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Bioniche Pharma has received the FDA’s approval for its Abbreviated New Drug Application (ANDA) for fludarabine phosphate injection USP, 25 mg/mL. The product is packaged in 50-mg/2-mL, single-dose vials. Fludarabine is a chemotherapy agent for treating B-cell chronic lymphocytic leukemia (CLL).
The product is bioequivalent and therapeutically equivalent to Teva Parenteral’s Fludarabine Phosphate Injection USP, 25 mg/mL. Fludarabine is also sold as Fludara (Berlex).
Bioniche Pharma is a subsidiary of Mylan Institutional.
Source: Mylan, October 4, 2010, www.mylan.com
Dabigatran etexilate mesylate capsules (Pradaxa, Boehringer Ingelheim) have been approved to prevent stroke and blood clots in patients with atrial fibrillation (AF), the most common type of arrhythmia. Patients with AF are at a higher risk of developing blood clots, which can cause a disabling stroke if the clots travel to the brain.
Dabigatran, an anticoagulant, inhibits thrombin, an enzyme in the blood that is involved in clotting. In a clinical trial, patients taking dabigatran had fewer strokes than those who took warfarin (Coumadin, Bristol-Myers Squibb). Dabigatran is the first approved anti-clotting agent since the approval of warfarin more than 50 years ago. Unlike warfarin, which requires that patients have periodic blood tests, such monitoring is not necessary with dabigatran.
As with other approved anti-clotting drugs, life-threatening and fatal bleeding was among the most common adverse reactions reported by patients receiving dabigatran. Dyspepsia, stomach pain, nausea, heartburn, and bloating also were reported.
Dabigatran was approved with a medication guide for patients to highlight the risk of serious bleeding. The drug was originally approved in Europe in 2008 for patients undergoing hip and knee replacement surgery.
The capsules will be sold in strengths of 75 mg and 150 mg.
A drug already used to treat alcohol dependence is now approved to treat patients with an addiction to heroin, morphine, and other opioids, as well as pain medications such as oxycodone (Oxy-Contin, Purdue Pharma) and hydrocodone/acetaminophen (Vicodin, Abbott).
A long-acting version of naltrexone, Vivitrol (Alkermes/Cephalon) was approved in 2006 to treat alcohol dependence. The drug is now also indicated to treat and prevent relapse after patients have undergone detoxification. It is the first non-narcotic, non-addictive, extended-release medication approved for the treatment of opioid dependence. Given by injection once monthly, Vivitrol blocks the brain’s opioid receptors, leaving patients unable to get high if they attempt to use opioids. In a six-month study, patients receiving Vivitrol were more likely to stay in treatment (36%), compared with 23% in the placebo group.
Vivitrol is administered by a doctor as an intramuscular injection via special needles. Patients must not have any opioids in their system when they start taking Vivitrol because of the risk of withdrawal symptoms.
Adverse effects may include nausea, tiredness, headache, dizziness, vomiting, decreased appetite, painful joints, and muscle cramps, injection-site reactions, liver damage, pneumonia, depressed mood, suicidal thoughts or behavior, rashes, hives, and facial swelling.
Source: WebMD News, October 14, 2010
The FDA has approved Beyaz tablets (Bayer), an estrogen/progestin combined oral contraceptive (OC) that also contains 0.451 mg of levomefolate calcium. Beyaz is based on Yaz, another FDA-approved OC, also made by Bayer.
A water-soluble B vitamin, levomefolate calcium is a metabolite of folic acid. A known association of low folate levels and neural tube defects, such as spina bifida, has resulted in recommendations that women of childbearing age supplement their diet with folate.
Women older than 35 years of age who smoke should not use Beyaz because cigarette smoking further increases the risk of serious cardiovascular events. Adverse events are expected to be the same as those for Yaz.
Beyaz is discussed in detail in the Pharmaceutical Approval Update column on page 640 in this issue of P&T.
Source: FDA, September 30, 2010
The FDA has asked companies to stop making and selling unapproved oral colchicine products. The drug is commonly used to prevent gout and treat gout flare-ups and familial Mediterranean fever.
The companies were expected to stop manufacturing single-ingredient oral colchicine by mid-November and were ordered to stop shipping the product in interstate commerce by the end of the year.
Many single-ingredient oral colchicine products have been used for decades, but these agents and others have not received the mandatory current FDA approval required of all prescription drugs.
Colcrys (Mutual/AR Scientific/URL Pharma) is the only FDA-approved, single-ingredient oral colchicine product available in the U.S. The prescribing information for Colcrys includes important safety data that are not available with unapproved products.
This action is part of the FDA’s initiative against the marketing of unapproved drugs. Unapproved versions of colchicine are not the same as generic drugs, which must meet the same standards as the corresponding innovator drugs. The FDA previously took action against unapproved colchicine products in February 2008.
Abbott Laboratories has agreed to withdraw its weight-loss drug sibutramine (Meridia) from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke.
The FDA approved the drug in November 1997 for weight loss and for maintenance of weight loss in obese patients as well as in some overweight people with other risks for heart disease. The approval was based on data showing that more people receiving sibutramine lost at least 5% of their body weight than people receiving a placebo who relied on diet and exercise alone.
The FDA reviewed data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). The trial demonstrated a 16% increase in the risk of serious heart events, including nonfatal heart attack, nonfatal stroke, the need for resuscitation if the heart stopped, and death in patients who received sibutramine when compared with those given placebo. The difference in weight loss between the groups was small.
Although patients in the European SCOUT trial did not have the same characteristics as patients for the approved indication in the U.S., the results raised questions about the drug’s safety for all patient groups. The FDA is advising physicians to stop prescribing Meridia, and patients are advised to stop taking it.
Source: FDA, October 8, 2010
The FDA has asked manufacturers to add new warnings to the labeling of gonadotropin-releasing hormone (GnRH) agonists, a class of drugs used primarily to treat men with prostate cancer.
The warnings are intended to alert patients and health care professionals about the potential risk of heart disease and diabetes in men using these agents.
In May, the FDA said that a preliminary and ongoing analysis found that patients receiving GnRH agonists were at a small increased risk for diabetes, heart attack, stroke, and sudden death. The new labels will include updates in the warnings and precautions section about these potential risks.
GnRH agonists suppress the production of testosterone, a hormone involved in the growth of prostate cancer. Suppressing testosterone has been found to shrink or slow the growth of prostate cancer. Examples of GnRH agonists include Eligard, Lupron, Synarel, Trelstar, Vantas, Viadur, and Zoladex. Several generic products are also available.
Source: FDA, October 20, 2010
The FDA has issued a warning about the possible risk of atypical femoral fractures in patients taking bisphosphonates to prevent and treat osteoporosis. A labeling change and a patient medication guide will reflect this risk.
The warnings apply only to oral bisphosphonates approved for osteoporosis, including alendronate (Fosamax, Fosamax Plus D, Merck), risedronate (Actonel, Actonel/Calcium, Atelvia (a delayed-release version of Actonel, Warner Chilcott), and ibandronate (Boniva, Roche), as well as injectables such as zoledronic acid (Reclast, Novartis) and Boniva. The changes do not affect etidronate (Didronel, Norwich/Procter & Gamble), zoledronic acid injection (Zometa, Novartis), tiludronate (Skelid, Sanofi-Aventis), or their generic versions, which are used for Paget’s disease, cancer, and hypercalcemia.
It is not clear whether bisphosphonates are causing the fractures, but the FDA recommends that patients who have been taking these agents for longer than five years be periodically re-evaluated to determine the need for continued therapy. Patients should not stop using these drugs unless they are advised to do so, and they should report any new thigh or groin pain to their physician and be evaluated for a possible femur fracture.
Sources: FDA and The Wall Street Journal, October 13, 2010
New safety information is being added to the label for the HIV antiviral drug saquinavir (Invirase, Genentech/Roche), to describe potentially life-threatening adverse effects on the heart when used with Abbott’s ritonavir (Norvir), another HIV antiviral medication.
In February 2010, the FDA warned patients and health care professionals that when used together, the two drugs could prolong the QT and PR intervals. Prolongation of the QT interval may lead to torsades de pointes, an arrhythmia that can progress to ventricular fibrillation or heart block. The FDA is also requiring a medication guide for patients who use saquinavir.
This drug was first approved in 1995.
Source: FDA, October 21, 2010
The FDA has issued a final rule that clarifies which safety data must be reported during clinical trials of investigational drugs and biologics. The changes should expedite the agency’s review of critical safety information and protect people who are enrolled in clinical trials.
Certain safety information must be reported to the FDA within 15 days after the investigators become aware of findings indicating risks to enrollees, more adverse reactions than expected, and adverse events relating to bioavailability and bioequivalence.
The rule provides examples of evidence suggesting that an investigational product may be the cause of a safety problem. Currently, drug sponsors often report all serious adverse events even if there is little reason to believe that the product caused the event. Such reporting delays the FDA’s ability to detect a safety signal. The examples address when a single event should be reported or when it is alright to wait for more than one occurrence. The FDA also issued guidelines explaining the new requirements to industry and investigators.
Source: FDA, September 28, 2010
Statin drugs, which are indicated for lowering cholesterol and reducing the risk of heart disease, may also decrease the risk of colon cancer by as much as 12%. In a new study, it was noted that the longer people took the drugs, the lower the risk of colon cancer. The findings were presented at a meeting of the American College of Gastroenterology.
In a meta-analysis of 22 studies with more than 2.5 million volunteers, patients who took statins had a 12% overall lower risk of having colon cancer compared with those who did not take the drugs. In other studies, the long-term use of statins has also been associated with reduced rates of breast, prostate, lung, pancreas and liver cancers.
Products showing the greatest effect included atorvastatin (Lipitor, Pfizer), fluvastatin (Lescol, Novartis), lovastatin (e.g., Mevacor, Merck), pitavastatin (Livalo, Kowa), and simvastatin (Zocor, Merck). The research so far suggests that these drugs may help control tumor development and growth.
However, statins have also been associated with liver dysfunction, kidney failure, muscle weakness, and cataracts.
Source: Reuters, October 18, 2010
An experimental vaccine that had been intended to prevent genital herpes disease in women has proved ineffective after it was tested in the Herpevac Trial for Women. The phase 3 trial, sponsored by GlaxoSmithKline and the National Institutes of Health (NIH), began in 2002. A total of 8,323 women, 18 to 30 years of age, were enrolled at 50 sites in the U.S. and Canada. Participants were free of herpes simplex viruses HSV-1 and -2.
Patients were randomly divided into two groups: one group received the candidate vaccine, containing HSV protein, along with an adjuvant intended to boost immune responses; the control group received a version of Havrix (GlaxoSmithKline), a licensed vaccine against hepatitis A. The study was designed to give all subjects the opportunity to be protected against either genital herpes or hepatitis A.
All volunteers were vaccinated at the start of the study and again one and six months later. They were observed for 20 months after the initial injection and were evaluated at each visit.
Two earlier studies involved men and women who did not have genital herpes but whose sexual partners were infected. In these studies (which later formed the basis of the larger Herpevac study for women only), the candidate vaccine prevented genital herpes in more than 70% of the females who were free of HSV-1 and HSV-2, but it had no clear effect in men. In the Herpevac study, however, the investigational vaccine was ineffective in protecting against genital herpes even though it was safe and well tolerated.
It is not known why the experimental vaccine was ineffective. Study participants are being notified as to which vaccine they received, and subjects who received the candidate herpes vaccine are being offered Havrix.
Source: NIH, September 30, 2010
Patients who received injections of exenatide (Byetta, Amylin/Eli Lilly) to treat diabetes for one year had markedly reduced total fat mass, including visceral fat, compared with those who used insulin glargine (Lantus, Sanofi-Aventis). Lean body mass was not significantly altered, according to researchers from Amsterdam, Sweden, and Finland. Circulating cardiac biomarkers such as high-sensitive C-reactive protein (hs-CRP) also improved.
Research had shown that exenatide improved glycemic control to the same extent as insulin glargine; however, exenatide reduced body weight and insulin glargine raised it. In that study, 69 participants taking metformin (Glucophage, Bristol-Myers Squibb) received exenatide or insulin glargine. At one year, the exenatide resulted in these reductions: body weight (−6%), waist circumference (−5%), total body fat mass (−11%), and trunk fat mass (−13%). Total adiponectin levels rose by 12%, and hs-CRP levels declined by 61%. The use of insulin glargine resulted in lower endothelin-1 levels, whereas exenatide did not.
The changes in biomarkers were interesting, appearing to be independent of changes in body fat mass. Although animal studies have found similar beneficial effects of exenatide on visceral fat mass and circulating adiponectin, leptin, and hs-CRP, the investigators say that to their knowledge, no controlled clinical studies have been conducted on the long-term effects of glucagon-like peptide (GLP-1) receptor agonists on body composition and biomarkers of cardiac risk.
Source: Diabetes Care 2010;33:1734–1737
Omeprazole (Prilosec, AstraZeneca) is commonly used to prevent upper gastrointestinal (GI) bleeding in patients with stress-related mucosal disease, even though little is known about the incidence, cause, or outcomes of such bleeding in patients who are not seen in the intensive-care unit. For this reason, there is no consensus about the treatment. In fact, in a retrospective study reported from Portugal, no advantage to omeprazole prophylaxis was observed.
Researchers evaluated the incidence of upper GI bleeding thought to have been associated with stress-related mucosal disease in 535 patients admitted to an internal medicine ward. Of those patients, 140 received 40 mg of omeprazole intravenously, 193 received 20 mg orally, and 202 were given no prophylactic treatment. There was only one episode of clinically relevant bleeding in a patient from the no-prophylaxis group.
Mean age of the patients was 70 years, and mean length of hospitalization was 9.6 days. Most of the patients had comorbidities and were taking more than one drug, including nonsteroidal anti-inflammatory agents (NSAIDs), anti-platelet or anticoagulant drugs, or steroids, all of which carry a higher risk of stress-related mucosal disease bleeding. However, even if a risk did exist, the short time of admission probably lowered the likelihood of relevant bleeding.
Source: Eur J Intern Med 2010;21:386–388
Although antipsychotic agents have been linked to a risk of venous thromboembolism (VTE), studies have been either small or restricted to certain populations (e.g., nursing-home residents), or they have not involved the newer atypical (second-generation) drugs. In a large nested case–control study of 115,000 primary care patients conducted in the United Kingdom, the risk of VTE increased dramatically in some patients.
Researchers identified 25,532 patients with VTE; 15,975 of these had deep vein thrombosis (DVT) and 9,557 had a pulmonary embolism (PE). Those patients were matched with 89,491 controls.
Patients who had been taking anti-psychotic drugs in the previous 24 months had a 32% greater risk of VTE than non-users, despite adjustments for potential risk factors. The risk doubled for patients who had started a new drug in the previous three months. The risk was greater in patients who took atypical antipsychotics rather than conventional drugs and for those taking low-potency rather than high-potency agents.
Patients with dementia were at higher risk for VTE than those with schizophrenia or bipolar disorder. Patients with a higher risk of VTE were also more likely to have the usual risk factors for VTE, although for many conditions the difference was small. However, cancer more than tripled the risk, and recent surgery or fractures multiplied the risk by 13.
Patients with VTE were also more likely to have a high body mass index (BMI) and were slightly more likely to live in an area of socioeconomic deprivation. Case patients were more likely to be using drugs that increase the risk of VTE, such as oral contraceptives.
If other studies replicate the findings, the researchers advise prescribing anti-psychotic drugs more cautiously for nausea and agitation, especially among patients at high risk of VTE. They also suggest new algorithms designed to estimate a patient’s absolute risk of VTE that takes account of factors such as age, sex, socioeconomic status, smoking, comorbidities, and concurrent drugs.
Source: BMJ 2010;341:c4245
A multicomponent, low-intensity intervention to improve adherence to blood pressure (BP) medications was effective: patients stuck to their regimen and their readings improved—but the intervention did not appear to reduce cardiovascular (CV) events over the long term.
A multicenter study involved 79 physicians and 875 patients. For the intervention group, physicians counted patients’ tablets, designated a family member to support adherence, and provided educational information to patients. Two-thirds of the patients were observed for at least three years.
Patients receiving the intervention were more adherent and took their correct dose on more days, compared with the control patients (92% vs. 89%). At six months, the intervention patients had significantly lower mean systolic BP (148.9 vs. 151.1 mm Hg for controls) and diastolic BP (81.9 vs. 83 mm Hg). They were also less likely to have an uncontrolled systolic BP (140 mm Hg or higher).
After five years, 153 patients had at least one CV event: 67 patients, or 16% in the intervention group and 86 (19%) of controls. Although the BP intervention patients experienced fewer CV events, the difference was not significant.
The fact that adherence was close to 90% in both groups could suggest a Hawthorne effect, the researchers say, but they concluded that the differences were both clinically and statistically significant.
Source: Circulation 2010;122:1183–1191
A new oral formulation of tranexamic acid (Lysteda, Xanodyne), approved in 2009, may offer women with heavy menstrual periods relief with fewer gastrointestinal (GI) adverse effects (AEs) than the older immediate-release (IR) form. A competitive plasminogen inhibitor, tranexamic acid has been used outside the U.S. for several decades to treat menorrhagia.
The drug is well tolerated, despite GI effects. The new formulation provides a higher per-tablet dose and increased absorption to reduce the rate of drug delivered to the gastric mucosa, thus maintaining efficacy while minimizing AEs.
A multicenter, randomized phase 3 trial was conducted to evaluate effectiveness. Women with a mean blood loss of 80 mL or more per cycle received tranexamic acid 3.9 g/day or placebo for up to five days per menstrual cycle for six cycles. Blood loss was significantly reduced (by 40.4%, or 69.6 mL) in 115 women who received tranexamic acid, compared with 72 women who received placebo (a reduction of 8.2%, or 12.6 mL).
The decrease in blood loss from baseline with tranexamic acid was reported after the first treatment cycle and was maintained in each measured treatment cycle. Tranexamic acid led to decreased menstrual bleeding regardless of the presence of leiomyomas or baseline menstrual blood loss. Blood loss declined to less than 80 mL in 43% of menstrual cycles in the treated group, compared with 17% of cycles in the placebo patients. Women in the treatment group also reported better quality of life, with higher scores for being able to engage in work as well as social, leisure, and physical activities. Most adverse events were mild to moderate, and the incidence of GI adverse events was comparable with that of placebo.
Eye examinations were included in the safety evaluation because focal areas of retinal degeneration had been observed in animal studies of intravenous (IV) tranexamic acid; visual abnormalities had also been noted in postmarketing surveys. In this study, one woman receiving tranexamic acid missed a blue-yellow color vision plate, and another patient reported a nonspecific visual disturbance; these conditions were not considered clinically significant.
Source: Obstet Gynecol 2010;116:865–875
Compared with placebo and other drugs, the long-term use of finasteride (Proscar, Merck) improves urinary tract symptoms associated with benign prostatic hyperplasia (BPH) and reduces disease progression. This conclusion was reached from the combined findings of 23 randomized clinical trials that evaluated almost 21,000 men.
Finasteride is often given to men with lower urinary tract symptoms (e.g., nocturia, incomplete emptying, hesitancy, weak stream, and frequent or urgent urination). Symptoms are often caused by prostatic smooth-muscle contractions and by BPH.
The size of the prostate gland is influenced by hormones, such as dihydro-testosterone (DHT). Finasteride is a 5-alpha reductase inhibitor that reduces prostate size and blocks the body’s ability to make DHT.
Finasteride was even more effective in lowering symptom scores when it was used with doxazosin (Cardura, Pfizer), an alpha blocker used to treat hypertension. Finasteride seemed to be more effective in men with a large prostate gland who used the drugs for at least one year, compared with men who had a small prostate.
Drug-related adverse effects were uncommon in men using finasteride. Compared with placebo, however, finasteride may slightly raise the risk of impotence, erectile dysfunction, decreased libido, and ejaculation disorder.
Source: Cochrane Database Syst Rev 2010(10), Art. No. CD006015.
There is no evidence that increasing the dose of inhaled corticosteroids (ICs) at the onset of an asthma exacerbation, as part of a patient-initiated action plan, reduces the need for rescue oral corticosteroids, according to a study published in The Cochrane Library.
Patients with asthma experience bronchoconstriction (which is treated by inhaling bronchodilator drugs) and an underlying inflammation (which is often treated with daily ICs). In theory, increased inflammation could be treated with higher doses of ICs, but patients do not always respond sufficiently and may need to use rescue oral corticosteroids.
Although many doctors recommend that patients minimize flare-ups by doubling their usual dose of ICs at the first sign of an asthma attack, this strategy has not been shown to be effective. In five studies involving 28 children and 1,222 adults who had mild-to-moderate asthma, the daily dose of ICs was, on average, 500 mg/day and was increased to either 1,000 mg or 2,000 mg/day. There was no indication that the high doses reduced the need for rescue oral corticosteroids, and the evidence was insufficient to determine whether this approach was safe.
More pediatric studies are needed to guide therapy for exacerbations. The best approach might be to prevent an exacerbation by ensuring the regular use of ICs.
Source: Cochrane Database Syst Rev 2010(10), Art. No. CD007524.
Tiotropium bromide inhaled powder (Spiriva HandiHaler, Pfizer/Boehringer Ingelheim), which is used to treat chronic obstructive pulmonary disease (COPD), has been successful in adults whose asthma had not been well controlled with low doses of inhaled corticosteroids (ICs).
Sponsored by the National Institutes of Health (NIH), this is the first study to explore adding an anticholinergic inhaler to low-dose ICs. Adding tiotropium was more effective at controlling asthma than doubling ICs alone and was as effective as adding the long-acting beta agonist (LABA) salmeterol (Serevent Diskus, GlaxoSmithKline). The results were presented in September at the Annual Congress of the European Respiratory Society in Spain.
Increasing ICs or supplementing them with LABAs is a preferred therapy for adults whose asthma is poorly controlled with low doses of ICs. However, higher IC doses do not improve symptoms for all patients, and they can result in adverse effects. LABAs have come under scrutiny because they can exacerbate asthma symptoms. Tiotropium relaxes smooth muscle in the airways through a different mechanism than LABAs.
The study compared three therapies: doubling the IC dose, supplementing a low dose of ICs with a LABA (salmeterol), and supplementing a low dose of ICs with a long-acting anticholinergic (tiotropium). Anticholinergic drugs block a part of the autonomic nervous system that can cause airway muscle contractions. Patients received each treatment for 14 weeks with two-week breaks in between, for a total of 48 weeks.
Tiotropium improved daily lung function as well as the number of days in which patients did not need albuterol rescue inhalers. When the trial began, the average number of such asthma control days was 77 per year (extrapolated from the treatment period). Doubling the ICs gave patients another 19 symptom-free days on average, and adding tiotropium to low-dose ICs gave them another 48 symptom-free days.
Sources: N Engl J Med and NIH, September 19, 2010
Name: MicroThermX Microwave Ablation System (MTX-180)
Manufacturer: BSD Medical, Salt Lake City, Utah
Approval Date: August 18, 2010
Purpose: Synchronous phased-array technology is used to deliver microwave energy to ablate soft tissue in surgical oncology procedures.
Description: This compact, mobile system includes a microwave generator, single-patient-use disposable antennas, and a thermistor-based temperature-monitoring system. A single generator can deliver high power levels. The deliver y of microwave energy is accomplished with an interactive, touch-screen monitor that allows the operator to control treatment quickly.
Benefit: Large, uniform zones of ablation can be provided during a single procedure. Microwave energy has advantages over radiofrequency energy in delivering ablation, such as faster set-up and shorter ablation times as well as high intratumoral temperatures. For these reasons, microwave technology is being regarded as the future of soft-tissue ablation. The MTX-180 is minimally invasive and can be used in open surgery as well as in percutaneous ablation. The device is designed for both surgeons and interventional radiologists.
Name: Titan Modular Total Shoulder System
Manufacturer: Ascension Orthopedics, Inc., Austin, Texas
Approval Date: September 2, 2010
Purpose: This bone-preserving device provides an option for patients needing total or hemi-shoulder arthroplasty. All primary and fracture bodies can be used with either press-fit or cemented stems. Several surgical solutions are provided for shoulder arthroplasty with one implant system.
Description: Twenty-six options are available for sizing the humeral head to obtain the correct anatomic fit. Glenoid options are also included for patients needing total shoulder replacement.
Benefit: The system’s modularity enables the surgeon to select distal stems and proximal bodies that best match the patient’s anatomy and bone quality.
Name: FASTx Sternal Intraosseous Device
Manufacturer: Pyng Medical Corp., Richmond, British Columbia, Canada
Approval Date: September 6, 2010
Purpose: This infusion system can be used on the battlefield, in hospitals, and in other emergencies. It enhances the ease of use of its FAST1 Intraosseous Infusion System. FASTx is an alternative to conventional IV infusion for shock and trauma patients.
Description: The device establishes an intraosseous access route in patients 12 years of age and older who require vascular administration of medications or fluids to facilitate resuscitation. Drinker et al. first introduced this technique in 1922 as a way to access non-collapsible venous plexuses through the bone marrow cavity to systemic circulation. The method was abandoned with the development of IV catheters until the 1980s, when intraosseous access was re-introduced, particularly for rapid fluid infusion during resuscitation.
Benefit: As with the previously FDA-approved FAST1 device, FASTx provides a rapid, reliable, and safe alternative to conventional IV infusion systems. The re-engineered system features an infusion tube that is easy to remove, and its light, compact form is designed for single-handed use. This next-generation device can be deployed for use in ambulances, aboard helicopters, and on stretchers. Vascular access is achieved within 10 seconds, and fluids and drugs can reach the heart in 30 seconds.