Blood tends to pool in the atrial chamber of individuals with atrial fibrillation, which can lead to clotting and an increased risk for strokes. Patients with atrial fibrillation are generally treated with blood thinners to help prevent blood clots from forming.

However, blood thinners like heparin can cause serious bleeding episodes and allergic reactions. Alternatives to long-term use of blood thinners has many cardiologists taking notice.

“The findings from this clinical trial are very impressive,” said Dr. Gregg C. Fonarow, professor of cardiology at the University of California, Los Angeles. “Treatment with this novel device will be very attractive and provide patients with atrial fibrillation effective, long-term protection from stroke and systemic embolization without the bleeding risks associated with (blood thinners).”

The PROTECT-AF Trial, which involved 707 patients with a type of atrial fibrillation, showed that patients who had the device had a 32 percent lower risk of stroke and cardiovascular death compared with those on blood thinners. The study also found fewer complications with the implanted device compared to the use of blood thinners.

A Food and Drug Administration (FDA) advisory panel will meet in April to consider the sale of the device in the United States.

Source:
Eflux Media News

SOURCE: Heparin Recall › Heart device may eliminate need for heparin, warfarin

The Quaids also sued Baxter Healthcare Corp. over the packaging and labeling of its high-dose and low-dose heparins, arguing the two bottles are easily confused. Other cases of heparin overdose have been reported and linked in part to the confusing packaging. The Quaid’s lawsuit against Baxter was dismissed on jurisdictional grounds because the event occurred in California.

Baxter was no stranger to the spotlight in 2008, facing numerous lawsuits most notably for the tainted heparin scandal earlier in the year. More than 80 Americans died and hundreds more were sickened after receiving doses of heparin made at Baxter China plant. An investigation found that lots made in that plant were contaminated with over-sulfated chondroitin sulfate (OSCS). The contaminant can cause serious allergic reactions and even death. The FDA issued a recall on batches of Baxter’s heparin.

According to news reports, the Quaid-Cedars-Siani case indicates that Baxter may also sue Cedars-Siani for improperly administering the blood thinner to several patients at the hospital, including the Quaid’s newborn twins.

SOURCE: Heparin Recall › Quaid-Cedars-Siani lawsuit over heparin overdose finally closed

Nearly 100 pharmacists and the hospitals they work for were fined $2,000 to $5,000 by the Board of Pharmacy, according to the report.

The Food and Drug Administration (FDA) recalled heparin early last year after a large number of patients suffered adverse effects after taking the drug. The FDA later determined that batches of heparin made in China contained a contaminant that ultimately killed more than 80 people and made hundreds more ill.

In 2004, California took the lead in making sure recalled medicines were removed from pharmacy and hospital shelves by becoming the only state in the country to approve a stringent electronic system for drug makers, wholesalers and pharmacies to track all prescription drugs from manufacturer to patient, according to the San Francisco Chronicle.

But implementing this system has been challenging. The law originally was set to go into effect in 2007, but was delayed until January 1, 2009. Last March, the California Board of Pharmacy voted to give until Jan. 2011 to start electronic tracking. Board officials were concerned if they did not extend the deadline that the law would be poorly implemented or drug makers would refuse to sell their medications in California.

SOURCE: Heparin Recall › Recalled heparin still appearing in hospitals, pharmacies

Last month I told you that California Rep. Harry Waxman, who serves as head of the House Oversight and Government Reform Committee, raised concerns that items outlined on the FDA’s 2007 priorities list appeared to prioritize industry desires over consumer protection.

This, just months after more than 80 American deaths were linked to tainted heparin that was made in Baxter International Inc.’s facility in China. FDA officials later acknowledged they had not inspected that facility and claimed they had insufficient staff and financial resources to regularly inspect overseas manufacturers.

Today, the Washington Post reported that the FDA has hired a public relations company it improve its image. However, in yet another PR blunder, the story reports that the way it hired the company may also be raising eyebrows.

The story suggests that the FDA may have violated government contracting rules by not holding a bidding competition for a $300,000 contract hiring a firm to create “a lasting positive public image for the agency.” Instead it made a deal with Alaska Newspapers Inc., (ANI) which is exempt from having to compete for federal work because it qualifies for special set-asides. ANI agreed to funnel all the work to the FDA’s agency of choice, Qorvis Communications. Apparently the FDA’s new PR head, Mildred Cooper, had connections to the firm and wanted to use it.

The FDA cancelled its contract with ANI/Qorvis Communications after the Washington Post’s story ran. And while the FDA claims it never meant to do anything questionable during the selection process, this latest blunder certainly hasn’t helped the organization’s public image.

SOURCE: Heparin Recall › FDA makes blunder during hiring of PR firm to improve image

The FDA also planned to change its regulations to protect device makers’ FDA-approved products from lawsuits with a so-called preemptive clause, according to Reuters.

The news agency says that in a letter from California Rep. Henry Waxman, to FDA Commissioner Andrew von Eschenbach, Waxman raised concerns that the items outlined on the FDA’s 2007 priorities list “all appear to prioritize industry desires over consumer protection.”

Then-FDA Chief Counsel Sheldon Bradshaw told Waxman in an e-mail that he planned to forward the list of priorities to Deputy Secretary of Health and Human Services Tevi Troy. Both Bradshaw and Troy have ties to the pharmaceutical industry, Reuters reports.

Waxman, who serves as the head of the U.S. House of Representatives Oversight and Government Reform Committee, suggested that political appointees at the agency may be promoting industry priorities at the expense of FDA’s core public health mission.

Highly publicized safety scares, including bacteria-laced foods and contaminated batches of heparin, have put the FDA in the hot seat in recent years. According to Reuters, an FDA spokesperson said the agency would respond directly to Waxman about the concerns he raised.

SOURCE: Heparin Recall › Lawmaker questions FDA priorities, suggests industry ties