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PRESCRIPTION DRUG LEGALGLOSSARY |
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Glossary of
Prescription Drug Terms
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FDA: Food and Drug Administration; an agency of the federal government established by Congress in 1912 and presently part of the Department of Health and Human Services.
Fen-Phen: Short for fenfluramine phentermine, a drug combination used for weight loss purposes. Fen-Phen has been linked to heart valve disease in numerous cases, prompting the FDA to request that manufacturers recall the drug. A combination of fenfluramine (Podimin), phentermine (Ionamin), and dexfenfluramine, Fen-Phen, a defective drug, was used by at least 6 million Americans until it was recalled in 1997 after reports linked it to heart valve disease, primary pulmonary hypertension (PHH), heart failure, lung failure, aortic and mitral heart valve damage (regurgitation), and other serous conditions.
Fentanyl: On Friday, July 15, 2005, the FDA warned that the pain relief patch Duragesic could cause drug overdoses and said it was looking into reports of 120 deaths and other serious side effects from overdoses in patients using the skin patches for pain control. Johnson & Johnson’s Duragesic patch contains fentanyl, which is a strong, opioid narcotic painkiller. Deaths and overdoses have occurred in patients using both the brand name product Duragesic and the generic product fentanyl. The FDA believes that the chief cause of the deaths and overdoses of patients using fentanyl transdermal (skin) patches is lack of knowledge: The agency has stated that some patients and health care providers may not be fully aware of the dangers of the potent morphine-like drug. The directions for using the patch must be followed exactly to prevent death or other serious side effects. The FDA has proposed precautions regarding the safe use of the patches, including patient education regarding signs of overdose, proper patch application, use of other medications while using the patch, safeguards for children, and proper storage and disposal. Duragesic has been on the market since 1990, and the FDA said the 120 deaths reported to the agency spanned the entire period from 1990 to present. Mylan Laboratories Inc. began marketing a generic version of the drug this year. The Duragesic patch can provide up to three days' relief from severe chronic pain, but an overdose of the morphine-like drug can put a patient into a coma and shut down breathing. In addition to trouble breathing or shallow breathing, the other signs of fentanyl overdose include:
- Tiredness
- Extreme sleepiness
- Inability to think, talk or walk normally
- Feeling faint, dizzy or confused
People experiencing the symptoms should get medical attention immediately. The FDA also alerted doctors that they should prescribe the lowest effective dose of the medication, and that the patches should not be used to treat short-term pain or pain after an operation. Patients should not use patches that are damaged or broken, the FDA said. They also should not drink alcoholic beverages or sit in the sun while taking the drug, because alcohol and a rise in body temperature can accentuate the narcotic effects. While the FDA is primarily targeting patient education, it is not ruling out the possibility that problems or defects with the patches may have caused some of the 120 deaths. The fentanyl investigation is in its early stages, FDA officials said, and the agency has reached no decision on whether the patches should be recalled or their use limited.
Final Judgment: The written ruling on a lawsuit by the judge who presided at trial. This completes the case unless it is appealed to a higher court. May also be referred to as a final decree or final decision.
Fosamax: Manufactured by Merck, gained FDA approval in 1995. It is a medication used for bone loss, but has been implicated in the serious necrosis of the jaw and other bones, a condition known as “osteonecrosis,” also called “bone death.” Fosamax is a bisphosphonate medication used to increase bone mass, reduce bone fractures and prevent and treat osteoporosis in post-menopausal women. However, cases of osteonecrosis (involving the jaw) have been reported in patients treated with bisphosphonates. The majority of the reported cases are in cancer patients who are having, or have had, a dental procedure. With osteonecrosis, the bone tissue in the jaw fails to heal after minor trauma, such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. Experts say that prevention and early treatment of individuals using bisphosphonates such as Fosamax is extremely important in preserving the jaw bone. Individuals using Fosamax or other bisphosphonates should attempt to avoid tooth extractions and other major dental work while on the drugs. The discovery of the Fosamax-osteonecrosis connection was first published in the Journal of Oral and Maxillofacial Surgeons in May 2004. That information prompted the U.S. Food and Drug Administration to require that all bisphosphonate labels should mention osteonecrosis. Other drug companies updated their labels to include the warnings in 2004. To date, Merck has not included the warning on its Fosamax label. Bisphosphonates remain in bone indefinitely. Symptoms of bone death in the jaw include:
- Pain
- Swelling
- Infection of the gums
- Loosening of the teeth
- Poor healing of the gums
- Numbness, or a feeling of heaviness in the jaw
- Exposed bone
Fosamax can also irritate the esophagus, and care must be taken in order to avoid such irritation. Recently, researchers discovered that taking Fosamax in combination with the popular arthritis drug Naproxin may increase the risk of developing stomach ulcers.
Fraud: Occurs when intentional false statements are made to entice a victim to give up something of value.
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