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Posicor

(Mibefradil Dihydrochloride)

 

What is Posicor?

  

Posicor, was produced by Roche Pharmaceutical and typically prescribed to treat hypertension (high blood pressure) and chronic angina. It worked by blocking the movement of calcium into the heart cells and blood vessels.  The blood vessels would relax and increase the supply of oxygen and blood to the heart, thereby reducing the stress on the heart.  Posicor was very effective in treating hypertension, but had disastrous side effects.  After causing more than 123 deaths, it was withdrawn June, 8 1998, for its harmful interactions with other drugs. Posicor was prescribed to over 200,000 patients during the 12 months it was on the market.

Why was Posicor recalled?

Posicor was contraindicated with over 25 different drugs.  When combined with these other medications, one of two events occurred:

1.      The heart rhythm slowed to dangerously low rates

2.      Contraindicated medications stayed in the body too long and produced dangerously high levels in the blood, causing harmful and sometimes fatal side-effects, including arrhythmia and death

These side effects occurred primarily, because:

Posicor reduces the activity of certain liver enzymes that are important in helping the body eliminate many other drugs. 

FDA Talk Paper June, 8th, 1998.

 

 

Side Effects and Signals

Ø      Difficulty breathing

Ø     Irregular/slow heartbeats (arrhythmia)

Ø      Fainting or dizzy spells

      (torsade de pointes)

Ø      Swelling of legs and feet

Ø      Seizures

Ø      muscle or joint pain

Ø      Vomiting

Ø      Unusual tiredness

Ø      Weakness

 

Medications that may detrimentally interact with Posicor:

  • Amiodarone (Cordarone)
  • Astemizole (Hismanal)
  • Bepridil (Vesture)
  • Cisapride (Propulsid)
  • Cyclosporine (Neoral, sandimmune)
  • Cyclophosphamide (Cytoxan)
  • Desipramine (Norpramin)
  • Erythromycin (Erythrocin, ilosone, others)
  • Etoposide (Vepesid)
  • Flecainide (Tambocor)
  • Flutamide (Eulexin)
  • Halofantrine (Halfan)
  • Ifosfamide (Ifex)
  • Imipramine (Tofranil)
  • Lovastatin (Mevacor)
  • Mexiletine (Mexitil)
  • Pimozide (Orap)
  • Propafenone (Rythmol)
  • Quinidine (Cardioquin, quinaglute, quinidex, others)
  • Simvastatin (Zocor)
  • Tacrolimus (Prograf)
  • Tamoxifen (Tamoxifen)
  • Terfenadine (Seldane)
  • Thioridazine (Mellaril)
  • Vinblastine (Velban)
  • Vincristine (Oncovin)

 

 

   
 

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