July 1, 2001 - Safety Alert Issued on Sporanox and Lamisil

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The FDA alerted physicians prescribing a tablet form of itraconazaole (Sporanox), manufactured by Janssen Pharmaceutica and Ortho Biotech, and terbinafine HCl (Lamisil), produced by Novartis, of serious health risks to their patients. Generally, these drugs are offered in a form of a cream or an ointment and are safe and effective in treating fungal infections. However, the agency warns, a pill form of these medications could possibly cause some severe health problems like heart and liver failure in some patients.

The agency further commented that "there is a small but real risk of developing congestive heart failure (CHF) associated with the use of Sporanox, and that both Sporanox and Lamisil have been associated with serious liver problems resulting in liver failure, transplantation, and death. However, there is insufficient data to allow the FDA to make any kind of statement about the comparative safety of Sporanox and Lamisil."

The agency's warning reports are mostly based on 94 studied cases in which patients who took Sporanox had later developed CHF. The FDA further states that in more than half of the studied cases, Sporanox might have caused or contributed to CHF and that 28 patients who used it for fungus were hospitalized and 13 died.

Based on this information, the FDA now requires companies manufacturing Sporanox to label its product and warn patients using it for fungal nail infection not to take it if they have a history of congestive heart failure or develop a cardiac dysfunction after taking the drug.

The FDA had also reviewed a small number of cases where patients who took Lamisil had also developed some severe health complications, including 11 recorded studies that resulted in death. These case studies possibly connect Lamisil to liver failure in patients that took Lamisil tablets. The agency further advises doctors to use lab testing and verify their diagnosis of fungal nail infections before they prescribe either Sporanox or Lamisil tablets.

If you or a loved one has suffered an injury as a result of taking any drug or supplement, call The Gunn Law Group now at (813) 228-7070 or CLICK HERE TO SUBMIT A SIMPLE CASE FORM. The initial consultation is free of charge, and if we agree to review your case, we will work on a contingent fee basis, which means we get paid for our services only if there is a monetary award or recovery of funds. Don't delay! You may have a valid claim and be entitled to compensation for your injuries, but a lawsuit must be filed before the statute of limitations expires.

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The Gunn Law Group handles cases involving Insurance Claims, Homeowners Insurance, Property Insurance Coverage and Disputes, Insurance Bad Faith, Hurricane Insurance Claims, as well as the most serious of Personal Injury such as: Automobile Accidents, Spinal Cord Injuries, Cerebral Palsy, Traumatic Brain Injuries, Medical Malpractice, Product Liability and Wrongful Death. The Gunn Law Group serves the following Florida areas: Altamonte Springs, Apopka, Arcadia, Atlantic Beach, Bartow, Boca Raton, Bonita Springs, Boynton Beach, Bradenton, Brandon, Brooksville, Cape Coral, Casselberry, Clearwater, Cocoa, Cocoa Beach, Coral Gables, Coral Springs, Crestview, Crystal River, Dade City, Dania, Daytona Beach, Deerfield Beach, Deland, Delray Beach, Destin, Dunedin, Englewood, Eustis, Fernandina Beach, Fort Lauderdale, Fort Myers, Fort Pierce, Fort Walton Beach, Gainesville, Green Cove Springs, Gulf Breeze, Hallandale, Hialeah, Hollywood, Homestead, Hudson, Inverness, Islamorada, Jacksonville, Jacksonville Beach, Jupiter, Key Biscayne, Key Largo, Key West, Kissimmee, Lake City, Lake Mary, Lake Wales, Lake Worth, Lakeland, Largo, Leesburg, Live Oak, Longwood, Lutz, Maitland, Marathon, Marco Island, Melbourne, Merritt Island, Miami, Miami Beach, Milton, Mount Dora, Naples, New Port Richey, New Smyrna Beach, Niceville, North Fort Myers, North Miami Beach, North Palm Beach, Ocala, Okeechobee, Orange Park, Orlando, Ormond Beach, Oviedo, Palatka, Palm Bay, Palm Beach, Palm Beach Gardens, Palm City, Palm Coast, Palm Harbor, Panama City, Pensacola, Perry, Plant City, Pompano Beach, Ponte Vedra Beach, Port Charlotte, Port Richey, Port Saint Lucie, Punta Gorda, Quincy, Rockledge, Safety Harbor, Saint Augustine, Saint Petersburg, Sanford, Sanibel, Sarasota, Satellite Beach, Sebring, Seminole, Shalimar, Spring Hill, Stuart, Tallahassee, Tampa, Tarpon Springs, Tavares, Tavernier, Titusville, Venice, Vero Beach, West Palm Beach, Weston, Winter Haven, Winter Park, Winter Springs Copyright 2008 © Gunn Law Group, P.A. , All Rights Reserved Terms & Conditions Site Map