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P T. 2011;36(4): 187-190, 192-194

New Drugs/Drug News/New Medical Devices April 2011


Benlysta, a Long-Awaited Lupus Therapy

Belimumab (Benlysta, Human Genome Sciences/GlaxoSmithKline) has been approved to treat patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal antiinflammatory drugs (NSAIDs).

This is the first new drug approved for lupus since 1955, when the malarial agent hydroxychloroquine (Plaquenil, Sanofi-Synthelabo) and corticosteroids (prednisone) were approved for lupus. In 1948, aspirin was approved for this indication.

Delivered as a once-monthly intravenous (IV) infusion, this monoclonal antibody is designed to target B-lymphocyte stimulator protein, which may reduce the number of abnormal B cells thought to be a problem in lupus.

The joints, skin, kidneys, lungs, heart, and brain are primarily affected. Symptoms include joint pain or swelling, light sensitivity, fever, chest pain, hair loss, and fatigue.

Belimumab should not be given with live vaccines. A medication guide will be provided to inform patients of the risks.

Sources: FDA, March 9, 2011; Medscape Medical News, March 10, 2011

Edarbi for Hypertension

The FDA has approved azilsartan medoxomil tablets (Edarbi, Takeda) to treat high blood pressure in adults. In clinical studies, azilsartan was more effective in lowering 24-hour blood pressures than valsartan (Diovan, Novartis) and olmesartan medoxomil (Benicar, Daiichi Sankyo). A boxed warning mentions that the drug should be avoided in pregnant women because of potential injury to the fetus.

Azilsartan will be sold as 80-mg and 40-mg doses; the recommended dose is 80 mg once daily. For further information, please see the Pharmaceutical Approval Update column on page 229.

Source: FDA, February 25, 2011

Daliresp for Lung Disease

Roflumilast tablets (Daliresp, Forest) have been approved to decrease the frequency of exacerbations or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD) accompanied by cough and excess mucus linked to bronchitis. Roflumilast is not intended to treat another form of COPD that involves primary emphysema.

The FDA’s approval was based on two phase 3 studies enrolling more than 1,500 patients 40 years of age and older. A medication guide mentions the risks of changes in mood, thinking, or behavior, as well as unexplained weight loss.

Roflumilast is not recommended for people younger than 18 years of age.

Source: FDA, March 1, 2011

Generic Taxotere for Cancer

Hospira has won approval for the first U.S. generic version of Taxotere (docetaxel, Sanofi-Aventis), which is used to treat breast, prostate, and lung cancers.

Unlike original product formulations that require a two-step process prior to infusion, Hospira’s docetaxel comes in a single-vial formulation that reduces the number of steps needed in preparation.

Hospira will provide 20-mg, 80-mg and 160-mg vials of docetaxel at the original 10-mg/mL concentration. The company already sells docetaxel in Europe and Australia.

Sources: Biospace, Reuters, March 9, 2011

Lomitapide, an Orphan Drug, For Lipid Disorders

Orphan drug status has been granted to Aegerion’s lomitapide (AEGR 733), a once-daily therapy for severe hyperlipidemia. In Europe, the drug is used to treat homozygous familial chylomicronemia, a rare genetic disorder that leads to extremely high levels of triglycerides. Lomitapide is currently being evaluated in a pivotal phase 3 clinical trial.

Source: Associated Press, March 15, 2011

Yervoy for Advanced Melanoma

The FDA has approved ipilimumab (Yervoy, Bristol-Myers Squibb) as an initial therapy for patients with widespread melanoma. Yervoy is expected to cost $30,000 per dose, or $120,000 for a four-dose course of treatment.

Although the drug is linked to severe adverse effects (colon inflammation, diarrhea, skin rashes, and even death), the lack of options for advanced-stage melanoma patients prompted the approval.

Dacarbazine and interleukin-2 are usually used to treat metastatic melanoma, but neither agent has been proven to extend survival.

Source: Bloomberg, March 25, 2011


Water-Dispersible Zidovudine Tablets

Matrix Laboratories, a subsidiary of Mylan, has announced that the FDA, under the President’s Emergency Plan for AIDS Relief (PEPFAR), has approved water-dispersible zidovudine tablets, a generic version of Retrovir (Glaxo-SmithKline). The new formulation allows for easy administration to adults or children who are unable to swallow tablets or capsules.

The tablets will be sold in a 100-mg dosage strength. Zidovudine is indicated for the treatment of HIV infection and for the prevention of maternal–fetal HIV transmission.

Source: Monthly Prescribing Reference,, March 11, 2011

Acetadote Injection For Acetaminophen Overdose

Acetylcysteine injection (Acetadote) is now available without ethylene diamine tetra-acetic acid (EDTA) or other stabilization or chelating agents. The medication is given intravenously within eight to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen. The new formulation was approved in January and replaces the previously marketed product.

Source: Cumberland Pharmaceuticals, March 23, 2011


Use Pradaxa Tablets in 30 Days

Patients who use the anticoagulant dabigatran etexilate (Pradaxa, Boehringer Ingelheim) as loose capsules in a bottle should discard unused capsules 30 days after opening the bottle. Unlike most drugs, which are stable for at least one year, dabigatran capsules deteriorate quickly when exposed to humidity.

The product is sold in 60-count, unit-of-use bottles and blister packages. A supply of 60 capsules (one 75-mg capsule twice daily) lasts for 30 days. Patients might open more than one bottle at a time if they have refilled the prescription, and they might not correctly differentiate the new and old containers. The bottles lack a tamper-evident seal; therefore, patients cannot rely on a seal as evidence that a bottle has not been opened.

Patients should not open a new bottle until the current one is empty. Pharmacists should mention the expiration warning to patients and should advise patients to write the date on their bottle when they first open the container. Pharmacists should not open the bottles, because this can shorten the life of the capsules. Pharmacies could provide unit-dose blister packaging to prevent exposure to air.

Sources: American Society of Health-System Pharmacists, January 2011; Heart-wire, February 4, 2011; The Philadelphia Inquirer, February 28, 2011

Unapproved Drugs Removed From Market

The FDA has taken action against companies that manufacture, distribute, or market prescription oral cough, cold, and allergy products that cannot be legally marketed in the U.S. These unapproved agents have not been evaluated by the FDA for safety, effectiveness, or quality and pose health risks.

Health care providers may have unknowingly prescribed the drugs because the labels do not disclose that they lack FDA approval.

This is the 17th action on a drug class as part of the FDA’s Unapproved Drugs Initiative, which began in June 2006.

Source: FDA, March 3, 2011


Jantoven and Other Upsher-Smith Products

Upsher-Smith Laboratories is voluntarily extending its previously announced recall of warfarin sodium (Jantoven) 3-mg tablets to include additional products that were packaged on the same packaging line between May 17 and November 17, 2010. The original recall was initiated as a precaution after a retail pharmacy discovered that a single bottle, labeled as Jantoven warfarin sodium (USP) 3-mg tablets, contained tablets at a higher 10-mg strength. The recall now includes these tablet strengths: amantadine 100 mg; amlodipine 5 mg; androxy 10 mg; baclofen 10 mg; bethanechol 5, 10, and 25 mg; Jantoven 1, 2, 2.5, 3, 4, 5, 6, 7.5, and 10 mg; and oxybutynin 5 mg.

Sources:; Monthly Prescribing Reference,, February 22, 2011

Embeda for Pain

On March 16, just weeks after Pfizer completed its purchase of King Pharmaceuticals/Alpharma for $3.6 billion, the company recalled 100,000 bottles of Embeda, an opioid for moderate-to-severe pain. Embeda contains pellets of morphine that surround naltrexone, which blocks opiate effects if the product is crushed or chewed, thereby deterring misuse or abuse. The drug was recalled in the U.S. because of a defect found in the extended-release product. The naltrexone component degraded to unacceptable degrees in samples that were tested. The problem is unlikely to pose a safety risk, and patients can continue taking the drug as prescribed.

Embeda, approved in 2009, was recalled three times in 2010 because of problems relating to how it dissolves. The drug carries a boxed warning indicating an increased risk of dependence and withdrawal symptoms.

Sources:; Drug Watch, Reuters, March 16, 2011

Label Changes

Kaletra and Problems in Infants

Serious heart, kidney, and breathing problems have been reported in premature infants receiving Abbott’s lopinavir/ritonavir oral solution (Kaletra), which contains alcohol and propylene glycol. Premature babies may be at an increased risk for health problems because they have a decreased ability to eliminate propylene glycol. The label is being revised to include a new warning.

Kaletra is used with other antiretroviral drugs to treat HIV-1 infection in adults and premature and full-term pediatric patients 14 days of age or older.

Sources: FDA,, March 8, 2011

Topamax and Birth Defects

Topiramate (Topamax, Ortho-McNeil) and its generic versions may increase the risk of cleft lip and cleft palate in infants born to women who use the medication during the first trimester of pregnancy. Topiramate is approved to prevent and treat seizures and to prevent migraine headaches; however, it is not indicated for relieving migraine pain.

A stronger warning will be added to the label, and there will be a change from Pregnancy Category C to Pregnancy Category D. The medication guide and the prescribing information for the brand and generic forms will also be updated.

Source: FDA. March 4, 2011

PPIs May Lower Magnesium Levels

Proton pump inhibitors (PPIs), widely used for treating ulcers and acid reflux, will carry a new warning that their long-term use may reduce magnesium levels. Hypomagnesemia can lead to muscle spasms, arrhythmias, and seizures.

Most cases of low magnesium levels occurred after one year of PPI use, but some patients were affected as early as three months. In an FDA review, magnesium supplements did not help in 25% of cases and patients had to stop taking the PPI. The average period of use for the prescription PPI is about six months.

The FDA said that the risk of hypomagnesemia was small with lower-dose, nonprescription PPIs taken for a short time (a few weeks up to three times a year). The FDA is advising physicians to consider obtaining serum magnesium levels before prescribing long-term PPI treatment. Warnings regarding the risk of hypomagnesemia will be included in all labels for prescription PPIs.

Sources: FDA, Reuters, March 2, 2011; Medical News Today, March 4, 2011

Boxed Warning Modified for Letairis

Monthly liver enzyme tests are no longer required for patients taking ambrisentan tablets (Letairis, Gilead), which are used to treat pulmonary arterial hypertension (PAH). The FDA said that the drug poses only a low risk of liver injury. Information related to the potential for serious liver injury and to the need to monitor for serious injury is being removed from the drug’s boxed warning.

Ambrisentan slows the worsening of symptoms and improves the ability to exercise. Approved in 2007, the drug blocks endothelin, which narrows blood vessels and prevents normal blood flow in patients with PAH.

Letairis was approved with a Risk Minimization Action Plan (RiskMAP) to manage liver damage and fetal malformation. The RiskMAP called for liver enzyme testing before treatment and monthly during treatment for all patients. Monthly pregnancy testing was also required for women of childbearing age because ambrisentan had caused birth defects in animals. In 2009, the Letairis RiskMAP was converted to a Risk Evaluation and Mitigation Strategy (REMS).

The boxed warning concerning the risk of serious birth defects and the contra indication for use during pregnancy will remain. The drug will continue to be available only through the Letairis Education and Access Program (LEAP).

Source: FDA, March 4, 2011

Drug Misuse Keeps Emergency Rooms Busy

In 2007, almost 700,000 Americans were taken to the hospital after ingesting both legal and illegal drugs. The cost of emergency department (ED) visits alone was nearly $1.4 billion.

In a study based on information from the 2007 Nationwide Emergency Department Sample (a government database), children younger than six years of age had a higher rate of ED visits for accidental drug poisoning than any other age group. Most of the visits were pre-cautionary, and the children had not ingested toxic levels of medication.

The rate in rural areas was three times that of other areas. Many emergencies have involved prescription drugs, especially antidepressants and opioids. Drug-related poisoning deaths are second only to motor vehicle crashes among the leading causes of death from injury.

Sources: Am J Emerg Med (online) and The New York Times, March 3, 2011; American College of Emergency Physicians, March 16, 2011

Heart Patients Are Missing Out On Lipid-Lowering Therapy

From 2005 to 2009, only about one-third of patients hospitalized with acute coronary syndrome (ACS) were discharged on intensive lipid-lowering therapy, according to a multicenter study. Even among patients whose admission levels of low-density lipoprotein-cholesterol (LDL-C) required at least a 50% reduction to achieve an optional goal of below 70 mg/dL, only half of these individuals were discharged with a prescription for lowering LDL-C.

These findings suggest a need for better implementation of guidelines for statin therapy. There is an early clinical benefit for statins that persists with long-term follow-up in various patient groups.

The researchers analyzed data from 65,396 patients with ACS in 344 hospitals participating in the American Heart Association’s Get With the Guidelines program. At discharge, 25,036 patients (38%) were receiving therapy for lowering LDL-C levels and 40,360 (62%) were receiving less intensive therapy. Patients receiving intensive LDL-C therapy were younger males who had higher LDL-C levels upon hospital admission. One-third of these patients were receiving statin monotherapy, 8% received a statin plus ezetimibe (e.g., Vytorin, Merck/Schering). When the researchers confined their analysis to the 76 hospitals that collected data regarding the dose, the findings were similar: 39% of 28,724 patients were receiving intensive therapy.

What had been a slight but general rise in the rate of intensive therapy usage at discharge became a marked decline in 2008 and 2009, mainly because of the significant drop in the use of a statin plus ezetimibe, from 11.4% in 2007 to 3.4% in 2009. When the combination treatment was excluded, the use of intensive therapy at hospital discharge was 28% in 2005 and 33% in 2009, without a significant change between 2007 and 2009.

Statins, which help lower LDL-C levels, may also reduce the extent of myocardial ischemia and remodeling and promote plaque stabilization and endothelial function. Early, intensive statin therapy for ACS is associated with reduced inpatient mortality and morbidity, improved long-term survival, and fewer recurrent coronary events. However, the current guidelines do not specify a dose of statin for ACS; they specify only an optional target of below 70 mg/dL in high-risk patients. Moreover, many clinicians may believe that titration to intensive lipid-lowering therapy can occur after patient discharge, which may explain the treatment gap.

Source: Am Heart J 2011;161(2):418–424.e1–e3

Artesunate May Be Better Than Quinine for Malaria

Quinine should no longer be the drug of choice for treating severe malaria, according to a Cochrane review. Derived from herbs used in Chinese medicine, artesunate has been found to decrease deaths from the disease.

Severe malaria is associated with cerebral malaria, a rare condition that affects the brain and can lead to long-term disability. More than one million people die each year from severe malaria, the majority in sub-Saharan Africa.

In 2006, the World Health Organization (WHO) recommended artesunate as the preferred treatment for adults with severe malaria, but there was insufficient evidence at the time to recommend a change from the standard treatment of quinine in children. The Cochrane researchers updated the review of artesunate by adding a new trial of African children to the existing eight trials. Compared with quinine, artesunate reduced the risk of death by 39% in adults and by 24% in children.

IV artesunate is now being recommended as the treatment of choice for adults and children with severe malaria throughout the world. Although the drug resulted in more neurological problems in children, compared with quinine, these events usually resolved within one month and were outweighed by the increase in survival rates.

Sources: Cochrane Database Syst Rev, Issue 3, March 16, 2011; Lancet 2010; 366(9753):1621–1622

Breast Cancer Drugs May Be Linked to Urogenital Disorders

Urogenital symptoms appear to be much more common than previously estimated in breast cancer patients, say researchers from Sweden. They found that more than 50% of women who were treated with an aromatase inhibitor, such as letrozole (Femara, Novartis), had at least one moderate-to-severe symptom of vaginal atrophy, as did one-third of women taking tamoxifen (Nolvadex, AstraZeneca). These numbers were higher than those previously published.

Because no comparative studies had been done, it wasn’t known whether urogenital symptoms would be more common in women with breast cancer than in healthy women. The researchers believe that theirs is the first study to compare urogenital symptoms and vaginal atrophy in controls and in breast cancer patients receiving adjuvant endocrine therapy.

Vaginal atrophy was assessed in 97 breast cancer patients and in 105 women without breast cancer. The women also answered questionnaires about atrophy-related signs and symptoms and urinary incontinence. Of 33 women receiving an aromatase inhibitor, 19 (58%) reported at least one symptom of vaginal atrophy, as did 11 of 34 tamoxifen users (32%). By contrast, only one woman out of 55 who were not taking estrogen treatment and 11 women out of 49 who were taking estrogen had any signs or symptoms.

Vaginal dryness and pain were more common in patients receiving aromatase inhibitors than in either controls or tamoxifen users. The only symptom of vaginal atrophy that was more common among tamoxifen users was moderate-to-severe vaginal discharge. Patients receiving aromatase inhibitors also had higher vaginal pH than all the other groups and had a higher grade of atrophy than women taking tamoxifen or estrogen.

Both drug-treated groups reported hot flashes, cold sweats, and night sweats, more often compared with the control groups. There was no difference in the frequency or intensity of incontinence symptoms among the groups. Between 49% and 73% of women in all groups reported frequent urination, urgency incontinence, and stress incontinence.

In previous studies, 2% to 26% of women had symptoms of vaginal atrophy. Similarly, studies have reported that 15% to 25% of women receiving aromatase inhibitors have dyspareunia; in this study, that number was 65%. One reason the numbers were higher is that women might be more inclined to reveal symptoms to a gynecologist than to an oncologist. In this study, experienced gynecologists performed all examinations.

As more patients can now be expected to live longer with the disease and receive adjuvant endocrine therapy after primary therapy, treating the adverse effects becomes a concern.

Source: Am J Obstet Gynecol 2011; 204(1):26.e1–26.e7

Financial Help With Xeomin

Merz Pharmaceuticals is providing financial assistance to patients taking incobotulinumtoxinA (Xeomin), which is indicated for adults with cervical dystonia or blepharospasm.

A copayment program covers out-of-pocket costs for the drug, guidance therapy, and administrative fees. For eligible patients with financial hardship who lack third-party drug coverage, the Xeomin Patient Assistance Program provides the medication at no cost.

Patients usually need treatment every three to four months. Wholesale costs to the physician are approximately $1,100 per treatment. Application forms are available at 1-888-4-xeomin (1–888-493–6646) or through health care providers.

Source:, March 11, 2011

Patients Are Not Using Asthma Inhalers Correctly

Many patients with asthma or emphysema appear to be taking inhaled medications incorrectly. When researchers asked 100 adults who were hospitalized for asthma or emphysema to demonstrate how they used their inhalers at home, patients misused the metered-dose inhalers nearly 90% of the time and the Diskus inhaler 70% of the time.

Both types of devices deliver medication directly to the airways. Diskus inhalers are used to keep symptoms under control; metered-dose inhalers can be used as controller or rescue medications during severe episodes.

Patients using metered-dose inhalers must breathe in slowly, and patients using the Diskus must inhale sharply. Ideally, patients should bring the device to their doctor appointments and show how they use it at home. It was noted that patients were not breathing out fully before placing the inhaler in the mouth.

Nearly all patients with poor vision used the Diskus inhaler incorrectly. Vision problems might make it more difficult to read the instructions, which are typically written in very small print.

Sources: J Gen Intern Med, Reuters, February 9, 2011

Strokes Are Affecting Younger Patients

Younger and middle-aged Americans are having more strokes, but the rate in people 45 years of age and older is dropping.

In a study by the Centers for Disease Control and Prevention (CDC), researchers used records from hospitals in 41 states to compare hospitalizations for ischemic stroke in the mid-1990s with those in the mid-2000s. From 1994 to 2007, strokes rose by 51% among males 15 to 34 years of age, by 7% in females 15 to 34 years of age, by 47% in men 35 to 44 years of age, and by 36% in females 35 to 44 years of age.

Among children five to 14 years of age, stroke rates increased by 31% among boys and by 36% among girls. Among people 45 to 64 years of age, strokes declined by 12% and 13% in men and women, respectively. In people 65 years of age and older, the incidence dropped by 25% in men and by 28% in women.

Despite these decreases, strokes still affect older people more often. The fact that the number of strokes is rising among young and middle-aged Americans suggests that the obesity epidemic is starting to shift the age burden of the disease. A greater awareness of stroke symptoms and newer imaging methods to confirm the diagnosis could also account for some of that change.

Doctors think that better prevention and treatment of hypertension might have contributed to the decline in older people. Stroke is now said to be the fourth leading cause of death in the U.S., instead of the third. More strokes are occurring in younger people with risk factors such as smoking, obesity, hypertension, alcohol overuse, and diabetes.

Sources: WebMD, Associated Press, February 9, 2011


Test for Outbreaks Of Salmonella Foodborne Illness

FDA scientists successfully used a new genome-sequencing test to retrospectively examine a foodborne illness outbreak that occurred in 2009 to 2010 to help trace the source of the infection. A Salmonella montevideo outbreak that began early in 2010 and sickened nearly 300 people in 44 states was linked to spice rubs on certain salamis.

Field investigators collected samples of the product in question to find the source of contamination. However, conventional laboratory testing methods could not distinguish between the outbreak involving spiced meat and certain previous Salmonella events. The FDA team then turned to next-generation sequencing to test 35 samples thought to be contaminated with the Salmonella strain. The samples came from suppliers, consumers who became ill, and various food sources. The results showed a recent common origin of the outbreak strain to be a single food facility and indicated a single source—a spiced meat rub. The findings suggest an important role for this novel tool as an adjunct in future studies.

Source: FDA, February 24, 2011

Test for Outbreaks Of Norovirus Infection

The first test for the preliminary identification of Norovirus is now approved. The Ridascreen Norovirus 3rd Generation EIA assay (R-Biopharm AG, Germany) is indicated when several people have contracted gastroenteritis at the same time and there is a clear avenue for virus transmission, such as a shared location or food.

Norovirus infection is a leading cause of foodborne disease outbreaks in the U.S. It usually occurs in settings of close group contact, such as cruise ships, hospitals, long-term care facilities, schools, and child-care centers. The virus spreads rapidly by direct person-to-person contact, by contaminated food or water, and by touching contaminated surfaces.

The assay is not sensitive enough for use when only one person has symptoms. The FDA approved the test under an accelerated review process.

Source: FDA, February 24, 2011

Test for Hepatitis C

OraSure Technologies has received federal approval for its OraQuick HCV Rapid Antibody test. This test can detect hepatitis C virus (HCV) with a finger-stick blood sample in 20 minutes. In June 2010, the FDA had approved the product with the use of a whole-blood sample.

Source: The Morning Call, February 8, 2011

Total Knee Replacement

ConforMIS has received approval for its iTotal CR Knee Replacement System. The device builds on the company’s iFit technology to generate custom-tailored implants and individualized jigs. Computer modeling is used to build a three-dimensional image of a patient’s knee from computed tomography scans. Each replacement is made to fit the patient precisely, and more bone is preserved compared with traditional replacements. Patients have described the device as feeling close to natural.

Source: Business Wire, February 3, 2011; ConforMIS, February 7, 2011

Implant for Epilepsy

The Aspire High-Capacity Generator has been approved for use as vagus nerve stimulation therapy in patients with epilepsy. This fifth-generation device provides a long battery life and simplified features for programming. The company has applied for the CE Mark. To date, more than 60,000 patients worldwide have received the implant.

Source: Cyberonics, February 1, 2011,

Four Assays for Drugs of Abuse

OraSure Technologies and Roche have announced the approval of four homogeneous, automated oral assays to be used as part of OraSure’s Intercept oral fluid drug test. The test can detect traces of commonly abused drugs such as phencyclidine (PCP), cocaine, opiates, amphetamines (including methamphetamine and Ecstasy), barbiturates, methadone, and benzodiazepines.

Oral fluid drug testing is less intrusive than urine testing. The test is easily administered, and the likelihood of adulterants that can be used to tamper with these assays is reduced.

Sources: Bloomberg News, March 3, 2011; Yahoo Business News, OraSure,

Epicyn Gel for Dermatoses

Epicyn HydroGel is classified as a medical device to treat burning, itching, and pain associated with atopic dermatitis, radiation dermatitis, and first-degree and second-degree burns. The gel must be administered under the supervision of a health care professional.

Available by prescription only, the device is based on a Microcyn oxychlorine compound made by Oculus Innovative Sciences. As a shelf-stable hypochlorous acid formulation, the gel maintains a moist wound and skin environment to help treat dry, waxy skin.

Sources: Oculus, February 8, 2011;

Dermatology Times,, February 16, 2011

ELANA Bypass Surgery Kit

With the Excimer Laser Assisted Non-occlusive Anastomosis (ELANA) Kit, neurosurgeons can create a bypass without shutting off the blood flow. The ELANA surgical kit allows blood flow to be rerouted around an aneurysm or a brain tumor in patients at high risk of stroke during standard bypass surgery. During standard bypass surgery in the brain, the artery must be clipped in order to stop blood flow. However, temporarily shutting off the blood flow raises the risk of stroke in patients 13 years of age and older who have a cerebral aneurysm or a tumor at the base of the skull that could affect blood flow in brain arteries.

The FDA approved the kit as a Humanitarian Use Device to treat or diagnose a disease or condition in fewer than 4,000 people in the U.S. each year.

Patients with arteriosclerosis or with calcification at the surgery site should not undergo laser bypass surgery with this device.

Source: FDA, March 10, 2011

A Safe Pacemaker for MRI

The Medtronic Revo MRI SureScan Pacing System is the first heart pacemaker that can be used safely for patients needing magnetic resonance imaging (MRI). Many patients with pacemakers are advised not to undergo MRI because the machine’s powerful magnetic and radiofrequency fields can disrupt the pacemaker’s setting or cause wires to overheat, resulting in unintended heart stimulation, electrical failure of the pacemaker, or tissue damage.

The FDA is requiring training for cardiologists and radiologists who use the system. In a clinical trial, a group of patients with the implant did not experience MRI-related complications. The results confirmed earlier data from animal studies and other research.

Source: FDA, February 8, 2011

Gadavist MRI Contrast Agent

The FDA has approved gadobutrol (Gadavist, Bayer), a gadolinium-based contrast agent, for use in MRI of the central nervous system (CNS). Contrast-enhanced imaging assists in detecting lesions and abnormalities in the blood supply of the CNS. Gadobutrol is more concentrated than other similar agents and should be given at half the volume.

All gadolinium contrast agents carry a boxed warning about the risk of nephrogenic systemic fibrosis, a rare but serious condition associated in some patients with kidney dysfunction. Gadobutrol is considered to carry a low risk in renally impaired patients and is therefore not contraindicated in this population.

Source: FDA, March 15, 2011


Marvin M. Goldenberg, PhD, RPh, MS

Name: Deployable Oxygen Concentrator Systems

Manufacturer: Pacific Consolidated Industries, Riverside, Calif.

Approval Date: February 7, 2011

Purpose: USP grade oxygen (at 93% ± 3% purity) is needed in disasters when bottled or bulk oxygen is not available; in hospital backup systems; in emergencies when the primary oxygen supply is unusable; in high-pressure oxygen cylinders in remote locations; or for ambulatory patients. Trained military personnel may also use this oxygen during peacetime and wartime.

Description: Based on existing technology used in its militar y medical oxygen generators, the company has developed a commercial line of on-site generators. To produce oxygen, these systems use a vacuum swing adsorption process. Outputs range from 66 to 500 L/minute (280 pounds/day to 1 ton/day). The FDA considers equipment that can simultaneously fill cylinders and provide oxygen directly to the hospital to be a class II device, and the agency’s marketing approval is therefore required.

Benefit: Hospitals are becoming more aware of the need to upgrade their disaster-preparedness programs so that equipment can continue to operate independently for 72 hours. The deployable systems are lightweight and compact and can be installed in hours, not days. Operating costs are low, and delivery of oxygen is reliable.


Name: Selenia Dimensions System

Manufacturer: Hologic, Inc., Bedford, Mass.

Approval Date: February 11, 2011

Purpose: This is the first x-ray mammography device to provide three-dimensional (3-D) images of the breast in cancer screening and diagnosis.

Description: As an upgrade to Hologic’s existing two-dimensional (2-D) system, the device provides 2-D and 3-D x-ray images, revealing the inner architecture of the breast, free from the distortion typically caused by tissue shadowing or density. A 3-D tomosynthesis image, in combination with a 2-D image, takes only seconds longer than a conventional 2-D digital mammogram. The 3-D scan produces a stack of thin, high-resolution image slices that provide a clear rendition of structures in the breast and their spatial relationship with the surrounding breast tissue. The images are displayed on a standard diagnostic workstation for review by the radiologist.

Benefit: In two studies, radiologists who received training viewed both 2-D and 3-D images and obtained a 7% improvement in their ability to distinguish between cancerous and non-cancerous cases, compared with viewing 2-D images alone. Although the 2-D and 3-D images combined almost doubled the radiation dose, accuracy of detection was improved. The radiation risk is still uncertain, but the increase in cancer risk from both examinations is expected to be less than 1.5%, compared with the natural cancer incidence, and less than 1%, compared with the risk from conventional 2-D mammography.


Class 1 Recall

On January 14, 2011, Medtronic sent health care providers an Urgent: Medical Device Correction letter that described a problem with its SynchroMed II Programmable Pump and the SynchroMed EL Infusion System. In the letter, the company reminded health care professionals to check the needle placement within the pump septum during the drug-refill procedure. The needle must be inserted through the refill septum until it has reached the needle stop in the pump reservoir. At ever y refill, patients and caregivers should be reminded about the signs and symptoms of a drug overdose, underdose, and withdrawal.

Affected products include Synchro-Med II (Model 8637); SynchroMed EL (Models 8626 and 8627); and Refill Kits (Models No: 8551, 8555, 8561, 8562, 8564, 8565, and 8566).

The unintended injection of drugs or fluids into the patient’s subcutaneous tissue at the pump pocket site, instead of the pump, can lead to serious injury or death resulting from a drug overdose or an underdose. The pump manuals and refill kit manual include warnings related to the potential for improper injection. Medtronic is updating the labeling for the pumps and associated refill kits.

Source: FDA, February 16, 2011