Archive for the 'Heparin' Category

How to clean up the FDA?

Monday, December 15th, 2008

One of the most important jobs of the FDA is to provide the public with clear information about drug safety. Another mission is to reveal what it knows about potentially defective drugs.

How well the FDA is doing with its primary mission is being questioned by Representative Joe Barton (R-Texas) who wrote a letter to the US Government Accountability Office: asking is the FDA telling us everything it knows?

The GAO is being asked to review the FDA’s handling of the contaminated heparin problems of 2007 and 2008. In his letter, Barton notes that the FDA’s statements to the media in July 2008 indicate that the agency had “conclusively linked” deaths of three patients to oversulfated chondroitin sulfate found in specific lots of the drug, which is manufactured by Baxter Healthcare.

Yet when Barton requested information, the agency told him in October 2008 that it was merely “possible” that heparin caused two of the deaths and that it could not assess whether heparin caused the third death, while Baxter’s investigation of the situation concluded that it was unlikely that heparin had caused any of the three deaths.

The FDA did not interview Baxter to get more information about the deaths and that inconsistency troubles Barton.

FDA may have mishandled the Heparin scandal

Wednesday, November 26th, 2008

Questions are being raised as to the adequacy of the Food and Drug Administration’s handling of the contaminated blood thinner Heparin earlier this year. It is thought that the FDA misreported deaths tied to the product and didn’t thoroughly investigate the problem. It appears that the FDA released conflicting statements to the public and Congress about the number of deaths tied to contaminated Heparin.

The FDA said it linked three deaths to the defective drug in May, but last month claimed that only two of the deaths were possibly linked to Heparin when reporting to congressional staff.

Baxter International Inc., a company involved in the scandal, did its own investigation of the deaths and concluded that Heparin was not the likely cause in the three cases. Their investigation included obtaining medical records from patients, visiting a hospital where one of the patients had gone before dying, and interviewing pharmacists and nurses.

The FDA didn’t follow up with a clinical staff at the hospitals, talk with Baxter to find out further information about deaths, or access other medical databases it uses to evaluate drug safety problems.

Reports of serious drug reactions hit record

Friday, October 24th, 2008

The Associated Press is reporting the number of serious drug reactions and deaths reported to the government shot up in the first three months of this year, setting a record.

According to the report, the Food and Drug Administration received nearly 21,000 reports of serious drug reactions, including reports of more than 4,800 deaths.

Two drugs accounted for a large share of the latest reports. One was the blood thinner heparin. Most of the drug’s problems were prompted by tainted heparin imported from China.

The other was Chantix, a new kind of anti-smoking drug from Pfizer.

The 20,745 cases reported from January through March was 38 percent higher than the average for the previous four calendar quarters, and the highest for any quarter, the report said.

The number of deaths, 4,824, was a nearly threefold increase from the last calendar quarter of 2007. The FDA said contaminated heparin was largely to blame.