are generally beneficial to health and without clinically relevant adverse effects, their preventive use in psychosis merits investigation.
Objective: To determine whether omega-3 PUFAs reduce the rate of progression to first-episode psychotic disorder in adolescents and young adults aged 13 to 25 years with subthreshold psychosis.
Design: Randomized, double-blind, placebo-controlled trial conducted between 2004 and 2007.
Setting: Psychosis detection unit of a large public hospital in Vienna, Austria.
Participants: Eighty-one individuals at ultra-high risk of psychotic disorder.
Interventions: A 12-week intervention period of 1.2-g/d omega-3 PUFA or placebo was followed by a 40-week monitoring period; the total study period was 12 months.
Main Outcome Measures: The primary outcome measure was transition to psychotic disorder. Secondary outcomes included symptomatic and functional changes. The ratio of omega-6 to omega-3 fatty acids in erythrocytes was used to index pretreatment vs posttreatment fatty acid composition.
Results: Seventy-six of 81 participants (93.8%) completed the intervention. By study's end (12 months), 2 of 41 individuals (4.9%) in the omega-3 group and 11 of 40 (27.5%) in the placebo group had transitioned to psychotic disorder (P = .007). The difference between the groups in the cumulative risk of progression to full-threshold psychosis was 22.6% (95% confidence interval, 4.8-40.4). Omega-3 Polyunsaturated fatty acids also significantly reduced positive symptoms (P = .01), negative symptoms (P = .02), and general symptoms (P = .01) and improved functioning (P = .002) compared with placebo. The incidence of adverse effects did not differ between the treatment groups.
Conclusions: Long-chain omega-3 PUFAs reduce the risk of progression to psychotic disorder and may offer a safe and efficacious strategy for indicated prevention in young people with subthreshold psychotic states.
Trial Registration: clinicaltrials.gov Identifier: NCT00396643
Author Affiliations: Department of Child and Adolescent Psychiatry, Medical University of Vienna, Vienna, Austria (Drs Amminger, Schäfer, Papageorgiou, and Klier); Orygen Research Centre, Centre for Youth Mental Health, The University of Melbourne, Melbourne, Australia (Drs Amminger, Cotton, Mackinnon, and McGorry and Ms Harrigan); and Department of Research and Education, The Schlössli Clinic, Oetwil am See, Switzerland (Dr Berger).
Other sources for this story include:
BBC:
http://news.bbc.co.uk/2/hi/health/8...
WSJ:
http://online.wsj.com/article/SB100...
(NaturalNews) An important new study published in the Archives of General Psychiatry reveals that fish oil supplements beat mental illness. The study involved 81 people deemed to be at high risk for psychosis. The randomized, placebo-controlled study provided fish oil supplements to half the study subjects for just 12 weeks (the other half received placebo supplements). The results? While 11 people in the placebo group developed a psychotic disorder, only 2 in the fish oil group did.
Although the study was relatively small, it helps demonstrate the wide-ranging benefits of omega-3 fatty acids, which are thought to be the key nutritional factor in fish oils. We already know that omega-3 fatty acids / polyunsaturated fatty acids (PUFAs) help protect people against cardiovascular disease. We also know they can play a role in preventing diabetes and cancer. It's little surprise that they also protect against mental illness, given the importance of healthy fatty acids for the functioning of the nervous system.
As the BBC reports, Alison Cobb, from the mental health charity Mind, said in response to this study: "If young people can be treated successfully with fish oils, this is hugely preferable to treating them with antipsychotics, which come with a range of problems from weight gain to sexual dysfunction, whereas omega-3s are actually beneficial to their general state of health."
She's exactly right: Antipsychotic drugs actually cause diabetes. They promote blood sugar disorders and weight gain, among other problems. Some psychiatric drugs have also been linked to school shootings and violent outbursts (suicides, murders, etc.). They're also expensive and they pose an environmental hazard, since many of the chemicals used in those drugs pass right through the body and end up in waters downstream.
Fish oils have none of these negative side effects. In fact, they have positive effects throughout the body. That's why fish oils are such a remarkable solution to replace antipsychotic drugs: They're safer, cheaper and they work better!
You're supposed to keep taking drugs, says Big Pharma
The drug companies, of course, are terrified that people might learn this truth. They want to keep patients on expensive, patented antipsychotic drugs while discrediting "natural remedies" like fish oils or nutritional supplements. The entire war being waged against nutrition and supplements is, of course, nothing more than the pharmaceutical industry trying to protect its own turf by destroying the competition.
Because, let's face it: For (virtually) every popular pharmaceutical on the market, there's a nutritional supplement that works better (and that's also safer and more affordable). Antipsychotic drugs can be replaced with fish oils. Cholesterol drugs can be replaced with B vitamins. Anti-cancer drugs can be replaced with vitamin D and medicinal mushrooms. Diabetes drugs can be replaced with a healthy plant-based diet and targeted supplements. The list goes on and on...
Nutrition works so well that in this study, subjects experienced a protective effect from fish oils for an entire year even though they only took those fish oils for 12 weeks! Imagine how much better the outcome might have been if they continued on the fish oils for the entire year...
Get quality fish oils
Of course, when it comes to fish oils, don't settle for just any cheap fish oil supplement. Many of the cheaper store-bought brands are largely made of olive oil filler combined with a tiny amount of fish oil extract. Search out quality supplements or oils from companies like Moxxor, Nordic Naturals or Carlson Labs.
Make sure your supplements are free from heavy metals, pesticides and other residues. Make sure they are harvested in a truly sustainable way, and make sure you can trust the source to provide consistent quality.
Fish oils can provide astonishing health benefits. If the medical industry were truly honest about researching what works for patients rather than what makes money for drug companies, they would have openly prescribed fish oils long ago (and abandoned many of the antipsychotic drugs they still push).
But as you already know, the pharmaceutical industry isn't interested in what works for people unless it's something they can sell at monopoly prices. They don't want people to know about natural remedies, nutritional cures or healing foods. They would much rather see people stay ignorant about those things while pumping their minds full of advertisements and propaganda that ridiculously suggests the human brain is somehow deficient in Big Pharma's patented chemicals and that the only way you'll ever be truly healthy, happy or sane is to keep swallowing their pills for the rest of your life.
The real insanity in the world is not in the minds of mental patients; it's in the evil plans of the FDA, the WHO and the pharmaceutical cartel -- all of whom conspire to peddle dangerous medications when far safer, more natural and more effective alternatives are readily available.
Abstract of study from the Archives of General Psychiatry
Long-Chain Omega-3 Fatty Acids for Indicated Prevention of Psychotic Disorders
http://archpsyc.ama-assn.org/cgi/co...
A Randomized, Placebo-Controlled Trial
G. Paul Amminger, MD; Miriam R. Schäfer, MD; Konstantinos Papageorgiou, MD; Claudia M. Klier, MD; Sue M. Cotton, PhD; Susan M. Harrigan, MSc; Andrew Mackinnon, PhD; Patrick D. McGorry, MD, PhD; Gregor E. Berger, MD
Arch Gen Psychiatry. 2010;67(2):146-154.
Context: The use of antipsychotic medication for the prevention of psychotic disorders is controversial. Long-chain omega-3 (omega-3) polyunsaturated fatty acids (PUFAs) may be beneficial in a range of psychiatric conditions, including schizophrenia. Given that omega-3 PUFAs are generally beneficial to health and without clinically relevant adverse effects, their preventive use in psychosis merits investigation.
Objective: To determine whether omega-3 PUFAs reduce the rate of progression to first-episode psychotic disorder in adolescents and young adults aged 13 to 25 years with subthreshold psychosis.
Design: Randomized, double-blind, placebo-controlled trial conducted between 2004 and 2007.
Setting: Psychosis detection unit of a large public hospital in Vienna, Austria.
Participants: Eighty-one individuals at ultra-high risk of psychotic disorder.
Interventions: A 12-week intervention period of 1.2-g/d omega-3 PUFA or placebo was followed by a 40-week monitoring period; the total study period was 12 months.
Main Outcome Measures: The primary outcome measure was transition to psychotic disorder. Secondary outcomes included symptomatic and functional changes. The ratio of omega-6 to omega-3 fatty acids in erythrocytes was used to index pretreatment vs posttreatment fatty acid composition.
Results: Seventy-six of 81 participants (93.8%) completed the intervention. By study's end (12 months), 2 of 41 individuals (4.9%) in the omega-3 group and 11 of 40 (27.5%) in the placebo group had transitioned to psychotic disorder (P = .007). The difference between the groups in the cumulative risk of progression to full-threshold psychosis was 22.6% (95% confidence interval, 4.8-40.4). Omega-3 Polyunsaturated fatty acids also significantly reduced positive symptoms (P = .01), negative symptoms (P = .02), and general symptoms (P = .01) and improved functioning (P = .002) compared with placebo. The incidence of adverse effects did not differ between the treatment groups.
Conclusions: Long-chain omega-3 PUFAs reduce the risk of progression to psychotic disorder and may offer a safe and efficacious strategy for indicated prevention in young people with subthreshold psychotic states.
Trial Registration: clinicaltrials.gov Identifier: NCT00396643
Author Affiliations: Department of Child and Adolescent Psychiatry, Medical University of Vienna, Vienna, Austria (Drs Amminger, Schäfer, Papageorgiou, and Klier); Orygen Research Centre, Centre for Youth Mental Health, The University of Melbourne, Melbourne, Australia (Drs Amminger, Cotton, Mackinnon, and McGorry and Ms Harrigan); and Department of Research and Education, The Schlössli Clinic, Oetwil am See, Switzerland (Dr Berger).
Other sources for this story include:
BBC:
http://news.bbc.co.uk/2/hi/health/8...
WSJ:
http://online.wsj.com/article/SB100...
Monday, February 1, 2010
Recall of Rituxan (rituximab) - PML
October 23, 2009
Audience: Rheumatological healthcare professionals
Genentech and FDA notified healthcare professionals about a third case of progressive multifocal leukoencephalopathy [PML], the first case of PML in a patient with rheumatoid arthritis [RA] treated with Rituxan who has not previously received treatment with a TNF antagonist. Information to date suggests that patients with RA who receive Rituxan have an increased risk of PML.
Physicians should consider PML in any patient being treated with Rituxan who presents with new onset neurologic manifestations. Consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated.
[10/2009 - Dear Healthcare Professional Letter - Genentech]
Audience: Rheumatological healthcare professionals
Genentech and FDA notified healthcare professionals about a third case of progressive multifocal leukoencephalopathy [PML], the first case of PML in a patient with rheumatoid arthritis [RA] treated with Rituxan who has not previously received treatment with a TNF antagonist. Information to date suggests that patients with RA who receive Rituxan have an increased risk of PML.
Physicians should consider PML in any patient being treated with Rituxan who presents with new onset neurologic manifestations. Consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated.
[10/2009 - Dear Healthcare Professional Letter - Genentech]
Actemra for Treatment of Rheumatoid Arthritis
Generic Name: tocilizumab
Date of Approval: January 8, 2010
Company: Genentech USA, Inc.
Treatment for: Rheumatoid Arthritis
FDA Approves Actemra
The United States (US) Food and Drug Administration (FDA) approved Actemra (tocilizumab, RoActemra in the European Union) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Actemra, the result of a research & development collaboration with Chugai, is the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody approved to treat RA, may be used alone or in combination with methotrexate or other disease modifying anti-rheumatic drugs (DMARDs).
Actemra Medication Guide
What is the most important information I should know about Actemra?
Actemra can cause serious side effects including:
Serious Infections
Actemra is a medicine that affects your immune system. Actemra can lower the ability of your immune system to fight infections. Some people have serious infections while taking Actemra, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.
Your doctor should test you for TB before starting Actemra.
Your doctor should monitor you closely for signs and symptoms of TB during treatment with Actemra.
You should not start taking Actemra if you have any kind of infection unless your healthcare provider says it is okay.
Before starting Actemra, tell your healthcare provider if you: think you have an infection or have symptoms of an infection such as:
fever, sweating, or chills
muscle aches
cough
shortness of breath
blood in phlegm
weight loss
warm, red, or painful skin or sores on your body
diarrhea or stomach pain
burning when you urinate or urinating more often than normal
feel very tired
are being treated for an infection
get a lot of infections or have infections that keep coming back
have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance for infections.
have TB, or have been in close contact with someone with TB
live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections (histoplasmosis, coccidiomycosis, or blastomycosis). These infections may happen or become more severe if you use Actemra. Ask your healthcare provider, if you do not know if you have lived in an area where these infections are common.
have or have had hepatitis B.
After starting Actemra, call your healthcare provider right away if you have any symptoms of an infection. Actemra can make you more likely to get infections or make worse any infection that you have.
Tears (perforation) of the stomach or intestines.
Before taking Actemra, tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking Actemra get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.
Tell your healthcare provider right away if you have fever and stomach-area pain that does not go away, and a change in your bowel habits.
Changes in certain laboratory test results. Your healthcare provider should do blood tests before you start receiving Actemra and every 4 to 8 weeks during treatment to check for the following side effects of Actemra:
low neutrophil count. Neutrophils are white blood cells that help the body fight off bacterial infections.
low platelet count. Platelets are blood cells that help with blood clotting and stop bleeding.
increase in certain liver function tests.
You should not receive Actemra if your neutrophil or platelet counts are too low or your liver function tests are too high.
Your healthcare provider may stop your Actemra treatment for a period of time or change your dose of medicine if needed because of changes in these blood test results. You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start receiving Actemra, and then every 6 months after that. Normal cholesterol levels are important to good heart health.
Cancer.
Actemra may decrease the activity of your immune system. Medicines that affect the immune system may increase your risk of certain cancers. Tell your healthcare provider if you have ever had any type of cancer. See "What are the possible side effects with Actemra?" for more information about side effects.
What is Actemra?
Actemra is a prescription medicine called an Interleukin-6 (IL-6) receptor inhibitor. Actemra is used to treat adults with moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called a Tumor Necrosis Factor (TNF) antagonist has been used and did not work well.
It is not known if Actemra is safe and effective in children.
What should I tell my healthcare provider before receiving Actemra?
Actemra may not be right for you. Before starting Actemra, tell your healthcare provider if you:
have an infection.
have liver problems
have any stomach-area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines
have or had a condition that affects your nervous system, such as multiple sclerosis
have recently received or are scheduled to receive a vaccine. People who take Actemra should not receive live vaccines. People taking Actemra can receive non-live vaccines
plan to have surgery or a medical procedure
have any other medical conditions
plan to become pregnant or are pregnant. It is not known if Actemra will harm your unborn baby.
Pregnancy Registry: Genentech has a registry for pregnant women who take Actemra. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking Actemra, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll.
plan to breast-feed or are breast-feeding. You and your healthcare provider should decide if you will take Actemra or breast-feed. You should not do both.
Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Actemra and other medicines may affect each other causing side effects.
Especially tell your healthcare provider if you take:
any other medicines to treat your RA. You should not take etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), rituximab (Rituxan), abatacept (Orencia), anakinra (Kineret), certolizumab (Cimzia), or golimumab (Simponi), while you are taking Actemra. Taking Actemra with these medicines may increase your risk of infection.
medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.
Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How will I receive Actemra?
You will receive Actemra from a healthcare provider through a needle placed in a vein in your arm (IV or intravenous infusion). The infusion will take about 1 hour to give you the full dose of medicine.
You will receive a dose of Actemra about every 4 weeks.
If you miss a scheduled dose of Actemra, ask your healthcare provider when to schedule your next infusion.
While taking Actemra, you may continue to use other medicines that help treat your rheumatoid arthritis such as methotrexate, non-steroidal anti-inflammatory drugs (NSAIDs) and prescription steroids, as instructed by your healthcare provider.
Keep all of your follow-up appointments and get your blood tests as ordered by your healthcare provider.
What are the possible side effects with Actemra?
Actemra can cause serious side effects, including:
Hepatitis B infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus may become active while you use Actemra. This happens with other biologic medicines used to treat RA. Your doctor may do blood tests before you start treatment with Actemra and while you are using Actemra. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B infection:
feel very tired
skin or eyes look yellow
little or no appetite
vomiting
clay-colored bowel movements
fevers
chills
stomach discomfort
muscle aches
dark urine
skin rash
Nervous system problems. Multiple Sclerosis has been diagnosed rarely in people who take Actemra. It is not known what effect Actemra may have on some nervous system disorders.
Allergic Reactions. Serious allergic reactions can happen with Actemra. These reactions may not happen with your first infusion, and may happen with future infusions of Actemra. Tell your healthcare provider right away if you have any of the following signs of a serious allergic reaction:
shortness of breath or trouble breathing
skin rash
swelling of the lips, tongue, or face
chest pain
feeling dizzy or faint
Common side effects of Actemra include:
upper respiratory tract infections (common cold, sinus infections)
headache
increased blood pressure (hypertension)
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Actemra. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555.
General information about Actemra
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This Medication Guide summarizes the most important information about Actemra.
If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about Actemra that is written for health professionals.
For more information, go to www.actemra.com or call 1-800-ACTEMRA.
What are the ingredients in Actemra?
Active ingredient: tocilizumab
Inactive ingredients: sucrose, polysorbate 80, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate.
Date of Approval: January 8, 2010
Company: Genentech USA, Inc.
Treatment for: Rheumatoid Arthritis
FDA Approves Actemra
The United States (US) Food and Drug Administration (FDA) approved Actemra (tocilizumab, RoActemra in the European Union) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Actemra, the result of a research & development collaboration with Chugai, is the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody approved to treat RA, may be used alone or in combination with methotrexate or other disease modifying anti-rheumatic drugs (DMARDs).
Actemra Medication Guide
What is the most important information I should know about Actemra?
Actemra can cause serious side effects including:
Serious Infections
Actemra is a medicine that affects your immune system. Actemra can lower the ability of your immune system to fight infections. Some people have serious infections while taking Actemra, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.
Your doctor should test you for TB before starting Actemra.
Your doctor should monitor you closely for signs and symptoms of TB during treatment with Actemra.
You should not start taking Actemra if you have any kind of infection unless your healthcare provider says it is okay.
Before starting Actemra, tell your healthcare provider if you: think you have an infection or have symptoms of an infection such as:
fever, sweating, or chills
muscle aches
cough
shortness of breath
blood in phlegm
weight loss
warm, red, or painful skin or sores on your body
diarrhea or stomach pain
burning when you urinate or urinating more often than normal
feel very tired
are being treated for an infection
get a lot of infections or have infections that keep coming back
have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance for infections.
have TB, or have been in close contact with someone with TB
live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections (histoplasmosis, coccidiomycosis, or blastomycosis). These infections may happen or become more severe if you use Actemra. Ask your healthcare provider, if you do not know if you have lived in an area where these infections are common.
have or have had hepatitis B.
After starting Actemra, call your healthcare provider right away if you have any symptoms of an infection. Actemra can make you more likely to get infections or make worse any infection that you have.
Tears (perforation) of the stomach or intestines.
Before taking Actemra, tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking Actemra get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.
Tell your healthcare provider right away if you have fever and stomach-area pain that does not go away, and a change in your bowel habits.
Changes in certain laboratory test results. Your healthcare provider should do blood tests before you start receiving Actemra and every 4 to 8 weeks during treatment to check for the following side effects of Actemra:
low neutrophil count. Neutrophils are white blood cells that help the body fight off bacterial infections.
low platelet count. Platelets are blood cells that help with blood clotting and stop bleeding.
increase in certain liver function tests.
You should not receive Actemra if your neutrophil or platelet counts are too low or your liver function tests are too high.
Your healthcare provider may stop your Actemra treatment for a period of time or change your dose of medicine if needed because of changes in these blood test results. You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start receiving Actemra, and then every 6 months after that. Normal cholesterol levels are important to good heart health.
Cancer.
Actemra may decrease the activity of your immune system. Medicines that affect the immune system may increase your risk of certain cancers. Tell your healthcare provider if you have ever had any type of cancer. See "What are the possible side effects with Actemra?" for more information about side effects.
What is Actemra?
Actemra is a prescription medicine called an Interleukin-6 (IL-6) receptor inhibitor. Actemra is used to treat adults with moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called a Tumor Necrosis Factor (TNF) antagonist has been used and did not work well.
It is not known if Actemra is safe and effective in children.
What should I tell my healthcare provider before receiving Actemra?
Actemra may not be right for you. Before starting Actemra, tell your healthcare provider if you:
have an infection.
have liver problems
have any stomach-area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines
have or had a condition that affects your nervous system, such as multiple sclerosis
have recently received or are scheduled to receive a vaccine. People who take Actemra should not receive live vaccines. People taking Actemra can receive non-live vaccines
plan to have surgery or a medical procedure
have any other medical conditions
plan to become pregnant or are pregnant. It is not known if Actemra will harm your unborn baby.
Pregnancy Registry: Genentech has a registry for pregnant women who take Actemra. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking Actemra, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll.
plan to breast-feed or are breast-feeding. You and your healthcare provider should decide if you will take Actemra or breast-feed. You should not do both.
Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Actemra and other medicines may affect each other causing side effects.
Especially tell your healthcare provider if you take:
any other medicines to treat your RA. You should not take etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), rituximab (Rituxan), abatacept (Orencia), anakinra (Kineret), certolizumab (Cimzia), or golimumab (Simponi), while you are taking Actemra. Taking Actemra with these medicines may increase your risk of infection.
medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.
Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How will I receive Actemra?
You will receive Actemra from a healthcare provider through a needle placed in a vein in your arm (IV or intravenous infusion). The infusion will take about 1 hour to give you the full dose of medicine.
You will receive a dose of Actemra about every 4 weeks.
If you miss a scheduled dose of Actemra, ask your healthcare provider when to schedule your next infusion.
While taking Actemra, you may continue to use other medicines that help treat your rheumatoid arthritis such as methotrexate, non-steroidal anti-inflammatory drugs (NSAIDs) and prescription steroids, as instructed by your healthcare provider.
Keep all of your follow-up appointments and get your blood tests as ordered by your healthcare provider.
What are the possible side effects with Actemra?
Actemra can cause serious side effects, including:
Hepatitis B infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus may become active while you use Actemra. This happens with other biologic medicines used to treat RA. Your doctor may do blood tests before you start treatment with Actemra and while you are using Actemra. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B infection:
feel very tired
skin or eyes look yellow
little or no appetite
vomiting
clay-colored bowel movements
fevers
chills
stomach discomfort
muscle aches
dark urine
skin rash
Nervous system problems. Multiple Sclerosis has been diagnosed rarely in people who take Actemra. It is not known what effect Actemra may have on some nervous system disorders.
Allergic Reactions. Serious allergic reactions can happen with Actemra. These reactions may not happen with your first infusion, and may happen with future infusions of Actemra. Tell your healthcare provider right away if you have any of the following signs of a serious allergic reaction:
shortness of breath or trouble breathing
skin rash
swelling of the lips, tongue, or face
chest pain
feeling dizzy or faint
Common side effects of Actemra include:
upper respiratory tract infections (common cold, sinus infections)
headache
increased blood pressure (hypertension)
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Actemra. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555.
General information about Actemra
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This Medication Guide summarizes the most important information about Actemra.
If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about Actemra that is written for health professionals.
For more information, go to www.actemra.com or call 1-800-ACTEMRA.
What are the ingredients in Actemra?
Active ingredient: tocilizumab
Inactive ingredients: sucrose, polysorbate 80, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate.
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