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Pradaxa Lawsuit News - 2/29/2012: Did you take Pradaxa? Please contact us today if you took Pradaxa and later experienced harmful side effects. We will connect you with a lawyer that is experienced in complex litigation that may be able to help you recover monetary damages.

Pradaxa Lawsuit: Intracerebral hemorrhage (ICH) accounts for 10-15% of all strokes. Primary ICH occurs when small intracranial vessels are damaged by chronic hypertension (HTN) or cerebral amyloid angiopathy (CAA), and accounts for 78-88% of all ICH. The incidence of ICH worldwide ranges from 10 to 20 cases per 100 000 population and increases with age. Certain populations, in particular, the Japanese and those of Afro-Caribbean descent, have a heightened incidence of 50-55 per 100 000 that may reflect a higher prevalence of HTN and/or decreased access to healthcare. The incidence of hemorrhage increases exponentially with age and is higher in men than in women. Neurologic deficits from ICH reflect the location of the initial bleeding and associated edema. In addition, seizures, vomiting, headache, and diminished level of consciousness are common presenting symptoms. A depressed level of alertness on initial evaluation occurs infrequently in acute ischemic stroke (AIS) but is seen in approximately 50% of patients with ICH.

Pradaxa Lawsuit: Spontaneous, or non-traumatic, ICH has a much poorer outcome than AIS.¹ There is a 62% mortality rate by 1 year, and only about 20% of survivors are living independently by 6 months. About half of the deaths due to ICH over the first 30 days will occur within the first 2 days, largely from cerebral herniation. Later, mortality is more commonly due to medical complications, such as aspiration pneumonia or venous thromboembolism. By far the most important modifiable risk factor for spontaneous ICH is HTN. Primary hypertensive hemorrhage results from the rupture of small penetrating arteries originating in the anterior, middle (i.e., articulateness), and posterior cerebral (i.e., thalamostriate) arteries and the pons (i.e., paramedian perforators) (1.3). HTN causes vessel rupture at or near the bifurcation of affected vessels, where degeneration of components of the arterial wall (media and smooth muscle) are identified. The annual risk of recurrent hemorrhage is 2% without antihypertensive treatment.

Pradaxa Lawsuit: Cerebral amyloid angiopathy. This multiloculated, oparietal region (left)lobar lesion seen on non-contrast head CT scan (A), started in the right front and by the next day (right), developed extensive intraventricular involvement, subfalcine herniation with right-to-left shift, and a subarachnoid component. The hyperdense finding in the frontal horns is an intraventricular catheter (arrowhead). Macropathology: lobar hematoma, with adjacent edema (B). Note the midline mass effect on and compression of the adjacent lateral ventricle (arrows). Micropathology: amyloid angiopathy, demonstrated by deposits within the vessel wall of an acellular, eosinophilic material (hematoxylin and eosin (H&E) stain) (C, 40x; D, 100x; arrows). The amyloid material exhibits a fluorescent green birefringence under polarized light (thioflavin S stain, 100x) (E). Illicit drug use and coagulopathic disorder are associated with an increased risk of ICH. Over-the-counter stimulants, particularly if taken in excessive quantities, may predispose to ICH (case study 1). A large case-control study associated phenylpropanolamine use with ICH in young patients.Up to 70% of patients with primary ICH develop some measurable amount of lesion expansion over the initial few hours.Hematoma growth is an independent determinant of both mortality and functional outcome after ICH.

Pradaxa Lawsuit

Pradaxa Lawsuit

: By far the most important modifiable risk factor for spontaneous ICH is HTN.Primary hypertensive hemorrhage results from the rupture of small penetrating arteries originating in the anterior, middle (i.e., lenticulostriate), and posterior cerebral (i.e., thalamostriate) arteries and the pons (i.e., paramedian perforators). HTN causes vessel rupture at or near the bifurcation of affected vessels, where degeneration of components of the arterial wall (media and smooth muscle) are identified. The annual risk of recurrent hemorrhage is 2% without antihypertensive treatment. A hematoma incites local edema and neuronal damage in the adjacent brain parenchyma. This edema typically increases in size over an interval as long as 3 weeks following the initial bleeding, with the greatest growth rate over the first 2 days. Thrombin within the hematoma plays a central role in promoting perihematomal edema. Hemoglobin and its products, heme and iron, are potent mitochondrial toxins, thereby increasing cell death.

Pradaxa Lawsuit: Hemorrhage may dissect from the brain parenchyma into the adjacent ventricular space, carrying a poor prognosis, Hemorrhage may also be isolated to the intraventricular space,and lesions can expand substantially by rupturing into the ventricular system. Ventricular involvement may cause obstructive hydrocephalus and can result in long-term cognitive impairment.

Pradaxa Lawsuit: Significant clinical deterioration associated with PH is known as ‘symptomatic hemorrhage, an important outcome measure in acute stroke treatment. One common definition for symptomatic hemorrhage is a clinical deterioration of >4 points on the National Institutes of Health Stroke Scale (NIHSS) associated with hemorrhage seen on CT scan. Various predictors for symptomatic hemorrhage include hyperglycemia, concur­rent heparin use, the timing of successful recanalization, a history of diabetes and cardiac disease, leukoariosis, early signs of infarct on CT scans, and elevated pretreatment mean blood pressure. Neurosurgical evacuation typically is not a helpful treatment for symptomatic hemorrhage, because the lesion is frequently large and multifocal. Extra-ischemic hematomas are: located remotely from the initial ischemic stroke lesion; may be isolated or multifocal, with or without mass effect (1.17);²³ and associated with concurrent coagulopathy and previously occult vasculopathies, such as CAA, microhemorrhages, or hypertensive vasculopathy. In the NINDS (National Institute of Neurological Disorders and Stroke) trial of IV t-PA for AIS, the incidence of extra-ischemic cerebral hematomas was 1.3%.

Pradaxa Lawsuit

Pradaxa Lawsuit

: Venous occlusive intracranial disease is associated with oral contraceptive use the immediate post-partum period, and a wide range of hypercoagulable medical conditions. Significant cerebral venous thrombosis involves one or more of the major venous sinuses and typically results in parenchymal hemorrhage. By definition, the territories of the ischemic and hemorrhagic lesions are in a venous, rather than arterial, distribution. Involvement of the deep venous system (case study 3) carries a much worse prognosis than if only the superficial sinuses and/or cortical veins (1.20) are involved. Magnetic resonance venography (MRV) is commonly used to identify major venous sinus occlusions.

Pradaxa Lawsuit: The single mandated indication for neurosurgical decompression is cerebellar hemorrhage. Early craniotomy, prior to brainstem compression, is critical. The best surgical candidates are patients with an initial GCS <14 and hematoma volume >40 ml, while those with higher GCS and smaller lesions are likely to have a good outcome with conservative, non-surgical management. Neurosurgical evacuation of clot in primary hemispheric ICH has had mixed results in randomized and non­randomized clinical trials. The leading study, I-STICH (International Surgical Trial in Intracerebral Haemorrhage), identified neutral outcomes for early evacuation. Nonetheless, a role for neurosurgical decompression to reduce clot size may exist in highly selected patients, particularly younger patients (e.g., <60 years old) who have cerebellar hemorrhage, treated with neurosurgery. Head CT scan shows a large, primary ICH based in the cerebellar vermis, causing effacement of the basal cisterns around the pons and early obstructive hydrocephalus, with markedly enlarged temporal horns (arrows) (A). The patient underwent emergent craniotomy over the next few hours, and subsequent CT scan the following day (B) shows recovery of basal cisterns, reduction in ventricular size, and a pocket of air in the left cerebellar hemisphere (arrowhead), with some edema in the left middle cerebellar peduncle. Note the craniotomy defect from the left suboccipital approach.

Pradaxa Lawsuit: Less invasive surgical interventions, such as catheter-based clot aspiration or thrombolysis, are being studied. Intraventricular ICH may contribute to elevated intra­cranial pressure (ICP) by causing obstructive hydrocephalus. The amount of ventricular blood to cause hydrocephalus need not be great (1.22). In this setting, external drainage of cerebrospinal fluid via ventricular catheter may be indicated to reduce ICP.

Pradaxa Lawsuit

Pradaxa Lawsuit:

Commonly considered agents: beta-blockers (labetalol, esmo­lol), calcium channel blockers (nicardipine), angiotensin con­verting enzyme (ACE) inhibitors (enalapril), and hydralazine. Other agents such as nitroprusside are effective as second-line options but carry the risk of significant vasodilation.Mass effect causing significant elevation of ICP, with the risk for cerebral herniation syndromes, may be managed emergently with osmotic agents, such as mannitol and/or hypertonic saline, and hyperventilation.However, these approaches have never been formally studied in clinical trials. Seizures occur in 10% of patients with primary ICH, usually at onset or within the initial 24 hours, and reflect cortical involvement of the lesion.

Pradaxa Lawsuit:Anticonvulsant agents are empirically recommended for patients with significant hematomas in peripheral territories in the cerebral hemispheres. The appropriate duration of anticonvulsant use has not been established. For patients who are seizure- free, guidelines suggest discontinuation of the anti-epileptic drug after the first month post-hemorrhage. Neurointensivist management of ICH in an intensive care unit (ICU) setting may improve patient outcomes.

Pradaxa Lawsuit: News and Information from related Sources

Pradaxa Lawsuit: Various clinical trials, including SHEP (Systolic Hypertension in the Elderly Program)and PROGRESS (Perindopril Protection Against Recurrent Stroke Study), have documented the critical role of antihypertensive agents in both primary and secondary stroke prevention of ICH. The JNC-7 report (Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) provides an extensive overview of the role of HTN in stroke risk, specific drug classes, lifestyle modifications, and target blood pressures. In general, lower blood pressures are associated with a proportional reduction of recurrent stroke and stroke mortality.

Pradaxa Lawsuit

Pradaxa Lawsuit

: By far the most important modifiable risk factor for spontaneous ICH is HTN.Primary hypertensive hemorrhage results from the rupture of small penetrating arteries originating in the anterior, middle (i.e., lenticulostriate), and posterior cerebral (i.e., thalamostriate) arteries and the pons (i.e., paramedian perforators). HTN causes vessel rupture at or near the bifurcation of affected vessels, where degeneration of components of the arterial wall (media and smooth muscle) are identified. The annual risk of recurrent hemorrhage is 2% without antihypertensive treatment. A hematoma incites local edema and neuronal damage in the adjacent brain parenchyma. This edema typically increases in size over an interval as long as 3 weeks following the initial bleeding, with the greatest growth rate over the first 2 days. Thrombin within the hematoma plays a central role in promoting perihematomal edema. Hemoglobin and its products, heme and iron, are potent mitochondrial toxins, thereby increasing cell death.

Hemorrhage may dissect from the brain parenchyma into the adjacent ventricular space, carrying a poor prognosis, Hemorrhage may also be isolated to the intraventricular space,and lesions can expand substantially by rupturing into the ventricular system. Ventricular involvement may cause obstructive hydrocephalus and can result in long-term cognitive impairment.

Significant clinical deterioration associated with PH is known as ‘symptomatic hemorrhage, an important outcome measure in acute stroke treatment. One common definition for symptomatic hemorrhage is a clinical deterioration of >4 points on the National Institutes of Health Stroke Scale (NIHSS) associated with hemorrhage seen on CT scan. Various predictors for symptomatic hemorrhage include hyperglycemia, concur­rent heparin use, the timing of successful recanalization, a history of diabetes and cardiac disease, leukoariosis, early signs of infarct on CT scans, and elevated pretreatment mean blood pressure. Neurosurgical evacuation typically is not a helpful treatment for symptomatic hemorrhage, because the lesion is frequently large and multifocal. Extra-ischemic hematomas are: located remotely from the initial ischemic stroke lesion; may be isolated or multifocal, with or without mass effect (1.17);²³ and associated with concurrent coagulopathy and previously occult vasculopathies, such as CAA, microhemorrhages, or hypertensive vasculopathy. In the NINDS (National Institute of Neurological Disorders and Stroke) trial of IV t-PA for AIS, the incidence of extra-ischemic cerebral hematomas was 1.3%.

Pradaxa Lawsuit