Combination Pill Of Topamax And Phentremine Was Approved By FDA, But EMA Points To Heart Side Effects, Birth Defects, And Other Safety Issues

(Posted by Tom Lamb at DrugInjuryWatch.com)

On October 18, 2012 European drug regulators took a different course than the FDA with regard to a new anti-obesity medication which contains the active ingredient in Topamax, topiramate, and phentermine. This new diet-drug pill is called Qsymia here in the US and Qsiva in Europe.

For some background on this decision by the European Medicines Agency (EMA), we look to this October 19, 2012 Fierce Pharma news report, "EMA committee shoots down Vivus diet pill":

Vivus wasn't expecting a warm reception from European officials, and those expectations bore out. The committee said it was worried about Qsiva's long-term effects on the heart and blood vessels, particularly because Qsiva contains the active ingredient phentermine, once notorious for its use in the fen-phen diet-pill combo. Phentermine isn't approved in Europe, though it is in the U.S.

The drug's other active ingredient, topiramate [brand name: Topamax], is a seizure remedy that's been on the market for years–and known to carry a risk of birth defects. Plus, the [EMA's Committee for Medicinal Products for Human Use (CHMP)] noted concerns about long-term psychiatric effects, because depression and anxiety cropped up in clinical trials, and long-term memory and attention problems.

As for the actual determination, we get these details from this European Medicines Agency document (PDF), "Refusal of the marketing authorisation for Qsiva (phentermine / topiramate)":

The CHMP noted that the main studies showed clinically relevant weight loss following treatment with Qsiva but had concerns about the medicine’s long-term effects on the heart and blood vessels, particularly due to the effects of phentermine, which is known to increase the heart rate but whose long-term effects are not clear. Secondly, there were concerns about the long-term psychiatric effects (depression and anxiety were reported in the studies) and cognitive effects (such as problems with memory and attention) related to the topiramate component of Qsiva. Topiramate is also known to be potentially harmful to the unborn baby if taken by pregnant women.

With regard to that last point, having to do with the Topamax (topiramate) component of Qsymia / Qsiva, we have covered the birth defect safety issue associated with this anti-seizure drug before:

FDA Seeks Information About Topamax-Related Oral Cleft Birth Defect Cases — Request For Historical Incidence Data Made In Connection With NDA For New Obesity Drug  (February 2011)

Topamax During Pregnancy Increases Risk Of Cleft Lip And/Or Cleft Palate Birth Defects — Oral Clefts In Babies Are 20 Times More Likely With Women Who Used Topamax (topiramate) After Getting Pregnant  (March 2011)

Returning to the Fierce Pharma report about the EMA's negative opinion on Qsymia / Qsiva:

Vivus says it plans to appeal the CHMP's decision. Cowen & Co. analyst Simos Simeonidis said new reviewers will look at Qsiva during its appeal, which may improve its chances. Regardless of the outcome–and regardless of the expected slow-but-steady build in prescriptions, Simeonidis figures that the demand for obesity drugs and Qsymia's early reputation for "robust weight loss" will fuel peak sales of $1.6 billion in the U.S. by 2019.

We will continue to monitor the safety profile of Qsymia in the US, where this new obesity drug has been available for patient use since July 2012.

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