Alcohol-induced dilated cardiomyopathy

Note the enlarged ventricular chambers - the increased size causes the appearance of thinned ventricular walls. Assumption that there is decreased musculature in heart walls can cause incorrect diagnosis of cause-of-death.

Dilated cardiomyopathy can cause systolic dysfunction and atrial fibrilation, as well as being a source of thromboembolism.

3,000th Lifesaving Heart & Lung Surgery at UC San Diego Health System
Lowest Mortality Worldwide, Most Patients Treated, Heart-Stopping Procedure

Surgeons at UC San Diego Health System have performed their 3,000th pulmonary thromboendarterectomy (PTE), a lifesaving surgery to clear the lung’s arteries of scar-like tissue that robs patients of their ability to breathe. During the extraordinary eight to ten hour surgery, the patient is put into a form of suspended animation in which the heart and blood circulation is completely stopped and the brain ceases activity while surgeons clear the pulmonary arteries of disease.

“Patients arrive at UC San Diego Sulpizio Cardiovascular Center from all over the world seeking this safe, highly specialized surgery. Some patients walk in unaided while others arrive by wheelchair or air ambulance,” said Nick Kim, MD, pulmonologist and director of pulmonary vascular medicine at UC San Diego Health System. “They all share a common burden: breathlessness. The clots cause chronic thromboembolic pulmonary hypertension, which not only leads to shortness of breath, but in most cases, progression to end-stage heart failure, and death, if not effectively treated.”

The surgery is a feat for the patient and the surgeon. In order for the clots to be removed, the surgeon must be able to see clearly into the lung’s tiny arteries. This requires operating without any blood present. To achieve this environment, the patient’s body is cooled and the blood is completely drained while the patient is on a heart-lung machine. The bypass machine is then stopped for 20 minutes while the surgeon races against the clock to remove the blockages. During this time, both heart and brain wave monitors are flat lined.

Using sophisticated techniques and special long, slender instruments, the surgeon rapidly dissects out the chronic clots without perforating the paper-thin artery wall. The clots look like white scar tissue, which when arranged on a surgical table takes the shape of the intricate inner branches of the lung’s arteries.

More here

Objective To review the diagnostic accuracy of D-dimer testing in older patients (>50 years) with suspected venous thromboembolism, using conventional or age adjusted D-dimer cut-off values.

Design Systematic review and bivariate random effects meta-analysis.

Data sources We searched Medline and Embase for studies published before 21 June 2012 and we contacted the authors of primary studies.

Study selection Primary studies that enrolled older patients with suspected venous thromboembolism in whom D-dimer testing, using both conventional (500 µg/L) and age adjusted (age×10 µg/L) cut-off values, and reference testing were performed. For patients with a non-high clinical probability, 2×2 tables were reconstructed and stratified by age category and applied D-dimer cut-off level.

Results 13 cohorts including 12 497 patients with a non-high clinical probability were included in the meta-analysis. The specificity of the conventional cut-off value decreased with increasing age, from 57.6% (95% confidence interval 51.4% to 63.6%) in patients aged 51-60 years to 39.4% (33.5% to 45.6%) in those aged 61-70, 24.5% (20.0% to 29.7% in those aged 71-80, and 14.7% (11.3% to 18.6%) in those aged >80. Age adjusted cut-off values revealed higher specificities over all age categories: 62.3% (56.2% to 68.0%), 49.5% (43.2% to 55.8%), 44.2% (38.0% to 50.5%), and 35.2% (29.4% to 41.5%), respectively. Sensitivities of the age adjusted cut-off remained above 97% in all age categories.

Conclusions The application of age adjusted cut-off values for D-dimer tests substantially increases specificity without modifying sensitivity, thereby improving the clinical utility of D-dimer testing in patients aged 50 or more with a non-high clinical probability.

Ahi lo tienen, para pacientes mayores de 50 años con sospecha clinica de tromboembolismo pulmonar y baja probabilidad clinica los valores del dimero-D ajustados para la edad son superiores.

FDA Grants New Indication For Pfizer, Bristol-Myers Squibb Drug

The FDA today approved an expanded indication for  the oral anticoagulant apixaban (Eliquis, Bristol-Myers Squibb and Pfizer). Apixaban will now be indicated for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE (collectively known as venous thromboembolism) after initial therapy. The supplemental new drug application was based on findings from the previously published AMPLIFY and AMPLIFY-EXT studies.

http://twt.lu/1pj1pQ3

To the Editor: The factor V Leiden (F5) R506Q mutation is associated with a genetic disorder that has a solid phenotype and a poor response to activated protein C, which may lead to venous thromboembolism, pulmonary thromboembolism, or both (with the use of combined oral contraceptives), and… via The New England Journal of Medicine: Search Results in Hematology\Oncology

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Cubist Pharmaceuticals Issues Voluntary Nationwide Recall of Nine Lots of CUBICIN (daptomycin for injection) 500 mg in 10 mL single use vials Following Complaints of Foreign Particulate Matter in Reconstituted Vials [ ] 08/09/2014 08:51 AM EDT
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced it is voluntarily recalling nine lots of CUBICIN (daptomycin for injection) to the user level following complaints of foreign particulate matter in reconstituted vials. The administration of particulate matter, if present in an intravenous drug, poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary embolism.

. For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

You are subscribed to Recalls, Market Withdrawals and Safety Alerts for U.S. Food & Drug Administration (FDA).

This information has recently been updated and is now available.

Cubist Pharmaceuticals Issues Voluntary Nationwide Recall of Nine Lots of CUBICIN (daptomycin for injection) 500 mg in 10 mL single use vials Following Complaints of Foreign Particulate Matter in Reconstituted Vials [ ] 08/09/2014 08:51 AM EDT
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced it is voluntarily recalling nine lots of CUBICIN (daptomycin for injection) to the user level following complaints of foreign particulate matter in reconstituted vials. The administration of particulate matter, if present in an intravenous drug, poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary embolism.

. For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

Assessment of left atrial volume before and after pulmonary thromboendarterectomy in chronic thromboembolic pulmonary hypertension

Impaired left ventricular diastolic filling is common in chronic thromboembolic pulmonary hypertension (CTEPH), and recent studies support left ventricular underfilling as a cause. To investigate this further, we assessed left atrial volume index (LAVI) in patients with CTEPH before and after…
Source:Assessment of left atrial volume before and after pulmonary thromboendarterectomy in chronic thromboembolic pulmonary hypertension

ViewRecalls.com - Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced it is voluntarily recalling nine lots of CUBICIN (daptomycin for injection) to the user level following complaints of foreign particulate matter in reconstituted vials. The administration of particulate matter, if present in an intravenous drug, poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary embolism. - http://ift.tt/12cTYii

FDA MedWatch - CUBICIN (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Foreign Particulate Matter

MedWatch logoMedWatch - The FDA Safety Information and Adverse Event Reporting Program

CUBICIN (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Foreign Particulate Matter

[Posted 08/09/2014]

*AUDIENCE:* Risk Manager, Health Professional, Pharmacy, Nursing

*ISSUE:* Cubist Pharmaceuticals, Inc.is voluntarily recalling nine lots of CUBICIN (daptomycin for injection) to the user level following complaints of foreign particulate matter in reconstituted vials. Refer to the Press Release [ http://www.fda.gov/Safety/Recalls/ucm408928.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery ] for a list of affected products.

The administration of particulate matter, if present in an intravenous drug, poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary embolism. Other events such as phlebitis, mechanical block of the capillaries or arterioles, activation of platelets or subsequent generation of microthrombi are also possible. Patients with a preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material. To date, no reports of adverse events have been associated with product complaints of particulate matter from these lots.

*BACKGROUND: *CUBICIN is an intravenously administered prescription product indicated for the treatment of skin infections and certain blood stream infections. CUBICIN was distributed Nationwide to multiple consignees.

*RECOMMENDATION:* Anyone with an existing inventory of the product lots listed should determine whether they have product from the recalled lots, quarantine, and discontinue distribution of these recalled lots of the product and call Cubist at (855) 534-8309 between the hours of 9 a.m. to 7 p.m. EDT, Monday through Friday, to arrange for return and replacement of the affected lots.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:


* Complete and submit the report Online: www.fda.gov/MedWatch/report.htm [ http://www.fda.gov/MedWatch/report.htm?source=govdelivery&utm_medium=email&utm_source=govdeliverywww.fda.gov/MedWatch/report.htm [ http://www.fda.gov/MedWatch/report.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery ]
* Download form [ http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery ] or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 

Read  the MedWatch safety alert, including links to the Press Release at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm408934.htm [ http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm408934.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery ]

FDA MedWatch - CUBICIN (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Foreign Particulate Matter

MedWatch logoMedWatch - The FDA Safety Information and Adverse Event Reporting Program

CUBICIN (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Foreign Particulate Matter

[Posted 08/09/2014]

*AUDIENCE:* Risk Manager, Health Professional, Pharmacy, Nursing

*ISSUE:* Cubist Pharmaceuticals, Inc.is voluntarily recalling nine lots of CUBICIN (daptomycin for injection) to the user level following complaints of foreign particulate matter in reconstituted vials. Refer to the Press Release [ http://www.fda.gov/Safety/Recalls/ucm408928.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery ] for a list of affected products.

The administration of particulate matter, if present in an intravenous drug, poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary embolism. Other events such as phlebitis, mechanical block of the capillaries or arterioles, activation of platelets or subsequent generation of microthrombi are also possible. Patients with a preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material. To date, no reports of adverse events have been associated with product complaints of particulate matter from these lots.

*BACKGROUND: *CUBICIN is an intravenously administered prescription product indicated for the treatment of skin infections and certain blood stream infections. CUBICIN was distributed Nationwide to multiple consignees.

*RECOMMENDATION:* Anyone with an existing inventory of the product lots listed should determine whether they have product from the recalled lots, quarantine, and discontinue distribution of these recalled lots of the product and call Cubist at (855) 534-8309 between the hours of 9 a.m. to 7 p.m. EDT, Monday through Friday, to arrange for return and replacement of the affected lots.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:


* Complete and submit the report Online: www.fda.gov/MedWatch/report.htm [ http://www.fda.gov/MedWatch/report.htm?source=govdelivery&utm_medium=email&utm_source=govdeliverywww.fda.gov/MedWatch/report.htm [ http://www.fda.gov/MedWatch/report.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery ]
* Download form [ http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery ] or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 

Read  the MedWatch safety alert, including links to the Press Release at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm408934.htm [ http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm408934.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery ]

FDA MedWatch - Cubicin (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Presence Of Particulate Matter

MedWatch logoMedWatch - The FDA Safety Information and Adverse Event Reporting Program

Cubicin (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Presence Of Particulate Matter

*AUDIENCE*: Pharmacy, Nursing

*ISSUE*: Cubist Pharmaceuticals, Inc. announced a recall of certain lots of Cubicin (daptomycin for injection) to the user level due to the potential presence of glass particulate matter in vials produced by a contract manufacturer. See the Press Release [ http://www.fda.gov/Safety/Recalls/ucm408576.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery ] for a listing of affected lot numbers.

The administration of a glass particulate, if present in an intravenous drug, poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary emboli. Other events such as phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, or subsequent generation of microthrombi are also possible. Patients with a preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a glass particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material.

*BACKGROUND*: Cubicin is an intravenously administered prescription product indicated for the treatment of skin infections and certain blood stream infections. Cubicin was distributed nationwide to multiple consignees.

*RECOMMENDATION*: Cubist is notifying customers by letter and phone. Anyone with an existing inventory of the product should determine whether they have product from the recalled lots, quarantine and discontinue distribution of the recalled lots of the product and call Cubist at (855) 534-8309 between the hours of 9 a.m. to 7 p.m. EDT, Monday through Friday, to arrange for return and replacement of the affected lots.

Read the MedWatch safety alert, including a link to the press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm408677.htm [ http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm408677.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery ]

FDA MedWatch - Cubicin (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Presence Of Particulate Matter

MedWatch logoMedWatch - The FDA Safety Information and Adverse Event Reporting Program

Cubicin (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Presence Of Particulate Matter

*AUDIENCE*: Pharmacy, Nursing

*ISSUE*: Cubist Pharmaceuticals, Inc. announced a recall of certain lots of Cubicin (daptomycin for injection) to the user level due to the potential presence of glass particulate matter in vials produced by a contract manufacturer. See the Press Release [ http://www.fda.gov/Safety/Recalls/ucm408576.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery ] for a listing of affected lot numbers.

The administration of a glass particulate, if present in an intravenous drug, poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary emboli. Other events such as phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, or subsequent generation of microthrombi are also possible. Patients with a preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a glass particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material.

*BACKGROUND*: Cubicin is an intravenously administered prescription product indicated for the treatment of skin infections and certain blood stream infections. Cubicin was distributed nationwide to multiple consignees.

*RECOMMENDATION*: Cubist is notifying customers by letter and phone. Anyone with an existing inventory of the product should determine whether they have product from the recalled lots, quarantine and discontinue distribution of the recalled lots of the product and call Cubist at (855) 534-8309 between the hours of 9 a.m. to 7 p.m. EDT, Monday through Friday, to arrange for return and replacement of the affected lots.

Read the MedWatch safety alert, including a link to the press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm408677.htm [ http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm408677.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery ]

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