FDA Recalls Diet Drug After Link To Pulmonary Hypertension Found By Mayo Research
Although Primary Pulmonary Hypertension (PPH) and Primary Arterial Hypertension (PAH) are known as rare diseases, with PPH affecting the health of only one or two individuals in a million, a link has been found between a diet drug and the devastating condition. This is significant because there is no cure for PPH and the disorder can prove fatal.
The Fen Phen Pulmonary Hypertension link was first recognized during a study at the Mayo Clinic in Minnesota. As part of the research, 24 women were given a combination of the diet drugs Redux (dexfenfluramine), Pondimin (fenfluramine), and Phentermine, which combined make up the drug in question, and were monitored closely. Of the controlled group, 8 of the 24 women developed PPH (a 230% increase) while 30% showed signs of heart valve damage.
No one is exactly sure what causes PPH, although a genetic link has been found. What is known is that the disorder leads to high blood pressure in the lungs. Blood vessels constrict, putting abnormal levels of stress on the pulmonary artery. This restricts the flow of blood to the lungs and causes dizziness, faintness, shortness of breath and, in severe cases, heart failure. Detection is crucial to helping people get the treatment they need early on.
The importance of the connection was highlighted when the United States Food and Drug Administration (FDA) recalled the fenfluramine-phentermine combination on September 15, 1997. The combination had never actually been approved by the FDA, but it was prescribed legally by Doctors to millions of individuals during the 90s. Nevertheless, thousands of lawsuits followed as people began to seek medical advice and learned that they too had developed PPH. As treatment for the disorder can prove costly, and it is chronic and without cure, patients sought compensation from American Home Products (AHP). The courts found that the company sold the drug even though it was aware of the potential dangers since at least 1994. ADP’s failure to disclose the truth to the doctors or to the FDA resulted in legal settlements of billions of dollars for the organization and thousands of potentially fatal cases of PPH. To date, the FDA has received reports of 123 deaths related to use of the product.
Over 11,000 cases have been filed against the company since the recall. The PPH class action settlement resulting from these suits cost the company $4.83 billion, the largest product settlement of any kind to date. An FDA reviewer stated that the company was aware of the danger of taking the medication and failed to report those concerns.
Over ten years later, Fen Phen attorneys are still reviewing cases, as the disease is capable of lying dormant for up to two decades. Therefore, lawyers expect claims to continue over the next several years, and the class of plaintiffs is only growing. In April 2004, a state court in Texas awarded $1 billion to the family of a woman who died from the disorder.
Pulmonary Arterial Hypertension (PAH) is another term used for PPH and is diagnosed only after other illnesses are ruled out. Because many of the symptoms are often present in overweight people, they are often overlooked. However, proper medical attention is crucial. If you have been suffering from any of the following symptoms below and you were administered the diet pill, consider seeking the advice of a doctor.
Symptoms to be aware of are:
• Progressive shortness of breath (especially with activity)
• Hyperventilation (breathing harder and faster)
• Fatigue (tiring easily)
• Progressive weakness
• Fainting spells
• Lightheadedness or dizziness
• Coughing up blood
• Progressive cyanosis (blue tinge to lips hands and feet)
Remember that you are also entitled to compensation if you have suffered damage. For further information about your legal rights, consult an attorney.
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Fen Phen PPH Lawsuits Attorneys
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