Uchino K, Hernandez A “Dabigatran association with higher risk of acute coronary events” Arch Intern Med 2012; DOI: 10.1001/archinternmed.2011.1666.

ONLINE FIRST
Dabigatran Association With Higher Risk of Acute Coronary Events

Meta-analysis of Noninferiority Randomized Controlled Trials

Ken Uchino, MD; Adrian V. Hernandez, MD, Phd

Arch Intern Med. Published online January 9, 2012. doi:10.1001/archinternmed.2011.1666

http://archinte.ama-assn.org/cgi/content/full/archinternmed.2011.1666

Conclusions Dabigatran is associated with an increased risk of MI or ACS in a broad spectrum of patients when tested against different controls. Clinicians should consider the potential of these serious harmful cardiovascular effects with use of dabigatran.

http://www.fda.gov/Drugs/DrugSafety/ucm286226.htm

FDA Public Health Advisory on Certain Opiate Products Made for Endo Pharmaceuticals

FDA is advising healthcare professionals and patients of a potential problem with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site.  Due to problems that occurred when these products were packaged and labeled at the site, tablets from one product type may have carried over into packaging of another product.  This could result in a stray pill of one medicine ending up in the bottle of another product.  The likelihood of this occurring in medication dispensed to patients is estimated to be low. 

Endo Pharmaceuticals reports that they are aware of only three product mix-ups with respect to these products since 2009; all three were detected by pharmacists.  Endo is not aware of any patient having experienced a confirmed product mix-up, nor any adverse events attributable to a product mix-up.  Nonetheless, to ensure continued patient safety and access to these needed medicines, FDA advises patients and healthcare professionals to examine opiate medicines made by Endo in their possession and ensure that all tablets are the same.  FDA and Endo are providing instructions on how to identify an incorrect tablet in these medicines.

Opiates are potent medications used to alleviate pain and are available only by prescription.  The following Endo Pharmaceutical products^{1 2}may be affected by the packaging problem (see also www.endo.com³):

• Opana® ER (oxymorphone hydrochloride) Extended-Release Tablets CII
• Opana® (oxymorphone hydrochloride) CII
• Oxymorphone hydrochloride Tablets CII
• PERCOCET® (oxycodone hydrochloride and acetaminophen USP) Tablets CII
• PERCODAN® (oxycodone hydrochloride and aspirin, USP) Tablets CII
• ENDOCET® (oxycodone hydrochloride and acetaminophen USP) Tablets CII
• ENDODAN® (oxycodone hydrochloride and aspirin, USP) Tablets CII
• MORPHINE SULFATE Extended-Release Tablets CII
• ZYDONE® (hydrocodone bitartrate/acetaminophen tablets, USP) CIII

The likelihood of finding a wrong tablet in an opiate pain medication dispensed to patients is low and patients should not be unduly alarmed.  For medications already in homes and pharmacies, there are simple steps (see links below) that patients and healthcare professionals can take to identify whether they have any affected products.

Patients should follow the instructions provided by FDA⁴ and Endo^{5 6}and look carefully at all of the pills in their pain medicine bottle.  For any questions, patients should contact Endo Pharmaceuticals at1-800-462-3636 or ask their pharmacist or doctor for additional help in identifying whether there are any problems with their medication.  

When dispensing a medication, pharmacists should perform a visual inspection according to the instructions provided by FDA⁷.

FDA is actively working with Novartis and Endo to address the manufacturing problems.  Due to the problems that occurred when these products were packaged and labeled at the manufacturer, tablets from one product may have carried over into packaging of another product. 

In the coming weeks we expect there will be periods of shortages for these products.  FDA is working with Endo and Novartis to minimize the degree of impact.  The degree of shortage will depend upon how quickly safeguards can be put in place to prevent this manufacturing issue from happening in the future and how soon manufacturing can be re-started.

Novartis has initiated a consumer level recall of the other non-opiate products made at their Lincoln, Nebraska manufacturing facility out of an abundance of caution for these other products.  Please see the Novartis Press Release⁸ for more information.

FDA will update the public if this situation changes and more information is available.

http://www.ems1.com/medical-clinical/articles/1216507-Maine-medical-center-develops-bath-salts-protocol/

EMS1

Maine medical center develops bath salts protocol

Hospitals from around the state that want to send bath salts patients who are in severe crisis to EMMC for specialized care also may have to temporarily paralyze them for the trip

By Nok-Noi Ricker
Bangor Daily news

http://www.nytimes.com/2012/01/03/nyregion/nowhere-to-go-patients-linger-in-hospitals-at-a-high-cost.html?_r=1&nl=nyregion&emc=ura1

NYT

By SAM ROBERTS

http://www.ems1.com/ems-news/1211731-man-steals-ambulance-to-drive-himself-to-fla-hospital/

EMS1

13News, 1/1/12

TAMPA, Fla. — “The suspect who allegedly stole an ambulance in Tampa on Thursday night told officers he had been attacked and was driving himself to the hospital…..”

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm283520.htm

FDA NEWS RELEASE
For Immediate Release: Dec. 13, 2011
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov �
Consumer Inquiries: 888-INFO-FDA
FDA permits marketing of the first hand-held device to aid in the detection of bleeding in the skull
Helps to determine if immediate CT scan is needed

The U.S. Food and Drug Administration today allowed marketing of the first hand-held device intended to aid in the detection of life-threatening bleeding in the skull called intracranial hematomas, using near-infrared spectroscopy.

The device, called the Infrascanner Model 1000, can help health care providers identify patients with critical head injuries who need an immediate brain imaging study.

Intracranial hematomas occur when blood from a ruptured blood vessel collects within the brain or between the skull and the brain. As blood expands within the brain or in the narrow space between the brain and the skull, the brain becomes compressed. This can produce symptoms such as headaches, vomiting, dizziness, lethargy, weakness in the arm or leg on one side of the body, seizures, or unconsciousness. An intracranial hematoma can be life-threatening if it is not treated immediately.

According to the Centers for Disease Control and Prevention, each year about 1.7 million people in the United States experience a traumatic brain injury.
�
The Infrascanner, Model 1000, uses a scanner that directs near-infrared light, a wavelength of light that can penetrate tissue and bone, into the skull. Blood from intracranial hematomas absorbs the light differently than other areas of the brain. The scanner detects differences in light absorption (optical density) and transmits the information wirelessly to a display on a hand-held computer.

By comparing the optical density from a series of scans of specific areas on both sides of the skull, a trained health care provider can use the information provided by the device, in conjunction with other clinical information, to determine the likelihood of an intracranial hematoma and the need for further diagnostic procedures, such as a computed tomography (CT) scan.

“While patients with suspected brain injuries routinely receive a CT scan, this portable device offers emergency room physicians a non-invasive mechanism to aid in assessing whether an immediate CT scan is needed,” said Christy Foreman, director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health.

The FDA reviewed data for the Infrascanner Model 1000 through the “de novo” classification process, a regulatory pathway for some low to moderate risk medical devices that are not comparable to a legally marketed device.

The FDA granted the de novo petition for the Infrascanner Model 1000 based on a review of data comparing results from 383 CT scans of adult subjects with Infrascanner scan results. The Infrascanner was able to detect nearly 75 percent of the hematomas detected by CT scan. When CT scans detected no hematoma, the Infrascanner detected no hematoma 82 percent of the time. The Infrascanner Model 1000, however, is not a substitute for a CT scan.

The FDA is specifying special controls in an accompanying regulation classifying the Infrascanner Model 1000 as a Class II device with special controls. The special controls provide information about specific risks that must be addressed by other manufacturers who may wish to market a similar device.

The Infrascanner Model 1000 is manufactured by InfraScan Inc. of Philadelphia.

For more information:

FDA: Medical Devices1
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

http://www.medicalnewstoday.com/articles/239274.php

MNT

Magnetic Stimulation Of Brain For Stroke Recovery

“…..The study, published in Neurology……explains the use of transcranial magnetic stimulation, a treatment that involves placing large electromagnetic coils against the scalp. It creates electrical currents that stimulate nerve cells….The research so far has only involved 20 people, with…..hemispatial neglect…….
10 patients were treated for two weeks, while the other 10 received a placebo treatment. Tests on those who did not receive the real treatment showed little improvement, while those who underwent the real magnetic stimulation had a 16% improvement at the end of the two weeks and a 22% improvement two weeks later……”

http://www.healthleadersmedia.com/page-1/QUA-274180/Immediate-Jeopardy-14-CA-Hospitals-Fined-850000##

Immediate Jeopardy: 14 CA Hospitals Fined $850,000

http://www.medpagetoday.com/Gastroenterology/ColonCancer/30182?utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=WC&eun=g380841d0r&userid=380841&email=ndmsmd@aol.com&mu_id=

By Shalmali Pal, Contributing Editor, MedPage Today
Published: December 12, 2011

“The incidence of colorectal cancer (CRC) among adults younger than 50 has increased by 2.1% in the past decade, according to results from a study of the National Cancer Database.

“The median age for young-onset CRCs was 44 years, with most (75.2%) occurring between ages 40 and 49 years…..”

IV Access Difficulty: Incidence and Delays in an Urban Emergency Department
Published online: 05 December 2011
Michael D. Witting
DOI: 10.1016/j.jemermed.2011.07.030
Journal of Emergency Medicine, The, http://www.jem-journal.com/article/S0736-4679%2811%2900907-3/abstract

In an urban, tertiary care ED, mild and moderate IVAD (Intravenous access difficulty) was common and led to mild delays, but severe IVAD, requiring a physician, caused substantial delays.