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New Drugs/Drug News/New Medical Devices January 2011


Ready-to-Use Nexterone Injection for Arrhythmias

The FDA has approved the supplemental New Drug Application (sNDA) for amiodarone HCl (Nexterone Pre-mixed Injection, Prism Pharma). This is the first premixed intravenous (IV) bag formulation of amiodarone IV, an anti-arrhythmic agent. Nexterone is indicated for the initiation and prophylaxis of recurring and refractory ventricular fibrillation and hemodynamically unstable ventricular tachycardia. The product is sold in two ready-to-use dosage forms as 1.5 mg/mL (150 mg/100 mL) for rapid loading infusions and as 1.8 mg/mL (360 mg/200 mL) for subsequent infusions.

Before this approval, the drug had to be mixed at the time of use. The newly formulated product helps to eliminate the potential for errors. It can be stored at the point of use in automated dispensing cabinets and crash carts, and it has a two-year shelf life.

Nexterone injection for IV use was approved in December 2008.

Sources:,; Prism Pharma, November 18, 2010,

Lo Loestrin Fe, a Contraceptive

Warner Chilcott has announced the FDA’s approval of Lo Loestrin Fe (norethindrone acetate/ethinyl estradiol/ferrous fumarate). This oral contraceptive contains only 10 mcg of daily estrogen, half the amount in the lowest-dose tablets on the market.

The FDA recommends the least amount of estrogen and progestin necessary to prevent pregnancy. The new low dose of estradiol in Lo Loestrin Fe may reduce the risk of estrogen-related side effects, including bloating, breast tenderness, and nausea.

Loestrin Fe was first approved in 1968. The previous lowest dose of ethinyl estradiol in Loestrin was 20 mcg.

Source: Warner Chilcott,, October 22, 2010


Newer Breast Cancer Drugs May Raise Heart Risks

Women who use aromatase inhibitors such as exemestane (Aromasin, Pfizer), anastrozole (Arimidex, AstraZeneca), and letrozole (Femara, Novartis) for breast cancer may be 26% more likely to experience heart attacks, angina, and heart failure compared with women taking older therapies.

The data, presented at the 33rd Annual San Antonio Breast Cancer Symposium, suggest that women with breast cancer who have risk factors for heart disease should use these drugs for a shorter time. The antiestrogen agent tamoxifen (Nolvadex, AstraZeneca), which was approved by the FDA in 1977, carries a lower risk of heart complications.

Aromatase inhibitors block the production of estrogen, which can promote cancer growth. These drugs are often used after treatment with tamoxifen, which prevents tumor cells from using estrogen.

In December 2008, the FDA added a warning label to anastrozole, which indicated potential increased risk for heart disease. For this reason, an analysis of seven studies was conducted to determine whether the risk of heart disease was raised with the use of any aromatase inhibitor. The research, which involved postmenopausal women with early breast cancer, revealed that those who took aromatase inhibitors were 47% more likely to experience a fracture compared with women taking tamoxifen, regardless of how long they took the drug. The tamoxifen patients were more likely to develop endometrial cancer and dangerous blood clots in the legs. It was thought that women who switched to aromatase inhibitors after starting tamoxifen were less likely to die from a condition other than breast cancer. However, the approach did not seem to reduce the risk of serious side effects.

In another study, exemestane worked as well as anastrozole. The researchers had originally thought that exemestane might be more effective than anastrozole with fewer side effects. The aromatase inhibitors resulted in a reduced risk of venous thrombosis and endometrial carcinoma, and patients taking exemestane were less likely to have osteoporosis and elevated cholesterol levels; however, they had more mood changes and liver dysfunction.

Sources: Bloomberg News, WebMD, December 9, 2010;

‘ACE Cough’ More Common Than Reported

Many more patients than had been thought may be experiencing the irritating dr y cough associated with angiotensin-converting enzyme (ACE) inhibitors, compared with rates reported in the Physicians’ Desk Reference (PDR) and on drug labels. In most cases, the rates of cough have been grossly underreported. The reported rate of 1.3% in the PDR for enalapril (e.g., Vasotec, Biovail/Merck) is so low that physicians consider it laughable. Yet the cough is one reason why patients might stop using this medication.

Researchers from Brigham and Women’s Hospital and St. Luke’s Roosevelt Hospital found 125 studies, enrolling 198,130 patients, that reported the incidence or withdrawal rates attributable to cough. Searching the PDR from 1990 to 2009, they extracted the reported incidence of cough and withdrawal of the drug, because of cough, for individual ACE inhibitors and for each indication, such as heart failure or hypertension. They also searched the FDA Web site for approval letters, approved drug labels, the number of labeling revisions, and the change in reported rates of cough with the revision. Not surprisingly, reported rates of cough in product labels were the same as those in the PDR. If the PDR reported a range of rates, the higher of the two rates was used.

Among the 55 arms enrolled, 23,559 patients were randomly assigned to receive enalapril. The pooled weighted incidence of cough for enalapril was 11.48%, nine times greater than the rate repor ted in the PDR. The pooled weighted withdrawal rate caused by cough for enalapril was 3.08%, 31 times higher than the rate of 0.1% listed in the PDR. Similarly, the incidence of cough with other ACE inhibitors was significantly greater than what was published in the PDR. Only the rates for ramipril (Altace, Monarch) and perindopril (Aceon, Solvay) approached the PDR figures.

The researchers acknowledge that the incidence rates for cough vary in the literature. Variations can be attributed to the sample size, the length of follow-up, and the metric used to assess symptoms. Rates of cough and withdrawal were lower in studies when ACE inhibitors were combined with non–angiotensin receptor blockers (ARBs), and they were higher among patients with heart failure, in whom the cause of cough could have been multifactorial and misdiagnosed as cough caused by ACE inhibitors. These rates were also higher when a questionnaire was used to evaluate cough.

Discontinuation rates were similar, suggesting that those rates might be a more objective measure of adverse drug events than reported incidence rates. Moreover, placebo-adjusted rates from the meta-analysis were greater than the corresponding adjusted rates from the PDR or drug label; this indicates that regardless of how the data are viewed, the rates are substantially less in the PDR or drug label.

What are the consequences of under-reporting?

Reported low rates of adverse events can create a false sense of security for physicians and patients and can result in evaluation for other causes of cough, leading to misdiagnosis and mistreatment. Underreported rates may also cause one drug to be promoted over another to the detriment of treatment. For example, a lower reported incidence of cough with enalapril (1.3%), compared with that of ramipril (12%), could erroneously imply that enalapril is better tolerated, whereas the analysis indicates that cough is a class effect, with a similar incidence among all ACE inhibitors.

One way to improve the statistics might be to regularly update drug labeling both for safety and for medication-specific adverse effects.

Source: Am J Med 2010;123:1016–1030

DHA Enhances Memory

In a multicenter study by researchers from Martek Biosciences Corporation in Columbia, Md., and Stedman Clinical Trials in Tampa, Fla., a six-month course of docosahexaenoic acid (DHA) supplements improved learning and memory function in adults with age-related cognitive decline.

The study, which enrolled 485 healthy older adults, began with a screening visit, followed one week later by a baseline visit and then by three follow-up visits. Those in the treatment group received DHA 900 mg/day in three capsules. The primary outcome was a change from baseline in the Cambridge Neuropsychological Test Automated Batter y (CANTAB) Paired Associate Learning (PAL), a computer-based visual-spatial learning and episodic memory test.

After 24 weeks, the DHA group had a twofold reduction in the number of errors on the PAL test, compared with the placebo group, and showed improved verbal recognition memory. At week 12, the groups did not differ significantly on the PAL or on other CANTAB tests.

DHA supplementation did not result in altered working memory or executive function (which are typically impaired late-stage Alzheimer’s disease). The investigators suggested that a longer course of supplementation might produce changes in those domains. DHA was well tolerated, with no reports of treatment-related serious adverse drug events.

Mean PAL errors at baseline corresponded to a cognitive age of 72.6 years. After 24 weeks of DHA supplementation, the cognitive age represented by the PAL scores was 65.6 years (a seven-year improvement). By comparison, PAL error performance scores for the placebo group corresponded to 70.6 years at baseline and 66.9 years at week 24 (a 3.6-year improvement).

Some medical professionals consider cardiovascular disease to be a potential risk factor for cognitive disorders such as dementia. Within the study population, 68% had a history of cardiovascular disease, 36% were taking statins, and 50% were taking antihypertensive agents, suggesting that coexisting cognitive and cardiovascular problems might be ameliorated with additional DHA supplementation. The study revealed a significant reduction in heart rate associated with DHA supplementation, which could help reduce the risk of fatal cardiovascular events.

Studies have shown that changes in episodic memory may predict preclinical Alzheimer’s disease. This study’s positive findings, which are considered moderate, nonetheless have important implications, indicating that DHA at a dose of 900 mg/day might be neuroprotective.

Source: Alzheimer Dementia 2010;6: 456–464

Allopurinol (Zyloprim) And Heart Failure Risk

How much allopurinol (Zyloprim, Faro/Prometheus/DSM) is used by heart patients could be a clue to their risk of death from systolic heart failure. Researchers analyzed the relationship of uric acid levels and allopurinol, which is used in gout treatment, among 1,152 patients. Elevated uric acid levels and allopurinol use were independent predictors of high mortality and morbidity rates.

The patients were participants in the Prospective Randomized Amlodipine Survival Evaluation (PRAISE) study. Patients taking allopurinol and those with the highest levels of uric acid had the highest total mortality rates (42 and 42 per 100 person-years, respectively) and combined morbidity/mortality rates (46 and 51 per 100 person-years, respectively).

Allopurinol use can be an indicator of underlying hyperuricemia. The causes of elevated uric acid in patients with chronic heart failure are multifactorial, such as impaired renal function and metabolic derangements, including insulin resistance. Logically, allopurinol use implies higher levels of uric acid. The researchers caution against inferring a link between allopurinol use and adverse outcomes; instead, they say, the use of allopurinol is a risk marker.

Source: Am Heart J 2010;160:928–933


Can Gene Therapy Correct A Rare Bleeding Disorder?

German researchers have been able to correct a malfunctioning gene responsible for Wiskott–Aldrich syndrome. This rare childhood disorder can result in prolonged bleeding from even minor scrapes and leaves children vulnerable to cancer and dangerous infections.

The syndrome is an inherited disorder of the immune system and affects males but not females, although some females appear to have the same physical problems as males with the syndrome without the genetic mutation. Characterized by recurrent infections, low numbers of circulating blood platelet cells, and eczema, the disorder is caused by a mutation in the Wiskott–Aldrich syndrome protein (WASP) gene.

Patients with Wiskott–Aldrich syndrome are mostly boys and are born with an inherited genetic defect on the X chromosome that affects the number and size of platelets. If a bone marrow transplant is successful, the patient is considered cured. However, even if a good match is found, transplant recipients can still have problems with infections, such as graft–versus–host disease, in which the body rejects the foreign tissue.

In this study, the researchers inserted a healthy gene capable of producing the syndrome’s protein into hematopoietic stem cells, which give rise to different blood cells. Using a viral vector, they then transferred these stem cells back into the patient. The experiment was considered successful and resulted in increased platelet counts. However, one child developed acute T-cell lymphoma, apparently as a result of the vector that was used to insert the healthy gene.

Another group of German researchers noted that donors of peripheral blood stem cells or bone marrow do not face a heightened risk of cancer. There had been concern that drugs needed to get the stem cells out of the bone marrow and into the bloodstream where they could be accessed might pose a risk of leukemia. The study, based on questionnaires returned from more than 12,500 donors, showed that the donors were healthy and were willing to donate again.

In another study, rituximab (Rituxan, Genentech/Biogen Idec) was able to reduce graft–versus–host disease in stem cell transplant recipients.

Source: Health Day, December 6, 2010

Aspirin May Cut Cancer Risk

Scientists from Britain suggest that low-dose aspirin use over a long period of time might modestly reduce the risk of death from some cancers. Experts warn, however, that the study was not powered sufficiently to recommend aspirin for healthy people because of the risk of bleeding.

In an observational analysis, investigators from the University of Oxford looked at eight studies involving more than 25,000 patients. Aspirin use reduced the risk of death from certain cancers by 20%. However, the study did not show that benefits applied equally to women.

Men who took at least 75 mg of aspirin daily for heart problems were compared with people who took a placebo or another drug. On average, the studies lasted at least four years. National cancer registries were used to obtain information about participants after the studies ended. It was not clear how many enrollees continued to use it or how many people in the comparison groups might have started. It was projected that the risk after two decades of dying from lung or prostate cancer would be 20% lower in groups who had taken aspirin and 35% lower for gastrointestinal cancers such as colon cancer.

Only one-third of the subjects in the analysis were women, and this number was not enough to calculate estimates for breast cancer. There seemed to be no benefit to taking more than 75 mg/day.

The analysis omitted an experiment that had tested aspirin every other day in nearly 40,000 U.S. women. No reduction in cancer risk was seen except for lung cancer deaths in that trial. Scientists said it would take time to figure out which people should take aspirin.

One concern was that the studies were designed to evaluate cardiovascular risks. Thus, the groups of people being compared might have differed in their family history of cancer, for example.

Aspirin has long been recommended for some people with heart problems, but it can have serious side effects, like gastrointestinal bleeding. It also poses risks in elderly people, who are prone to falls. A U.S. health task force has recommended against aspirin for people with an average cancer risk.

Balancing the risks and benefits of aspirin needs to be done on an individual basis. Patients should consult with their physicians before starting a regimen and should not think of aspirin as a guarantee against cancer.

Sources: The Lancet, online; Drug Discovery Dev, December 7, 2010; Associated Press

Unlocking the Origins Of Medulloblastoma

Scientists are finding that the most common malignant childhood brain tumor, medulloblastoma, actually represents several different diseases. This breakthrough is expected to alter the diagnosis and treatment of this cancer.

St. Jude Children’s Research Hospital investigators have confirmed that certain brain tumors (and possibly other cancers regarded as the same disease) are separate diseases with different origins, with each tumor type likely to benefit from a different therapy.

Ten years ago, medulloblastoma was regarded as one disease, and all children with this brain tumor received the same measures. The new study shows that distinct subtypes of this cancer come from uniquely susceptible cell types in the brain that acquire specific mutations. These findings should allow therapies to be designed for each tumor subtype.

The research builds on work published in Nature in 2010 by Gilbertson and colleagues. That research used the same method to show similar mechanisms at work in generating subtypes of ependymoma, the third most common brain tumor in children and the most common adult spinal tumor. The approach in both investigations mapped gene expression to compare cells in the normal nervous system with cells in different subtypes of brain tumors. The goal was to identify the specific origins of different brain tumor subtypes.

The more recent study focused on the wingless (WNT) and sonic hedgehog (SHH) subtypes of medulloblastoma, which together account for about 40% of the estimated 400 medulloblastoma tumors diagnosed annually in children and adolescents in the U.S. The subtypes are named for the biochemical pathways abnormally activated in particular tumors.

Investigators used gene expression mapping to unmask a set of cells in the brainstem as the possible source of WNT-subtype medulloblastoma. The cells had not previously been linked to cancer. The cells also are located beneath and apart from the cerebellum. In the past, this brain structure was thought to be the source of all medulloblastomas.

Because mutations in the CTNNB1 genes occur specifically in patients with WNT-subtype medulloblastoma, researchers mutated the CTNNB1 gene in these same cells in the developing mouse brainstem. By six months of age, about 20% of those mice developed medulloblastomas that mimicked the anatomy, histology, and genetics of human WNT-subtype medulloblastoma.

Earlier research had traced the origin of SHH-subtype medulloblastoma to a subset of cells (granule neuron precursor cells), destined to become part of the cerebellum. In this study, Gilbertson et al. showed that overexpression of CTNNB1 in those precursor granule cells had no effect on the developing mouse cerebellum and did not lead to medulloblastoma.

The latest findings suggest that WNT-subtype medulloblastoma begins in a subset of cells that become mossy fiber cells in the adult brainstem. More research is needed to confirm this. The study also points to the loss of the p53 tumor suppressor gene and, possibly, to the TULP4 tumor suppressor gene as fueling WNT-subtype tumor development.

In 2006, the Gilbertson team showed that medulloblastoma could be classified according to whether the WNT, the SHH, or another biochemical pathway was abnormally activated. Researchers then found that the WNT and SHH subtypes also appeared different under the microscope, targeted patients of different ages, and had different outcomes. The SHH subtype tends to arise in very young children. About 80% of these patients become long-term survivors. The WNT subtype usually strikes older adolescents and is considered curable.

Patients with WNT-subtype tumors might be candidates for less intensive therapy and may be less likely to experience long-term treatment side effects.

Sources: Nature; December 8, 2010; Drug Discovery Dev, December 9, 2010

Beating Cancer on a Large Scale

Scientists are proposing an international effort on the scale of the Human Genome Project to identify all the proteins present in cancer cells. Within a decade, results of the new effort might be able to provide patients with more effective treatments tailored to their own biology.

Medicine today is increasingly moving toward a personalized approach instead of a one-size-fits-all strategy. Health care professionals are using information from tissue biopsies, medical imaging, and other sources to select the most effective treatment for patients. Analyzing protein biomarkers in each patient would be a major advance, because these proteins could allow doctors to determine how a particular cancer might respond to a specific drug. Scientists have already identified hundreds of these “cellular calling cards” and will need to identify more to begin applying the knowledge in treating patients.

Accomplishing this goal will require a worldwide effort among hospitals, research centers, and governments to identify the cancer-related proteins. Doctors would collect blood samples from patients with the major forms of cancer before surgery or during chemotherapy to profile the proteins associated with a therapy’s success or failure. The scientists suggest that improved treatment results could appear within five years of completing the project.

Source: J Proteome Res, October 27, 2010

H1N1 Vaccine Benefits Patients with Asthma

A trial of inactivated 2009 H1N1 influenza vaccine in patients with asthma indicated that a single dose of vaccine was safe and induced a strong immune response predictive of protection. The study, cosponsored by the National Institutes of Health (NIH), also suggested that patients with severe asthma who were older than 60 years of age might require a larger dose of the vaccine.

Asthma was the most common underlying health condition among those hospitalized in the U.S. with 2009 H1N1 influenza infection during the 2009–2010 flu season. H1N1 vaccine is a component of the seasonal influenza vaccine being distributed for the 2010–2011 flu season.

Asthmatic patients who are infected with the influenza virus are at risk for severe disease. There is also a concern that the long-term use of corticosteroids, which are used to control asthma symptoms and are known to suppress the immune system, might affect the patient’s ability to mount a healthy immune response to the vaccine.

The study enrolled 390 patients 12 to 79 years of age. Participants were divided into two groups based on asthma severity; the first group had mild or moderate asthma, and the second group had severe asthma. Patients with mild or moderate asthma were characterized as needing no or low-to-moderate doses of inhaled corticosteroids (ICSs) to control disease symptoms. Those with severe asthma needed high doses of ICSs and often needed oral corticosteroids to control symptoms.

Half of the participants in each group received a 15-mcg dose of vaccine, and the other half received a 30-mcg dose, both by injection. Three weeks later, each participant received a second dose in the same amount as the first dose. The Novartis vaccine contained inactivated 2009 H1N1 influenza virus and thus could not cause influenza infection.

The vaccine proved safe and produced an effective immune response indicative of protection. In patients with mild-to-moderate asthma, and in most participants with severe asthma, a single 15-mcg dose was sufficient to induce protection. The immune response after the first dose was not further improved after a second dose.

Patients older than 60 years of age with severe asthma had diminished immune responses to the 15-mcg dose but responded adequately to the 30-mcg dose.

Based on these observations, physicians might consider immunizing older patients with severe asthma with the high-dose version of the 2010–2011 seasonal flu vaccine, which contains the 2009 H1N1 influenza virus component.

Sources: J Allergy Clin Immunol, December 2010; NIH, December 13, 2010

Improving PSA Test Accuracy

Adding genetic information to the prostate-specific antigen (PSA) test for prostate cancer might help physicians determine which men need a biopsy.

Blood tests are used to measure PSA, a protein, but it is difficult to define normal PSA levels. Cancer can be missed in some men, and other men may have a false-positive result when they do not have cancer. PSA screening also detects small prostate tumors that will grow too slowly to prove fatal, but there is no definite way to predict who will need aggressive therapy. What is needed is a test that can differentiate lethal from non-lethal prostate cancers.

Scientists from Iceland have discovered several DNA variations, or single-nucleotide polymorphisms (SNPs), that affect background blood levels of PSA. William Catalona, who developed the original PSA test and was involved in the new research, said that some men have naturally high or low levels of PSA. In the future, by testing for the gene variations that affect baseline PSA levels, it should be possible to create more accurate individual thresholds.

Routine screening is controversial. Although most men older than age 50 have had at least one PSA test, some medical groups say that the test may do more harm than good. The American Cancer Society advises that men make an informed decision with their doctor about whether to be tested. One problem is that more than one-third of men with PSA levels of 10 ng/dL or higher have no evidence of prostate cancer at biopsy. Conversely, some men with very low PSA levels (2.5 ng/dL) can have cancer.

Decode Genetics, based in Reykjavik, plans to incorporate the new markers into its prostate diagnostic test.

Sources: Sci Translat Med, December 14, 2010; Associated Press and Reuters, December 15, 2010

The RAD51 Assay and PARP-1 Inhibitors in Ovarian Cancer

Scientists from the United Kingdom, collaborating with Pfizer Inc., have developed a test to select which women with ovarian cancer will benefit from receiving poly (ADP-ribose) polymerase-1 (PARP-1) inhibitors. PARPs are enzymes that repair DNA damage. In normal cells, this is useful, but cancer cells may use the PARP repair method to their advantage. PARP-1 inhibitors block PARP function and disrupt chemotherapy resistance in cancer cells.

These drugs are the first targeted treatment to be developed for women with inherited forms of breast and ovarian cancer who have mutations in the BRCA gene. Early findings are showing promise for patients with the rare inherited forms of these cancers.

The RAD51 assay is almost 100% effective in predicting up to 60% of ovarian cancer patients who might benefit from PARP-1 inhibitors. The assay identifies which cancer cells contain defective DNA repair that can be targeted by the PARP inhibitor. The drug being studied, Pfizer’s PF-01367338, blocks the spread of tumor cells with low RAD51 expression. The test has been used in the laboratory, but it is not yet perfected for routine clinical practice.

Sources: Drug Discovery Dev, November/December 2010;;

Radio Waves Destroy Kidney Nerves To Lower Blood Pressure

An experimental treatment, being developed by Ardian Inc. may offer a new way to reduce blood pressure (BP). In an endovascular procedure similar to angioplasty, a catheter is inserted into a blood vessel in the groin. Low-power radiofrequency energy is used to deactivate the sympathetic nerves surrounding the kidney, reducing hyper-activation of the sympathetic nervous system.

Although the technique was used for only six months, it is still considered beneficial because of the high risk of heart attacks, strokes, and death faced by patients with uncontrolled BP. Many patients need multiple drugs to treat hypertension. Blood glucose levels also improved, making it a potentially valuable therapy for diabetic patients.

In the six-month Simplicity HTN-2 study, 39% of 106 patients with treatment-resistant BP had been taking an average of five drugs. In the denervation group, systolic BP fell by an average of 33 points. By contrast, drugs for hypertension often result in a drop of less than 10 points. No blood clots or kidney damage resulted.

More study is needed to determine whether the effects are longer-lasting. The test is available in Europe. Testing in the U.S. is expected to begin in 2011.

Sources: The Lancet, online;; Ardian,, November 17, 2010


Marvin M. Goldenberg, PhD, RPh, MS

Name: INSTI HIV-1 Antibody Test Kit

Manufacturer: BioLytical Laboratories, Inc., Richmond, B.C.

Approval Date: November 29, 2010

Purpose: This rapid, manual, visually read in vitro immunoassay is used to detect antibodies to HIV-1 infection in human whole blood, fingerstick blood, or plasma specimens. The single-use assay is classified as moderate in complexity.

Description: The screening test is to be administered by trained personnel in medical facilities, laboratories, emergency departments, and physicians’ offices. The assay can provide results in less than 60 seconds. The kit contains membrane units, sample diluent, color developer, and clarifying solution.

A nitrocellulose filtration membrane is positioned on top of an absorbent material within a plastic cartridge (the membrane unit). The membrane is spotted with HIV-1 and HIV-2 recombinant proteins, which react with HIV antibodies in the specimen. The assay is validated for the detection of HIV-1 antibodies only.

A protein-A spot is capable of capturing human immunoglobulin G (IgG) antibodies, normally present in blood and blood components. These antibodies react with a chromatic agent in the color developer to produce a visual blue spot on the membrane. Because IgG antibodies are present in blood from normal or HIV-positive human specimens, the control spot provides a visual signal to indicate that the test has been performed correctly and that the appropriate type and volume of specimen have been added. If the control agent does not appear, the test is considered invalid.

Benefit: The test is very sensitive and specific for the detection of antibodies to HIV-1. Results are available in less than 60 seconds, and individuals can be counseled immediately.


Name: Axle Interspinous Fusion System

Manufacturer: X-spine Systems, Inc., Miamisburg, Ohio

Approval Date: December 1, 2010

Purpose: The Axle system provides spinal stability during lumbar fusion procedures for degenerative disk disease, spinal tumors, and trauma.

Description: Implants are tailored to each patient’s anatomy to achieve optimal function. The device rigidly attaches to the rearmost portion of adjacent vertebrae (the spinous process) of the lower or middle spine. The implant can be placed through a 1-inch incision in the back with minimal disruption of tissue.

Benefit: The device is located on the spinous process, away from the spinal cord, spinal nerves, and large blood vessels. This position offers the potential for fewer complications and less tissue disruption, compared with traditional spinal-fixation systems.



One-Channel and Two-Channel Infusers

The FDA and Hospira have issued a class I recall notification for Symbiq infusion pumps. The affected units had been distributed from December 23, 2006, to January 22, 2010.

The pumps were recalled because of motor encoder failures in the pumping mechanism, causing the infuser to stop operating. Delay or interruption of therapy may result in serious injury or death in critical-care patients, pediatric patients, and neonates.

Until Hospira upgrades its pumping mechanisms, repaired pumps will be lent at no cost to customers for critical-care areas.

Source: FDA, November 4, 2010

Cochlear Implant Device

Advanced Bionics is voluntarily recalling its HiRes 90K cochlear implant device and is retrieving all devices that have been distributed but have not been implanted. In two instances, a malfunction occurred, requiring removal of the implant. The recipients experienced severe pain, overly loud sounds, and shocking sensations eight to 10 days after the initial activation of the device.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of the product to the FDA’s MedWatch program.

The risk of any significant adverse medical events appears to be remote.

Source: FDA, November 27, 2010