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WILLIS
LAW FIRM

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Legal Assistance for PPH & Diet Drug Victims since 1997  

DIET DRUG  & FEN- PHEN HISTORY EXPLAINED

    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 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.


FEN PHEN IS BORN

      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 Within weeks of a July 1997 Mayo Clinic paper being published, the drugs were withdrawn.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 PULMONARY HYPERTENSION (PPH)
FDA Announces Withdrawal Fenfluramine and Dexfenfluramine (Fen-Phen)

P97-32
FOR IMMEDIATE RELEASE
September 15, 1997
FOOD AND DRUG ADMINISTRATION
Lawrence Bachorik: (301) 827-6250
Broadcast Media: (301) 827-3434
Consumer Hotline: (800) 532-4440

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.

 


PPH LAWYER

Primary Pulmonary Hypertension (PPH) Legal Assistance LawyerIf you or a loved one took diet drugs and recently have been given a diagnosis of Primary Pulmonary Hypertension (PPH), idiopathic pulmonary hypertension, pulmonary arterial hypertension, PAH or pulmonary hypertension, then call us for a Free PPH Lawsuit Consultation. Talk to a Personal Injury Trial Lawyer with over 20+ years of product liability trial experience that understands the complications of PPH, legal options for patients with PPH and diet drug related PPH lawsuits and litigation.

Since 1997, we have aggressively represented PPH patients in diet drug lawsuits against the makers of Fen -Phen, Redux and PPH lawsuits against the nutritional supplement industry on herbal ephedrine / ephedra / ma huang PPH lawsuits. Get PPH Lawsuit Help. Talk to a PPH Attorney now. Call Toll Free 1-800-883-9858 or E-mail us.

Primary Pulmonary Hypertension (PPH) Legal Assistance Lawyer

BOARD CERTIFIED

Primary Pulmonary Hypertension (PPH) Legal Assistance LawyerIf you have been diagnosed with PPH then it very important that you talk with an attorney. Mr. Willis is a Board Certified Personal Injury Trial Lawyer, certified by the Texas Board of Legal Specialization since 1988. No Fees or Court Costs or Expenses charged to the client unless we obtain a recovery for you. We never send you a bill for our services! Call us if you have a question.

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