‘blood’ Tagged Posts

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FDA: MS Drug Linked to Circumstances of Stroke, Blood Vessel Wall Tears

 
Most cases occurred within 1 day of receiving Lemtrada

Most cases occurred within 1 day of receiving Lemtrada

The Food and Drug Administration (FDA) has issued a warning regarding rare cases of ischemic and hemorrhagic stroke and cervicocephalic arterial dissection in patients with multiple sclerosis (MS) shortly after receiving Lemtrada (alemtuzumab; Sanofi Genzyme). Alemtuzumab, a monoclonal antibody, is also approved for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) under the brand name Campath (alemtuzumab; Sanofi Genzyme).

Sine the approval of Lemtrada in 2014, the Agency has identified 13 cases worldwide of ischemic and hemorrhagic stroke or arterial dissection that occurred shortly after the patient received Lemtrada; 1 patient who suffered a hemorrhagic stroke died. Most cases (12/13) occurred within 1 day of receiving Lemtrada; 1 patient reported symptoms 3 days after starting treatment. While the etiology is unknown, the adverse events appear to have occurred within the same time frame as cytokine release syndrome, an inflammatory response associated with Lemtrada use. Reports of ischemic stroke and intracerebral hemorrhage have also been documented in patients treated with Campath for B-cell CLL and other leukemias/lymphomas.

The prescribing information and Medication Guide for Lemtrada have been updated with a new warning to reflect these risks. In addition, the risk of stroke has been added to the existing Boxed Warning. The Campath drug labeling has also been updated to include these risks in the Adverse Reactions section under Postmarketing Experience.

Healthcare professionals should advise patients at each infusion to seek medical attention if they experience symptoms of ischemic or hemorrhagic stroke or cervicocephalic arterial dissection. Patients who complain of symptoms suggestive of these conditions should be promptly evaluated.

Novel Blood Take a look at for Irritable Bowel Syndrome Now Accessible

 
A positive result indicates that a patient has IBS-D with positive predictive value of >90%

A positive result indicates that a patient has IBS-D with positive predictive value of >90%

Gemelli Biotech has announced the launch of ibs-smart, a second-generation blood test that aids in the diagnosis of diarrhea predominant and mixed-type irritable bowel syndrome (IBS-D and IBS-M).

Once the testing kit with the blood sample is received, results are available within 48 hours and are sent directly to the prescribing physician. A positive result indicates that a patient has IBS-D with positive predictive value of >90%; the test does not provide definitive results for patients with constipation predominant IBS. The Company notes that while it is generally not known whether medications affect the test, it is possible that advanced anti-inflammatory drugs may potentially reduce antibodies and result in a false negative test.

“Replacing the traditional path of invasive, expensive procedures from CT scans to multiple colonoscopies with a simple blood test allows for a faster diagnosis. A faster diagnosis most importantly means a faster path to treatment and reduced costs,” stated Matt Mitcho, Gemelli Biotech’s CEO.

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