A record number of serious drug-reaction reports were submitted to the U.S. Food and Drug Administration during the first quarter of this year, according to an analysis by a health industry watchdog group.
Nearly 21,000 serious adverse reactions, including 4,800 deaths, were received by the FDA in the first three months of 2008, the nonprofit Institute for Safe Medication Practices said. The group analyzed yearly totals dating back to the 1990s, according to the Associated Press.
Two drugs accounted for a disproportionate share of the reports: the blood thinner heparin, and the Pfizer anti-smoking drug Chantix.
Chantix, which the FDA has warned may be linked to psychological problems including suicidal behavior, had more reports than any other drug. The medication is meant to affect the smoker's brain directly, easing withdrawal symptoms and inhibiting the pleasurable effects of nicotine.
While the FDA had no immediate reaction to the report, the AP cited a Pfizer statement that the company stood by Chantix and attributed the number of adverse-reaction reports to publicity about the drug's side effects.
Some adverse reports about heparin stemmed from a scandal earlier this year, in which global authorities identified contaminated heparin linked to 12 Chinese companies that were involved in the drug's manufacture.
A serious drug reaction is defined by the FDA as one that causes hospitalization, requires medical intervention, or is life-threatening. Since the agency relies on voluntary submissions from doctors, its tally is believed to represent a fraction of actual cases, the AP said.
Smokers Urged to Get Pneumonia Vaccine
All adult smokers under age 65 should get a pneumococcal vaccine, an influential group of experts that advises the U.S. government is recommending.
The Advisory Committee on Immunization, noting that the nation's 31 million adult smokers are at higher risk of pneumococcal disease, voted 11-3 Wednesday to recommend that all adult smokers get the vaccine, the Associated Press reported. In addition to bacterial pneumonia, the shot would protect against other illnesses such as meningitis.
Smokers are about four times more likely to acquire pneumococcal disease, and their risk increases the more cigarettes they smoke, the AP said.
While the precise link between smoking and pneumococcal disease isn't understood, it's thought that bacteria are better able to thrive in people whose lungs and windpipe have been damaged by smoking, the wire service said.
Problems Linked to Mesh Used as Incontinence Remedy
Surgical mesh used to treat women's health issues, including severe incontinence and prolapsed uterus, may cause rare but serious complications, U.S. Food and Drug Administration officials say.
The FDA this week said it has received more than 1,000 reports during the past three years of complications from the vaginally inserted mesh, including infection, pain and urinary problems, the Associated Press reported.
Nine manufacturers produce the product, and the FDA said it is investigating possible reasons for the complications.
In the interim, the agency is advising doctors to get special training before using the product, to monitor patients closely for signs of infection and other complications, and to disclose possible complications to prospective patients in advance, the AP said.
FDA Cited for Lax Oversight of Foreign Drug Makers
The U.S. Food and Drug Administration has been lax in overseeing and inspecting foreign drug plants, the Government Accountability Office has found in a report to be released Wednesday.
According to the Wall Street Journal, the analysis by the investigative arm of the U.S. Congress comes as a House committee continues its investigation of the agency's handling of problems at two Indian plants run by generic drug maker Ranbaxy Laboratories. In September, the FDA banned import of 30 generic drugs produced at the two plants. The action came several years after the FDA first found manufacturing problems at one of the plants, the newspaper said.
In the five years ending in fiscal 2007, the FDA issued 15 warning letters to foreign drug makers that had serious problems, including manufacturing or record-keeping deficiencies. But only four of those companies were eventually re-inspected, the Journal reported.
In what the newspaper called "an unusual move," the GAO urged the FDA to conduct as many inspections of foreign drug makers as it performs on domestic ones.
The FDA has plans to open offices in China, India and Latin America, the newspaper said.