A record number of deaths and serious injuries associated with prescription drug usage were reported to the U.S. Food and Drug Administration (FDA) in the first quarter of 2008. Serious injuries associated with prescription medications reached a total of 20,745 new cases; reported deaths totaled 4824 cases. The total was 38 percent higher than the average for the previous four quarters, and the highest for any quarter.
Varenicline (Chantix, Champix), a smoking cessation aid, accounted for more reported serious injuries than any other prescription drug for a second quarter, a total of 1001 new cases, including 50 additional deaths. Varenicline was the subject of a previous Quarter Watch special report1 and a separate FDA Public Health Alert about psychiatric side effects. Ranked second in reported serious injuries was heparin, a drug that helps prevent injury from blood clots. In the first quarter of 2008, the FDA received reports of 779 cases of serious injury in which heparin was the principal suspect drug.
These reported data findings come from a program being developed by the Institute for Safe Medication Practices (ISMP) to improve patient safety through increasing understanding of how drug-related injuries and medication errors occur. The results come from analyzing new adverse drug events reports submitted to the FDA.
The recent report has fueled new calls for increased public warnings about dangers of Pfizer smoking cessation drug Chantix. Deaths and record levels of serious injuries have been reported to the FDA. Law firm Cory Watson Crowder & DeGaris is urging pharmaceutical giant Pfizer Inc. to strengthen its public warnings about potentially serious or fatal injuries that may be caused by its smoking cessation drug Chantix.
On October 22, 2008 the Institute for Safe Medication Practices (ISMP) released the results of an analysis performed by independent experts of adverse event reports. According to the ISMP report, Chantix accounted for more serious injuries being reported to the FDA than any other prescription drug for a second consecutive quarter. Specifically, the report says Chantix accounted for more serious injuries than all of the top ten prescription drugs combined during the first quarter of 2008.
Attorneys Kristian Rasmussen and Beth Ellis Chambers of Cory Watson Crowder & DeGaris have been investigating claims on behalf of Chantix victims for more than a year now. "Pfizer requested and received an 'expedited' review from the FDA in an effort to rush the drug onto the open market. Based on our investigation and review of information available to the public, we believe Chantix was rushed to market before it was adequately studied, placing consumers at significant risk of serious injury," said Rasmussen.
The FDA has already required Pfizer to strengthen the information contained in the drug label and the Federal government banned the use of Chantix by pilots and air traffic controllers. The new ISMP report urges the FDA and Pfizer to add a prominent warning about accident risks to the patient medication guide and prescribing information for doctors.
"The public needs to know all of the risks and benefits associated with using a drug like Chantix. We encourage the FDA to take a closer look at what's going on," said Rasmussen who said his firm represents more than 300 Chantix victims after investigating claims from more than 2,300 individuals with inquiries about potential Chantix related injuries.
Join us! Acupuncture & Massage College will have a booth in the center courtyard at The Falls shopping center during this year’s Health and Wellness Fair, held Saturday and Sunday, November 1 and 2 from 12 to 5 pm. Fair attendees will be treated to FREE massages as well as FREE music and other activities. The Falls is located at 8888 SW 136 Street, Miami. For more information about the fair call (305) 595-9500.
For information about Acupuncture & Massage College’s Oriental Medicine and Massage Therapy programs call Joe Calareso, Admissions Director, at (305) 595-9500.