The number of serious problems and deaths linked to medications reported to the government set a record in the first three months of this year, according to a health industry watchdog group. The Food and Drug Administration received nearly 21,000 reports of serious drug reactions, including over 4,800 deaths, according to an analysis of federal data by the nonprofit Institute for Safe Medication Practices, which scrutinized data going back to 2004, and yearly totals dating to the 1990s. Two drugs accounted for a disproportionately large share of the latest reports. One was heparin, the tainted blood thinner from China that caused an international safety scandal.
The other was Chantix, a new kind of anti-smoking drug from Pfizer. Chantix, which had the most reports of any medication, works directly in a smoker’s brain to ease withdrawal symptoms. It also blocks the pleasurable effects of nicotine if the patient tries to light up again. But earlier this year, the FDA warned that Chantix may be linked to psychiatric problems, including suicidal behavior and vivid dreams. The government banned it for pilots. Pfizer still says it stands by Chantix.
The watchdog group, known as ISMP, has served hospitals and pharmacists for years as a clearinghouse for information on drug safety and medication errors. ISMP is now reaching out to consumers with regular reports on drug safety trends, drawn from FDA records. Thomas J. Moore, a senior scientist with the group, made this statement:
We believe that one of the most important tools to promote is to monitor trends on a regular basis. Knowing which drugs are causing injuries and how many people are being hurt is the raw material we need to fashion sound measures to promote patient safety.
The FDA defines serious drug reactions as those that cause hospitalization, require medical intervention, or place a life in jeopardy. The agency’s monitoring system relies on voluntary reports from doctors and is only believed to capture a fraction of overall problems. The total of 20,745 cases reported in the first quarter (January – March) was 38% higher than the average for the previous four calendar quarters. It also was the highest for any quarter, and that’s most disturbing.
Fatalities accounted for 23% of the cases. The total number of deaths, 4,824, was an increase of nearly 3% from the last calendar quarter of 2007. Previous research from ISMP had revealed that serious drug safety problems reported to the FDA increased markedly from 1998-2005. The FDA case reports provide a signal of possible problems with a drug, but a cause-and-effect connection can only be established through painstaking investigation.
The ISMP study found that heparin accounted for 779 reports of serious problems, including 102 deaths. The FDA, using data that covers a longer time period has reported 238 deaths possibly linked to heparin. The report found that Heparin “illustrates an example of a significant drug safety problem that was promptly and effectively resolved by the drug manufacturers and the FDA once the issue was detected and understood.” But, it concluded that was not the case with Chantix.
The FDA should forcefully warn patients taking Chantix that they may have blackouts and other problems that could lead to accidents, the report said. The current warnings say that patients may be too impaired to drive or operate heavy machinery, but such language is standard for many medications. That type warning is not adequate. The report found 15 cases of Chantix patients who appeared to have been involved in traffic accidents, and 52 additional cases involving blackouts or loss of consciousness. The FDA received 1,001 reports of serious injuries possibly linked to Chantix, more than for the ten best-selling brand name drugs combined.
Chantix “continued to provide a striking signal of safety issues that require investigation and action,” according to the report. The authors acknowledged Pfizer’s concern that publicity may be driving up the number of reports, but nonetheless concluded that there are enough to warrant further action by the FDA. Pfizer says that the benefits of Chantix benefits clearly outweigh the risks. If you would like more information on this matter, call Frank Woodson at 800-898-2034 or e-mail at Frank.Woodson@beasleyallen.com.
Source: Associated Press
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.