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P T. 2012;37(3): 140, 144-148

New Drugs/Drug News/New Medical Devices March 2012

NEW DRUGS

Inlyta Tablets For Advanced Kidney Cancer

Axitinib (Inlyta, Pfizer) tablets have been approved for patients with advanced renal cell carcinoma who have not responded to previous therapy. Taken twice daily, axitinib blocks kinases, which affect tumor growth and progression.

In a study of 723 patients, median progression-free survival rates were 6.7 months with axitinib and 4.7 months with a standard treatment, sorafenib (Nexavar, Bayer/Onyx).

Adverse effects included diarrhea, hypertension, fatigue, decreased appetite, nausea, loss of voice, hand–foot syndrome, weight loss, vomiting, asthenia, bleeding, and constipation. Hypertension should be controlled before a patient takes axitinib.

Patients with untreated brain tumors or gastrointestinal bleeding should not take this medication.

Other agents used to treat kidney cancer include sorafenib, sunitinib (Sutent, Pfizer), temsirolimus (Torisel, Pfizer), everolimus (Afinitor, Novartis), bevacizumab (Avastin, Genentech), and pazopanib (Votrient, GlaxoSmithKline).

The Apothecary Shops Specialty Pharmacies, in an agreement with Pfizer, will be distributing axitinib.

Sources: FDA, January 27, 2012; www.drugstorenews.com, February 8, 2012

Erivedge Capsules For Basal Cell Carcinoma

The FDA has approved once-daily vismodegib capsules (Erivedge, Genentech/Roche) for adults with locally advanced basal cell cancer (BCC) who are not candidates for surgery or radiation. The drug inhibits the Hedgehog signaling pathway, which is thought to play a role in several cancers.

The drug was evaluated in a single study of 96 patients with locally advanced or metastatic BCC. Of those patients with metastatic disease who received the drug, 30% experienced a partial response and 43% of patients with locally advanced disease experienced a complete or partial response. Adverse effects included muscle spasms, hair loss, weight loss, nausea, diarrhea, fatigue, distortion or loss of taste, decreased appetite, constipation, and vomiting.

Vismodegib carries a boxed warning because of a potential risk of fetal death or severe birth defects.

The capsules cost $7,500 per month.

Vismodegib was approved ahead of its prescription user fee goal date of March 8, 2012.

Sources: FDA, January 30, 2012; The Wall Street Journal, January 31, 2012

Kalydeco Targets Defective Protein in Cystic Fibrosis

Ivacaftor (Kalydeco, Vertex), an orphan drug, is now approved to treat a rare form of cystic fibrosis (CF) in patients 6 years of age and older who have the G551D mutation in the CF transmembrane regulator (CFTR) gene.

CF is the most common fatal genetic disease in Caucasians, affecting approximately 30,000 patients in the U.S. About 4% of those with CF are believed to have the G551D mutation.

Ivacaftor was approved ahead of its prescription user fee goal date of April 18, 2012. In two studies that included a total of 213 patients, ivacaftor resulted in significant improvements in lung function.

This medication is effective only for patients with the G551D mutation; it is not beneficial in CF patients with two copies of the F508 mutation in the CFTR gene, the most common mutation that results in CF.

The tablets are taken twice daily with fat-containing food. Adverse effects may include upper respiratory tract infection, headache, stomach ache, rash, diarrhea, and dizziness.

Source: FDA, January 31, 2012

Zioptan Eyedrops For Elevated Ocular Pressure

The FDA has approved Merck’s once-daily tafluprost ophthalmic solution (Zioptan) to help reduce elevated eye pressure in patients with open-angle glaucoma, providing potentially sight-saving treatment. The drug is also approved for ocular hypertension, a risk factor for glaucoma.

Tafluprost eyedrops are administered in the evening. In studies lasting for up to 24 months, patients with open-angle glaucoma or ocular hypertension who received tafluprost in the evening showed reduced pressures at 3 and 6 months. Side effects may include eyelash growth; darkening of the iris, which may be permanent; and darkening of the eyelid, which may be reversible.

Source: FDA, February 14, 2012

NEW INDICATIONS

Korlym for Glucose Control In Cushing’s Syndrome

Mifepristone (Korlym, Corcept) has been approved as a once-daily oral therapy for patients with Cushing’s syndrome who have type-2 diabetes or glucose intolerance. The 300-mg tablets are indicated for patients who are not candidates for surgery or who have not responded to previous surgery.

Mifepristone is best known as RU-486, an abortifacient. Because only about 5,000 patients are believed to be eligible for treatment, mifepristone is considered an orphan drug for Cushing’s syndrome. Corcept will have 7 years of exclusive rights to market the agent for this indication.

Endogenous Cushing’s syndrome, a rare endocrine disorder, is caused by the overproduction of cortisol, which raises blood glucose levels. Korlym does not decrease cortisol production but reduces the effects of excess cortisol (e.g., hyperglycemia).

A boxed warning mentions that the therapy terminates pregnancy; therefore, Korlym is contraindicated in pregnant women. A Risk Evaluation and Mitigation Strategy (REMS) was considered to be unnecessary, but a patient medication guide is being distributed.

Previously known as Corlux, Korlym is the company’s maiden marketed product. It is expected to be available for sale by May 1.

Adverse effects have included nausea, fatigue, headache, arthralgia, vomiting, swelling of the extremities, dizziness, decreased appetite, adrenal insufficiency, low potassium levels, vaginal bleeding, and a potential for heart-conduction abnormalities.

Sources: FDA, February 17, 2012; http://newsfeedresearcher.com

Gleevec for Postsurgical GISTs

Imatinib mesylate (Gleevec, Novartis) has been approved for adults following the surgical removal of CD117-positive gastrointestinal stromal tumors (GISTs). This rare form of cancer originates in cells in the wall of the GI tract. More than half of GISTs start in the stomach.

The drug’s label is being updated to include data from a study in which survival was increased when imatinib was taken for 36 months instead of the standard 12 months. At 60 months, 92% of patients who had received 36 months of treatment were alive compared with 82% of patients who had received the drug for 12 months.

The FDA first approved imatinib in 2001 to treat patients with advanced Philadelphia chromosome–positive chronic myeloid leukemia and granted an accelerated approval for patients with advanced GISTs in 2002. In 2008, an accelerated approval was granted for the drug’s adjuvant use in patients who had undergone GIST surgery but remained at risk for recurrence. Regular approval for the metastatic GIST indication was also granted in 2008. By 2011, imatinib was approved to treat 10 cancers.

The tablets are taken with a meal and a glass of water. Adverse events have included edema, nausea, vomiting, muscle cramps, bone or muscle pain, diarrhea, rash, fatigue, and abdominal pain.

Source: FDA, January 31, 2012

NEW FORMULATIONS

Once-Weekly Bydureon For Type-2 Diabetes

Extended-release exenatide (Bydureon, Amylin/Alkermes) has been approved for adults with type-2 diabetes. This injectable glucagon-like peptide-1 (GLP-1) receptor agonist is indicated as an adjunct to diet and exercise to improve glycemic control.

Bydureon, a long-acting form of Byetta (Amylin/Eli Lilly), is injected twice daily. Each dose contains biodegradable microspheres that provide a controlled release of exenatide throughout the week.

In the DURATION-5 trial, after 24 weeks, once-weekly Bydureon reduced glycosylated hemoglobin (HbA1c) levels by 1.6% from baseline, compared with a reduction of 0.9% with Byetta. Bydureon patients lost an average of 5.1 pounds, and Byetta patients lost an average of 3.0 pounds. Nausea was reported less often with Bydureon (in 14% of patients), compared with Byetta (in 35% of patients).

Bydureon was approved with a Risk Evaluation and Mitigation Strategy (REMS) because of the potential risk of acute pancreatitis and medullary thyroid carcinoma.

Originally, Amylin and Eli Lilly developed Bydureon, and Alkermes PLC developed the extended-release technology. After two delays in seeking FDA approval, Amylin and Lilly ended their partnership. Bydureon will compete with Novo Nordisk’s once-daily liraglutide (Victoza), which was approved in 2010.

Bydureon is discussed in the Pharmaceutical Approval Update column on page 137.

Sources: Amylin/Alkermes, www.bydureon.com, January 27, 2012; First Word, www.firstwordplus.com, January 29, 2012

A Subcutaneous Route For Velcade

Millennium, a subsidiary of Takeda, has announced the FDA’s approval of a supplemental New Drug Application (sNDA) for bortezomib (Velcade) to include subcutaneous (SQ) administration. The approval covers all current indications (multiple myeloma and mantle-cell lymphoma) after at least one prior therapy.

Previously, the intravenous (IV) route was the only approved method of administration for bortezomib. In a Takeda-sponsored phase 3 trial, 38% of patients who received the study drug subcutaneously experienced peripheral neuropathy, compared with 53% who received the drug by IV injection. The SQ route also lessened the severity of adverse effects.

SQ administration is considered more convenient for patients with poor vein access and for those with pre-existing peripheral neuropathy. Medical assistants, who may not give IV injections, are allowed to administer drugs under the skin.

Velcade was co-developed by Millennium and Janssen and was approved as an IV injection to treat multiple myeloma in 2003.

Sources: Bloomberg News, January 23, 2012; Multiple Myeloma Beacon; www.masshightech.com, January 24, 2012

DRUG NEWS

Lo/Ovral Oral Contraceptives Recalled

Fourteen lots of Lo/Ovral-28 and 14 lots of Norgestrel and Ethinyl Estradiol tablets (generic) have been recalled because of a packaging error. Some blister packs were found to contain an inexact count of inert or active ingredients, and in some packages, the tablets were out of sequence, possibly leaving women without adequate contraception. The cause of these errors was identified and corrected immediately.

The packaging defects did not pose an immediate health risk, but women were advised to begin using a nonhormonal contraceptive. The tablets, made and packaged by Pfizer Inc., were sold under the Akrimax Pharmaceuticals, LLC, brand.

Source: FDA, January 31, 2012; United Press International, February 1, 2012

More Counterfeit Drugs Are Entering the U.S

A fake version of the cancer drug bevacizumab (Avastin, Roche/Genentech) has been discovered to be circulating in the U.S. Fake versions of sildenafil (Viagra, Pfizer), atorvastatin (Lipitor, Pfizer), and orlistat (Alli, GlaxoSmithKline) have also been found.

The fake bevacizumab product says “Roche” on the packaging, and the writing on the box is in French rather than English. Roche distributes bevacizumab outside the U.S., but all legitimate bevacizumab packages intended for patients in the U.S. say Genentech. The phony vials did not contain the key ingredient and were sold to at least 19 doctors and clinics, mostly in the west and Midwest.

Most counterfeit activity previously took place in developing countries with lax regulations, such as in Asia and Latin America, where as many as 30% of drugs sold are fake, according to the World Health Organization. Only 1% of drugs dispensed in the U.S. and other developed nations are not legitimate.

More than 80% of the active ingredients used in U.S. products are now made overseas. A combination of large profits and low penalties has made drug counterfeiting an increasingly attractive business for criminals in the U.S. and abroad. The prison sentence for drug counterfeiting in the U.S. is 3 years; the sentence for counterfeiting money is 15 years.

Sources: Reuters and Associated Press, February 15, 2012

FDA Takes Steps to Relieve Severe Drug Shortages

On February 21, the FDA announced steps to increase the supply of critically needed cancer drugs and to build on President Obama’s executive order to help prevent future drug shortages. Methotrexate, which is used to treat cancer, psoriasis, rheumatoid arthritis, and polyarticular juvenile rheumatoid arthritis, was discovered to be in short supply in February.

The methotrexate shortage began in December 2011, however. The main cause was attributed to manufacturing deficiencies, leading to production shutdowns. Shortages of other drugs have also resulted when companies halted production of drugs with low profit margins.

In response to the critical shortage of doxorubicin liposome injection (Doxil, Janssen) and rapidly declining supplies of methotrexate, the FDA took steps to increase the available supply for patients in the U.S. Lipo-Dox (Sun Pharma) will be temporarily imported from India as a substitute for Doxil, which is used to treat ovarian cancer, AIDS-related Kaposi’s sarcoma, and multiple myeloma.

On February 22, APP Pharmaceuticals was granted approval for methotrexate to be made without preservatives; the preservative-free formulation is a key therapy for acute lymphoblastic leukemia in children. (APP has been making the product with a preservative.) Supplies should be available in March.

Hospira has expedited the release of additional supplies, resulting in 31,000 vials of new product. The FDA is also working with other manufacturers of methotrexate, including Mylan and Sandoz.

Shortages of daunorubicin, metoclopramide injection, phentolamine, prochlorperazine, telavancin, and diazepam injection have also been reported. Vecuronium is being recommended as a substitute for pancuronium, and etomidate has now been restored to normal quantities. In 2011, 267 new drug shortages were reported; most remain unresolved. At least 15 deaths have been attributed to the shortages since 2010.

Sources: FDA, February 21, 2012; American Society of Health System Pharmacists, February 14, 2012; Formulary and Drug Bulletin, February 2012; www.news-medical.net, February 22, 2012

Metformin, First-Line Therapy For Type-2 Diabetes

The American College of Physicians (ACP) recommends that generic metformin be used as the first-line medication to treat type-2 diabetes when diet, exercise, and weight loss do not improve blood glucose levels. Metformin is considered more effective than other similar drugs for type-2 diabetes when used alone and with other drugs; it reduces body weight, is associated with fewer adverse effects, and improves cholesterol profiles.

The ACP also recommends that a second medication be added to metformin if glycemic goals are not achieved with lifestyle modifications and metformin monotherapy. The new guideline was based on a review of literature published from 1966 to April 2010.

Source: American College of Physicians, February 7, 2012

Pneumonia Guidelines Online

New guidelines on the management of community-acquired pneumonia (CAP) in infants and children are now accessible online. Issued by the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America, the guidelines are also being developed in mobile device and pocket card formats for use at the point of care. The primary focus is on the prevention of bacterial pneumonia.

Source: Clin Infect Dis, August 30, 2011 (online), http://cid.oxfordjournals.org/content/early/2011/08/30/cid.cir531.full

Heart Concerns and Aclidinium

The long-acting anticholinergic drug aclidinium bromide (Forest/Almirall S.A.) appears to be effective in treating chronic obstructive pulmonary disease (COPD), but concerns remain about the potential for heart problems linked to medications in the same drug class.

The medication, which is inhaled at a dosage of 400 mcg twice daily, is intended for the long-term treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema. Forest is seeking the FDA’s approval.

Sources: Reuters, Med Page Today, Dow Jones, February 21, 2012

Byetta Promotes Weight Loss In Nondiabetic People

An incretin mimetic used to treat diabetes may also be an effective weight loss drug for people without diabetes, according to data from Beth Israel Deaconess Medical Center in Boston. In a study of obese women, those receiving exenatide (Byetta, Amylin/Lilly), a glucagon-like peptide (GLP)-1, lost an average of 2.5 kg.

The 35-week crossover study included two 16-week treatment periods, separated by a 3-week washout period. Excluded from the study were women with type-1 or type-2 diabetes (although 24% of participants were prediabetic at enrollment); women who had uncontrolled hypertension or dyslipidemia; those who had been treated with an antiobesity medication within 1 year; those with a history of bariatric surgery; and those who had previously used exenatide. The women’s weight had been stable within 6 months of their screening visit and, as a whole, cardiovascular risk factors were well controlled.

Participants injected 5 mcg of either exenatide or placebo before breakfast and supper. After 2 weeks, they increased the dosage to 10 mcg twice daily. The women were weighed at study visits every 2 weeks, and glycemic status was measured at the beginning and end of each treatment period.

Four months of exenatide treatment resulted in weight loss: 2.49 kg (a 2.7% decrease in body weight), compared with 0.43 kg gained during placebo treatment. Weight loss was significant after 2 weeks of exenatide, and the difference persisted throughout the treatment period. Exenatide was associated with a small, but statistically significant, decrease in body mass index (BMI); waist circumference decreased by 1.68 cm.

Eleven women lost as much as 12.5% of body weight; 14 women lost 0.4% to 4.8% of body weight; and 12 women either did not lose weight or gained weight. Of seven high responders who received exenatide first, five regained weight when they were switched to placebo.

Interestingly, exenatide was not associated with significant changes in blood pressure, lipid profiles, or insulin and adiponectin levels; however, leptin levels dropped significantly among high responders. With obesity considered to be a state of leptin resistance, exenatide may produce weight loss by increasing leptin sensitivity. There was a trend toward lower 2-hour glucose values with exenatide, but there was wide variability.

More than 50% of the women reported one or more episodes of nausea with exenatide treatment, compared with 21% receiving placebo. Nausea scores were highest at week 4, then declined over the rest of the treatment period until the scores did not differ significantly between exenatide and placebo at week 16.

This is the first study to report on stratified weight loss in response to exenatide treatment in obese, nondiabetic persons.

Source: Diabetes Care 2012;35:4–11 (January)

Giving Antiplatelet Drugs At the Right Time

Antiplatelet agents can affect survival in older patients, depending on whether they are prescribed before or after hospitalization for a stroke. In a retrospective study from Italy, researchers found that antiplatelet drugs conferred no advantages against short-term mortality rates when patients took them before hospitalization. In fact, there was a trend toward higher stroke severity and higher mortality rates. When the drugs were given after hospitalization for a stroke, mortality rates were reduced.

The researchers looked at data from 439 patients older than 65 years of age who had experienced a major acute ischemic stroke. Of these patients, 115 had taken antiplatelet agents before hospital admission and 195 patients received the drugs after hospitalization.

Of the study sample, 28% died within 30 days. Previous use of antiplatelet agents was not associated with lower mortality rates, although antiplatelet therapy in the hospital was generally associated with reduced mortality rates in the short term.

After adjusting for age, sex, blood glucose levels, congestive heart failure, and previous stroke, the researchers found that the reduced risk of short-term mortality remained, but it was significant only in patients who had not previously received antiplatelet agents.

Source: Arch Gerontol Geriatr 2012; 54:214–217

Tool to Measure Anticoagulant Risks In Atrial Fibrillation

CHADS2 is a simple measure for predicting the risk of stroke in patients with atrial fibrillation (AF) who are not receiving anticoagulants, but its usefulness in patients who take these drugs has been unclear. Researchers from the Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial conducted a subgroup analysis of data from 18,112 patients and now say that CHADS2 scores could help those patients too.

The CHADS2 score assigns 1 point each for Congestive heart failure, Hypertension, Age 75 or older, and Diabetes, and 2 points (S) for a history of stroke or transient ischemic attack. International guidelines recommend warfarin (e.g., Coumadin or Jantoven) for patients with a CHADS2 score of 2 or higher. U.S. guidelines suggest either warfarin or aspirin for patients with a score of 1 because of a concern that the bleeding risk may outweigh the benefits of treatment.

In this analysis, patients with all levels of CHADS2 scores were eligible for enrollment: 5,775 patients had scores of 0 to 1; 6,455 had a score of 2; and 5,882 had scores of 3 or higher. The study compared two blinded doses of dabigatran (Pradaxa, Boehringer Ingelheim) (110 mg and 150 mg twice daily) with open-label warfarin. The primary outcome was stroke or systemic embolism. Secondary outcomes included major bleeding, intracranial hemorrhage, vascular death, and death.

In the overall cohort, the rate of stroke or systemic embolism increased for each 1-point increase in CHADS2 scores. A score of 6 (5.40% per year) carried five times the risk of a score of 0 (0.53% per year). By comparison, in a previous study of patients with AF who were not receiving oral anticoagulants, the increase was 1.5-fold per point.

There was an almost linear increase in the annual rate of major bleeding for each 1-point increase in CHADS2 scores: from 1.60% per year in the group with the lowest scores to 5.40% per year in the group with the highest scores. Higher CHADS2 scores were also associated with a greater risk of major bleeding, intracranial bleeding, and death. A strong relationship between these higher risks and vascular and total mortality in all three treatment groups was noted.

Increasing CHADS2 scores were also linked to increased rates of adverse events in all three groups. However, dabigatran (150 mg twice daily) showed a consistent reduction in stroke or systemic embolism compared with warfarin, and both doses of dabigatran lowered the rates of intracranial bleeding when compared with warfarin.

Source: Ann Intern Med 2011;155: 660–667

DEVICE NEWS

Reducing Unnecessary Prostate Biopsies With Progensa Assay

DiagnoCure, Inc., has announced the FDA’s approval of Gen-Probe’s Progensa PCA3 (Prostate Cancer Antigen 3) assay. The PCA3 gene is overexpressed in prostate cancer.

The urine-based assay is used with other patient information to help physicians decide whether to order a repeated biopsy in men 50 years of age or older who have had one or more previous negative results. A negative Progensa PCA3 assay finding is associated with a decreased likelihood of a positive biopsy.

The test is now approved in the U.S., Canada, and Europe. DiagnoCure granted Gen-Probe exclusive worldwide diagnostic rights to the PCA3 gene in November 2003.

The assay should not be used if atypical small acinar proliferation was present on the most recent biopsy specimen.

Source: Gen-Probe, February 15, 2012, www.gen-probe.com

NEW MEDICAL DEVICES

Marvin M. Goldenberg, PhD, RPh, MS

Name: mySentry Glucose Monitoring System

Manufacturer: Medtronic, Inc.

Approval Date: January 4, 2012

Purpose: The mySentry remote glucose monitor enables parents or caregivers to monitor blood glucose levels in a diabetic child from another room.

Description: mySentry provides information about the insulin pump’s battery life and the amount of insulin remaining. Placed conveniently at the bedside of the parent or caregiver, the system consists of a monitor with a color screen, a power supply, and an outpost that transmits information from the child’s MiniMed system to the monitor. The outpost enables the operator to keep watch from up to 50 feet away or more. The monitor costs about $3,000.

Benefit: Approximately 75% of all episodes of severe hypoglycemia in children occur at night. Advances in continuous glucose monitoring have provided an added level of protection from dangerous nighttime hypoglycemia that can occur in a sleeping person. Caregivers can hear alerts and alarms from their bedside.

Easy-to-use buttons and a touch-sensitive display are supplied for navigating through various settings and status screens. The monitor can be adjusted for brightness or dimness for nighttime monitoring. A built-in night light is also included. A privacy screen can be turned on to hide the results from broader view.

Sources: www.medtronicdiabetes.net; www.firecemedicaldevices.com

Name: Progel Extended Applicator Spray Tip

Manufacturer: Neomend, Inc., Irvine, Calif.

Approval Date: January 9, 2012

Purpose: The spray tip is used with Neomend’s Progel Pleural Air Leak Sealant, which is used to seal air leaks from the lungs during surgery.

Description: The applicator spray tip delivers the only FDA-approved pleural air leak sealant in the U.S. Progel (hydrogel) sealant is delivered after the surgeon applies sutures or staples to close visible air leaks incurred in the pleura during open resection of lung parenchyma.

Benefit: Progel sealant has been found to reduce postoperative air leaks, length of hospital stay, costs, and associated complications. The malleable spray tip makes it convenient for thoracic surgeons to reach difficult-to-access areas. By bending the device’s flexible tip, the surgeon can direct Progel in a stream or spray pattern to the targeted surface.

Sources: www.neomend.com; www.pmpmews.com

Name: Pico Negative Pressure Wound Therapy System

Manufacturer: Smith and Nephew

Approval Date: January 9, 2012

Purpose: Negative pressure wound therapy is a therapeutic technique in which a vacuum dressing is used to promote healing of wounds and first-degree and second-degree burns.

Description: The pocket-sized, single-use system is indicated for patients recovering from high-risk orthopedic, plastic, and general surgery. The device is used to treat wounds, partial-thickness burns, diabetic or pressure ulcers, flaps and grafts, and closed surgical incisions.

Benefit: Each year, 28 million surgical incisions are performed in the U.S.; 10% to 15% of these incisions are considered to carry a high risk. The system’s one-button pump is easy for patients to use, and its small size and silent operation provide an unobtrusive way to carry on with daily activities. The disposable device works with a dressing technology that manages fluids, eliminating the need for bulky canisters. The system is as easy to apply as a conventional wound dressing. Staff time, training, and paperwork associated with traditional negative pressure wound therapy are reduced.

Patients can wear the device on a wound for up to 7 days, depending on the level of exudates. A gentle silicone wound contact layer helps minimize pain at a dressing change. The 7-day period allows patients with postoperative wounds and skin grafts to be sent home more rapidly. With the simple pump, on–off design and the absence of a canister or reservoir for fluid, patients can manage their wound therapy at home. Negative pressure wound therapy is regarded as a way to produce fewer complications when it is used correctly.

Sources: www.global.smith-nephew.com; www.pmpnews.com; The Miami Herald, February 7, 2012

Device Recall

A Class 1 recall of the Respironics Trilogy 100 ventilators was announced after a manufacturing defect was discovered. The ventilator is indicated for continuous or intermittent breathing support for patients of all ages. There was a possibility that part of the blower that circulates air and other gases through the ventilator could move out of position and fail to deliver therapy to the patient.

Source: FDA, January 12, 2012