Is Nasogastric Lavage Beneficial for Acute Gastrointestinal Bleeding?

The procedure increased the likelihood of early endoscopy but not better patient outcomes, such as lower mortality. The question merits prospective analysis.

Nasogastric lavage (NGL) was once a standard initial procedure for all patients with acute gastrointestinal (GI) bleeding, but its use is now under debate. Although some data suggest that patients with a bloody NGL are more likely to have severe bleeding (Gastrointest Endosc 2004; 59:172), the test’s presumed benefits — confirming an upper GI source of bleeding, clearing the stomach for better endoscopic visualization, and reducing the risk for aspiration — have not been tested.

To evaluate the effects of NGL during triage on clinical outcomes, investigators conducted a retrospective database study of 632 patients from a Veterans Administration hospital. To control for confounding factors that might influence the decision to perform lavage, researchers identified 24 variables a priori that were associated with receiving NGL and used them to develop a propensity score — or likelihood of undergoing NGL — among patients with acute GI bleeding. They then matched 193 patients who received lavage and 193 who did not by propensity score and compared clinical outcomes.

Patients who underwent NGL were more likely to have an endoscopy (odds ratio, 1.71) and to receive it sooner (hazard ratio, 1.49) than other patients. Lavage did not affect mortality, length of hospital stay, or the need for transfusions or surgery. Bloody aspirates were associated with high-risk lesions at endoscopy (OR, 2.69).

The authors conclude that NGL is associated with receiving early endoscopy and might be useful in triage but does not affect clinical outcomes.

Comment: This paper will be of interest to many physicians caring for patients with upper GI bleeding and likely will be interpreted differently, depending on when they are seeing the patient and what they are trying to accomplish. One thing remains clear though — routine use of NGL in these patients is not justified. We already know that NGL cannot be used to exclude ongoing upper GI bleeding as one sixth of patients with active bleeding will have a negative NGL. Now, this study demonstrates that NGL results in no difference in a number of important clinical outcomes. However, certain targeted uses of NGL — such as to enhance visualization before endoscopy, thereby assisting in lesion identification — were not part of this study. These possible roles for NGL as an adjunctive tool to enhance endoscopy or to improve specific patient outcomes will require appropriately designed prospective studies. Until then, routine use of NGL in patients with upper GI bleeding is not indicated, but there are likely selected patients who might benefit from this intervention.

source: Journal Watch Gastroenterology

Tranexamic Acid Might Reduce Traumatic Brain Hemorrhage

A small trial shows nonsignificant positive trends, but neither moderate benefits nor moderate harms can be excluded.

The CRASH-2 trial showed that the antifibrinolytic agent tranexamic acid reduced mortality in adult trauma patients with extracranial hemorrhage, without increasing vascular occlusions . In a planned substudy, researchers assessed the effect of tranexamic acid in a cohort of CRASH-2 patients with traumatic brain injury (TBI; Glasgow Coma Scale score ≤14).

In the CRASH-2 trial, 20,111 patients with or at risk for significant extracranial hemorrhage were randomized to receive tranexamic acid (loading dose of 1g over 10 minutes followed by an infusion of 1 g over 8 hours) or placebo within 8 hours of injury. The substudy involved 123 patients with TBI who were randomized to tranexamic acid and 126 patients with TBI who were randomized to placebo. Computed tomography scans were obtained within 8 hours of injury and 24 to 48 hours later. No significant differences were noted between the tranexamic acid and placebo groups in mean total hemorrhage growth (5.9 and 8.1 mL), proportion of patients with new focal ischemic lesions (5% and 9%), and mortality within 28 days (11% and 18%).

Comment: The authors hypothesized that tranexamic acid might be beneficial in patients with TBI because as many as one third of such patients have coagulopathy. The trend toward a reduction in new focal ischemic lesions in tranexamic acid recipients could be explained by reduced hemorrhage growth and thus, less pressure on cerebral arteries. As the findings of this small study were not statistically significant, we await clearer direction from the upcoming CRASH-3 trial of tranexamic acid administration in patients with primary TBI.

source: Journal Watch Emergency Medicine

Acellular pertussis vaccine’s waning immunity caused California epidemic


Pertussis Immunity Wanes Over Time

The acellular pertussis vaccine’s failure to deliver durable infection protection to children aged 7-10 years led to the 2010 California pertussis epidemic, and prompted infectious diseases experts to question the current schedule of childhood pertussis vaccination.

“An increase in the risk of pertussis is occurring in the time since completion of the five-dose DTaP [diphtheria, tetanus, acellular pertussis] series, with similar trends…

Novartis update




Novartis will showcase more than one hundred and sixty presentations on data from its robust oncology portfolio at two key medical congresses this month, demonstrating significant advances for patients with cancers and hematological diseases.

The CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), held from December 6-10, will feature data presentations from Phase III studies of Afinitor® (everolimus) tablets for investigational uses and Zometa® (zoledronic acid) 4mg/5mL Injection, as well as early-stage studies of the investigational drug BKM120, an inhibitor of PI3K, a key cancer pathway[1].

The American Society of Hematology (ASH) annual meeting in San Diego, held from December 10-13, will showcase key data for Tasigna® (nilotinib), Exjade® (deferasirox) and the investigational drug INC424 (ruxolitinib)(1). Several early-stage studies will also be presented, including everolimus in Hodgkin lymphoma and Waldenström’s macroglobulinemia and LBH589 (panobinostat) in relapsed and bortezomib (BTZ)-refractory multiple myeloma[2].

“These important data are examples of our research and development strategy to focus on significant unmet medical needs by targeting the fundamental mechanisms of disease,” said Hervé Hoppenot, President, Novartis Oncology. “Through our collaborations with the scientific and patient communities, we continue to advance our goal of transforming patients’ lives.”

Highlights at SABCS include:

  • Everolimus – Updated data from the BOLERO-2 (Breast cancer trials of OraL EveROlimus) Phase III trial of everolimus in combination with exemestane for postmenopausal women with ER+HER2- advanced breast cancer who recurred or progressed while on or following previous treatment with the hormonal therapies letrozole or anastrozole (SABCS abstract #S3-7; December 8, 9:30 – 11:15AM).
  • Zometa ABCSG-12 (Austrian Breast & Colorectal Cancer Study Group Trial) long-term data will examine possible carry-over anticancer benefits of zoledronic acid three years after treatment completion in premenopausal women with endocrine-responsive early breast cancer receiving adjuvant goserelin and endocrine therapy (SABCS abstract #S1-2; December 7, 9:15 – 11:30AM) and five-year ZO-FAST (ZOmeta-Femara Adjuvant Synergy Trial) follow-up data on long-term overall survival outcomes among postmenopausal women with hormone receptor-positive early breast cancer receiving adjuvant zoledronic acid and letrozole (SABCS abstract #S1-3; December 7, 9:15 – 11:30AM).
  • BKM120 – Two studies investigating the activity of BKM120, a pan-PI3K inhibitor, in advanced breast cancer: data from a trial evaluating the safety profile and clinical activity of BKM120 as a single agent for the treatment of patients with metastatic breast cancer (SABCS abstract  #P3-16-01; December 8, 5:00 – 7:00PM) and data from a Phase I/II study evaluating BKM120 in combination with trastuzumab in patients with HER2 overexpressing metastatic breast cancer resistant to trastuzumab-containing therapy (SABCS abstract #PD09-03; December 9, 5:00 – 7:00PM).

Highlights at ASH include:

  • Tasigna – ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials)  36-month update of the ENESTnd study comparing Tasigna to Glivec in patients with newly diagnosed chronic phase Ph+ chronic myeloid leukemia (ASH abstract #452; December 12, 10:30AM – 12:00PM) and  results from ENESTcmr trial assessing the efficacy and safety of switching patients with residual molecular disease on Glivec® (imatinib)(2) treatment to Tasigna (ASH abstract #606; December 12, 2:45 – 4:15PM).
  • Exjade – Data from the first randomized, placebo-controlled study evaluating the reduction of liver iron concentration and serum ferritin in patients with non-transfusion-dependent thalassemia after one year of treatment with Exjade oral iron chelation therapy (ASH abstract #902; December 13, 7:30 – 9:00AM) and data from a retrospective analysis of hematological response during iron chelation therapy in patients with myelodysplastic syndrome (MDS) and aplastic anemia with transfusional iron overload (ASH abstract #611; December 12, 2:45 – 4:15PM).
  • INC424 – Data from multiple research programs will be presented, including two pivotal Phase III studies evaluating INC424 benefit versus placebo (COMFORT-I [COntrolled MyeloFibrosis study with ORal JAK inhibitor Therapy]) (ASH abstract #278; December 12, 7:00 – 8:30AM) and versus best available therapy (COMFORT-II) (ASH abstract #795; December 12, 4:30 – 6:00PM). These data will assess measures of spleen reduction, symptom improvement, health-related quality of life and overall survival.
  • Everolimus – Results from a Phase II study evaluating everolimus as a monotherapy in relapsed/refractory Hodgkin lymphoma (ASH abstract #2717; December 11, 6:00 – 8:00PM) and data from a Phase I trial of everolimus in combination with rituximab or in combination with BTZ and rituximab in relapsed/refractory Waldenström’s macroglobulinemia (ASH abstract #2705; December 11, 6:00 – 8:00PM).
  • LBH589 – Results from PANORAMA-2 (PANobinostat ORAl in Multiple myelomA), a Phase II study of LBH589 in combination with BTZ and dexamethasone in patients with relapsed and BTZ-refractory multiple myeloma (ASH abstract #814; December 12, 4:30 – 6:00PM). Data from two trials in myelofibrosis: final results from a Phase I trial of prolonged low dose therapy with LBH589 in myelofibrosis patients (ASH abstract #794; December 12, 4:30 – 6:00PM) and a preclinical study of LBH589 in combination with INC424 in JAK2V617F-driven disease (ASH abstract #798; December 12, 4:30 – 6:00PM). 

About everolimus tablets

Everolimus is approved as Afinitor® (everolimus) tablets in more than 80 countries including the United States and throughout the European Union in the oncology settings of advanced renal cell carcinoma (RCC) following progression on or after vascular endothelial growth factor (VEGF)-targeted therapy and in the US and EU for locally advanced, metastatic or unresectable progressive neuroendocrine tumors of pancreatic origin (pNET).


Everolimus is also available from Novartis for use in non-oncology patient populations under the brand names Afinitor® or Votubia®, Certican® and Zortress® and is exclusively licensed to Abbott and sublicensed to Boston Scientific for use in drug-eluting stents.


Indications vary by country and not all indications are available in every country. Access to everolimus outside of the approved indications is carefully controlled and monitored in clinical trials designed to better understand the potential benefits and risks of the compound. As an investigational compound, the safety and efficacy profile of everolimus has not yet been established outside the approved indications. Because of the uncertainty of clinical trials, there is no guarantee that everolimus will become commercially available for additional indications anywhere else in the world.


Everolimus tablets Important Safety Information

Everolimus can cause serious side effects including lung or breathing problems, infections, and renal failure which can lead to death. Mouth ulcers and mouth sores are common side effects. Everolimus can affect blood cell counts, kidney and liver function, and blood sugar and cholesterol levels. Everolimus may cause fetal harm in pregnant women. Women taking everolimus should not breast feed.


The most common adverse drug reactions (incidence >=15%) are mouth ulcers, diarrhea, feeling weak or tired, skin problems (such as rash or acne), infections, nausea, swelling of extremities or other parts of the body, loss of appetite, headache, inflammation of lung tissue, abnormal taste, nose bleeds, inflammation of the lining of the digestive system, weight decreased and vomiting. The most common Grade 3-4 adverse drug reactions (incidence >=2%) are mouth ulcers, feeling tired, low white blood cells (a type of blood cell that fights infection), diarrhea, infections, inflammation of lung tissue, and diabetes. Cases of hepatitis B reactivation and blood clot in the lung and leg have been reported.


About Zometa (zoledronic acid)

Zometa® (zoledronic acid) Injection is indicated for the prevention of skeletal-related events (SREs; pathological fractures, spinal compression, radiation or surgery to bone, or tumor-induced hypercalcemia) in patients with multiple myeloma and advanced malignancies involving bone. The recommended dose is a 4 mg, 15-minute infusion every 3-4 weeks.


Zometa Important Safety Information

Zometa has been associated with reports of renal insufficiency. Adequately rehydrate patients and assess serum creatinine prior to each dose. Single doses of Zometa should not exceed 4 mg and the duration of infusion should be no less than 15 minutes in 100 ml of dilutent. The risk of renal adverse events may be greater in patients with renal insufficiency and dose adjustments are required. Not recommended in patients with severe renal impairment. Monitor serum levels of calcium, phosphate and magnesium and treat as necessary. Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported. Monitor for thigh, hip or groin pain, evaluate for femur fractures as necessary and discontinue treatment if required. Use caution in aspirin-sensitive patients, and when using aminoglycosides, loop diuretics and other potentially nephrotoxic drugs. Use caution in multiple myeloma patients using thalidomide. Patients being treated with Zometa should not be treated with Aclasta(3) concomitantly. Zometa should not be used in patients who are pregnant, or plan to become pregnant, or who are breast-feeding. Contraindicated in patients with hypersensitivity to zoledronic acid, other bisphosphonates, or any of the excipients in Zometa.


In clinical trials, the most commonly reported adverse events included flu-like syndrome (fever, arthralgias, myalgias, skeletal pain), fatigue, gastrointestinal reactions, anemia, weakness, cough, dyspnea and edema.  Osteonecrosis of the Jaw (ONJ): ONJ has been reported in patients with cancer receiving treatment including bisphosphonates, chemotherapy, and/or corticosteroids. The majority of reported cases have been associated with dental procedures such as tooth extraction. A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors. While on treatment, these patients should avoid invasive dental procedures if possible. No data are available to suggest whether discontinuation of bisphosphonate therapy reduces the risk of ONJ in patients requiring dental procedures. A causal relationship between bisphosphonate use and ONJ has not been established.


Please see full Prescribing Information. Approved indications vary by country.


About BKM120 and LBH589 (panobinostat)

Because these are investigational compounds, the safety and efficacy profile of BKM120 and LBH589 have not yet been established. Access to these investigational compounds is available only through carefully controlled and monitored clinical trials. These trials are designed to better understand the potential benefits and risks of the compound. Because of uncertainty of clinical trials, there is no guarantee that BKM120 and LBH589 will ever be commercially available anywhere in the world.


About Tasigna (nilotinib)

Tasigna® (nilotinib) is approved in more than 90 countries for the treatment of chronic phase and accelerated phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) in adult patients resistant or intolerant to at least one prior therapy, including Glivec, and for the treatment of adult patients with newly diagnosed Ph+ CML in chronic phase. Take twice daily 12 hours apart. Do not take with food. No food to be consumed for 2 hours before or one hour after dosing. Avoid grapefruit juice and CYP3A4 inhibitors.


Tasigna Important Safety Information

Use with caution in patients with uncontrolled or significant cardiac disease and in patients who have or may develop prolongation of QTc. Low levels of potassium or magnesium must be corrected prior to Tasigna administration. Monitor closely for an effect on the QTc interval. Baseline ECG is recommended prior to initiating therapy and as clinically indicated. Uncommon cases (0.1 to 1%) of sudden death have been reported in clinical studies in patients with significant risk factors.


Use with caution in patients with liver impairment, with a history of pancreatitis and with total gastrectomy. Patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption should not use Tasigna. Tasigna may cause fetal harm in pregnant women. Women taking Tasigna should not breastfeed.


The most frequent Grade 3 or 4 adverse events are hematological (neutropenia and thrombocytopenia) which are generally reversible and usually managed by withholding Tasigna temporarily or dose reduction. Monitor blood counts regularly. Pancreatitis has been reported. The most frequent non-hematologic adverse events were rash, pruritus, nausea, fatigue, headache, alopecia, myalgia, constipation and diarrhea. Most of these adverse events were mild to moderate in severity.


Please see full Prescribing Information.


About Glivec (imatinib)

Glivec® (imatinib) is approved in more than 110 countries for the treatment of all phases of Ph+ CML, for the treatment of adult patients with KIT (CD117)-positive gastrointestinal stromal tumors (GIST), which cannot be surgically removed and/or have metastasized and for the treatment of adult patients following complete surgical removal of KIT+ GIST. Take with food and a large glass of water.


Glivec Important Safety Information

Glivec can cause fetal harm in pregnant woman. Glivec has been associated with severe edema (swelling) and serious fluid retention. Cytopenias (anemia, neutropenia, thrombocytopenia) are common, generally reversible and usually managed by withholding Glivec or dose reduction. Monitor blood counts regularly. Severe congestive heart failure and left ventricle dysfunction, severe liver problems including cases of fatal liver failure and severe liver injury requiring liver transplants have been reported. Use caution in patients with cardiac dysfunction and hepatic dysfunction. Monitor carefully.


Bleeding may occur. Severe gastrointestinal (GI) bleeding has been reported in patients with KIT+ GIST. Skin reactions, hypothyroidism in patients taking levothyroxine replacement, GI perforation, in some cases fatal and tumor lysis syndrome, which can be life threatening, have also been reported with Glivec. Correct dehydration and high uric acid levels prior to treatment. Long-term use may result in potential liver, kidney, and/or heart toxicities; immune system suppression may also result from long-term use. In patients with hypereosinophilic syndrome and heart involvement, cases of heart disease have been associated with the initiation of Glivec therapy. Growth retardation has been reported in children taking Glivec. The long-term effects of extended treatment with Glivec on growth in children are unknown.


The most common side effects include fluid retention, muscle cramps or pain and bone pain, abdominal pain, loss of appetite, vomiting, diarrhea, decreased hemoglobin, abnormal bleeding, nausea, fatigue and rash.


Please see full Prescribing Information.


About Exjade (deferasirox)

Exjade® (deferasirox) is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in adult and pediatric patients (aged 2 years and over). It is approved in over 100 countries including the U.S., Switzerland, Japan, and the countries comprising the European Union. The approved indication may vary depending upon the individual country.


Exjade Important Safety Information

Exjade is contraindicated in patients with an estimated creatinine clearance <60 mL/min, with hypersensitivity to the active substance or any of the excipients, or in combination with other iron chelator therapies. Exjade is not recommended in patients with severe hepatic impairment.


There have been postmarketing reports of acute renal failure, hepatic failure, and cytopenias. Renal failure requiring temporary or permanent dialysis, renal tubulopathy, and interstitial nephritis have been reported. Upper gastrointestinal ulceration and hemorrhage, sometimes fatal, have been reported. Caution should be used in elderly patients due to a higher frequency of adverse reactions. Exjade is not recommended in patients with a short life expectancy (e.g., high-risk myelodysplastic syndromes), especially when co-morbidities could increase the risk of adverse events.


Skin rashes, serious hypersensitivity reactions, decreased hearing, and lens opacities have been reported. The most common adverse reactions are nausea, vomiting, diarrhea, abdominal pain, rash, non-progressive increases in serum creatinine, increased transaminases, abdominal distension, constipation, dyspepsia, proteinuria, and headache.


Please visit for more information.


About INC424 (ruxolitinib)

INC424 (ruxolitinib) is an oral inhibitor, of the JAK1 and JAK2 tyrosine kinases. INC424 is being investigated in primary myelofibrosis as well as post-polycythemia vera myelofibrosis (PPV-MF) and post-essential thrombocythemia myelofibrosis (PET-MF). INC424 is also being investigated in clinical trials for the treatment of polycythemia vera (PV).


Novartis licensed INC424 from Incyte for development and potential commercialization outside the US. Incyte has retained rights for the development and potential commercialization of INC424 in the US. Both the US Food and Drug Administration and the European Medicines Agency have granted INC424 orphan drug status for myelofibrosis.


(1) Novartis and Incyte Corporation have a worldwide collaboration and licensing agreement for INC424.

(2) Known as Gleevec® (imatinib mesylate) tablets in the US, Canada and Israel.

(3) Known as Reclast in the US.


Source:Novartis release.






New media – drivers of democratization and development?

Today a panel of experts in media, technology and healthcare are gathering to discuss the topic “New media – drivers of democratization and development?” at the 2011 Novartis Foundation for Sustainable Development (NFSD) symposium in Basel, Switzerland. They are exploring the ways that modern telecommunications technology has the power to transform the developing world – and how these technologies can specifically be harnessed to help improve access to healthcare.


“I believe that the rapid adoption of technology in the emerging world provides us with an unprecedented opportunity to leverage that power to significantly and rapidly improve access to quality healthcare,” says Joseph Jimenez, CEO of Novartis. “Novartis wants to be a leader and work closely with governments, international organizations, NGOs and industry in finding, developing and implementing innovative solutions to reach patients in need.”


Several speakers are focusing on the broad context of new media and the role it is playing in democratization. Zahi Alawi, journalist and online media expert, and Astrid Frefel, a Swiss journalist based in Egypt, start by analyzing the role of Facebook and other social media platforms in the recent revolutions sweeping through the Arab world.


June Arunga, CEO of Open Quest Media LLC, then examines the impact of mobile phone penetration into the African continent. Her presentation highlights the potential for fundamental change that widespread mobile phone acceptance can bring in terms of mobility and productivity, and how the Africa of tomorrow might differ from that of today.


Another group of experts are looking more closely at the potential for Information and Communication Technology (ICT) to improve access to quality healthcare, and ultimately help contribute to the achievement of the health-related Millennium Development Goals (MDGs).


“New media are fundamentally transforming the way we live,” says Klaus M. Leisinger, President and Managing Director, Novartis Foundation for Sustainable Development. “It is crucial that nobody is excluded from the new global knowledge society we are building. The increased interaction made possible through Information and Communication Technologies has the potential to help overcome the challenges that emerge in our globalized world.”


Hamadoun Touré, Secretary-General, International Telecommunication Union (ITU),  delves into the opportunities for, and lessons learned from, mobile health and telemedicine. “ICTs can be an important driver of social and economic development,” he says. “M-health applications in particular can provide quality primary health services that are affordable, sustainable and meet the needs of patients in rural areas.”


Suvi Lindén, former Finnish communications minister and ITU’s Special Envoy to the Broadband Commission for Digital Development, speaks about better coordinating the many initiatives in the area of e-health, where she proposes the creation of a global platform to better connect and plan e-health initiatives.


Alexander Schulze, Access Program and Research Manager at the Novartis Foundation, provides a practical example of how ICTs can help assess and improve the quality of services in health facilities. The innovative technology was developed in collaboration with Vodafone and is currently being introduced in the frame of the foundation’s ACCESS project in rural Tanzania.


The Novartis Foundation has pioneered several other projects in the area of e-health. Together with the World Health Organization, the foundation developed ICATT, an e-learning tool to globally scale up training in childhood illness, and currently works on a similar tool for maternal and newborn health. In Ghana, the foundation collaborated with the Millennium Villages Project (MVP) to introduce a telemedicine approach to support health personnel in rural areas.




The Novartis-led SMS for Life project is another example of mobile technology being used to tackle a complex health issue – in this case treating malaria in rural areas of sub-Saharan Africa. SMS for Life uses mobile phones and electronic mapping to help eliminate stock-outs of malaria medicines in endemic countries.


Sir Richard Feachem, Professor of Global Health at the University of California, San Francisco, and the University of California, Berkeley, and Director of the Global Health Group at UCSF Global Health Sciences, follows by looking again at the broader perspective, and examining how development cooperation should be reformed to accommodate the technological revolution and prepare it for the 21st century.


The scope of this year’s symposium goes beyond examining the impact of technology on healthcare in the developing world – rather it is looking at how modern media and social networks can be harnessed to tackle some of society’s most persistent challenges while at the same time considering the obstacles, risks and limitations of the current trends.


Source: Novartis relaease

Computerized Neurocognitive Testing Increasingly Used for Managing Sports-Related Concussions

Computerized neurocognitive testing is being used more often for managing young athletes with concussions and is associated with delays in return-to-play, according to a Pediatrics study.

Researchers examined data on nearly 200 high schools participating in a national athletic injury reporting system during the 2009–2010 school year. They found that 40% of concussions were managed with computerized neurocognitive testing, representing an increase from the previous year, when just 26% of concussions were thus assessed.

Athletes who underwent computerized testing were less likely to return to play within 10 days, compared with those who did not have such testing. The authors speculate: “Presumably, the tests were able to detect persistent symptoms … that were not detected by the remainder of the clinical assessment.”

The authors conclude that such testing is a “valuable component of a comprehensive concussion management program.”



Excess Bleeding Risk in Patients Taking SSRIs plus Antiplatelet Drugs

An interaction was noted in patients with coronary disease.

Release of serotonin by platelets enhances platelet aggregation at sites of vascular damage. By depleting platelets of serotonin, selective serotonin reuptake inhibitors (SSRIs) thus impair platelet function. In several observational studies, SSRIs were associated with elevated risk for bleeding, but these studies did not focus specifically on interactions between SSRIs and other antiplatelet drugs.

In this population-based retrospective study, researchers examined data on all 27,000 patients (age, 50) in Quebec who were discharged from hospitals after myocardial infarctions between 1997 and 2007. During average follow-up of 3 years, about 4% of patients were hospitalized for bleeding. In analyses adjusted for potential confounders, bleeding risk was elevated by about 50% in patients who took an SSRI plus aspirin or clopidogrel (vs. aspirin or clopidogrel alone) and in those who took an SSRI plus dual antiplatelet therapy (vs. dual antiplatelet therapy alone).

Comment: SSRIs appear to raise bleeding risk in patients with coronary disease who are taking antiplatelet drugs. Confounding could have been a factor in this observational study, but it’s unlikely that a randomized trial will be performed to confirm these results. For severely depressed patients who require antiplatelet agents, benefits of SSRIs might well outweigh risks. For patients with milder depression, however, clinicians should think twice before prescribing SSRIs alongside antiplatelet drugs.

Source:Journal Watch General Medicine