|
Redux and Pondimin FAQ
1. What is Fen Phen?
Fen Phen is the combination of fenfluramine and phentermine that
was used as an appetite suppressant marketed under the names Redux,
Pondimin, Fenfluramine, and Dexfenfluramine. There were no studies
presented by AHP to the FDA that demonstrated the safety or effectiveness
of the combination of drugs, leading to the 1997 recall.
Top of Page
2. What is the difference
between
Redux and Pondimin?
Both Redux and Pondimin have resulted in deadly and serious health
complications, including primary pulmonary hypertension (PPH). Pondimin
is the marketed name for fenfluramine and Redux is the marketed
name for dexfenfluramine, but both drugs were manufactured by AHP
and were intended for the management of obesity.
Top of Page
3. Why were Redux and Pondimin
FDA withdrawn?
The Mayo Clinic reported that 24 patients had developed heart valve
disease on July 8, 1997, after taking Fen Phen. Five patients had
undergone valve replacement surgery and the disease valves were
found to have a distinct feature that was similar to carcinoid syndrome.
This suggested the Fen Phen use and valve disease link. Following
this report, the FDA issued a Public Health Advisory on July 8,
1997 that was published in the New England Journal of Medicine along
with an FDA letter to the editor describing additional cases of
over 100 reports of heart valve disease. The FDA received more information
after these reports concerning heart disease in Redux and Pondimin
patients that further convinced the FDA of the dangers regarding
the diet drugs.
Top of Page
4. Why did it take so long
for Redux and Pondimin to be recalled?
Evidence that Fen Phen causes deadly effects has been dated as far
back as 1997 and it was believed that AHP had access to studies
showing the potential heart problems with their diet drugs far before
that. An FDA investigation in September 1997 found that there were
many problems with AHPs reporting, quality control, record
keeping, and safety surveillance. The product was not removed from
the U.S. market until the FDA requested the recall of Redux and
Pondimin. The FDA claims it took them so long to issue the withdrawal
request because of the unusual types of drug reactions patients
experience with Redux and Pondimin were not found until later.
Top of Page
5. What is primary pulmonary
hypertension (PPH)?
Primary pulmonary hypertension is a potentially fatal cardiovascular
disease without a cure. While there is no known cause of primary
pulmonary hypertension (PPH), it has been found to have a twenty-three-fold
increase in risk in as little as three months of using Redux or
Pondimin to develop.
Top of Page
6. What are common side effects
of primary pulmonary hypertension (PPH)?
- Shortness of breath
- Weakness
- Fatigue
- Fainting
- Tiredness
- Chest Pain
- New Heart Murmur
- Bluish Lips and Skin
- Increased Chest Pain
- Ankle and Lower Leg Swelling
- Death
Top of Page
7. Am I qualified to receive
compensation for the use of Redux and Pondimin?
On January 3, 2002, the Nationwide Class Action Settlement Agreement
with American Home Products received Final Judicial Approval. Under
the Settlement it allows former Redux and Pondimin patients to receive
compensation if they have developed the deadly and serious conditions
that have been linked to the once popular diet drugs. If you have
used the diet drug Fen Phen, including Redux and Pondimin, you are
eligible to file a claim by August 2002. If
you would like to learn more about your legal rights regarding the
Redux/ Pondimin recall, please contact us.
Top of Page
8. How can I learn more about my
legal rights?
Contact us to speak directly
with an expert Redux lawyer.
|