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OFF LABEL USE and Baclofen

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OFF LABEL USE Symptoms and Causes

Normally, your cells grow and die in a controlled way. Cancer cells keep growing without control. Chemotherapy is drug therapy for cancer. It works by killing the cancer cells, stopping them from spreading, or slowing their growth. However, it can also harm healthy cells, which causes side effects.

You may have a lot of side effects, some, or none at all. It depends on the type and amount of chemotherapy you get and how your body reacts. Some common side effects are fatigue, nausea, vomiting, pain, and hair loss. There are ways to prevent or control some side effects. Talk with your health care provider about how to manage them. Healthy cells usually recover after chemotherapy is over, so most side effects gradually go away.

Your treatment plan will depend on the cancer type, the chemotherapy drugs used, the treatment goal, and how your body responds. Chemotherapy may be given alone or with other treatments. You may get treatment every day, every week, or every month. You may have breaks between treatments so that your body has a chance to build new healthy cells. You might take the drugs by mouth, in a shot, as a cream, or intravenously (by IV).

NIH: National Cancer Institute

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OFF LABEL USE treatment research studies

Baclofen clinical trials, surveys and public health registries


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Baclofen Side Effects

Overdose (180)
Coma (125)
Muscle Spasticity (122)
Pain (99)
Confusional State (96)
Muscle Spasms (94)
Convulsion (92)
Completed Suicide (92)
Fatigue (82)
Fall (77)
Somnolence (76)
Pyrexia (75)
Nausea (73)
Hypertension (73)
Dizziness (72)
Headache (70)
Death (70)
Vomiting (69)
Mental Status Changes (68)
Poisoning (68)
Pneumonia (66)
Hypotension (65)
Delirium (63)
Asthenia (62)
Bradycardia (62)
Neurotoxicity (62)
Agitation (60)
Urinary Tract Infection (59)
Dyspnoea (58)
Loss Of Consciousness (55)
Condition Aggravated (54)
Cardiac Arrest (52)
Intentional Overdose (51)
Hypotonia (49)
Implant Site Effusion (48)
Gait Disturbance (47)
Malaise (47)
Depressed Level Of Consciousness (46)
Multiple Sclerosis Relapse (45)
Respiratory Arrest (45)
Withdrawal Syndrome (45)
Medical Device Complication (44)
Hallucination (43)
Tremor (43)
Pain In Extremity (42)
Suicide Attempt (42)
Respiratory Failure (42)
Disorientation (40)
Muscular Weakness (39)
Toxicity To Various Agents (39)

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Recent Reviews

Alopecia areata

Husbnd is a 15 yr. stroke survivor who had a baclofen pump since about 2001. It was replaced Nov. 2009 and nothing but trouble... passing out, weakness, falling, etc. 4 ER trips and not one dr. ever mentioned b

I had a devastating experience with this drug. I had been using Flexeril for back and neck pain but found it no longer as effective. I asked my doctor if there was something stronger. He prescribed Baclofen. Having not read the label carefully, m

I have experience hads spasm,diziness,headaches,shallow or hard breathing,slepiness,pain in the side (new)

I too had a nasty bite from baclofen.I had a craving for alcohol and was on 10 mg TID.I took 90mg at once. within one hour I feel like i was on shrooms! Very vivid CEVs(closed eyed visuals) and some ope eyed visuals(OEVs).Actually I enjoyed this.But

Just was looking around and saw your post. We experienced a very similar situation with our child. Was the pump just installed?

Male 42 prescribed baclofen 30-60mg daily for the control of cervical dystonia, great for first week then started to get pain and discumfort in my bowels by week two i was being physicaly sick and unable to control the pain , had to stop taking the m

My mom 77 years old suddenly becomes weaksinceshe started taking baclofen..she's having a difficulty in walking and maintaning her balance..that wasnt her condition before..

My son was overdosed on baclofen, they doubled his does and then took him back down to a lower dose all in a day and a half. he started taking 5 breaths a minute, and the doctor said it was not the pump. duh i am no rocket scientest, but it

What are all side effects of baclofen?

45 yr old male, went to dentist had a lot of calc buildup, gave me peridex, told me it might be a little strong might need to cut it down or test it first, he gave this to me, I didnt read the label or anything I thought it was just a mouthwash WARNI

Anthony, thank you. I thought I was going nuts. Weight gain would be an understatement. Bloating and gas too. Not sure I want to continue this and I have not been on the 'full' dose --- misread the label and am happy I d

Hi i need information toward somatropin label price?

I had a devastating experience with this drug. I had been using Flexeril for back and neck pain but found it no longer as effective. I asked my doctor if there was something stronger. He prescribed Baclofen. Having not read the label carefully, m

I have been on 20 mg of Cipralex for over 3 years. It does it's job and I do not experience anxiety. In doing your homework, you will see Cipralex is for anxiety which is part of the 'depression' family. One does not label the other. One of the bigg

I have been sick with allergies/asthma/sinusitis for over a week and when I took Mucinex DM I made sure to read the label carefully. My carton said to take 1 every 12 hours and no more than 2 in 24 hours. After taking the first pill it had no effect

I haven't had an abortion induced but the medicine label clearly states to use two forms of protection. If the patient has unprotected sex, that the patient's problem. Every doctor visit my doctor stressed to me how much the medicine could

I may try Lyrica off label for GAD and PD as well as some antidepressive effects I read in journals, articles. Lyrica has been approved for GAD in Europe but hasn't gotten the FDA approval for it here yet. The above poster, Case Report #Self-49

I take Centrum Silver and wanted a label that I could read.

Is a GG 40 with a Sandoz label made in a different laboratory than a GG 40 with a Geneva label? (I know they are both 10 mg of amitriptyline.) Thank you. Appreciate reply as soon as possible.

OFF LABEL USE Clinical Trials and Studies

Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses. People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.
Rank Status Study
1 Recruiting Safety Study of 3 mg/mL Baclofen Injection (Intrathecal) Using A Programmable Pump
Condition: Severe Spasticity
Intervention: Drug: Gablofen® 3 mg/mL (Baclofen injection)
Outcome Measures: The rate of inflammatory granulomas in patients given 3 mg/mL Gablofen® (Baclofen injection) 3mg/mL by the intrathecal route of administration.;   Overall safety of 3 mg/mL Gablofen® (Baclofen injection) given by the intrathecal route of administration
2 Recruiting Preventing Alcohol Withdrawal With Oral Baclofen
Conditions: Alcoholism;   Alcohol Withdrawal
Intervention: Drug: Baclofen
Outcome Measures: Alcohol withdrawal severity as measured on CIWA-AR (Clinical Institute for Withdrawal Assessment) scale;   Total benzodiazepine dose required
3 Not yet recruiting Oral and IV Baclofen in Adult Volunteers
Condition: Baclofen Withdrawal Syndrome
Interventions: Drug: Oral Baclofen;   Drug: Intervenous Baclofen
Outcome Measures: oral bioavailability;   Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)];   Plasma Decay Half-Life (t1/2);   Maximum concentration (Cmax);   Tmax;   assessment of sedation;   Ataxia;   Nystagmus;   blood pressure
4 Not yet recruiting Dose Escalation Study of Intravenous Baclofen in Healthy Adult Volunteers
Condition: Safety and Pharmacokinetics of Intravenous Baclofen
Intervention: Drug: Intravenous Baclofen
Outcome Measures: Safety assessments;   Maximum Concentration(Cmax);   AUC(0-inf);   Plasma Decay Half-life (T1/2)
5 Not yet recruiting Action of Baclofen Capsules in Spasticity Due to Multiple Sclerosis
Condition: Spasticity
Interventions: Drug: Baclofen dose 1;   Drug: Baclofen dose 2;   Drug: Placebo
Outcome Measures: Primary efficacy outcome: Improvement in Ashworth score;   Spasm frequency;   Nighttime awakening score;   Clinical global impression of change;   Subject's global impression of change
6 Recruiting Baclofen Effects in Cigarette Smokers
Condition: Nicotine Dependence
Interventions: Drug: Baclofen;   Drug: placebo
Outcome Measures: fMRI response in the ventral striatum/medial orbitofrontal cortex during smoking cue exposure;   Urine cotinine;   Cigarettes smoked per day
7 Recruiting Efficacy and Safety of Baclofen ER Capsules (GRS) in Subjects With Spasticity Due to Multiple Sclerosis
Condition: Spasticity
Interventions: Drug: Baclofen ER Capsules;   Drug: Placebo GRS
Outcome Measures: The primary efficacy outcome is the proportion of subjects who become a treatment failure during double-blind randomized withdrawal;   Determining the safety profile when administered over >12 weeks;   Subject Global Impression of Severity (SGIS)assessment
8 Recruiting Efficacy and Safety of High Dose Baclofen for Alcohol Dependence
Condition: Alcoholism
Interventions: Drug: Baclofen;   Drug: Placebo
Outcome Measures: Mean % Heavy Drinking Days;   Mean % Abstinent Drinking Days;   Anxiety level based on Spielberger Scale for State Anxiety
9 Recruiting Baclofen Effects on Marijuana Dependence
Condition: Marijuana Dependence
Interventions: Drug: Baclofen;   Behavioral: Psychosocial;   Drug: Placebo
Outcome Measure: Change in brain and behavioral responses during reward and inhibitory tasks at fMRI 1, fMRI 2, and fMRI 3; A composite measure
10 Recruiting A Clinical Evaluation Of The Safety Of Baclofen Er Capsules (Grs) When Administered Once Daily To Subjects With Spasticity Due To Multiple Sclerosis (Ms): An Open Label, Long Term, Safety Trial
Condition: Spasticity
Intervention: Drug: Baclofen
Outcome Measures: No. of participants with adverse events;   No. of participants with adverse vital signs;   Number of participants with adverse laboratory parameters
11 Not yet recruiting Preventing Alcohol Withdrawal Syndrome With Oral Baclofen
Condition: Alcohol Withdrawal Syndrome
Interventions: Drug: Baclofen;   Drug: Placebo
Outcome Measures: Prevention of Progression to Severe Alcohol withdrawal;   Reduced Severity of alcohol withdrawal (measured be SEWS score);   Reduced benzodiazepine administration in treatment group
12 Unknown  Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients
Condition: Alcohol Dependence
Intervention: Drug: Baclofen (as add-on to standard treatment of alcohol dependence)
Outcome Measures: clinical efficacy and safe side-effect profile of Baclofen in patients suffering from alcohol dependence;   an improvement of the quality of life and associated psychosocial variables such as self-perceptions
13 Not yet recruiting A Study of Baclofen ER
Condition: Cocaine Dependence
Interventions: Drug: Baclofen ER;   Drug: Placebo
Outcome Measure: Urines positive for benzoylecgonine (BE), (a metabolite of cocaine)
14 Unknown  Placebo Controlled Study of Baclofen for GERD in Children With Cerebral Palsy
Conditions: Cerebral Palsy;   GERD
Interventions: Drug: Baclofen;   Drug: placebo
Outcome Measures: Symptom control;   GERD control;   side effects of Baclofen
15 Recruiting A Study to Examine the, Safety, Tolerability and Pharmacokinetics Co-Administered Baclofen and Memantine in Obese and Lean, Otherwise Healthy Adults
Conditions: Healthy Volunteers;;   Obese, Otherwise Healthy Volunteers
Interventions: Drug: Baclofen;   Drug: Memantine;   Drug: Placebo
Outcome Measures: Safety and tolerability of co-administered Baclofen and memantine via C-SSRS;   Safety and tolerability of co-administered Baclofen and memantine via Adverse Events;   Safety and tolerability of co-administered Baclofen and memantine via Vital Signs;   Safety and tolerability of co-administered Baclofen and memantine via ECG;   Safety and tolerability of co-administered Baclofen and memantine via Clinical Laboratory Tests;   Pharmacokinetic parameters of co-administered Baclofen and memantine via Cmax;   Pharmacokinetic parameters of co-administered Baclofen and memantine via Tmax;   Pharmacokinetic parameters of co-administered Baclofen and memantine via AUC;   Pharmacokinetic parameters of co-administered Baclofen and memantine via MRT;   Pharmacokinetic parameters of co-administered Baclofen and memantine via CL/F;   Pharmacokinetic parameters of co-administered Baclofen and memantine via T1/2;   Pharmacokinetic parameters of co-administered Baclofen and memantine via CLR
16 Recruiting Baclofen in the Treatment of Alcoholic Liver Disease
Condition: Alcoholic Liver Disease
Interventions: Drug: Baclofen 30mg/day;   Drug: Baclofen 75mg/day;   Drug: Placebo
Outcome Measures: alcohol consumption;   clinical markers of liver injury;   incidence of hepatic side effects;   craving for alcohol;   early termination due to side effects
17 Recruiting Baclofen for Treating Anxiety and Alcoholism
Conditions: Alcoholism;   Alcohol Dependence;   Alcohol Drinking Related Problems;   Alcohol Drinking;   Anxiety Disorder
Intervention: Drug: Baclofen
Outcome Measures: Alcohol drinking during the Alcohol Self-Administration, expressed as Standard Drinking Units (SDUs) will be measured as the primary outcome during the CR/ASA session.;   Secondary objectives include Baclofen s effects on alcohol cue-induced responses (urge to drink, attention to cues, blood pressure, heart rate, saliva), on the subjective effects of alcohol and on anxiety levels.
18 Unknown  Open Label Treatment of Severe Tactile Defensiveness With Intrathecal Baclofen
Conditions: Tactile Defensiveness;   Autism Spectrum Disorder
Intervention: Drug: Baclofen, intrathecal
Outcome Measures: Modified Short Sensory Profile.;   Clinical Global Impression of Change in Autism Symptoms
19 Unknown  Does Oral Baclofen Improve Care and Comfort in Spastic Children in Nursing Homes?
Condition: Cerebral Palsy
Interventions: Drug: oral Baclofen + placebo;   Drug: placebo + oral Baclofen
Outcome Measure: care and comport questionnaires
20 Recruiting GABA-B Receptor Function in Healthy Volunteers
Conditions: No Condition;   Brain GABA-B Function
Interventions: Drug: Baclofen 10mg;   Drug: Baclofen 60mg;   Drug: placebo
Outcome Measure: EEG spectral power in theta band