News: Press Releases
Fougera Marks Fifth Snakebite Season with CroFab® -
Snakebite myths and misconceptions remain barrier to treatment
Melville, NY – August 9, 2005 – Fougera® Inc. announced today that CroFab® - Crotalidae Polyvalent Immune Fab (Ovine) has marked its fifth season of use as the primary antivenom* for crotalid snakebites from snake species common to the United States. Crotalid is used to describe the Crotalinae subfamily (formerly know as Crotalidae) of venomous snakes that compose the vast majority of common North American snakes, including rattlesnakes, copperheads and cottonmouths/water moccasins. When CroFab® was launched in 2001, it was the first new snakebite antivenom to be made available in nearly 50 years. It is currently the only widely-available antivenom for Crotalid snakes. Snakebite experts remain concerned, however, about the level of misinformation about the diagnosis and treatment of snakebites. Experts advocate more prompt treatment of snakebites and more widespread treatment of milder bites.
“CroFab® changed the way we treat victims of snakebite. Unfortunately, misinformation in the general public about the treatment of snakebites persists,” said Richard C. Dart, MD, PhD, Director, Rocky Mountain Poison and Drug Center, Denver Health Authority and Professor of Medicine, Surgery and Pharmacy, University of Colorado Health Sciences Center.
Understanding of How to Treat Snakebites with CroFab® Has Increased
Since CroFab® was launched in 2001, numerous studies and reports have contributed to a better understanding of how to treat snakebites, including:
· Extensive efficacy and safety experience with CroFab®
· Guidelines for the treatment of children bitten by rattlesnakes
· Use of CroFab® for bites from copperheads and Southern Pacific rattlesnakes
· Repeated administration of CroFab® in the same patient
· The management and control of adverse reactions
A full list of recent snakebite publications is available at www.snakebitenews.com.
“All snakebites are unique. Through organized studies and general use, we know more about the safety and efficacy of CroFab® and how to effectively treat a diverse range of patients. We now have experience on how to treat children, how to treat bites from species that differ from those originally studied for CroFab® and how to treat patients who have been bitten multiple times or who have received CroFab® more than once,” said Dr. Dart.
Early Intervention Gives Better Outcomes
The most important thing a snakebite victim can do is get to the nearest emergency room as quickly as possible. Experts also advise not trying to capture the snake. Snakes can make multiple venomous bites. Trying to capture a snake wastes valuable time and puts a person at risk of being bitten again. Snakebite experts do not advise applying tourniquets, making any kind of cut near the wound or trying to suck out the poison.
* CroFab® is indicated for the management of patients with minimal or moderate North American crotalid envenomation.
“Snake venom is filled with digestive enzymes. The longer you wait to introduce the antivenom, the more destruction the enzymes can do. If you’ve been bitten by a snake, get to the hospital as quickly as you can,” said Dr. Sean Bush, Staff Emergency Physician and Envenomation Specialist, Loma Linda Medical University Center.
In addition to the risk of death, there is significant morbidity associated with snakebites, including loss of limb, decreased mobility and tissue death or necrosis at the site of the injury. These morbidities are exacerbated by delays in treatment. Transferring patients to hospitals with a supply of antivenom or waiting for antivenom to be shipped can significantly delay treatment, which can increase tissue loss and other morbidities associated with snakebites.
“Fougera and our production partner, Protherics, have worked extremely hard to meet the demand for antivenom. In 2003, we more than doubled our 2002 production and we have maintained or exceeded those levels in 2004 and 2005,” said David Klaum, Senior Vice President, Commercial Operations, Fougera.
Important Safety Information
CroFab® has been used successfully to treat several thousand snakebites in the U.S. to date. In clinical studies, the majority of adverse reactions to CroFab® were mild to moderate in severity. The most common adverse events were urticaria and rash. One patient experienced recurrent coagulopathy due to envenomation. Two patients experienced severe allergic reactions (severe hives and a severe rash and pruritus) following treatment. All patients made a complete recovery. One patient discontinued CroFab® therapy due to an allergic reaction. Patients with allergies to papain, chymopapain, other papaya extracts, or the pineapple enzyme bromelain may also be at risk for an allergic reaction to CroFab®. For additional information on adverse events, precautions or warnings, please refer to the full prescribing information for CroFab® available at www.fougera.com.
About CroFab®
CroFab® is indicated for the management of patients with minimal or moderate North American crotalid envenomation. The term crotalid is used to describe the Crotalinae subfamily (formerly know as Crotalidae) of venomous snakes that includes rattlesnakes, copperheads and cottonmouths/water moccasins.
Of the estimated 45,000 snakebites each year in the United States, approximately 7,000 to 8,000 involve venomous species. Additional information about snakebites and snakebite treatments can be found at www.snakebitenews.com.
In October 2002, Fougera® assumed responsibility for the distribution of CroFab® from Savage Laboratories. Both companies are divisions of Altana Inc. CroFab® was developed and is manufactured by Protherics PLC.
About Fougera®
Fougera is a leading manufacturer and distributor of a wide range of multi-source topical and ophthalmic pharmaceuticals in prescription and over-the-counter dosage forms, as well as treatments for emergency/critical care.
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