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FDA Warning: High Doses of Celexa May Be Dangerous

  • September 21, 2011
  • RPh on the Go

The FDA has issued a warning about new dosage recommendations for the antidepressant Celexa (citalopram). Aftermarket testing found that dosages higher than 40mg per day can result in dangerous changes to heart rhythm. Celexa is a selective serotonin reuptake inhibitor (SSRI) that’s been marketed in the U.S. since 1988.

 While it seems to take forever for the FDA to approve a new drug, occasionally something happens to remind us why extensive testing is necessary. Aftermarket reports bolstered by the results of a clinical trial showed that people who take 60mg of Celexa per day, a dose previously approved for some patients, are at increased risk of electrical disruption around the heart that can cause changes in the heartbeat. This potentially fatal condition is called “QT interval prolongation.” Patients taking a lower dose, typically 20 to 40mg per day, were not found to be at increased risk for this condition. The statement from the FDA also noted that patients did not experience increased benefits from a higher dose, so taking more than 40mg works out to a lose-lose situation.

 The people most at risk for this condition are those with existing heart problems and people with chronic low levels of potassium and magnesium in their blood.

 Celexa is currently being tested for efficacy in treating 17 other conditions, everything from diabetic neuropathy to irritable bowel syndrome. Even premature ejaculation is on the list. If it turns out to be a miracle cure for a whole host of assorted ailments, Celexa could become a staple of American medicine cabinets, like Flintstones chewable vitamins. Judging by the number of truly depressing commercials on TV, it’s already a household name for depression.

 Antidepressant drugs in general are pretty scary stuff. The potential side effects or Celexa are the garden variety for most SSRIs: Headache, nausea, dry mouth, sweating, sleepiness, diarrhea or constipation, weight gain, and loss of libido. Most of the symptoms, with the exception of weight gain and loss of libido, typically lessen or vanish in a couple of weeks. Less common side effects are tremors, increased anxiety, acne, and disruption of the menstrual cycle. Rare (and truly unpleasant) side effects include hiccups that may never end – ever – and rectal bleeding. Yikes.

 Interestingly, the FDA warning did not mention a closely related drug, Lexapro. I have to wonder if erring on the side of caution might be the wise course of action until similar studies have been done on Lexapro. What’s your take? Would it be prudent for the FDA to jump the gun and lower dosage recommendations on other SSRIs based on the information from the Celexa study?

 In the meantime, the best advice for your customers currently taking 60mg doses of Celexa is to discuss changes in dosage with their doctors. Like most drugs, changes to dosages should be done gradually under medical supervision. The warning signs that there might be a heart irregularity issue are irregular heartbeat, shortness of breath, dizziness, or fainting. If a patient taking Celexa complains about these symptoms, advise an immediate trip to the doctor or emergency room.

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