Hussam A. Yacoub Md

Guillain–Barré syndrome after Gardasil vaccination: Data from Vaccine Adverse Event Reporting System 2006–2009

Using data from Vaccine Adverse Event Reporting System, we identified 69 reports of Guillain-Barré Syndrome (GBS) after Gardasil vaccination that occurred in the United States between 2006 and 2009. The onset of symptoms was within 6 weeks after vaccination in 70% of the patients in whom the date of vaccination was known. The estimated weekly reporting rate of post-Gardasil GBS within the first 6 weeks (6.6 per 10,000,000) was higher than that of the general population, and higher than post-Menactra and post-influenza vaccinations. Further prospective active surveillance for accurate ascertainment and identification of high-risk groups of GBS after Gardasil vaccination is warranted.

The Safety Profile of Home Infusion of Intravenous Immunoglobulin in Patients with Neuroimmunologic Disorders.

Objectives: To assess the overall safety of high-dose intravenous immunoglobulin (IG) products used to treat patients with neuroimmunological disorders in a supervised home-based setting. Methods: The incidence of adverse reactions was assessed in a retrospective chart review of 420 patients who consecutively received 4076, home-based, individual, intravenous immunoglobulin (IVIG) infusions between January 2009 and December 2009. Results: A total of 90 patients (21.4%) developed adverse reactions related to IVIG administration (2.6% per individual infusion). A total of 95.5% of adverse reactions were mild, and no serious side effects were observed. The incidence of adverse reactions was significantly lower in the subgroup of patients with neuroimmunological disorders who received premedication (18.2% compared with 29.3%, P = 0.02). There was no significant statistical difference in the incidence of side effects among the different brands of IVIG used in this study. Conclusions: The combination of premedication and well-defined clinical, IVIG infusion policies may reduce the incidence of high-dose IVIG adverse reactions administered in a home-based setting in patients with neuroimmunological disorders.

SEROTONIN SYNDROME AFTER ADMINISTRATION OF MILNACIPRAN FOR FIBROMYALGIA

We report a patient who presented with classic serotonin syndrome (SS) after being started on milnacipran for fibromyalgia. To our knowledge, this is the first case of serotonin toxicity reported since milnacipran was approved by the Food and Drug Administration (FDA) for the treatment of fibromyalgia. ### Level of evidence. This is a case report describing a single patient treated for classic symptoms of serotonin toxicity with milnacipran, while on a chronic dose of paroxetine, and is therefore a Class IV study. ### Case report. A 76-year-old man with a history of chronic pain presented to the emergency room with progressive worsening of lethargy and confusion. The patient was initially noted by the family to be confused and asking the same questions repeatedly. Throughout the following 2 days, the patient became more confused and eventually severely dysarthric. He was ultimately brought to the emergency room after he was found on the floor lethargic with incomprehensible speech. The patient had a history of depression and had been on paroxetine, 25 mg daily, for 5 years. Eight days prior to this presentation, the patient had been diagnosed with fibromyalgia and started on milnacipran 50 mg twice daily, a newly approved medication for the treatment of fibromyalgia. On physical examination, the patient was found to have a temperature ranging from 100.5 …

Cranial Nerve-VI Palsy as the Main Clinical Manifestation of Neurosarcoidosis.

Introduction:Sarcoidosis is a chronic, systemic, inflammatory disorder that is characterized by the formation of noncaseating granulomas. Patients may present with cranial nerve palsy, paresthesia, paresis, pyramidal signs, progressive cognitive decline, urinary retention, seizures, or hypothalamic-pituitary syndrome. Although the diagnosis of neurosarcoidosis can be challenging, neurological manifestations of sarcoidosis occur more frequently than previously described. Case Report:A 23-year-old African American man presented to our emergency department with diplopia, which was worsened on left horizontal gaze. On the day of admission, he had a witnessed seizure. Laboratory studies were significant only for mild leukopenia and erythrocyte sedimentation rate of 17 mm/h. Brain magnetic resonance imaging revealed diffuse thickening and enhancement of the dura, mild mass effect, and soft tissue enhancement through the foramen rotundum and left orbital apex. The patient was treated with intravenous methylprednisolone and discharged on 60 mg oral prednisone daily followed by a taper over a 2-month period. Conclusions:Our case demonstrates that mild neurological deficits can be the initial presentation of neurosarcoidosis in patients with undiagnosed or proven sarcoidosis.

Analysis of data from the CDC/FDA Vaccine Adverse Event Reporting System (1990-2009) on Guillain-Barre syndrome after hepatitis vaccination in the USA

We used data from the Vaccine Adverse Event Reporting System, supplemented by additional data provided by the Center for Biologics Evaluation and Research, to identify 189 patients with Guillain-Barré syndrome (GBS) reported after hepatitis vaccination with a mean age of 30.65 years, affecting men and women equally. Among vaccinated patients, 133 (70%) developed GBS within six weeks, 30 (15.9%) after six weeks, and for the remaining 26 (13.7%), the time between GBS occurrence and vaccination was not specified. The reporting rate of post-hepatitis vaccine GBS is approximately 3.4 cases per one million vaccinations, which is in the range expected in the general population. The unbalanced distribution of reports in the first six weeks after vaccination suggests that some cases of GBS may be triggered by vaccination. Nonetheless, the low incidence of hepatitis vaccine-associated GBS, and the dramatic incidence reduction of hepatitis and its complications after vaccination, support the current guidelines for vaccination.

Recurrent Ischemic Stroke in Paroxysmal Nocturnal Hemoglobinuria: Paroxysmal Nocturnal Hemoglobinuria or Missed Patent Foramen Ovale?

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, acquired bone-marrow disorder characterized by hemolytic anemia, hemoglobinuria, and cytopenia. Most patients die from venous thrombotic events. Stroke is a common cause of morbidity and mortality in PNH and it is almost exclusively a result of cerebral venous thrombosis. Case reports of ischemic stroke complicating PNH have implicated a similar propensity for arterial events caused by the disease. We present a case of recurrent cerebral infarctions complicating PNH initially attributed to arterial thrombosis but ultimately determined to be a result of the disease and a concomitant patent foramen ovale identified only after repeated evaluations. This case emphasizes the pitfalls of diagnostic testing and the importance of a persistent search for a venous cause for cerebral embolic events in patients with hematologic diseases not classically known to involve the arterial system.