Miracle Pill Part 2
The FDA is under a lot of pressure for some patient groups and now congress (the Senate appropriations committee has directed the FDA to submit a report on how it plans to develop new obesity treatment by the end of March) to approve the latest “miracle pill” for weight loss – Qnexa. As the rate of overweight Americans hovers near 68% and obese Americans near 33% we have an “epidemic” on our hands. But as with all epidemics, you can’t just treat the symptoms, you need to find and eliminate the cause.
A pill that, when combined with lifestyle and nutrition changes, can reduce the clients total weight by 10% sounds good but let’s take a closer look at the information. The two components of Qnexa are phentermine-which has similar characteristics as amphetamine and topiramate- an anti-convulsant used in the control of seizures.
On the plus side:
- The people selected had a BMI of 30 or greater of 25 and weight related health risks
- Patients using Qnexa did show significant weight loss over those on placebo
- Patients using Qnexa did have improved weight related cardiovascular and metabolic risk factors than those using placebo.
On the negative side:
- The most common reported side effects were dry mouth, constipation, insomnia, altered taste, tingling, sinus infection and runny nose.
- Topiramate is linked to birth defects when taken during pregnancy the most common is cleft pallet
- Topiramate caused a fairly high incidence of confusion, memory loss, concentration problems and “psychomotor slowing” resulting in difficulty finding the correct words among other things
- Topiramate carries additional warnings for depression, mood problems, sleepiness, and “suicidal ideation”
- 42% of patients prescribed topiramate reported one of more cognitive problems
- Phentermine is known to have two heart-related side effects: increased heart rate and elevated blood pressure
- The effects of phentermine last a few weeks requiring higher doses to maintain results
- According to the NIH those with even slightly elevated blood pressure, hyperthyroidism, and “excitability” should not use phentermine
- FDA reviewers noted that after 12 months of continued use the weight started to “creep” back on even though the patient continued to take the drug.
- The FDA reviewed Qnexa in 2010 and rejected it!
Now let’s look at the control of distribution.
- The FDA and Vivus propose restricting the availability of Qnexa so that women that are pregnant do not receive the drug. This does little for those that are taking the drug and become pregnant.
- The FDA is also recommending that the drug only be prescribed to patients with a BMI of 30 or greater or and BMI of 25 with underlying weight related health conditions but again admit that there is little that can be done to control who doctors prescribe to.
- The FDA is also urging Vivus to limit online availability to “certified” online pharmacies. Again the FDA has little control of the online pharmaceutical industry.
The FDA and Vivus propose additional studies for the next four years on the potential for heart damage and other long term risks but the studies will most likely be conducted after the drug is approved.
The effects of the use of Qnexa will not be known for a long time. We will have to wait to see if this drug is a miracle cure for obesity or another disaster like Fen-Phen.