Potential Problems With Three New Drugs Highlighted in Report

Published: October 21st, 2011

According to a new report, several newer drugs, including Pradaxa, Ampyra and Tracleer, appear to be causing a surge in reports of adverse health events and even patient deaths, raising concerns among some experts.  

The Institute for Safe Medication Practices (ISMP) released its fourth quarter 2010 adverse drug event report (pdf) earlier this month, which highlighted safety concerns surrounding the number of adverse event reports submitted to the FDA involving Pradaxa, Ampyra and Tracleer.

The ISMP report also continued to monitor older drugs which are still causing disproportionate amounts of adverse side effects among consumers, such as the smoking cessation drug, Chantix, the heart drug Multaq and the antibiotic Levaquin.

Pradaxa (dabigatran) was only released in October 2010, but the ISMP notes that there were more consumer complaints to the FDA’s MedWatch adverse event reporting system during the first three months the anti-clotting drug was available than 98.7% of the other drugs the organization monitors.

Some patients and doctors reported that it sometimes had too much of an effect on clotting, leading to hemorrhages. Other reports indicated that at times it did not have enough of an effect, resulting in pulmonary embolism or deep vein thrombosis.

The ISMP reports that hundreds of complaints about the Boehringer Ingelheim drug were sent to the FDA, with the agency receiving 307 complaints about Pradaxa problems during the last quarter of 2010. Most of the cases were of bleeding problems in elderly users. The drug is meant to be a replacement for warfarin, which was associated with only 202 adverse events in the same time period.

The drug was only approved by the FDA for the prevention of stroke in patients with atrial fibrillation, but the ISMP report indicates that doctors are already beginning to use it extensively off-label as a general-use anticoagulant. Only about one-third of the prescriptions so far have actually been for the FDA-approved purpose.

The ISMP also warned that the new multiple sclerosis (MS) drug Ampyra (dalfampridine) received 217 adverse event reports during the last three months of 2010. The drug, which is also a powerful bird poison, is designed to help MS patients with walking problems, increasing their walking speed. However, many of the reports were submitted by doctors and patients who found that Ampyra side effects actually appeared to have a detrimental effect on walking speed.

Ampyra, an Acorda Therapeutics drug, was controversial even before it was released because many experts say it appears to provide minimal actual benefits. Clinical trials indicated that it may increase the walking speed of a person with MS by three seconds for every 25 feet they walked. However, some viewed key test results as statistically insignificant.

The drug with the most adverse event reports was the pulmonary arterial hypertension drug Tracleer (bosentan), which was associated with 4,133 reports of patient deaths. However, those deaths range back to 2006 and ISMP indicates that some may have nothing to do with the drug at all.

The reports came after the FDA sent the manufacturer, Actelion Pharmaceuticals, a warning letter that it was not properly reporting patient deaths as required by federal law. The company responded by sending a report for the death of every patient taking the drug. The problem is that pulmonary arterial hypertension is a fatal lung disease and the patient death reports Actelion sent often contained no useful information beyond the word “death;” not even patient ages and genders, the ISMP reported.

“The net result of this enforcement program was to inject into the agency’s vital Adverse Event Reporting System thousands of death reports of low quality and without any investigation or information about whether the drug might have played a role in the patient death,” the ISMP report states. “Not only do the reports have no value in postmarket safety surveillance, they obstruct the assessment of genuine potential threats to the public health by diminishing report quality.”