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Англоязычные новости FDA

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Здесь буду выкладывать новости Американского управления по контролю качества пищевых продуктов и лекарственных средств. К сожалению ни в одной стране мира нет аналога этому органу.  

а, да... Все эти новости можно найти на сайте управления.

Edited by Berryl

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FDA Approves First Intravenous Formulation of Acetaminophen

November 4, 2010 — The US Food and Drug Administration (FDA) has approved the first and only intravenous formulation of acetaminophen (Ofirmev; Cadence Pharmaceuticals, Inc) for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.

Acute pain, particularly postoperative pain, is often treated with oral acetaminophen in combination with opioids. The availability of intravenous acetaminophen in the first quarter of 2011 is expected to fill a significant therapeutic gap.

"Ofirmev is a long-awaited and much needed addition to postoperative pain management," said Eugene R. Viscusi, MD, in a company news release. "With the approval of Ofirmev, clinicians will now be better able to use a multi-modal approach to pain management in the hospital setting, when oral medication can't be used." Dr. Viscusi is director of Acute Pain Management at Thomas Jefferson University in Philadelphia, Pennsylvania.

FDA approval was based on data from a 3-study clinical trial program of 1020 adult and 355 pediatric patients.

In a study of 101 orthopedic patients undergoing either hip or knee replacement surgery, 1000 mg intravenous acetaminophen administered every 6 hours was significantly more effective than placebo for reducing pain intensity over the course of 24 hours (P < .01), resulting in a 33% decrease in morphine consumption (P < .01).

These findings were supported by data from a second study of 244 patients undergoing abdominal laparoscopic surgery showing that use of intravenous acetaminophen (1000 mg every 6 hours or 650 mg every 4 hours) was significantly more effective than placebo for decreasing pain intensity over the course of 24 hours (P < .02).

The third study, conducted in adult volunteers with induced fever, showed that a single dose of 1000 mg intravenous acetaminophen took effect within 15 minutes and yielded a significant decrease in temperature for 6 hours, relative to placebo (P < .01).

Use of intravenous acetaminophen in pediatric patients older than 2 years is supported by data from adult clinical trials and additional safety and pharmacokinetic data for this age group, company officials said in the news release, noting that a postmarketing efficacy study will be conducted in infants and neonates.

Intravenous acetaminophen should be administered only as a 15-minute infusion. As with other formulations of acetaminophen, the daily dose should not exceed 4 g because of the potential for potentially severe hepatotoxicity.

Adverse events most commonly reported in adult clinical trials included nausea, vomiting, headache and insomnia; nausea, vomiting, constipation, pruritus, agitation, and atelectasis were most commonly reported in pediatric patients.

Acetaminophen is contraindicated in patients with severe hepatic impairment or severe active liver disease, and those with known hypersensitivity to formulation excipients or the drug itself. Treatment should be immediately discontinued if allergic or hypersensitivity reactions occur.

Caution is advised when treating patients with hepatic impairment or active liver disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment.

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FDA Approves Duloxetine for Chronic Musculoskeletal Pain

November 5, 2010 — The US Food and Drug Administration (FDA) has approved duloxetine HCl delayed-release capsules (Cymbalta; Eli Lilly and Co) for the once-daily treatment of chronic musculoskeletal pain.

"Up to three quarters of the population experience chronic pain at some time in their lives," said Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research, in an agency news release. "This approval means that many of those people now have another treatment option."

Regulatory approval followed a positive vote (8 - 5) in August from the FDA Anesthetic and Life Support Drugs advisory committee regarding the use of duloxetine to treat chronic low back pain. However, as reported by Medscape Medical News, the committee did not express the same confidence in the drug's usefulness as a treatment for osteoarthritis, voting 9 to 4 against its endorsement.

Concerns cited by members included duloxetine "noninferiority," rather than superiority, to currently available therapeutic options, as well as conflicting clinical trial results. In addition, most felt that not enough evidence had been presented as to the safety of the proposed 120-mg dose compared with the 60-mg dose.

According to the FDA news release, duloxetine has been approved for both chronic low back pain and osteoarthritis, based on data from 4 double-blind, randomized clinical trials showing that duloxetine was significantly more effective than placebo for decreasing pain in patients with those conditions. The recommended dose is 60 mg daily.

Treatment-emergent adverse events most commonly reported in patients with chronic musculoskeletal pain (incidence, 5% or higher — twice that of placebo) included nausea, dry mouth, insomnia, sleepiness, constipation, dizziness, and fatigue. Patients with osteoarthritis most commonly reported nausea, fatigue, and constipation.

Serious adverse events reported in less than 1% of duloxetine-treated patients include hepatotoxicity, allergic/hypersensitivity reactions, pneumonia, and suicidality.

Duloxetine delayed-release capsules previously were approved for the treatment of major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, and fibromyalgia.

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FDA Warns of IV Compatibility Issues for Prefilled Glass Syringes

November 19, 2010 — Compatibility issues have been reported between certain prefilled needleless glass syringes and pin-activated needleless intravenous (IV) access systems, the US Food and Drug Administration (FDA) announced yester-

Connection attempts may cause the pin to break, thus clogging the syringe or causing damage to the IV tubing and/or needleless connector that requires reestablishment of IV access.

The resulting delay in drug administration could cause serious harm to patients requiring urgent treatment, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program.

Most of the reports have reflected issues with prefilled syringes containing adenosine, made by Teva (NDC 00703-8781-23), Sagent (NDC 25021-0301-72), Baxter (NDC 10019-0063-08 [07]), and Wockhardt (NDC 64679-0630-01 [02]); problems with amiodarone-filled syringes from Sagent/Gland have also been reported (NDC 25021-0302-73).

Healthcare professionals are advised to check for affected products and to consider stocking adenosine vials or prefilled plastic syringes as a back-up measure in crash carts, operating room pharmacies, and emergency drug boxes/caches.

"While FDA is concerned about this incompatibility, we are most concerned with situations in which a delay in delivery of the drug could potentially result in serious harm to patients," the agency noted in a news release.

As a result, the FDA has initiated a review of all currently marketed prefilled needleless glass syringes intended for use with needleless IV access systems for which delays in drug administration could cause life-threatening harm. The FDA is also working with manufacturers to correct the problem and identify additional mitigation strategies while reviewing the problem to determine the appropriate regulatory actions.

More information on the announcement is available on the FDA Web site.

Adverse events related to use of needleless prefilled glass syringes should be reported to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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FDA Panel Recommends Lap-Band for Lighter Patients

December 6, 2010 — A US Food and Drug Administration (FDA) advisory panel has voted 8 to 2 in favor of approving an expanded indication for an implantable adjustable gastric band (Lap-Band Adjustable Gastric Banding System; Allergan) to be used for weight reduction in patients with a body mass index (BMI) of at least 30 kg/m2 and less than 40 kg/m2.

The device is currently indicated for patients with severe obesity (BMI of at least 40 kg/m2 or BMI of at least 35 kg/m2 with 1 or more severe comorbid conditions) or for those who are at least 100 pounds heavier than their estimated ideal body weight.

"Patients with a BMI of less than 35 kg/m2 (even with a comorbid condition) are usually not considered appropriate for bariatric surgery," note the manufacturers in a report prepared for the FDA. "Expansion of the indication to include lower BMI patients would change the current practice of medicine with respect to bariatric surgery."

The Gastroenterology and Urology Devices Advisory Committee voted on the expanded indication on December 3.

In a study evaluating the Lap-Band for its original indication, approximately 20% of patients were able to lose at least 50% of their excess weight by 3 years, and 10% lost 75% of their excess weight.

In patients with a BMI of at least 30 kg/m2 and less than 40 kg/m2, a single-group, prospective study was conducted to evaluate the device. A total of 151 patients were enrolled at 7 investigational sites in the United States.

Subjects were primarily female and white, with a median age of 40 years and a mean baseline BMI of 35.4 kg/m2 (range, 29.8 - 39.9 kg/m2). Mean weight at surgery was 214.9 pounds (range, 152.6 - 286.2 pounds), and mean excess weight was 62.8 pounds (range, 28.8 - 100.7 pounds).

Almost 66% of all implanted participants lost at least 50% of their excess weight at 1 year. In addition, the primary efficacy endpoint — more than 40% of participants achieving at least 30% excess weight loss at 12 months — was achieved (P < .0001); 83.9% of the intent-to-treat evaluable patients (n = 143) and 80.5% of the intent-to-treat participants (n = 149) achieved this endpoint. The primary endpoint was met in 84.4% of the per protocol patients.

The mean percentage weight loss (total weight loss) was 18.3% (n = 143) at 12 months. Excess weight decreased from a mean of 62.8 pounds at baseline to 22.8 pounds at 12 months (n = 143).

During the 12-month period, 131 patients (87.9%) experienced a total of 524 adverse events. About one third of the adverse events were considered related to treatment. The majority of device-related adverse events were mild (n = 118; 54.9%); 2.3% were severe (5 events in 3 patients).

The most common device-related adverse events were vomiting in 20.0%, dysphagia in 15.3%, postprocedural pain in 13.0%, and gastroesophageal reflux disease in 10.2% of the patients. Reoperations were necessary in less than 5% of patients, and no deaths were reported.

The panel voted on 3 questions regarding the new indication: whether the data supported the efficacy of this device for the new indication, whether the data supported its safety, and whether the benefits appeared to outweigh the risks. The panel voted in favor of each question: 8 to 2 for the first question, 8 to 1 with 1 abstention for question 2, and 8 to 2 for question 3.

"Although the current study is small, I think that there's reasonable assurance...that this is an acceptable change," said Jon C. Gould, MD, from the University of Wisconsin School of Medicine and Public Health in Madison.

The committee expressed concerns about the time frame of the study, suggesting that more long-term data are needed to adequately assess the efficacy and safety and that a registry could be set up to collect data on long-term outcomes.

According to the manufacturers, effectiveness of the Lap-Band for "the treatment of severe obesity with respect to long-term weight loss is less than that of other bariatric surgical procedures, but substantially better than traditional behavioral or medical therapy."

The Lap-Band was first approved for weight reduction in the morbidly obese on June 5, 2001. The device is intended to induce weight loss in obese patients by limiting food consumption.

The panel chair Dr. Woods has reported that she owns stock in Allergan.

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FDA Approves 60-Second HIV Test

December 3, 2010 — The US Food and Drug Administration (FDA) has approved a single-use rapid test (INSTI HIV-1; bioLytical Laboratories, Inc) that detects antibodies to HIV-1 in as little as 60 seconds.

The test is designed for use with whole blood, finger-stick blood, or plasma specimens and uses flow-through rather than lateral-flow technology to reduce processing time. According to a company news release, the test also includes a "unique antigen construct" composed of recombinant proteins for HIV-1 (gp-41) and HIV-2 (gp-36).

"The unique antigen is important because the HIV testing community appears to be headed toward a multi-rapid test algorithm [in which] we must deploy tests with different antigens, so bioLytical's use of a unique antigen satisfies that requirement. And since INSTI also utilizes a novel flow-through technology, it would be a strong addition to a rapid/rapid algorithm," notes Niel Constantine, PhD, INSTI clinical trial investigator and professor of pathology at the University of Maryland School of Medicine Institute of Human Virology, in Baltimore, in the news release.

FDA approval was based on clinical trial data showing minimum sensitivity and specificity of 99.8% and 99.5%, respectively, in finger-stick whole blood samples; HIV-1 was detected with 99.9% sensitivity and 100% specificity in venipuncture whole blood and plasma samples. As with all rapid HIV tests, positive findings must be confirmed before a diagnosis of HIV infection can be established.

"We believe the speed, accuracy, and unique technology of our 60-second HIV test will make the testing and early treatment of HIV/AIDS more efficient in all patient settings, including hospital emergency rooms and public health clinics," stated bioLytical Laboratories President Philip Bligh in the news release.

The test's speed and facility of use may also encourage HIV testing and counseling in novel settings, thereby providing early diagnoses that can help curb the spread of infection. These goals are in line with those of the Obama administration's national strategy on HIV, which calls for a 25% reduction in new HIV cases during the next 5 years.

The 60-second HIV test previously was approved for use in 56 other countries, including Canada and member states of the European Union.

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