A New Diet Pill Is Pending Approval By The FDA
The latest diet pill that promises to melt fat has finally been ‘tentatively’ approved by the Food and Drug Administration and will be hitting doctor’s offices soon. Once approved, Qnexa will be the first diet pill to receive FDA endorsement in the last 13 years. No doubt there will be plenty of people asking their docs to write a prescription for Qnexa.
Qnexa is an appetite-suppressing drug developed by Vivus, a California pharmaceutical company, that contains phentermine and topiramate. As with any diet pill there’s good new and bad. Here are five things you should know before asking the doctor for a prescription:
- Not all that long ago, Qnexa was denied approval by the FDA because tests showed there were too many side effects associated with it. The side effects included suicidal thoughts, heart palpitations, memory lapses and birth defects.
- In the test trials that have been done on the drug, there were five heart attacks among the people that took Qnexa. There were no heart attacks in the group that took the placebo.
- One of the main concerns with the drug is that it contains Topamax. The side effects of Topamax include the tendency for pregnant women to give birth to children with birth defects. The most common defect is cleft lip.
- There is a long history of safety problems with diet pills once they hit the market and are used outside of the pilot group. Diet pills like Fen-phen seemed like a good idea at one time. The manufactures of Fen-phen have now settled a class action lawsuit for 3.75 billion after the drug was linked to heart valve disease. Remember, if you’re one of the first to receive Qnexa, you’ll really just end up being part of a large test group.
- The FDA, maybe against their better judgment, may end up approving the drug because they are under pressure to find a remedy for the obesity epidemic the nation is faced with. A Senate appropriations committee has asked the FDA to submit a report by the end of this month with a plan for the development of new obesity treatments.
Why It’s So Difficult For Diet Pills To Obtain FDA Approval
The Fen-Phen debacle may be a big reason why it’s hard for new pills to receive the FDA seal of approval. Fen-Phen is a combination of two weight loss supplements: Fenfluramine (Fen) and Phentermine (Phen). Both ingredients were approved by the FDA; Phen in 1959 and Fen in 1973. While the FDA never approved a supplement that contained both ingredients, doctors began prescribing the ‘cocktail’ to their patients with good results and seemingly no side effects. In 1996, 6.6 million prescriptions for Fen-Phen were written in the U.S.
It took only a year for the magic pill with no side effects to come under fire. In the summer of 1997 the Mayo Clinic reported an alarming number of occurrences of heart-valve disease. All of the patients that the Clinic saw for the heart-valve issue had something in common. They had all taken Fen-Phen.
Heart-valve cases related to Fen-Phen continued to be reported to the FDA. The FDA eventually issued a Public Health Advisory advising people of the risks of taking the diet pill combo and asked manufacturers to voluntarily withdraw Fenfluramine from the market. Phen is still on the market, continues to be prescribed by docs for short-term treatment of obesity, and is making a re-appearance in Qnexa.
The Difference Between FDA Approved Supplements And All The Others
Non-FDA approved diet pills are the ones that are sold in abundance at the local drug stores, Wal Marts, and weight-loss clinics. These supplements have varying levels of effectiveness and numerous side-effects.
You’ll recall that just a few months ago the FDA issued warning letters to companies selling over-the-counter HCG weight loss products. The FDA stated that the manufacturers made unsubstantiated claims about the product’s ability to help people lose weight safely. The HCG diet is based on a 500 calorie/day diet and an injection of the hormone HCG (human chorionic gonadotropin) that is produced by the human placenta. I wrote about the risks of HCG in a post on December 8, and you can read more about it here. There have been many risky weight-loss scams prior to HCG and there are many more to follow.
The combination of the FDA being under pressure to approve a diet aid and the never-ending desire for a pill that will help people that have tried and failed in their attempts to not only lose weight, but keep it off, may be factors that will lead to the approval of Qnexa. Only after it’s approved and has been widely used on the market by the general public will we be able to determine its effectiveness and decide whether or not the side effects over-shadow any weight loss benefits that occur.
If you’ve followed this blog and have read some of other my posts about fads that promise to ‘melt fat’ or ‘torch calories’, you know I won’t be cheering on the FDA to put Qnexa on the market. I think if we’re all ready to be honest with ourselves, we know that the only way to lose weight and keep it off is to change our habits. Moving more and sitting less, keeping our portions under control, eating more fruits, and vegetables, and eliminating heavily processed foods from our diet isn’t exactly magic, but it’s what works. We don’t need another pill. We need the motivation to put down the cookies.