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Prescription Drug Side Effects & Litigation
Over the last decade, the Food & Drug Administration (FDA) has removed from the market numerous drugs. Generally the manufacturer had made assurances to get FDA approval that the drugs’ benefits outweighed the risks. However, after being released to the market, adverse reactions were reported and, on further investigation, it was shown that in some situations not all evidence of the drugs’ risks were disclosed. Some of the drugs listed below have been taken off the market while others are still being used.
Manufactured by American Home Products, this was a non-steroidal anti-inflammatory drug that was widely prescribed for pain in 1997 and 1998. In May 1998, it was removed from the market because of a large number of adverse drug reaction reports. In some cases use of this drug led to elevated liver enzymes and eventually to liver failure necessitating liver transplant. In some situations it even led to death. The initial symptoms of liver damage are abdominal pain, swelling in the stomach and extremities, brown urine, yellow eyes and jaundice.
Omniscan (MRI Dye)
Omniscan (gadodiamide) is a gadolinium containing contrast agent (MRI dye) commonly used by physicians in magnetic resonance imaging (MRI) and/or magnetic resonance angiography (MRA). In June 2006, physicians were warned about the use of the Omniscan contrast medium (dye) in an MRI or MRA where patients had a pre-existing renal (kidney) problem over concerns that the patient might develop a very serious medical condition involving the skin called Nephrogenic Systemic Fibrosis (NSF). That condition is characterized by a hardening of the skin and other serious health problems.
Fen - Phen
This diet drug combination involved the use of Fenfluramine (known as Pondimin) and Phentermine (Fastin, Adipex, etc.). In September of 1997, the FDA ordered the removal of both Pondimin and Redux from the market. The drugs were manufactured by American Home Products. These drugs caused Primary Pulmonary Hypertension (PPH) which is an elevation of blood pressure in the passageway between the heart and the lungs and damage to the user's mitral and aortic heart valves.
Trovan is a vigorous antibiotic that is used to combat a wide range of infections. Manufactured by Pfizer, the drug is highly liver toxic. In some cases use of this drug led to elevated liver enzymes and eventually to liver failure necessitating liver transplant. In some situations it even led to death. The following, initial symptoms are associated with liver damage: abdominal pain, swelling in the stomach and extremities, brown urine, yellow eyes, extreme fatigue and jaundice. In June 1999, Pfizer restricted the use of this drug to situations in a hospital environment and under life-threatening conditions.
Ketek (Telithromycin) is an antibiotic used to treat certain respiratory (lung and sinus) infections, including bronchitis and pneumonia. On January 20, 2006, researchers reported three cases of severe liver problems associated with Ketek, including one death, in patients at a North Carolina hospital.
Manufactured by Roche Laboratories, Posicor was a calcium channel blocker. It was used to treat blood pressure problems in patients. In June 1998, it was pulled from the market when it was determined it was dangerous when used in combination with one of more than 25 other drugs, ranging from antibiotics to allergy drugs. Problems associated with the drug include heart and liver problems.
This drug has been used to treat patients with schizophrenia. The drug has been found to cause heart related problems severe enough to cause death. An irregular heartbeat is the symptom most commonly associated with its use.
This drug is used primarily to treat rheumatoid arthritis. It has been on the market in the United States since November 1998. Recent studies have shown Enbrel can cause disorders of the central nervous system. Some patients using this drug have also developed bleeding problems.
Raplon was a muscle relaxant prescribed by doctors and anesthesiologists to some patients by injection before hospital or surgical procedures. In March of 2001, Organon, Inc., the manufacturer, voluntarily withdrew the product from the market because it may have been linked to 5 deaths and 90 other problems related to bronchospasm which is an inability to breath normally. Bronchospasm can range from mild to severe.
The FDA approved Raplon for sale in August of 1999. Before it was approved, there were reports of bronchospasm in the clinical trials but they were considered to be no different than what would be expected in the general population. New reports seriously challenge the pre-clinical findings. Indeed, the FDA noted that the post market survey of the drug indicates "that the risk of injury may be greater than what was suggested."
Coronary bypass patients that were given the drug Aprotinin, sold under the brand name of Trasylol, should be aware that the product has been linked to kidney failure, heart attacks and strokes -- and implicated in thousands of deaths.
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