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New Diet Drug Trades Brain Damage for Minimal Weight Loss

September 19, 2012 by admin in Pharmaceuticals with 2 Comments

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.

Obese man bulging over jeansby 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

  • Hypertension
  • Palpitations
  • Tachycardia
  • Blurred vision
  • Chills
  • Dysphoric mood
  • Dysuria
  • Excitement
  • Headache
  • Insomnia
  • Nervousness
  • Restlessness
  • Tremor
  • Urticaria
  • Hair loss
  • Impotence
  • Bad taste in mouth
  • Constipation
  • Diarrhea
  • Drug-induced gastrointestinal
    disturbance
  • Dry mouth
  • Nausea
  • Vomiting
  • Myalgia

Serious

  • Heart valve disorder
  • Psychotic disorder
  • Primary pulmonary hypertension
>10%

  • Dizziness (26-30%)
  • Fatigue (26-30%)
  • Ataxia (16-20%)
  • Nervousness (16-20%)
  • Paresthesia (16-20%)
  • Psychomotor slowing (16-20%)
  • Abnormal vision (11-15%)
  • Anorexia (11-15%)
  • Confusion (11-15%)
  • Decreased concentration (11-15%)
  • Decreased memory (11-15%)
  • Depression (11-15%)
  • Nausea (11-15%)
  • Nystagmus (11-15%)
  • Speech disorder (11-15%)
  • Weight loss (11-15%)

1-10%

  • Abdominal pain (6-10%)
  • Diplopia (6-10%)
  • Mood problems (6-10%)
  • Pharyngitis (6-10%)
  • Tremor (6-10%)
  • Abnormal gait (1-5%)
  • Apathy (1-5%)
  • Asthenia (1-5%)
  • Dry mouth (1-5%)
  • Kidney stones (1.5%)
  • Menorrhagia (1-5%)
  • Skin disorder (1-5%)
  • Taste change (1-5%)
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:

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  • Nessa

    My doctor gave me topiramate & phentermine because my insurance wouldn’t cover the brand name drug. He also have me lorazepam for my anxiety. I could feel myself changing. I felt like there was something in me i had to try to control. I started pulling away from others, I felt rage, I felt abandoned, I started wondering what the point of living was. I was confused as to why now I was having these feeling & these crazy thoughts. My anxieties grew worse. I started having strange paranoid dreams. About 3 weeks in I had the worse panic attack. I couldn’t stop crying, I felt pitiful. I hated myself & I lost all hope. I think if I didn’t have my son that depends on me I might not be here today. I just wanted it all to end. I wanted to die & be over with life. I didn’t see any other way out. But almost simultaneously the thought that I’ve never felt this despair before would pop into my mind. I’ve always been the strong one that can handle anything this world throws at me. So I knew something was wrong here. Something was out of wack. My chemistry was off. Neither my doctor or my pharmacist told me that my medications could cause this type of reaction. There was no explicit warning on my pill bottles. And only the topirate paperwork from the pharmacy notes the possibility of suicidal thoughts or actions, yet after doing more research I found out that all 3 if these medications can cause suicidal thoughts or actions. Now it’s been 2 weeks since i stopped taking these drugs and I don’t know if I’ll ever fully recover. I am depressed, my anxiety is much worse, I feel nervous & tremble, my body aches and feels fatigued, I have sudden mood swings from anger to sadness to paranoia. I feel more susceptible to stress. I don’t know how permanent these effects are. I worry. I am glad I realized in time that my desire is to live and that I was strong enough to overcome those awful thoughts. I share my experience In the hope that I can help others.

    • / Heidi Stevenson

      I, too, am glad you realized in time what was happening. Thank you for telling us your story. Maybe you’ll help others to realize the truth.

      There are a lot of people in your situation. If you are on Facebook, try looking for PsychRights or Irish Network of Critical Voices in Mental Health for information and support.

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