Fen Phen – Diet Drugs & Primary Pulmonary Hypertension (PPH)
Fen phen is a type of diet medication (anorectic) that was composed from a combination of fenfluramine and phentermine; hence its “fen phen” classification. In 1997, it was reported by the Mayo Clinic that a significant number of fen phen users had developed heart valve disease as a result of using the anorectic. Continued reports of serious side effects associated with the use of fen phen resulted in a Food and Drug Administration (FDA) recommendation of a voluntary withdrawal of the appetite suppressant drug from US markets.
Fen phen was never approved for use by the FDA because its individual components (fenfluramine and phentermine) had already been studied and approved by the organization. The combination of the previously approved drugs fell under the heading of “off label use,” meaning that there were no laws preventing such a use, though safety and efficacy had in no way been measured by the FDA.
Fen Phen Side Effects
There are a number of common side effects associated with the use of fen phen, most of which result from the individual components of fenfluramine and phentermine.
Common side effects associated with fenfluramine use include drowsiness, dry mouth and diarrhea; however, use of the drug could also result in: dizziness, confusion, nervousness, insomnia, constipation, abdominal pain, blurred vision, rash, fever, fainting, hypertension and heart valve disease.
Common side effects associated with phentermine use include headache, insomnia, irritability and nervousness; however, use of the appetite suppressant could also result in: tremor, dryness of the mouth, palpitation, tachycardia, euphoria, gastrointestinal disturbances, psychotic episodes, hypertension and heart valve disease.
Fen Phen Use & PPH
Fen phen use has been linked with the development of a serious condition called primary pulmonary hypertension (PPH). The FDA recommended the voluntary withdrawal of Fen phen in September of 1997 following significant evidence of serious side effects associated with use of the drug, notably the drug’s potential of causing heart valve defects and PPH.
Primary pulmonary hypertension results from a dangerously elevated blood pressure in the pulmonary artery (artery transporting blood from the heart to the lungs for oxygenation). The dangerously elevated blood pressure forces the heart muscles to work harder to pump sufficient quantities of blood to the lungs. Over time, the heart muscles can become weakened to such an extent from overexertion that they fail, culminating in heart failure and death.
Although there are a number of known causes of PPH in addition to a number of unknown (idiopathic) causes, the link between the use of fen phen and the potential development of PPH was such that it warranted FDA action.
Fen Phen & Dexfen Phen
In addition to a fenfluramine and phentermine combination, patients were often administered a dexfenfluramine and phentermine cocktail that was labeled as dexfen phen. Like fen phen, dexfen phen has also been linked with the development of a number of serious health conditions.
Fenfluramine was first introduced to the US market in 1973 as a drug designed to increase levels of a neurotransmitter called serotonin, depressing the central nervous system and helping to moderate a patient’s mood and appetite. As a single agent, fenfluramine is also known by its brand name of Pondimin. Fenfluramine was withdrawn from the US market in 1997.
Phentermine was approved for use in 1959 as an appetite suppressant for individuals facing an increased medical risk as a result of their weight. Although phentermine has been linked with the development of a number of side effects (including hypertension), it is currently still available for prescription as a single agent in the United States.
Dexfenfluramine was approved for use as an appetite suppressant in 1996 under the brand name of Redux. Dexfenfluramine was manufactured as an alternative to both fenfluramine and phentermine. Dexfenfluramine and Dexfen Phen (dexfenfluramine / phentermine combination) were withdrawn because of the drugs’ propensity towards causing heart valve disease and pulmonary hypertension.
Drug manufacturers are responsible for ensuring the safety and efficacy of their products before marketing them for public consumption. Failure to do so is considered negligent and grounds for personal injury litigation. The Pensacola personal injury attorneys of Aylstock, Witkin Kreis & Overholtz handle national litigation across the United States for victims injured by defective pharmaceuticals and medical devices. They have successfully represented and obtained substantial compensation for a number of patients who have been harmed by defective drugs. Contact AWKO law today at (844) 794-7402 to get more information about your rights as a Fen Phen injury victim.