Baxter warned by FDA for misleading email

The Food and Drug Association has reviewed a "Clinical Thank You Email" in which Baxter Healthcare Corp. overstated claims about their inhibitor bypassing clotting complex FEIBA VH.

The agency ordered Baxter to stop using the e-mail and any promotions that exaggerate the drug's safety and effectiveness. "By promoting misleading safety and efficacy claims, you are potentially encouraging the unsafe use of FEIBA VH," the FDA said in the letter dated July 7.

Baxter isn't a small outfit. You'd think they would have access to their own data. Why would they exaggerate these claims? Methinks someone's in trouble.

Heparin Problem has not gone away

I posted about the Heparin problem back in January here. Apparently the situation has gotten worse. A recent New York Times article details the latest developments.

Here's the opening graphs:

The number of suspicious deaths in the United States linked to the blood thinner heparin has risen to 62 from 19, with most of them reported this past December, January and February, according to the first detailed analyses of heparin fatalities by the Food and Drug Administration.

The F.D.A. is still investigating whether those deaths and hundreds of allergic reactions were caused by a heparinlike contaminant made in China that was added to the drug somewhere during the manufacturing process.

The drug agency defined suspicious deaths as those involving one or more allergic reactions or a drop in blood pressure. There have been no reports of deaths since the end of February, after Baxter International recalled heparin made with ingredients from a Chinese supplier.

Before we jump to conclusions about Baxter:

In addition to Baxter, companies that have recalled heparin products made with Chinese ingredients include Covidien, formerly Tyco Healthcare, and B. Braun. Both Covidien and Braun said that they had received no reports of adverse reactions from the heparin and that the recalls had been undertaken merely as a precaution.

The common thread between this product and some seemingly unrelated consumer goods is China. I posted about China's exports last year here. Coincidence for the 2008 Olympic Summer Games host? Time will tell.

Uh-oh.

Baxter recalls 9 lots of heparin sodium injection.

I note this as significant for the bleeding disorders community because heparin sodium is used to flush IV or port lines or to prevent unwanted clots in those same line.

We used a low-dose heparin sodium solution (just enough to fill the port reservoir and catheter) as part of our port infusion routine in the year and a half Jack had a port.

A list of the batches and lots are here.