Qnexa® is an experimental weight-loss drug developed by Vivus, Inc., a California-based pharmaceutical company. This medication is meant to lessen the effects of illnesses, including type 2 diabetes and high cholesterol, and weight loss, making it more effective than other diet tablets.
It’s a mix of Topamax® and phentermine, two prescription drugs. Despite this, the Food and Medicine Administration (FDA) rejected the drug for use in the United States in 2010 due to several adverse side effects.
The weight-loss aids Topamax® and phentermine are effective in the diet tablet Qnexa®. Topiramate, the active ingredient in Topamax®, was first created to treat epilepsy as an anticonvulsant. It was discovered to help treat post-traumatic stress disorder (PTSD) and prevent migraines as time went on (PTSD).
Phentermine, an appetite suppressant, reduces the desire to eat by releasing particular chemicals into the brain. Even though both medicines are said to help with weight loss, it is thought that they work better together than independently.
If a medicine enhances weight reduction by 5%, it must be categorized as an anti-obesity drug by the FDA. In the third portion of clinical tests done by Vivus, Inc., Qnexa® was revealed to have an average weight loss of 14.7 percent. The dose was divided into three intensities: total, medium, and low throughout this study phase.
To compensate for the higher amounts of Topamax®, which were given in a timed-release formulation, phentermine was given in smaller doses but in an immediate-acting form.
In October 2010, the Food and Drug Administration (FDA) rejected the use of Qnexa® in its current form. Heart palpitations and even birth abnormalities were also reported as side effects of this drug. Despite this, the FDA requested that Vivus, Inc. continue evaluating and reformulating the drug to address fetal growth issues and heart-related hazards.
This weight-loss drug was examined and shown to have severe minimal side effects. However, the manufacturer admits to a few minor ones. The most common minor side effects were headaches, stomach difficulties, and sleep disturbances. Many widely assumed that Qnexa’s positive effects outweighed the negative ones during clinical trials.
The FDA is Reviewing the Diet Pill Qnexa
On the 9th of November, 2011 — The FDA rejected this weight loss pill a year ago due to worries about potential heart problems and birth defects in babies delivered to women who take it. The FDA is now considering re-approving Qnexa for patients who like to lose weight.
The FDA has requested limited approval for Vivus Inc.’s oral combination drug Qnexa, which excludes women in their reproductive years.
The FDA is expected to decide on the product’s approval in April of next year, according to the company. The drug will likely be available for purchase soon after the FDA approves it.
In the United States, weight loss pill Qnexa was the first FDA-approved long-term appetite suppressor. Orlistat, the only other frequently prescribed prescription weight control medication, operates by preventing dietary fat from being absorbed. It’s sold as Xenical on prescription and as Alli over the counter.
People who took the total dose of Qnexa prescribed by Vivus for a year lost 14% of their body weight. The research was submitted to the FDA last year and was just published in the journal Obesitylate. As a result, blood pressure, cholesterol, triglycerides, and glucose levels improve.
Qnexa is A Pharmaceutical Combination
Low doses of the stimulant phentermine, which has long been used to treat binge eating, are mixed with Topiramate, an anti-seizure and migraine drug that has also been used “off label” to treat binge eating. Off-label drugs are those that doctors prescribe for conditions that the FDA has not approved.
According to the North American Drug Registry, children born to mothers who took Topiramate had a 20-fold increase in cleft palates, prompting an FDA panel to vote against its approval last year.
Further research merging numerous databases, according to Vivus Inc. CEO Peter Tam, demonstrates that the risk for the oral congenital disability is much lower than previously anticipated.
In light of the new findings, the FDA decided to allow the company to resubmit its application for limited approval for use in people unlikely to become pregnant.
According to Tam, there is also a probe into medical claims made by pregnant women who used Topiramate for seizures, migraines, and other ailments.
The current study included 1,267 highly obese patients treated in 91 different locations across the United States.
The trial participants were given one of two daily doses of Qnexa or a placebo. All participants were advised to seek counseling, reduce their calorie intake by 500 calories per day, increase their water intake, and increase their physical activity.
Only 53% of placebo patients continued in the study for the entire year, compared to those who received a lower dose and a higher dose of Qnexa.
The most prevalent side effects were a metallic taste on the tongue, tingling, dry mouth, constipation, and dry mouth.
The higher dosages of Qnexa caused an increase of one beat per minute in average heart rate, while the lower doses caused an increase of less than one beat per minute.
The research suggests that Qnexa appears to be the most effective weight loss medicine since the Fen-Phen diet, according to Doctor Timothy Garvey, a diabetes specialist and study co-researcher from the University of Alabama in Birmingham. Fen-phen is a combination of fenfluramine and phentermine. Fenfluramine was pulled off the market in the late 1990s due to concerns about the drug’s link to significant cardiovascular side effects.
According to data collected from patients who took part in the trial, the more significant Qnexa dose resulted in a 14.4% weight loss, compared to 6.7 percent for the lower amount and 2.1 percent for the placebo.
Compared to the lower-dose and placebo groups, more than twice as many patients in the higher-dose group lost 15% or more of their body weight.
Patients who received the highest dose of the experimental combination treatment dropped out of the research early due to adverse side effects, compared to only 11% of those who received the lower amount and 8.4% of those who received the placebo.
Weight-loss medicines are having a difficult time right now.
According to Tam, Qnexa will be approved. However, he does agree that the current regulatory environment for weight-loss drugs has been challenging.
In October of last year, the FDA denied Arena Pharmaceuticals’ application for its weight-loss drug lorcaserin, the same month that Qnexa was rejected. The FDA also pulled Meridia, a 13-year-old diet drug, from the market due to heart attack and stroke risk concerns.
The FDA may feel compelled to approve Qnexa because of its success, according to a weight-loss expert at Cornell University’s Weill Medical College, as long as the company can demonstrate that it can limit its usage to patients for whom it has been approved.
Aronne is the director of the Comprehensive Weight Control Program at New York-Presbyterian Hospital.
Obesity is a growing medical concern, and we need effective treatments to manage it.
Weight-loss surgery is now regarded as a medical procedure, and a new generation of weight-loss drugs will be treated similarly.
He clarifies that this is a medical issue, not an aesthetic one. Blood pressure and diabetes, sleep apnea, and the risk of stroke and heart attack can all be lowered by losing weight.
Dr. Mitchell Roslin, a bariatric surgeon, agrees, albeit he voices his concerns about Qnexa to WebMD. Roslin, the hospital’s chief of obesity surgery, is based at Lenox Hill Hospital in New York City.
Americans’ Reactions to Qnexa’s Harmful Side Effects
Weight-reduction medications The FDA panel (20-2) unanimously approved Qnexa for use in the United States. Why wouldn’t they do that? The FDA developed a 161-page dossier promoting the drug and strongly recommended that it be approved. The FDA created this less-than-objective document to finally get a prescription to address the obesity issue in the United States.
Currently, 38 percent of Americans are overweight or obese, and this number is rising. It’s getting government officials worried about an impending health crisis that’s already costing the American people billions in healthcare costs. Is it true that the FDA and the pharmaceutical industry claim that Qnexa is a miracle drug?
Diet Pill Use and Consumers in the United States
It is immediately desired when a diet medication is released to the market with little competition. As a result, the diet supplement Phen-fen, which is no longer available, failed. In the 1990s, an appetite suppressant and amphetamine combination were distributed without FDA approval.
Millions of people have prescribed it as soon as it became available, and some could even obtain it without a prescription. Every day, millions of people worldwide attempt to lose weight by taking diet pills in the hopes of seeing immediate effects.
Unfortunately, it resulted in heart valve damage, prompting FDA intervention. Meridia’s approval appears to be a carbon copy of Qnexa’s. A “miracle” medicine increased the risk of heart attack and stroke in overweight and obese people.
Despite the FDA’s shame, this product was removed from the market. Qnexa, which is the replacement, is now available. The FDA hopes that the predicted rush to purchase this treatment will be reduced this time. However, there are insufficient measures to guarantee that it is only given to people who need it, such as the exceedingly obese and at-risk.
According to Dr. Michael Lauer, director of the National Institutes of Health Division of Cardiovascular Sciences, if this treatment is approved, it might be prescribed to millions or tens of millions of people.
The lack of provision is due to pharmaceutical industry pressure to allow this potentially multibillion-dollar cash cow of a drug to be released to the general public, regardless of its potentially harmful effects.
Because the pharmaceutical business provides the majority of FDA funding, the pharmaceutical industry’s greed may overshadow the greater good that this treatment may provide. What harm can Qnexa cause the general public, and how much damage can it cause?
What Can You Expect From Qnexa?
Phillips Law Firm is not anti-pharmaceutical; instead, we are an anti-defective drug. Furthermore, this drug has the potential to be harmful. It is considered a safe alternative to the prohibited Phen-fen since it contains phentermine, an amphetamine, and Topiramate, an anti-seizure drug that reduces hunger. Two drugs with an extensive list of potentially hazardous side effects.
Adults and children can take Topiramate as young as two years old to treat epilepsy, a common side effect. This medicine is also commonly used as a preventative therapy for chronic headaches and migraines. Clinical study and consultation with the medical community, on the other hand, revealed that the medicine also caused substantial weight loss. Only Qnexa has been able to benefit from this method thus far. As a result, this is one of the negative consequences:
Anorexia can develop in patients who are not on Qnexa without sufficient monitoring, resulting in weight problems. Women who take the medication during pregnancy have been reported to have a higher risk of congenital disabilities.
Aggressive behavior can harm personal and professional relationships and lose a job or worsen one’s current circumstances.
Balance and Speech: The patient may have slurred or slower speech and challenges with how quickly they think.
Phentermine side effects: This amphetamine is harmful! Amphetamines were previously proven to be effective in assisting the body burn fat and enhancing metabolism.
As a result, people were driven to become more active and engage in fat-burning activities. However, the compounds were highly addictive, causing the body to slow down dramatically when the drug was not present.
On the other hand, the phentermine in Qnexa is intended to reduce hunger and increase metabolism. Several of the issues that raised concerns with Phen-fen persist even in small doses, including:
Impotence, a quality-of-life issue, can cause difficulty in acting sexually and the inability to conceive.
It may harm the patient’s ability to perform at work or live an everyday life due to the drug’s effects.
When high blood pressure is combined with other risk factors like high cholesterol or plaque formation, a person’s risk of heart disease and heart failure increases (heart attack).
Is Qnexa’s Value Greater Than Its Risk?
Even though the effectiveness of Qnexa is not at issue in the debate over its approval, not all patients who use the medication see considerable weight loss:
People who took the dose of Qnexa submitted for approval saw a loss of 6.6 percent of their body weight on average. The Food and Medicine Administration has a requirement that drug results in an average loss of at least 5 percent of body weight to be approved.
In one trial, persons who were obese or overweight and took Qnexa lost at least 5 percent of their body weight. This number is approximately three times more than the number of people who lost weight while taking the placebo. The standard set by the FDA requires thirty-five percent of people to shed five percent of their body weight.
People who continued to take Qnexa for an additional year as part of a follow-up trial gained back some of the weight they had lost during the first year of the study. They did not experience the same degree of weight gain as those who were given a placebo.
Since Qnexa surpasses the minimum effectiveness threshold set by the FDA, the question that arises is whether the additional safety data will be enough to influence the new FDA panel.
The final committee rejected the proposal by a vote of 10 to 6. However, many of those who voted believed that the outcome would be difficult to predict.
This year, there will be a vote cast by a panel consisting of 22 members. On the previous board, there were a total of twelve of them. The last time, seven of them voted against approval, while five voted in favor.
REFERENCES:
- https://www.npr.org/sections/health-shots/2010/07/16/128560245/diet-drug-qnexa-gets-thumbs-down-in-avandia-s-wake
- https://www.latimes.com/health/la-xpm-2012-feb-23-la-he-qnexa-fda-20120223-story.html
- https://www.livescience.com/36179-qnexa-lose-weight-fda-approval-side-effects.html
- https://diatribe.org/qnexa-treating-both-diabetes-and-obesity
- https://www.cnbc.com/2009/09/09/the-qnexa-question.html
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3369742/
- https://www.justiceforyou.com/consequences-of-qnexa-side-effects-to-american-consumers/
- https://www.nytimes.com/2010/10/29/health/policy/29drug.html
- https://www.webmd.com/diet/news/20120222/fda-panel-votes-favor-weight-loss-drug-qnexa
- https://www.webmd.com/diet/news/20111108/fda-reconsiders-weight-loss-drug-qnexa
