Ongoing Landmark ROADMAP Study Demonstrates Significant Improvement in Blood Pressure Control at One Year, According to Blinded Results
... in the prescribing information .
hypotension in Volume- or Salt-Depleted Patients
In ... with high doses of diuretics), symptomatic
hypotension may occur after initiation of treatment with ... should start under close medical supervision. If
hypotension does occur, the patient should be placed in the ...
New Data Shows Blood Pressure Reduction Therapy with BENICAR(R) and BENICAR HCT(R) Effectively Reduces Blood Pressure in Elderly Patients to Target Blood Pressure
... AEs included: dizziness (3.4 percent),
hypotension (2.2 percent), and/or headache (1.1 percent).
... patients, 2.2%), headache (4 patients, 2.2%), and
hypotension (4 patients, 2.2%). Among individual treatment ... Mortality in the prescribing information.
hypotension in Volume- or Salt-Depleted Patients
In ...
New Data Shows AZOR(R) (amlodipine and olmesartan medoxomil) Significantly Improves 24-Hour Ambulatory Blood Pressure
... Fetal/Neonatal Morbidity and Mortality.
hypotension in Volume- or Salt-Depleted Patients
In ... and/or salt-depleted patients, symptomatic
hypotension due particularly to the olmesartan component may ... to amlodipine in AZOR is gradual in onset, acute
hypotension has rarely been reported after oral ...
Continued Overall Survival Advantage Reported From Pivotal Trial of VELCADE(R) (Bortezomib) for Injection Based Therapy in Patients With Previously Untreated Multiple Myeloma
... include new or worsening peripheral neuropathy,
hypotension throughout therapy, cardiac and pulmonary ... pain (each 15%), bone pain (14%), back pain and
hypotension (each 13%), herpes zoster, nasopharyngitis, upper ... (13% vs 7%), abdominal pain upper (12% vs 9%),
hypotension (12% vs 3%), dyspepsia (11% vs 7%), ...
Prolonged Progression-Free Survival Demonstrated by VELCADE(R) (Bortezomib) for Injection Based Induction Regimens in Transplant-Eligible Previously Untreated Multiple Myeloma Patients
... include new or worsening peripheral
neuropathy,
hypotension throughout therapy, cardiac and pulmonary ... pain (each 15%),
bone pain (14%), back pain and
hypotension (each 13%), herpes zoster,
nasopharyngitis, upper ... (13% vs 7%), abdominal pain upper (12% vs 9%),
hypotension (12%
vs 3%), dyspepsia (11% vs 7%), ...
Novel VELCADE(R) (Bortezomib) for Injection Based Four-Drug Combination Was Well Tolerated In Previously Untreated Multiple Myeloma Patients
... include new or worsening peripheral
neuropathy,
hypotension throughout therapy, cardiac and pulmonary ... pain (each 15%),
bone pain (14%), back pain and
hypotension (each 13%), herpes zoster,
nasopharyngitis, upper ... (13% vs 7%), abdominal pain upper (12% vs 9%),
hypotension (12%
vs 3%), dyspepsia (11% vs 7%), ...
New England Journal of Medicine Publishes Phase III Results of VELCADE(R) (Bortezomib) for Injection in Previously Untreated Multiple Myeloma Patients
... (13% vs 7%), abdominal pain
upper (12% vs 9%),
hypotension (12% vs 3%), dyspepsia (11% vs ... include new or worsening
peripheral neuropathy,
hypotension throughout therapy, cardiac and
pulmonary ... pain (each 15%), bone pain (14%), back pain and
hypotension (each
13%), herpes zoster, nasopharyngitis, upper ...
FDA Files Application To Convert ONTAK(R) (Denileukin Diftitox) to Full Approval for Use in Cutaneous T-Cell Lymphoma (CTCL)
... as the incidence (%) in these 98 patients:
hypotension (50%), back
pain (30%), dyspnea (28%), ... type
of treatment will depend on whether edema or
hypotension is the primary
clinical problem. Pre-existing low ... (61%),
infection (48%), pain (48%), edema (47%),
hypotension (36%), anorexia
(36%), and rash (34%).
...
Azor(TM) Reduces Blood Pressure in Difficult to Treat Special Populations
... Morbidity and Mortality.
hypotension in Volume- or Salt-Depleted Patients
In ... salt-depleted patients, symptomatic
hypotension due particularly to
the olmesartan component may ... to amlodipine in AZOR is gradual in
onset, acute
hypotension has rarely been reported after ...
New Studies on Once-Daily Extended Release Pramipexole Presented at American Academy of Neurology Annual Meeting
... resulted in accidents. Hallucinations and postural (orthostatic)
hypotension may occur. In clinical trials for early PD using immediate release ... of pramipexole that were more frequent than with placebo are postural
hypotension (53% vs. 48%), dyskinesia (47% vs. 31%), extrapyramidal syndrome (28% vs. ...
New Study Shows BENICAR(R) (olmesartan medoxomil) Reverses Blood Vessel Damage Independent of Blood Pressure Lowering
... Morbidity and Mortality in the prescribing information.
hypotension in Volume- or Salt-Depleted Patients
In patients with an activated ... (eg, those being treated with high doses of
diuretics), symptomatic
hypotension may occur after initiation of treatment
with BENICAR. Treatment should ...
New Data Shows 45 Percent of Patients with Stage 1 Hypertension Reached Normotension with BENICAR(R) and BENICAR HCT(R)
... Morbidity and Mortality in the prescribing information.
hypotension in Volume- or Salt-Depleted Patients
In patients with an activated ... (e.g., those being treated with high doses of
diuretics), symptomatic
hypotension may occur after initiation of treatment
with BENICAR. Treatment should ...
Circulation Publishes Data Showing KYNAPID(TM) (Vernakalant Hydrochloride) Injection Rapidly Converted Short-Duration Atrial Fibrillation to Sinus Rhythm
... (29.9%), sneezing (16.3%),
skin sensation (10.9%), nausea (9%), and
hypotension (6.3%). These events
were generally transient. Four serious AEs possibly or probably related to
KYNAPID occurred in three patients and included
hypotension (2 events),
complete atrioventricular block and cardiogenic shock.
About ...
Twelve DOXIL(R) Clinical Studies to be Presented at American Society of Hematology Annual Meeting
... headache, chills, back pain, tightness in the chest or throat, and/or
hypotension have occurred in up to 10% of patients treated with DOXIL. In most ... with VELCADE therapy include new or worsening
peripheral neuropathy,
hypotension observed throughout therapy, cardiac and
pulmonary disorders, ...
A Phase II, Randomized, Double Blind, Placebo-Controlled Dose-Escalating Study, Meets the Clinical Endpoints of MTR106 Tablets During the Treatment of Acute Migraine Attacks Without Aura in Females
... proprietary products for the
therapeutic management of acute and chronic
hypotension and
hypotension-related disorders. The lead development compound is a ... for Migraine, and MTR105 (i.v. formulation) for
the treatment of
hypotension associated with cardiac (CABG) surgery.
Meditor's patent portfolio ...
FDA Advisory Committee Votes in Favor of Zyprexa for Two Adolescent Indications
... antipsychotic increase. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.
Zyprexa may induce orthostatic
hypotension associated with dizziness, tachycardia, bradycardia, and in some patients, syncope, especially during the initial dose-titration period. Particular ...
Results and Additional Analyses From Study Show That Corthera's Relaxin for Acute Heart Failure is the Strongest Predictor of Improved Longer-Term Outcomes Following Hospital Discharge When Compared to Other Variables
... of care includes diuretics and vasodilators. Available agents from both of these classes of agents have been associated with renal impairment,
hypotension and adverse outcomes.
About Relaxin
Relaxin is a naturally occurring peptide hormone that acts as a systemic and renal vasodilator. ...
RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed the Time to Relapse in Patients with Bipolar I Disorder
... higher levels of prolactin elevation than other antipsychotic agents.
Orthostatic Hypotension: RISPERDAL(R) CONSTA(R) may induce orthostatic
hypotension associated with dizziness, tachycardia, and in some patients, syncope, especially during the initial dose-titration period. Monitoring should be ...
RAPAFLO(TM) (silodosin) Provides Rapid and Sustained Benign Prostatic Hyperplasia (BPH) Symptom Relief in as Little as Three Days
... treatment effect, led to treatment discontinuation in only 2.8 percent of patients, and does not pose a safety concern. Incidences of orthostatic
hypotension among RAPAFLO(TM)- and placebo-treated patients were similar and low (2.6% and 1.5%, respectively). In addition, the incidence of treatment-related ...
Watson Announces United States Availability of RAPAFLO(TM) (silodosin), a Novel New Treatment in Benign Prostatic Hyperplasia (BPH)
... a three-point improvement in IPSS score, regardless of age or severity of symptoms. RAPAFLO(TM) is associated with a low incidence of orthostatic
hypotension and the associated symptoms of syncope, fainting and dizziness.
"The launch of RAPAFLO(TM) is an important milestone and, coupled with the ...
Results From Study Show Promising Efficacy and Safety Results for Corthera's Relaxin in Acute Heart Failure
... of care includes diuretics and vasodilators. Available agents from both of these classes of agents have been associated with renal impairment,
hypotension and adverse outcomes.
About Relaxin
Relaxin is a naturally occurring peptide hormone that acts as a systemic and renal vasodilator ...
FDA Issues a Complete Response Letter for Lilly's Olanzapine LAI for Treatment of Schizophrenia in Adults
... prior to
starting olanzapine. Patients receiving olanzapine should receive regular
monitoring of weight.
Olanzapine may induce orthostatic
hypotension associated with dizziness,
tachycardia, bradycardia, and in some patients, syncope, especially during the
initial dose-titration period. Particular ...
FDA Approves LUSEDRA(TM) (fospropofol disodium) Injection for Monitored Anesthesia Care (MAC) Sedation
... immediately available.
The following serious adverse reactions have been reported with the use of
LUSEDRA.
-- Hypotension
--
hypotension was reported in 18/455 (4%) patients treated with
LUSEDRA using the standard or modified dosing regimen.
-- Patients with ...
Study Finds DOXIL(R) Combination Therapy Delays Disease Progression for Patients With Metastatic Breast Cancer
... not limited to,
flushing, shortness of breath, facial swelling, headache, chills, back
pain, tightness in the chest or throat, and/or
hypotension have
occurred in up to 10% of patients treated with DOXIL. In most patients,
these reactions have resolved within several hours to a ...
Whatcom County, Washington Participating in NIH Study of Cardiac Arrest Resuscitation Techniques
... are ongoing in the United States to evaluate the
long-term benefit of the ResQPOD for indications related to patients
suffering from cardiac arrest,
hypotension during dialysis and severe blood
loss. The references in this communication are not intended to imply
specific outcome-based claims not yet cleared ...
FDA Approves Bayer HealthCare's Kogenate(R) FS Treatment for Routine Prophylaxis in Children with Hemophilia A
... no pre-existing joint damage. The most
serious adverse reactions are systemic hypersensitivity reactions including
bronchospastic reactions and/or
hypotension and anaphylaxis and the
development of high-titer inhibitors necessitating alternative treatments
to AHF. The most common adverse reactions observed ...
TRANSCEND(TM) Trial Results Presented at European Society of Cardiology Congress and Published in The Lancet
... an activated renin-angiotensin system, such as volume-
and/or salt-depleted patients (e.g., those receiving high doses of
diuretics), symptomatic
hypotension may occur after initiation of MICARDIS
therapy. This condition should be corrected prior to administration of
MICARDIS tablets, and treatment should ...
Nile Therapeutics Announces Dosing in Second Phase Ib Study of CD-NP in Heart Failure Patients
... for ADHF, including B-type
natriuretic peptide, have been associated with favorable pharmacologic
effects, but have also been associated with
hypotension and decreased renal
function which limit their utility in clinical practice. CD-NP was designed
to preserve the favorable effects of current ...
Nile Therapeutics Announces Dosing in Phase IIa Study of CD-NP in Heart Failure Patients
... for ADHF, including
B-type natriuretic peptide, have been associated with favorable
pharmacologic effects, but have also been associated with
hypotension and
decreased renal function which limit their utility in clinical practice.
CD-NP was designed to preserve the favorable effects of current ...
U.S. FDA Approves Requip(R) XL(TM), the First and Only Oral Once-Daily Non-Ergot Dopamine Agonist for Parkinson's Disease
... hallucination (7 percent vs. 3
percent), somnolence (7 percent vs. 4 percent), abdominal pain/discomfort
(6 percent vs. 3 percent) and orthostatic
hypotension (5 percent vs. 1
percent).
A Progressively Disabling Disease
Parkinson's disease is a chronic, progressive, and often disabling
neurological ...
Karmanos Cancer Institute Researchers Show Phase I Immunotherapy with Armed T Cells Improve Overall Survival of Metastatic Breast Cancer Patients
... the patients'
longevity and quality of life without undue toxicities. The predominant
side effects were chills, fever, headaches, and transient
hypotension that
were controlled with medications and fluid support."
"It appears that infusions of targeted T cells have boosted the immune
system to create a ...
Multiple Clinical Trials of VELCADE(R) (Bortezomib) for Injection Based Therapies Demonstrate High Complete Remission Rates in Patients with Newly Diagnosed Multiple Myeloma
... for patients with multiple myeloma
after first relapse.
Risks associated with VELCADE therapy include new or worsening
peripheral neuropathy,
hypotension observed throughout therapy, cardiac and
pulmonary disorders, gastrointestinal adverse events, thrombocytopenia,
neutropenia and tumor lysis ....
VELCADE(R) (Bortezomib) for Injection Based Treatment Delivers Impressive Complete Response and Survival in Patients With Newly Diagnosed Multiple Myeloma
... for patients with multiple myeloma
after first relapse.
Risks associated with VELCADE therapy include new or worsening
peripheral neuropathy,
hypotension observed throughout therapy, cardiac and
pulmonary disorders, gastrointestinal adverse events, thrombocytopenia,
neutropenia and tumor lysis ....
Two DOXIL(R) Studies to be Presented at American Society of Clinical Oncology (ASCO) Annual Meeting
... but not limited to, flushing, shortness of breath, facial swelling, headache, chills, back pain, tightness in the chest or throat, and/or
hypotension have occurred in up to 10% of patients treated with DOXIL. In most patients, these reactions have resolved within several hours to a day ...
New Data Support High Complete Remission Rates With VELCADE(R) (Bortezomib) for Injection Based Therapies in Patients With Newly Diagnosed Multiple Myeloma
... for patients with multiple myeloma
after first relapse.
Risks associated with VELCADE therapy include new or worsening
peripheral neuropathy,
hypotension observed throughout therapy, cardiac and
pulmonary disorders, gastrointestinal adverse events, thrombocytopenia,
neutropenia and tumor lysis ....
PRoFESS(R) Results Announced at XVII European Stroke Conference
... an activated renin-angiotensin system, such as volume-
and/or salt-depleted patients (e.g., those receiving high doses of
diuretics), symptomatic
hypotension may occur after initiation of MICARDIS
therapy. This condition should be corrected prior to administration of
MICARDIS tablets, and treatment should ...
Clinical Update - Debio 0614 (Istaroxime) in Acute Heart Failure
... consumption,"
said Kamel Besseghir, CEO of Debiopharm S.A.
"Compared to available inotropes, known to be associated with increase
of heart rate,
hypotension and increase in atrial or ventricular
arrhythmias, Debio 0614 demonstrated a rapid improvement of pulmonary
capillary wedge pressure, associated with ...
Landmark ONTARGET(TM) Trial Demonstrates Micardis(R) is Equally Effective as Ramipril, with Fewer Discontinuations, in a Broad High-Risk Cardiovascular Population
... an activated renin-angiotensin system, such as volume-
and/or salt-depleted patients (e.g., those receiving high doses of
diuretics), symptomatic
hypotension may occur after initiation of MICARDIS
therapy. This condition should be corrected prior to administration of
MICARDIS tablets, and treatment should ...
Alexza's AZ-104 (Staccato(R) Loxapine) Phase 2a Trial Meets Primary Endpoint of 2-Hour Pain Relief in Patients with Migraine Headache
... 0 2 5 2 Attention disturbance 0 5 0 2
hypotension 3 0 2 5
About Acute Migraine Headaches
According to the National Headache Foundation, ...
U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
... undergo fasting blood glucose testing. There have been few reports of hyperglycemia with ABILIFY ABILIFY may be associated with orthostatic
hypotension and should be
used with caution in patients with known cardiovascular disease,
cerebrovascular disease, or conditions which would predispose them ...