June 01, 2001 - Popular Thyroid Drug Faces Deadline

---

The Food and Drug Administration will not grant the status of "generally regarded as safe and effective drug'' to Synthroid, a widely used thyroid drug that has been on the market for more than 35 years if Abbott Laboratories does not meet the August deadline to get a formaln drug approval. Abbott had acquired Synthroid's manufacturer earlier this year.

However, the FDA has not decided what it will do if the August deadline to approve the drug is not met by Abbott.. The product could go off the market and patients could find themselves going back to their doctors and looking for other medicines. The drug's manufacturer did announced that it will seek a formal new-drug approval some time in the future.

Abbott Laboratories announced in April that it was filing a new drug application for the product, but the approval process can take more than 10 months.

The original manufacturer of Synthroid, Knoll Pharmaceutical Co., had already tried to place the product in a category known as "generally regarded as safe and effective,'' citing its long history of use. But because Synthroid's formula has changed over the years and the agency has investigated reports of problems with the drug's potency the FDA turned that offer down, noting that in order for a medication to be generally recognized as safe and effective, there must be some consistent drug product for experts to recognize.

Synthroid tablets are made using an "overage'' of the active ingredient that has varied in size. An overage occurs when the product contains more than the labeled amount of a chemical. This is intended to compensate for loss of the ingredient while the product is in storage, thus extending shelf life.

As a result, some patients may receive more than the listed dose, but too much of the drug can cause chest pain and rapid or irregular heartbeat. Others could receive less of Synthroid which could potentially lead to lethargy, mental impairment, depression, constipation and other problems.

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.

<< back

---

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