Seeing more drug- and medication-related cases lately?  No wonder…….

AHRQ Press Release Date: October 25, 2010

“The number of hospital admissions among Americans ages 45 and older for medication and drug-related conditions doubled between 1997 and 2008, according to a new report released today by the Department of Health and Human Services’ (HHS) Agency for Healthcare Research and Quality (AHRQ). Medication and drug-related conditions include effects of both prescription and over-the-counter medications as well as illicit drugs.

Hospital admissions among those 45 years and older were driven by growth in discharges for three types of medication and drug-related conditions—drug-induced delirium; “poisoning” or overdose by codeine, meperidine and other opiate-based pain medicines; and withdrawal from narcotic or non-narcotic drugs.

Admissions for all medication and drug-related conditions grew by 117 percent—from 30,100 to 65,400—for 45- to 64-year-olds between 1997 and 2008. The rate of admissions for people ages 65 to 84 closely followed, growing by 96 percent, and for people ages 85 and older, the rate grew by 87 percent. By comparison, the number of hospital admissions for these conditions among adults ages 18 to 44 declined slightly by 11 percent…..”

http://www.ahrq.gov/news/press/pr2010/hospmedpr.htm

Link:  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm230449.htm

Invirase (saquinavir): Label Change – Risk of Abnormal Heart Rhythm

[Posted 10/21/2010]

AUDIENCE: Cardiology, Infectious Disease

ISSUE: FDA notified healthcare professionals of new risk information added to the Warnings and Precautions, Contraindications, and Clinical Pharmacology sections of the antiviral drug Invirase (saquinavir), describing a potential change in the electrical activity of the heart when Invirase is used with another antiviral medication, Norvir (ritonavir). Changes in the electrical activity of the heart may lead to abnormal heart rhythms, known as prolonged QT or PR intervals. A prolonged QT interval can lead to a serious abnormal rhythm called torsades de pointes, which can be fatal. A prolonged PR interval can lead to a serious abnormal rhythm called complete heart block. Torsades de pointes and complete heart block have been reported in patients taking Invirase with Norvir.

BACKGROUND: The medications Invirase and Norvir are given together to treat HIV infection.  Norvir must be given at a low dose with Invirase in order to increase the level of Invirase in the body. In February 2010, FDA announced it was reviewing clinical trial data about a potentially serious effect on the heart from the use of Invirase in combination with Norvir.This new information was derived from a clinical study designed to study a drug’s impact on the electrical activity of the heart.

RECOMMENDATION: Patients at particular risk are those with underlying heart conditions or those who have existing heart rate or rhythm problems. An electrocardiogram should be performed prior to initiation of treatment. Physicians consider whether ongoing EKG monitoring is appropriate for patients and when it should be done. The Data Summary in the Drug Safety Communication provides more details.

FDA will require that a Medication Guide be given to patients when picking up a prescription for Invirase. The Medication Guide will include information on the risk of abnormal heart rhythms.

Link:  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm229244.htm

Bisphosphonates (Osteoporosis Drugs): Label Change – Atypical Fractures Update

including Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and Reclast

[Posted 10/13/2010]

AUDIENCE: Patient, Family Practice, Geriatric

ISSUE: FDA is updating the public regarding information previously communicated describing the risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take bisphosphonates for osteoporosis. This information will be added to the Warnings and Precautions section of the labels approved to treat osteoporosis, including Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and Reclast (and their generic products). A Medication Guide will also be required to be given to patients when they pick up their bisphosphonate prescription.

BACKGROUND: Atypical subtrochanteric femur fractures are fractures in the bone just below the hip joint. Diaphyseal femur fractures occur in the long part of the thigh bone. These fractures are very uncommon and appear to account for less than 1% of all hip and femur fractures overall. Although it is not clear if bisphosphonates are the cause, these unusual femur fractures have been predominantly reported in patients taking bisphosphonates.

RECOMMENDATIONS: Patients should continue to take their medication unless told to stop by their healthcare professional. FDA recommends that healthcare professionals should discontinue potent antiresorptive medications (including bisphosphonates) in patients who have evidence of a femoral shaft fracture. See the FDA Drug Safety Communication below for additional information.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[10/13/2010 - Drug Safety Communication - FDA]  

Previous MedWatch Alert:

[03/11/2010 - Oral Bisphosphonates: Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures]

Recall — Firm Public Notice

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Lipitor Recall Information

Contact:
Phone: 1-888-LIPITOR
Website: http://lipitor.com/recall.aspx⁹

Public Notice:

FDA NEWS RELEASE

For Immediate Release: Oct. 8, 2010
Media Inquiries: Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov
                        Erica Jefferson, 301-796-4988; erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

Abbott Laboratories agrees to withdraw its obesity drug Meridia

Abbott Laboratories has agreed to voluntarily withdraw its obesity drug Meridia (sibutramine) from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke, the U.S. Food and Drug Administration announced today.

“Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke,” said John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER). “Physicians are advised to stop prescribing Meridia to their patients and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs.”

Meridia was approved by the FDA in November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving sibutramine lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone.

The FDA requested the market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT was initiated as part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of this drug. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine compared to another given placebo. There was a small difference in weight loss between the placebo group and the group that received sibutramine.

“The patients in the European SCOUT trial did not have the same characteristics as the patients for the approved indication in the United States; however, these results, combined with other available safety data raised serious questions about Meridia’s safety for all patient groups,” said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology in CDER.

The agency’s analysis of SCOUT was the subject of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee meeting on Sept. 15.

For more information:

Drug Safety Communication: FDA Recommends against the Continued Use of Meridia (sibutramine)

Link:  https://www.faa.gov/news/press_releases/news_story.cfm?newsId=11958

FAA

October 07, 2010

WASHINGTON–The U.S. Department of Transportation’s Federal Aviation Administration (FAA) today proposed broad new rules for helicopter operators, including air ambulances, which, if finalized, would require stricter flight rules and procedures, improved communications and training, and additional on-board safety equipment.

“This is a significant proposal that will improve the safety of many helicopter flights in the United States,” said Transportation Secretary Ray LaHood. “The FAA’s initiatives have helped the helicopter industry make progress on many safety issues, but it’s time to take steps towards mandating these major safety improvements.”

Under the proposed rules, operators would use the latest on-board technology and equipment to avoid terrain and obstacles. The proposal also contains provisions which, if finalized, would require operators to use enhanced procedures for flying in challenging weather, at night, and when landing in remote locations.

“We can prevent accidents by preparing pilots and equipping helicopters for all of the unique flying conditions they encounter,” said FAA Administrator Randy Babbitt. “These new rules are designed to protect passengers, patients, medical personnel, and pilots.”

The FAA document includes new proposals covering a variety of helicopter operators.

The proposed rules would require air ambulance operators to:

• Equip with Helicopter Terrain Awareness and Warning Systems (HTAWS).
• The proposal seeks comments on requirements for light-weight aircraft recording systems (LARS).
• Conduct operations under Part 135, including flight crew time limitation and rest requirements, when medical personnel are on board.
• Establish operations control centers if they are certificate holders with 10 or more helicopter air ambulances.
• Institute pre-flight risk-analysis programs.
• Conduct safety briefings for medical personnel.
• Amend their operational requirements to include Visual Flight Rules (VFR) weather minimums, Instrument Flight Rules (IFR) operations at airports/heliports without weather reporting, procedures for VFR approaches, and VFR flight planning.
• Ensure their pilots in command hold an instrument rating.

Under the proposal, all commercial helicopter operators would be required to:

• Revise IFR alternate airport weather minimums.
• Demonstrate competency in recovery from inadvertent instrument meteorological conditions.
• Equip their helicopters with radio altimeters.
• Change the definition of “extended over-water operation” and require additional equipment for these operations.

The proposed rules would require all Part 135 aircraft, i.e. helicopter and fixed wing on-demand operators, to:

• Prepare a load manifest.
• Transmit a copy of load manifest documentation to their base of operations, in lieu of preparing a duplicate copy.
• Specify requirements for retaining a copy of the load manifest in the event that the documentation is destroyed in an aircraft accident.

In addition, the proposal would require Part 91 general aviation helicopter operators to revise the VFR weather minimums.

Since August 2004, the FAA has promoted initiatives to reduce risk for helicopter air ambulance operations. While accidents did decline in 2005 and 2006, 2008 proved to be the deadliest year on record with six accidents that claimed 24 lives. Overall, from 1992 through 2009, 135 helicopter air ambulance accidents claimed 126 lives. From 1994 through 2008, there were also 75 commercial helicopter accidents (excluding air ambulances) that resulted in 88 fatalities.

The estimated cost of the proposal in present value for the air ambulance industry is $136 million with a total benefit of $160 million over 10 years. The cost for other commercial operators is $89 million with a total benefit of $115 million over 10 years.

The Notice of Proposed Rulemaking is on display at the Federal Registerat www.archives.gov?federal-register. It’s also available at http://www.faa.gov/regulations_policies/rulemaking/recently_published/ and will be published in the Federal Register on October 12. A fact sheet on the FAA’s past initiatives is available at www.faa.gov/news/fact_sheets

The 90-day public comment period closes on January 10, 2011.

National Institute of Allergy and
Infectious Diseases (NIAID)
http://www.niaid.nih.gov

 

NIH Funds Advanced Development of Three Biodefense Vaccines

Research to Focus on Improving Delivery of Dengue and Anthrax Vaccines

 Link:  http://www.niaid.nih.gov/news/newsreleases/2010/Pages/biodefenseVax.aspx

“The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, today announced three new contracts to fund research on vaccines to protect against emerging infectious diseases and biological threats that could be used in a terror attack. Each project focuses on simple and efficient vaccine delivery approaches that could be deployed quickly. The total funding for the three contracts could reach $68 million, depending on the successful completion of defined project milestones……”

Out-of-Hospital Hypertonic Resuscitation Following Severe Traumatic Brain Injury

A Randomized Controlled Trial

Eileen M. Bulger, MD; Susanne May, PhD; Karen J. Brasel, MD; Martin Schreiber, MD; Jeffrey D. Kerby, MD; Samuel A. Tisherman, MD; Craig Newgard, MD; Arthur Slutsky, MD; Raul Coimbra, MD, PhD; Scott Emerson, MD; Joseph P. Minei, MD; Berit Bardarson, RN; Peter Kudenchuk, MD; Andrew Baker, MD; Jim Christenson, MD; Ahamed Idris, MD; Daniel Davis, MD; Timothy C. Fabian, MD; Tom P. Aufderheide, MD; Clifton Callaway, MD, PhD; Carolyn Williams, RN; Jane Banek; Christian Vaillancourt, MD; Rardi van Heest, MD; George Sopko, MD; J. Steven Hata, MD; David B. Hoyt, MD; for the ROC Investigators

JAMA. 2010;304(13):1455-1464. doi:10.1001/jama.2010.1405

Link:  http://jama.ama-assn.org/cgi/content/short/304/13/1455

Does out-of-hospital administration of hypertonic fluids improves neurologic outcome following severe TBI. ^?   

There was no difference in 6-month neurologic outcome among groups with regard to proportions of patients with severe TBI (GOSE ^<4) (hypertonic saline/dextran vs normal saline: 53.7% vs 51.5%; difference, 2.2% [95% CI, –4.5% to 9.0%]; hypertonic saline vs normal saline: 54.3% vs 51.5%; difference, 2.9% [95% CI, –4.0% to 9.7%]; P = .67). Survival at 28 days was 74.3% with hypertonic saline/dextran, 75.7% with hypertonic saline, and 75.1% with normal saline (P = .88).

^{Answer:  Nope!}

Use of Advanced Radiology During Visits to US Emergency Departments for Injury-Related Conditions, 1998-2007

Frederick Kofi Korley, MD; Julius Cuong Pham, MD, PhD; Thomas Dean Kirsch, MD, MPH

JAMA. 2010;304(13):1465-1471. doi:10.1001/jama.2010.1408

Link:  http://jama.ama-assn.org/cgi/content/short/304/13/1465

Are we using MRIs and CTs too much in the ER?   Seems so according to this study.

The prevalence of CT or MRI use during emergency department visits for injury-related conditions increased from 6% (257 of 5237 visits) in 1998 to 15% (981 of 6567 visits) in 2007 . There was a small increase in the prevalence of life-threatening conditions (1.7% [59 of 5237 visits] in 1998 and 2.0% [142 of 6567 visits] in 2007; P = .04 for trend).