In The News

FDA Warns of Burning Risk from Patches During MRIs
Transdermal patches that contain aluminum or other metals in the backing can overheat during MRI scans and cause skins burns in the area of the patch, the FDA cautions. While the agency reviews the labeling and composition of all medicated patches to ensure that those made with materials containing metal provide a warning about the risk of burns, FDA recommends that patients remove all patches prior to undergoing scans.

MRI facilities should follow published safe practice recommendations concerning patients wearing patches (Am. J. Roentgenol 188 (6):1447-74). Published initially in 2002, the ACR MR Safe Practice Guidelines established de facto industry standards in clinical and research MR environments. Regarding drug delivery patches and pads, the guidelines state:

"Some drug delivery patches contain metallic foil. Scanning the region of the metallic foil may result in thermal injury. Since removal or repositioning can result in altering of patient dose, consultation with the patient's prescribing physician would be indicated in assessing how to best manage the patient. If the metallic foil of the patch delivery system is positioned on the patient so that it is in the volume of excitation of the transmitting RF coil, the case should be specifically reviewed with the radiologist or physician covering the patient.

Alternative options may include placing an ice pack directly on the patch. This solution may still substantially alter the rate of delivery or absorption of the medication to the patient (and be less comfortable to the patient, as well). This ramification should therefore not be treated lightly, and a decision to proceed in this manner should be made by a knowledgeable radiologist attending the patient and with the concurrence of the referring physician as well. If the patch is removed, a specific staff member should be given responsibility for ensuring that it is replaced or repositioned."

New Alzheimer's Scale Published A new scale gauges 15 risk factors for dementia that can predict if people aged 65 and older have a high risk of developing AD. Published online May 13 in Neurology, the scale has a few surprise items: having underwent coronary bypass surgery, being underweight, abstaining from alcohol, or slowly performing tasks like buttoning a shirt. "A neurologist might use the scale in someone who is referred for an evaluation and is found to not have dementia or mild cognitive impairment," explains study author Deborah Barnes PhD of the Department of Psychiatry at UCSF. "Someone who was found to be high risk might be followed more aggressively so that treatment could be initiated as early as possible."

FDA Actions Migraine Pill OK'd for Children. Almotriptan (Axert, Ortho-McNeil-Janssen Pharmaceuticals, Inc.) has been approved for the acute treatment of migraines in adolescent patients, becoming the first triptan to gain the FDA seal approval for the young subset. The drug was first approved in the US in 2001 for the same indication in adults. Also, based on completion of the studies that supported its approval, the drug's patent has been extended six months, until November 2015.

Extended-Release AED Approved. Lamictal XR (lamotrigine, GlaxoSmith Kline) has been approved as a once daily adjunct therapy for epilepsy patients 13 years of age and older with partial onset seizures. Results of the ARMOR study showed that the reformulation reduced partial seizures by 47 percent, compared to 25 percent with placebo, over the entire 19-week treatment period (P=0.0001). The trial was an international, multicenter, randomized, double-blind, placebo-controlled study of 236 patients 13 years of age or older with inadequately controlled partial seizures, who were taking a stable regimen of one or two antiepileptic drugs (AEDs) and experienced eight or more partial seizures during the eight-week baseline phase of the study.

Up 20 Percent of MS Patients Delay Treatment, Study Patients just diagnosed with MS will often delay the start of treatment because of their fear or anxiety about current treatment options, according to the results of a new study. The survey, done on behalf of The National MS Society, compared the perspectives on treatments, psychosocial burdens of the disease, and delays in starting treatment between 250 neurologists, 250 MS nurses and other healthcare professionals (HCPs), and 250 people living with relapsing MS. It was co-sponsored by EMD Serono.

The telephone survey found that nearly 20 percent of people living with MS reported holding off on the start of a treatment regimen for a variety of reasons, such as fear or anxiety over treatment. Differences emerged between physicians' perceptions and the reports of people living with MS about how much fear affects patients' lives: A majority of physicians, MS nurses and other providers reported that anxiety surrounding treatment impacts MS patients "a great deal" or "somewhat."

The MS Viewpoints survey findings suggest that while individuals currently on treatment report being generally satisfied with their treatment, almost one-third of people living with MS feel their current treatment impedes their quality of life and daily activities "such as work/career, exercise routine and sleeping habits, topics that are more likely to be discussed by their MS nurse or other HCP than by their physician."

"The dialogue between a person living with MS and a nurse or other healthcare provider is important because it often focuses on the impact of MS on day-to-day activities," said Amy Perrin-Ross, APN, MSN, CNRN, MSCN, neuroscience program coordinator, Loyola University Chicago, and president of the International Organization of Multiple Sclerosis Nurses (IOMSN) in a statement. "Perhaps this is why the survey showed that nurses and other HCPs were more likely than physicians to believe people with MS who initially delayed starting their prescribed MS therapy would have instead started therapy more quickly if an oral medication had been available."

Short Takes
Vimpat Now Available. Vimpat is finally reaching the market and is now available to patients. The drug received FDA approval in October as an add-on treatment for epilepsy based on positive data from a Phase II and two Phase III clinical trials with roughly 1,300 adults with epilepsy who had uncontrolled partial-onset seizures prior to taking Vimpat at 200 and 400mg/day. Those taking the drug experienced a median reduction in seizure frequency per 28 days of 33.3 percent and 36.8 percent, respectively, versus only 18.4 percent in the placebo group. Also, 34.1 percent and 39.7 percent of patients taking Vimpat at 200 and 400mg/day, respectively, experienced ?50 percent reduction in seizure frequency versus only 22.6 percent in the placebo group.

Orally-Inhaled Migraine Drug Effective. The investigational, orally inhaled migraine drug Levadex (dihydroergotamine) achieved significant improvement in all four primary endpoints of the efficacy portion of a Phase III study. Randomized to receive the drug or placebo, for a single moderate or severe migraine, 792 patients participated in the FREEDOM-301 trial. The primary efficacy measures demonstrated that patients who took Levadex had significant improvement in pain relief, and also saw improvement in nausea and sensitivity to light and sound, compared to controls.

Spine Study Commences. A novel protein-based therapy for low back pain is now under investigation, according to DePuy Spine, Inc. (a Johnson & Johnson company), which is developing the treatment in collaboration with Advanced Technologies and Regenerative Medicine, LLC. The genetically engineered human protein, intradiscal rhGDF-5, injected into the lower spine may relieve pain and could slow or even reverse early stage degenerative disc disease, the company says.

Another J&J company and member of the DePuy family, Codman Neurovascular (formerly Cordis) has been established and may become familiar to neurologists. The company markets neurovascular coils, catheters, liquid embolics, and vascular reconstruction devices for minimally invasive treatment of aneurysms and cerebral arteriovenous malformations.

Gone Fishin'. Vitamin D in fish improved the brain function of middle-aged and older men, according to a new study published in Journal of Neurology, Neurosurgery and Psychiatry. Researchers looked at the cognitive performance of more than 3,000 men aged 40 to 79 in a multicenter study across Europe. Results of vitamin D studies have varied, the lead author concedes, but says the current study's large sample size and accounting for possible influences, including depression and physical activity level, make findings reliable.

Dementia Trial Enrolling. Two separate randomised Phase III studies of solanezumab (Eli Lilly) will begin enrolling patients to investigate whether the compound will slow the cognitive and functional decline of patients with mild-to-moderate Alzheimer's disease, the company said. The EXPEDITION trials, expected to enroll 2,000 patients aged 55 years and over, who compare placebo to intravenous solanezumab once every four weeks for 18 months.