Fen Phen Lawsuit – Everything To Know About Fenfluramine/Phentermine, Its Ban, And Weight Loss Study…
By Consider The Consumer on 09/18/2021
Weight Loss and Fen-Phen: The History
What Is Fen-Phen?
Fenfluramine/phentermine, or more commonly known as Fen-Phen, was used to treat obesity, and it is made of two anorexics or also known as anorectics. An anorexic is used to lessen the appetite, which may result in consuming a lesser amount of food which will end up in weight loss.
American Home Products advertised Fenfluramine as Pondimin, but it was later found out that it can cause fatal pulmonary hypertension and heart valve damage. The drug caused withdrawal and legal problems, amounting to more than $13 billion.
While fenfluramine releases serotonin, the phentermine diet drug releases norepinephrine, but it happens rarely. It also pushes the release of dopamine along with serotonin.
The name fen-phen started in 1994 after Pietr Hitzig and Richard B. Rothman relayed that the combination drugs fenfluramine and phentermine diet drug might cause a craving for alcohol and cocaine. They also mentioned that dopamine and serotonin agonists may also result in the same.
How Fen-Phen Works
Phentermine activates the fight or flight nervous system, the reason it’s called a sympathomimetic drug. What happens after is that the appetite is lessened, making people who take phentermine eat less. It also results in a person using more calories.
FDA-approved phentermine to be used for a short period, about 12 weeks at a time, to assist with weight loss. If someone is overweight and has health-related issues which contributed to the obesity, if a lifestyle change did not help, then phentermine can be an option.
But there are risks when using phentermine, which is why before deciding, a consult with a healthcare provider is of utmost importance.
There are also several conditions to think about before using phentermine:
- Don’t use it if not obese/overweight.
- Don’t use if there is heart disease, high blood pressure, hyperthyroidism.
- Don’t use it if there is a history of drug abuse.
Why Was Fen-Phen Banned?
First released in the 70s, it wasn’t initially known as a weight-loss drug. A research study in 1984 found that a 7.5 kg weight loss happens on average within 24 weeks, compared to a 4.4 kg weight loss under a placebo.
Wyeth, formerly American Home Products, official Fred Wilson was concerned about the labeling on Fenfluramine, where it only showed four instances of pulmonary hypertension. It was found out that the numbers actually total out to 41.
By 1995, American Home Products introduced dexfenfluramine, a dextro isomer. It was advertised as Redux, hoping it would have lesser side effects. A medical official from the Food and Drug Administration (FDA), Leo Lutwak, emphasized the importance of a black box to warn people of pulmonary hypertension risks.
Lutwak eventually did not approve the drug, but FDA Senior Drug Evaluator James Milton Bilstad pushed the drug through and approved it without warning in 1996. There were regulators in Europe that insisted on having a warning sign telling of the risks.
By 1996, a woman of 30 years had heart problems after a month of using fenfluramine/phentermine. She passed away in February 1997.
There was research published in the New England Journal of Medicine (NEJM) from the Mayo Clinic where the results from 24 people who took fen-phen were documented.
The researchers found a significant link between mitral heart valve dysfunction and using anorectic agents. The FDA ordered doctors that it received nine more reports with the same issue and asked all medical professionals to report any similar cases to FDA’s MedWatch program or to their respective pharmaceutical manufacturers.
The FDA has also received various reports of valvular heart disease in people taking fen-phen, Fenfluramine alone, or dexfenfluramine by itself. The agency has then asked manufacturers of drugs fenfluramine and dexfenfluramine to emphasize the possible risk to the heart.
By 1997, the FDA was still receiving reports of valvular heart disease in people who took the drugs, which involved aortic and mitral heart valves.
The FDA took Fenfluramine and dexfenfluramine off the market in September 1997 as they found the drugs to be associated with heart valve issues. Although with fen-phen, they did not ban phentermine diet drugs.
FDA asked for fen-phen to be removed from the market in September 1997 after there was an uptake of valvular heart disease and pulmonary hypertension, mostly in women who were taking fen-phen or dexfenfluramine.
Is It Still Available after the Fen Phen Lawsuit?
Fen-phen is not available in the market anymore.
American Lawyer magazine in April 2005 came up with a story about the Fen Phen Lawsuit, and they reported that over 50,000 product liability lawsuits were filed by alleged fen-phen victims. The liability costs went up as high as $14 billion. By February 2005, Wyeth was still negotiating with the affected class members.
Settlements amounted from $5,000 to $200,000 for the previous lawsuits and gave hints that they could give a higher settlement to people who had more serious injuries. Although with the prices Wyeth was offering, several plaintiffs’ lawyers from different law firms rejected them, thus prompting Wyeth to shell out $21.1 billion.
As of 2021, fen-phen claims are still ongoing since 1998.
The settlement trust was opened to manage the aortic and mitral valve injury claims for users of Pondimin or Redux. There is a law firm taking care of managing them.
Conditions for people to file a claim for the Fen Phen Lawsuit Settlement:
- Supplemental claims because of worsened injuries may be filed by people who got a Matrix Compensation from the AHP Settlement Trust.
- They also should not have taken part in the Seventh Amendment Supplemental Fund.
- They have been diagnosed with a condition qualifying them for a Matrix Compensation level and dollar value that will be above previous awards received.
- The condition that qualifies them for Matrix Compensation should have been diagnosed before their 80th birthday and should be within four years of filing the claim.
- Original claims may also be filed by people who have not yet received the Matrix Compensation.
- Filed an opt-out form on or before November 9, 2004, thus removing them from participating in the Seventh Amendment Supplemental Fund.
- Have not filed an opt-out form which should have removed them from the AHP Settlement Trust.
- Did not settle a claim for Pondimin or Redux injuries outside of the AHP Trust.
- They can show evidence that a Matrix Compensation medical condition existed before December 31, 2015.
Lasting Damage From Fen-Phen Drug
What Happened to Fen-Phen Users
On November 5, 2008, a study discussed the possibility that fen-phen will have lasting effects on the heart. It showed that the heart valve issues were connected to obesity drugs that were banned at the time.
The study was published in BMC Medicine, and it related to what occurred when 5,743 people used Fenfluramine alongside dexfenfluramine.
Medical experts, including Charles Dahl, MD, who worked at the Central Utah Clinic in Provo, observed the patients from July 1997 till February 2004. The patients were then subjected to an echocardiogram, and among them, 1,020 patients were given over two echocardiograms for an average of two months apart.
There were two things that the team looked for preexisting conditions with the echocardiograms, that is, if there are any signs of regurgitation or if blood was leaking back through the heart valves. They also noted the patients who went through surgery to have the heart valve issues corrected.
After checking if anyone met those preexisting conditions, the team found out that almost 20% of the women and nearly 12% of the men had mild regurgitation in the aortic valve or moderate regurgitation in the mitral valve.
These characteristics were more prevalent in women and in people who took fenfluramine or dexfenfluramine, each by itself or both for a specific duration. Upon further echocardiograms, it presented that aortic and mitral heart valve regurgitation was the same in most cases but also worsened in others. They also saw regurgitation to have improved sometimes.
It was not clear, though, why some patients worsened while others improved.
Thirty-eight of the participants went through heart surgery, which is uncommon. According to the research, in 25 cases, they associated the damage on the heart valves to the drugs.
Three out of four on the research team of the study became plaintiffs for the class action that was linked to fen-phen.
Is Phentermine the Same as Fen-Phen?
Phentermine is just one of the drugs that are effective for weight loss under the right circumstances. It is not the same as fen-phen as it’s only one of the two in that combination.
Fenfluramine is another drug that activates the sympathetic nervous system, but it has side effects that affect serotonin which leads to the suppression of a person’s appetite.
Fen-Phen and Weight Loss
Weight loss is on more people’s minds these days, and having a weight loss drug help. But there will be serious implications that are linked to overweight or obese conditions, which is the reason health care providers suggest getting to a healthy weight level appropriate for someone’s height and build. It is inexplicably hard, though, if it’s not done in the right mindset.
It is a pharmaceutical company that was founded in Philadelphia, Pennsylvania, in 1860. Known as American Home Products in the 1930s, it changed its name to Wyeth in 2002. They make over-the-counter drugs and prescription drugs.
Editor’s Note on Fen Phen Lawsuit – Everything To Know About Fenfluramine/Phentermine, Its Ban, And Weight Loss Study:
This piece is written about the history of Fen-Phen and its adverse effects on consumers’ heart. The Fen Phen lawsuit is still in the settlement phase since 1998. You might also be interested in NuBiotix History, a probiotic supplement.
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