Fen Phen Diet Drug Linked to PPH & PAH

    While dieters since the mid 1950's had used amphetemine types of diet aids it was not until in 1973, Pondimin (fenfluramine) first was approved by the FDA (Food & Drug Administration) to fight obesity for "single drug, short-term use." Pondimin promoted a feeling of fullness in users that caused them to have a decreased appetite. The problem with Pondimin is that it had side effects such as include diarrhea, drowsiness, and dry mouth.

Phentermine & PPH & PAH

Phentermine is another diet drug that also had a long history behind it, being approved for sale in 1959 by the FDA. Despite the side effects of insomnia and irritability, phentermine also spent its time on the market without event. Both of these drugs, Pondimin and Phentermine were not very popular because of their side effects. Phentermine by itself has not been proved to have caused PPH or PAH, but in combination with Pondimin or Fenfluramine, can be linked to PPH & PAH. Often one that has been diagnosed with PPH or PAH only took prescription phentermine, but with more digging into their herbal and diet history we find they also took St. John's Wort, Dexatrim Natural with Ephedra, Dexatrim Results with Ma huan or Ephedra , diet an dwieth loss products containing ephedra from Herbal Life and even some over the counter (OTC) brands of nasal decongestant.

Fen Phen is Born & PPH & PAH Numbers Rise !!!

In 1992, a study was published that showed that by using Pondimin (fenfluramine) with Phentermine, that side effects of dry mouth could be reduced while maintaining effective weight loss with both drugs being taken. However, since the doses were lower, the doctor performing the study lengthened the duration of administering the drugs. A critical note by the FDA at that time of approval for fenfluramine, was that safety of use beyond one year had not been established in clinical trials. Within weeks of a July 1997 Mayo Clinic paper being published, the drugs were withdrawn. The Mayo report showed heart valve damage in about one third (1/3) of those studied who had been taking Fen-Phen comdination, Pondimin or Redux.  Additionally eveidence was presented of an increase likelihood of primary pulmonary hypertension cases as well. Immediately the FDA announces it's withdrawal (see below)

PRIMARY PUMONARY HYPERTENSION (PPH)

FDA Announces Withdrawal Fenfluramine and Dexfenfluramine (Fen-Phen)

FDA ANNOUNCES WITHDRAWAL OF FENFLURAMINE AND DEXFENFLURAMINE

The Food and Drug Administration, acting on new evidence about significant side-effects associated with fenfluramine and dexfenfluramine, has asked the manufacturers to voluntarily withdraw both treaents for obesity from the market. Dexfenfluramine is manufactured for Interneuron Pharmaceuticals and marketed under the name of Redux by Wyeth-Ayerst Laboratories, a subsidiary of American Home Products Corp. of Madison, N.J., which also manufactures and markets fenfluramine under the brand name Pondimin. Both companies have agreed to voluntarily withdraw their drugs. The FDA is not requesting the withdrawal of phentermine, the third widely used medication for obesity.

The action is based on new findings from doctors who have evaluated patients taking these two drugs with echocardiograms, a special procedure that can test the functioning of heart valves. These findings indicate that approximately 30 percent of patients who were evaluated had abnormal echocardiograms, even though they had no symptoms. This is a much higher than expected percentage of abnormal test results.

"These findings call for prompt action, " said Michael A. Friedman, M.D., the Lead Deputy Commissioner of the FDA. "The data we have obtained indicate that fenfluramine, and the chemically closely related dexfenfluramine, present an unacceptable risk at this time to patients who take them."

FDA recommends that patients using either of these products stop taking them. Users of these two products should contact their doctors to discuss their treaent.These new findings suggest fenfluramine and dexfenfluramine are the likely cause of heart valve problems of the type that prompted FDA's two earlier warnings concerning "fen-phen, " a combination of fenfluramine and phentermine. "Fen-phen" has been widely used off-label in recent years for the long-term management of obesity.

In July, researchers at the Mayo Clinic and Mayo Foundation reported 24 cases of rare valvular disease in women who took the "fen-phen" combination therapy. FDA alerted medical doctors that it had received nine additional reports of the same type, and requested all health care professionals to report any such cases to the agency's MedWatch program (1-800-FDA-1088/fax 1-800-FDA- 0178) or to the respective pharmaceutical manufacturers.

Subsequently, FDA received 66 additional reports of heart valve disease associated mainly with "fen-phen." There were also reports of cases seen in patients taking only fenfluramine or dexfenfluramine. FDA requested that the manufacturers of fenfluramine and dexfenfluramine stress the potential risk to the heart in the drugs' labeling and patient package inserts. FDA continues to receive reports of cardiac valvular disease in persons who have taken these drugs.

What are PPH & PAH ?

Primary pulmonary hypertension (PPH) and Pulmonary Arterial Hypertension (PAH) are rare and often fatal diseases that results in the progressive narrowing of the blood vessels of the lungs which as a result causes high blood pressure in these blood vessels and eventually leads to heart failure. The lungs contain millions of tiny blood vessels called capillaries. These capillaries are extremely small, just wide enough for blood cells to move through. The capillaries are lined with endothelial cells that prevent blood from leaking out of the vessel. The outside of the blood vessels are muscle type cells that expand and contract as blood moves through from the heart into the lungs.

PAH & PPH causes the cell lining of the lung's blood vessels to weaken and allow leakage. The leaking of blood out of the vessels causes the muscles that surround the blood vessels to constrict. This continuous constriction increases the pressure within the blood vessels and cuts off blood flow. The constriction gradually worsens, eventually increasing the pulmonary arterial pressure. Secondary pulmonary hypertension (SPH) is the result of other types of lung disease, abnormal breathing processes or heart disease. 

PPH & PAH Symptoms

• Shortness of breath following exertion,  
• Excessive Fatigue
• Chest pain
• Ankle Swelling 
• Fainting
• Bluish Lips and skin

Causes of PPH & PAH

No one is certain as to what causes Primary pulmonary hypertension (PPH) and Pulmonary Arterial Hypertension (PAH), but research has shown that there are a number of factors that may be responsible for the disease. Some of the possible causes include immune system disease, congenital heart defects, portal hypertension, HIV infection, Collagen Vascular Disease, and intravenous drug use  or other chemical exposures. The use of certain appetite suppressants, herbal medicines, St Johns Wort, (ephedra ephedrine alkaloids, ma huang), Pondimin (fenfluramine) and  Redux (dexfenfluramine), have been found to greatly increase the risk of developing PAH or PPH.  Even if the disease has progressed, the signs and symptoms may be hard to detect or even confused with other conditions that affect the heart and the lungs. Early diagnosis of PAH or PPH is usually done by an echocardiogram. The echocardiogram is used to detect elevated pulmonary artery pressures. However, with some patients a cardiac categorization is necessary to confirm the diagnosis and gather additional artery pressures.

Treatment of Primary Pulmonary Hypertension (PPH) & Pulmonary Arterial Hypertension (PAH)

Since there is no cure for PAH / PPH, the treatments listed below at best only relieve the symptoms. Relief from these symptoms however can raise quality of life and raise the life expectancy by a number of years. Doctors have developed functional classifications of Primary Pulmonary Hypertension based on the level of the conditions and symptoms involved. The general treatments for PPH / PAH include: Calcium Channel blockers that can be used to lower pressure; oxygen enables the patient to breath easier and lowers pressure; Coumadin (warfarin) thins the blood and prevents clotting; diuretics or "water pills" relieve fluid that collects in the ankles and belly area, digoxin slows the heart rate to improve muscle force. These new treatments for PPH include use of Tracleer, Flolan, Reodulin (UT-15) and Bosentan. The most prescibed and so far the most effective PPH treatments have been with the use of Tracleer and Flolan.

Treatment Options for PPH & PAH Patients

• Anticoagulant therapy
• Vasoconstriction (Use of calcium channel blockers)
• Increased doses of prostaglandin
• Flolan-Prostacyclin ( Flolan with a Blood Thinner)
• Prostacyclin Infusion Therapy
• Diuretics
• Supplemental Oxygen
• Flolan Treatment
• Tracleer Treatment
• Use of other PPH Drugs- Bosentan, Remodulin (UT-15)
• PPH Surgery - Bilateral (Double) lung transplantation
• PPH Surgery -Single-lung transplant

Many important legal issues need to be addressed early after a PAH or PPH diagnosis, that can affect the outcome of the diet drug litigation. Call us for a Free Confidential Consultation. Talk with a Board Certified Personal Injury Trial Lawyer about your legal rights of a claim against the diet drug industry and others.

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