Tuesday, August 17, 2010

FDA Proposes Withdrawal of Low Blood Pressure Drug: Companies failed to provide evidence of clinical benefit of midodrine hydrochloride

The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done.

Patients who currently take this medication should not stop taking it and should consult their health care professional about other treatment options.

The drug, marketed as ProAmatine by Shire Development Inc. and as a generic by others, was approved in 1996 under the FDA’s accelerated approval regulations for drugs that treat serious or life-threatening diseases. That approval required that the manufacturer verify clinical benefit to patients through post-approval studies.

To date, neither the original manufacturer nor any generic manufacturer has demonstrated the drug’s clinical benefit, for example, by showing that use of the drug improved a patient’s ability to perform life activities.

Orthostatic hypotension is a condition in which patients are unable to maintain blood pressure in the upright position and, therefore, become dizzy or faint when they stand up.

Generic versions of the drug are made by Apotex Corp., Impax Laboratories Inc., Mylan Pharmaceuticals, Sandoz Inc., and Upsher-Smith Laboratories. According to a database used by the FDA, about 100,000 patients in the United States filled prescriptions for brand or generic forms of midodrine in 2009.

Access the FDA information at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm222580.htm

Friday, August 13, 2010

Disasters, crush syndrome, and acute kidney injury to be featured at Renal Week 2010: Denver, CO

In a terrorist attack, crush injury and crush syndrome may result from structural collapse after a bombing or explosion. Crush injury is defined as compression of extremities or other parts of the body that causes muscle swelling and/or neurological disturbances in the affected areas of the body. Typically affected areas of the body include lower extremities (74%), upper extremities (10%), and trunk (9%). Crush syndrome is localized crush injury with systemic manifestations. These systemic effects are caused by a traumatic rhabdomyolysis (muscle breakdown) and the release of potentially toxic muscle cell components and electrolytes into the circulatory system. Crush syndrome can cause local tissue injury, organ dysfunction, and metabolic abnormalities, including acidosis, hyperkalemia, and hypocalcemia.

Previous experience with earthquakes that caused major structural damage has demonstrated that the incidence of crush syndrome is 2-15% with approximately 50% of those with crush syndrome developing acute renal failure and over 50% needing fasciotomy. Of those with renal failure, 50% need dialysis.

-Centers for Disease Control and Prevention
http://www.bt.cdc.gov/masscasualties/blastinjury-crush.asp


Nephrology in Natural Disasters: What to Do with Acute Kidney Injury and End-stage Renal Disease Patients during Disasters
November 19, 2010 | 04:30 PM - 06:30 PM
Presented by the American Society of Nephrology – Renal Week 2010
Denver, Colorado

Session Description
This topic serves to educate physicians living in at-risk areas about how to respond to a natural disaster, prepare a dialysis unit, assess nephrology needs (e.g., continue chronic dialysis for existing patients, need for acute dialysis for acute kidney injury patients), how to respond appropriately to minimize renal injury, how to manage crush victims following disasters, and complications. The International Society of Nephrology (ISN) has spearheaded these efforts with the Renal Disaster Relief Task Force. ASN recently developed its own task force. The merging of experience may be of great value to the physicians from many countries who attend the Renal Week.

Session Objectives
Upon completion of this session, the participant will be able to: be better equipped to develop algorithms for: 1) evacuation; 2) recognizing and forming support networks; and 3) treatment plan for renal patients.

Moderators
Jeffrey B. Kopp, MD, FASN
Ricardo Correa-Rotter, MD

Lectures
Nephrology Experience in Natural Disasters
04:30 PM - 05:00 PM

Impact of Disasters on Dialysis Patients' Health
05:00 PM - 05:30 PM
Kenneth D. Lempert, MD

Haiti Earthquake from a Nephrology Point of View
05:30 PM - 06:00 PM
Didier Portilla, MD

Recommendations for the Management of Crush Victims Following Mass Disasters
06:00 PM - 06:30 PM
Raymond C. Vanholder, MD, PhD

Please see the registration information at http://www.asn-online.org/education_and_meetings/renal_week/2010/program-session-details.aspx?sess_id=36

Friday, August 6, 2010

NOAA Still Expects Active Atlantic Hurricane Season; La Niña Develops

The Atlantic Basin remains on track for an active hurricane season, according to the scheduled seasonal outlook update issued today by NOAA’s Climate Prediction Center, a division of the National Weather Service. With the season’s peak just around the corner – late August through October – the need for preparedness plans is essential.

NOAA also announced today that, as predicted last spring, La Niña has formed in the tropical Pacific Ocean. This favors lower wind shear over the Atlantic Basin, allowing storm clouds to grow and organize. Other climate factors pointing to an active hurricane season are warmer-than-average water in the tropical Atlantic and Caribbean, and the tropical multi-decadal signal, which since 1995 has brought favorable ocean and atmospheric conditions in unison, leading to more active seasons.

“August heralds the start of the most active phase of the Atlantic hurricane season and with the meteorological factors in place, now is the time for everyone living in hurricane prone areas to be prepared,” said Jane Lubchenco, Ph.D., under secretary of commerce for oceans and atmosphere and NOAA administrator.

Across the entire Atlantic Basin for the whole season – June 1 to November 30 – NOAA’s updated outlook is projecting, with a 70 percent probability, a total of (including Alex, Bonnie and Colin):

  • 14 to 20 Named Storms (top winds of 39 mph or higher), including:
  • 8 to 12 Hurricanes (top winds of 74 mph or higher), of which:
  • 4 to 6 could be Major Hurricanes (Category 3, 4 or 5; winds of at least 111 mph)

These ranges are still indicative of an active season, compared to the average of 11 named storms, six hurricanes and two major hurricanes; however, the upper bounds of the ranges have been lowered from the initial outlook in late May, which reflected the possibility of even more early season activity.

“All indications are for considerable activity during the next several months,” said Gerry Bell, Ph.D., lead seasonal hurricane forecaster at NOAA’s Climate Prediction Center. “As we’ve seen in past years, storms can come on quickly during the peak months of the season. There remains a high likelihood that the season could be very active, with the potential of being one of the more active on record.”

Be prepared for the hurricane season with important information available online at hurricanes.gov/prepare and at FEMA’s ready.gov.

NOAA’s mission is to understand and predict changes in the Earth's environment, from the depths of the ocean to the surface of the sun, and to conserve and manage our coastal and marine resources. Visit us on Facebook.