- Mar 26, 2004
New Safety Information for the Use of PAXIL® (paroxetine hydrochloride) and PAXIL CR™ (paroxetine hydrochloride controlled release tablets) in patients taking pimozide
GlaxoSmithKline Inc., following discussions with Health Canada, is informing patients of new safety information regarding Paxil and Paxil CR, both of which are medications used for treating the symptoms of depression and anxiety.
Based on the results of a recent clinical study, Paxil or Paxil CR must not be used together with pimozide (Orap®), an antipsychotic medication. Patients are advised NOT to take Paxil or Paxil CR with pimozide as their interaction increases the level of pimozide in the blood, which may result in arrhythmias (irregular heartbeats), that can sometimes be serious and even life-threatening. Patients should be aware that the symptoms of arrhythmia include dizziness, palpitations and fainting, and that they should seek immediate medical attention if these symptoms occur. If you are presently being treated with this drug combination, please consult your physician before changing your current therapy.
GlaxoSmithKline has sent a letter to healthcare professionals informing them of this new safety information. This information may be obtained on the Canadian website of GlaxoSmithKline (http://www.gsk.ca) or on the website of the Therapeutic Products Directorate of Health Canada (http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_advisories_professionals_e.html). Following consultation with Health Canada, the Canadian prescribing information and consumer information for Paxil and Paxil CR has been revised. If patients have questions regarding their current Paxil or Paxil CR prescription, they are asked to contact their doctor or pharmacist.