The US Food and Drug Administration (FDA) panel overwhelmingly approved (20-2) a new weight loss drug Qnexa. And why wouldn’t they? The FDA officials put together a 161 page dossier touting the benefits of the drug and highly recommending the approval of the drug. The FDA created this less-than objective document in order to finally get some kind of drug that addresses the problem of obesity in America. Statistics are now showing that 38% of the U.S. population is obese and growing. This is making people across the government agencies nervous over the pending health crisis that is already costing the American tax payers billions of dollars in healthcare costs. Is Qnexa the miracle pill that the FDA and the pharmaceutical community touting it to be?
Diet Pills and the American Consumer
Here’s the problem with introducing a diet pill onto the market with such limited competition: everyone wants it…now. That’s the problem now-defunct diet drug Phen-fen had. It was a mixture of a appetite suppressant and amphetamine that hit the market with no approval from the FDA in the 1990’s. As soon as it hit the market, millions of people began being prescribed it and were even able to get it without a prescription. It was alike a weight loss pill free-for-all with millions of people popping these pills in hopes for instant results. What it ended up giving them was heart valve problems that forced the FDA to pull it. In what seemed to be a mirror image of the Qnexa approval came Meridia. A “miracle” pill that turned out to put millions of people already at risk of having a heart attack and stroke due to their obesity that much more at risk. This too was pulled from the market much to embarrassment to the FDA. Now Qnexa is the next incarnation. The FDA is hoping this time to quell the inevitable frenzy to get this drug. However, it seems that there are few provisions set in place to make sure that only the people who really need it, i.e., morbidly obese and at-risk individuals, are the only ones to receive it. “This drug, if approved, would likely be prescribed to millions or tens of millions of people,” said Dr. Michael Lauer, director of the division of cardiovascular sciences at the National Institutes of Health. The reason for the lack of provision is the pressure from the pharmaceutical community to allow this potentially multibillion-dollar cash cow of a drug to be unleashed on the public regardless of its potential side effects. The FDA gets the majority of their funding from the pharmaceutical industry, so the voracious need for profit might over shadow the greater good that this drug could do. The questions is, what kind of harm can Qnexa do to the general public?
Qnexa and Side Effects
You see, we at Phillips Law Firm are not anti-pharmaceutical, we’re anti-defective-drug. And this drug has the potential to do some bad things. The reason why is because it has half of the ingredient of the banned Phen-fen in it, the amphetamine phentermine, and the other half is topiramate, an anti-seizure drug that also curbs people’s appetites. Two drugs with an impressive list of serious side effects.
Topiramate side effects:
This drug is used to treat seizures in both adults and children as young as two. It also is used to treat chronic headaches and migraines before they’ve started. However, through clinical trials and listening to the medical community, the drug manufacturer discovered that it also caused serious loss of appetite. Qnexa is the first drug to capitalize on this. That makes one of the side effects:
- Anorexia – A patient that is not prescribed Qnexa could not be in the proper weight ratio for the drug and without proper monitoring, may find themselves with weight issues.
- Birth Defects – The drug, when taken by pregnant women, has been linked to serious birth defects.
- Aggressive Behavior – This can effect your personal and professional relationships and may lead to loss of job or lower quality of life.
- Balance and Speech – The patient can have serious problems with how quickly they think, problems with balance, and may have slowed or slurred speech.
Phentermine side effects:
This is a serious amphetamine. Amphetamines in the past were found to help raise the metabolism and help the body burn fat. It also inspired people to be active and do things that would help them burn fat. The problem was that the substances were found to be highly addictive and would cause the body to slow severely when the drug wasn’t present. However, smaller amounts of phentermine in Qnexa is intended to suppress the appetite and raise metabolism. Unfortunately, even in small doses some of the problems that drove concerns over Phen-fen are still present in Qnexa such as:
- Impotence – This is a quality of life issue that leads to an inability to perform sexually and may effect a male patient’s ability to procreate.
- Insomnia – This is a serious problem that could effect the patient’s ability to perform at work or conduct a normal lifestyle while on the drug.
- High blood pressure – A rise in blood pressure could lead to a serious chance of heart disease or heart failure, particularly if weakened by cholesterol or plaque buildup.
- Circulatory issues – This could lead to a swelling of the feet and legs and may potentially promote the creation of blood clots.
There is no doubt that obesity, is a major problem in the US, and is one of the leading cause of diabetes, heart disease and other serious health problems. Many experts agree that it has reached epidemic proportions in the United States, with nearly 68% of the U.S. population considered overweight, and a third obese. However, it is for this reason, analysts predict that Qnexa, if approved, will be prescribed widely, with annual sales of $1 billion to $3 billion. “Perhaps the only thing that would be better than a pill to help you lose weight would be a pill that makes you more beautiful,” said Dr. David Gortler, a former FDA medical officer on the obesity team and current professor of pharmacology at Georgetown Medical School. “In fact, many fashion advertisers promote and equate beauty with the loss of weight. “There is going to be a huge demand for Qnexa… (and) if the FDA doesn’t regulate Qnexa appropriately there are going to be a deluge of lawsuits,” said Gortler.
If you or a loved one has taken Qnexa to lose weight and found that you have run into unexpected heart complications or your newborn child was born with a birth defect as a result of taking the drug, you need council of a good attorney. Phillips Law Firm is a team of experienced defective drug attorneys with a proven track record of successful defective drug litigation. If you or a loved one have experienced serious injuries or death due to the side effects of a generic drug call us today for a free consultation and to find out your legal rights.