Do you have a New Prescription? Get the Side Effects First.

A Bruno Byte
From Richard L. Bruno, HD, PhD
Director, International Centre for Polio Education

Although this particular article is about Vesicare, no polio survivor should take any new prescription medication without asking the doctor about SIDE EFFECTS!

This is a disturbing cautionary tale.

Polio survivor Jane Smith went to her gynecologist with a common complaint: the Ditropan she was taking no longer controlled her overactive bladder. So, her doctor prescribed a new medication, Vesicare, which Jane started on November 18. Four days later Jane was too exhausted to leave the house. The next day, all she did was sleep. By Wednesday Jane was unable to stay awake. When she was awakened she stared into space, unable to understand or respond appropriately to questions. Even more frightening, Jane's ability to breathe was compromised. While asleep her oxygen dropped to 78% (normal 90%). When she was awakened, her oxygen was in the low 90s (normal 95%) and carbon dioxide rose to 55% (normal 45%). Jane was placed on a ventilator with a facemask.

Vesicare was stopped on November 24th. The next day, Thanksgiving, Jane was still unable to stay awake on her own but, when prompted, did try to eat. She discovered that her stomach and intestines had shut down, a side-effect of medications like Vesicare that are anti-cholinergic (stop you from peeing, cause a dry mouth and, especially in polio survivors, can turn off your gut). Jane was placed on a liquid diet and given domperidone, a drug available through Canada, which activates the stomach and intestines without entering the brain, as does Reglan, the medication typically used to treat gastroparesis but that can cause Parkinson’s symptoms and should never be taken by polio survivors.

Unfortunately, Vesicare has an extremely long half-life. It would take Jane's body anywhere from 10 to 14 days for the Vesicare to clear out. During those days, although Jane mostly slept, she became progressively more aware and mentally sharp when awakened, but she could only eat very small amounts.

On the 15th day after Vesicare care was stopped, Jane awoke like Sleeping Beauty. She was able to stay awake on her own and was her usual intelligent and funny self, albeit easily tired. Although her intestines were functioning thanks to domperidone, Jane could still only eat small portions. She was given erythromycin, an antibiotic that stimulates stomach emptying. After three days, Jane was eating normally. One month after waking from her Vesicare-induced stupor, Jane was back on the Ditropan, which again controlled her bladder. Unfortunately, Jane still requires the ventilator at night and at times throughout the day as her diaphragm is unable to push enough carbon dioxide out of her lungs. Jane will need the ventilator for the rest of her life.

What are the morals of this frightening story? First, no polio survivor -- no one with breathing problems -- should take Vesicare. When I called Astellas, the drug's maker, about Jane's condition, the physician director of “adverse reactions” was aware that Vesicare not only turns off the bladder, but also turns off the stomach and intestines and enters the brain. Vesicare was known to block activity in brain areas damaged by the original polio infection, the brain activating system. In fact, the doctor told me that Astellas had just been required by the FDA to add “somnolence” to Vesicare's list of side effects. Somnolence? How about coma? I also was told that Vesicare was known to block brain diaphragm stimulating neurons. So, Vesicare did to Jane what the poliovirus had not done 60 years earlier: put Jane on a ventilator and, in effect, gave her the symptoms of "bulbar" polio.

I told Astellas' doctor that I was concerned Vesicare would very likely have the same effect in other polio survivors, especially those who originally had bulbar polio or any polio survivors who had breathing problems, such as central sleep apnea. What's more, I told him I was worried that individuals who had both difficulty breathing and bladder problems and might be prescribed Vesicare - - those with muscular dystrophy, multiple sclerosis and traumatic brain injury -- might have a reaction like Jane's. The doctor told me that people at Astellas were “discussing the issue.”

It took years for Astellas to notify physicians that “somnolence” is one of Vesicare's side effects. However, the drug’s affect on the diaphragm was never reported to the public. Here are the reported side effects of this potentially very dangerous drug:

• Psychiatric: Common (1% to 10%): Depression (Post-marketing reports: Confusion, hallucinations, delirium, somnolence)

• Nervous system: Common (1% to 10%): Fatigue, Dizziness, insomnia

• Musculoskeletal: Common (1% to 10%): Muscle pain, back pain

• Gastrointestinal: Very common (10% or more): Dry mouth (up to 28%), constipation (up to 13%).

  Common (1% to 10%): Nausea, dyspepsia, upper abdominal pain, vomiting

• Respiratory: Common (1% to 10%): Pharyngitis, cough, sinusitis, bronchitis (diaphragm weakness)

• Genitourinary: Common (1% to 10%): Urinary tract infection, urinary retention

• Cardiovascular: Common (1% to 10%): Lower limb edema, hypertension (Postmarketing reports:

  Peripheral edema, QT prolongation, Torsade de Pointes, atrial fibrillation, tachycardia, palpitations)

• Ocular: Common (1% to 10%): Blurred vision, dry eyes

• Immunologic: Common (1% to 10%): Influenza (https://www.drugs.com/sfx/vesicare-side-effects.html)

  In my 40+ year career I have never seen a drug with such a long and dangerous list of common and very common side effects having nothing to do with the "intended" application of the medication.

  The second moral to this story is that polio survivors can have difficulty blowing off carbon dioxide and should not be given oxygen without having their carbon dioxide monitored, since oxygen levels can be normal while carbon dioxide can become dangerously high.

  The final moral is that a polio survivor should never take any new medication that a doctor happens to prescribe without asking about and receiving a complete list of its side effects.

  The coma you prevent will be your own.