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New Diet Drug Trades Brain Damage for Minimal Weight Loss
How much risk is acceptable in the attempt to lose weight? The FDA seems to believe that there’s virtually no limit, not even a very large risk of brain damage, among many other adverse effects, from the new drug Qsymia.
by Heidi Stevenson
The latest entry into the prescription weight-loss drug market, Qsymia®, is a combination of two dangerous drugs, one of which, topiramate (Topamax brand name), is known to cause brain damage. Perhaps it’s worth that risk in the population for which it was originally designed: epileptics. However, taking topiramate as a diet aid means taking the gamble that a little weight loss won’t also result in nerve damage, vision damage, nervousness, speech damage, inability to concentrate, loss of control over body movements, or any of many other indications of brain damage.
The FDA approved Qsymia with only nods to other risks, including contraindication in people with hyperthyroidism or glaucoma, or pregnant women because of an increased risk of birth defects. They made no mention of the known risks of topiramate and the other drug phentermine.
Studies show that Qsymia provides an average of 3.5 – 9.4 kilograms (7.7 – 20.7 pounds) extra weight loss over placebo. Marvin Lipman, MD, of Consumer Reports, refers to the requirement that the manufacturer, Vivus, produce an after-approval trial:
The very idea that a post marketing risk evaluation strategy was a condition required by the FDA for approval of this combination drug product seems like putting the cart ahead of the horse. Such a study may very well result in preventable mortality and morbidity, a high price to pay in exchange for a few pounds of flesh.
People who are placed on Qsymia are expected to take it every day for the rest of their lives. Experience of trial subjects has shown that any weight lost as a result of the drug will be regained. Therefore, risks of the drug are not temporary. Let’s take a look at the risk profiles of each of the Qsymia drugs:
| Phentermine | Topiramate |
Frequency Not Defined
Serious
|
>10%
1-10%
|
| Note: These adverse effects of phentermine and topiramate come from Medscape. They have changed their method of reporting adverse effects. When they compiled them for phentermine, they were divided into more or less serious groups. Now though, Medscape reports on the percent of patients known to suffer from each of the adverse effects. | |
Careful scanning of these two lists shows that both have effects on the brain and central nervous system. Both can cause depression, called “dysphoric mood” in phentermine adverse effect and “depression” or “mood problems” in topiramate. In fact, although topiramate is noted for its adverse neurological effects, the fact that phentermine has been noted as capable of inducing psychosis should cause people who might take Qsymia to think twice.
When drugs are combined, their risks are often increased and new ones can show up. Since we know that both phentermine and topiramate can induce serious neurological effects, what will prove true of Qsymia?
The manufacturer, Vivus, admits that the drug combination can cause mental problems. On their own website, they state:
Qsymia may affect how you think and is associated with difficulty with attention and concentration, memory and word-finding. Therefore, use caution when operating hazardous machinery, including automobiles.
On that page, they also warn patients about risks to their vision, the potential of a racing heartbeat, and that it can cause low blood sugar—though they suggest only that diabetics may have their diabetes drugs modified by their doctors.
Phentermine is also associated with a deadly heart valve disorder. That’s the reason another diet drug combination was withdrawn. One of the drugs in that combination was phentermine.
Even the FDA admits that the safety of Qsymia is not clear in relation to heart disease. So, a condition of approval is that the manufacturer must do a post-marketing study on its safety in regard to its effect on the heart. If you think that your interests and safety are the FDA’s central concerns, surely this fact will open your eyes!
Topiramate can make you stupid. I’ve personally witnessed that effect on a loved one. His normally active and sharp mind deteriorated dramatically, to the point where he could barely converse. His concentration was destroyed. Later, he told me how utterly frustrated he was at being unable to focus on anything. Fortunately, those symptoms were temporary for him. They are not, though, unusual. Would you want to take the chance that your normal intelligence and concentration might never return?
We know that virtually no drug’s negative profile is known at the time of approval. In the case of this one, we have the advantage of knowing in advance a significant portion of the problems that can be expected. However, the combination of drugs is almost certain to produce even more harm.
While it’s certainly true that severe obesity is, itself, a serious risk to health, just how much extra risk is worth taking in exchange for a few pounds—especially when that risk will be induced for the rest of a person’s life?
Sources:
- FDA News Release for Qsymia
- FDA’s Qsymia Medication Guide
- FDA approves weight loss drug Qsymia, but we say skip it
- Adverse Effects of Phentermine
- Adverse Effects of Topiramate
- Qsymia manufacturer’s website
- Weight Loss Pill Qsymia Now for Sale Online
Tagged big pharma, fda, fda qsymia, pharmaceutical drugs, pharmaceuticals, phentermine, qsymia adverse effects, qsymia brain damage, qsymia dangers, qsymia health risks, qsymia heart problems, qsymia neurological effects, qsymia obesity, qsymia obesity drug, qsymia phentermine, qsymia phentermine topiraamate, qsymia side effects, qsymia topamax, qsymia topiramate, qsymia weight loss, qsymnia racing heart, topamax, topiramate
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