In the modern American society, the increasing percentage of citizens reaching obese and overweight BMI indexes is startling. At some point, these unfortunate men and women reach a threshold at which diet and exercise may become too difficult and even dangerous. For this reason, pharmaceutical companies have been researching chemicals that will help significantly reduce weight, but most have been met with opposition by the FDA due to the dangerous effects so many of these chemicals have on the heart. The most recent of these drugs trying for FDA approval is Vivus’s Qnexa; a combination of the FDA approved drugs, Phentermine and Topiramate. For those unfortunate and sick people plagued by obesity, Qnexa could be the deciding factor between life and death. For that reason, the FDA should approve Qnexa since the risk of taking Qnexa is very nominal, especially compared to the life-threatening risks of being obese.
Qnexa is not the heart hazardous drug the FDA has previously suspected it of being. Phentermine is unlike most previously banned drugs called amphetamines that increased chance of heart attack, caused dangerous increases in blood pressure, and eventually yielded heart valve damage. One of the reasons why Phentermine was denied approval by the FDA may be its affiliation with a banned drug, Fen-Phen. Interestingly enough, the reason why Fen-Phen was banned is because of its other component, Fenfluramine, which was banned for causing 30% testers to develop very abnormal cardiograms (FDA). Phentermine has not yielded kind of hazardous effects to the heart and is safe to use, and its safety is probably why the FDA approves it. However, the other component of Qnexa, Topiramate, has been found to cause negative side effects for pregnant women. Qnexa shouldn’t be taken by women who are pregnant due to Topiramate’s effect of doubling the likelihood of having a child born with a cleft palate from .7% to 1.4% (Roth). In that circumstance, an operation would have to be performed to correct the abnormality. This effect on pregnant women is the only risk a person would have to weigh before taking Qnexa and this applies to a very small fraction of obese people. Based on the results of its test trials, the drug is very safe and effective.
Being obese is like having a ticking time bomb to one’s chest since it poses so many risks in such a broad spectrum of bodily functions. Within the cardiovascular system, obesity causes plaque to build up in the arteries. This plague leaves an obese person susceptible to high blood pressure, coronary heart disease, and even stroke. For a woman in her childbearing years, an obese woman faces a plethora of long-term complications for both herself and the child. One of the largest issues occurs due to the heightened blood pressure of the mother, which results low birth weights from the restricted blood flow to the fetus. Oppositely, if Gestational Diabetes is developed, the child gains too much weight in development and is born with a predisposition to childhood obesity. Another issue the mother faces is the difficulty to gather fine details on the development of the child during ultrasounds. Since the high amount of fat obstructs the waves, the view of the child is often blurry and chances of picking up problems in fetal development are decreased. Due to the risk of having a child born with a cleft palate, Vivus has excluded pregnant women in its filing for FDA approval. Women in their child bearing years should keep in mind that remaining obese can endanger the life of their child if they should ever conceive and that taking Qnexa would unlikely affect a future child. Losing weight should be priority for women planning on having a child in the future and pregnancy should be avoided before reaching a healthy BMI.
The only possible way Qnexa could pose a danger to one’s health would be in the case of misuse. As with all drugs, it’s a chemical that should be taken responsibly. Obesity is much more detrimental to the lives of people it has taken hold of than just the heart and pregnancy risks. With enough time, obesity can indirectly cause a variety of issues to arise. Type 2 diabetes is another dangerous risk of having so much excessive weight. In this case, the individual’s body has become unable to produce insulin at sufficient levels or at all. Having diabetes only increases the risk of heart disease and stroke risk, but also predisposes individuals to kidney disease and blindness (National Heart Lung and Blood Institute). The increase weight also has a great toll on the support system for the body, the skeleton, since the bones experiences much more wear and tear. Finally, studies conducted by the National Caner Institute have shown that obesity increases the risk of cancers of the esophagus, pancreas, colon, rectum, breast, endometrium, kidneys, thyroid, and gallbladder (National Cancer Institute).
The FDA is supposed to be monitoring the safety of food and drugs available for commerical purchase. While it has done a great job at removing many dangerous chemicals from being ingested by so many Americans, the FDA needs to re-assess the ruling on Qnexa. At worst, Qnexa only affects a small number of women. It should not be denied approval just because of that small percentage. Qnexa should be approved based on the fact that it has not posed any serious risk for obese people who are living with biological time bombs strapped to their waists other than pregnant women.
The FDA should approve Qnexa since it has been proven to effectively combat the dangerous disease, obesity. The growing epidemic that the United States faces with the growing number of patients reaching obese BMI could finally start to reverse with Qnexa. Obesity is a serious condition that clearly endangers a person’s life with every single beat their heart makes, while Qnexa is a drug designed to safely and effectively reduce weight. Americans should have the option to treat the disease before it progresses and causes more problems in their lives.
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Roth, Jeffrey J. “FDA Warns Against Use of Topamax by Women of Childbearing Age.”Las Vegas Plastic Surgery. Web. 08 Mar. 2012.
“What Are the Health Risks of Overweight and Obesity?” – NHLBI, NIH. Web. 08 Mar. 2012.
“”Fen-Phen” Update (Fenfluramine, Phentermine, Dexfenfluramine).” FDA.gov. Web. 08 Mar. 2012.
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