Fungal Meningitis and the End of Lackadaisical FDA Involvement in Compound Pharmacies

New England Compounding Center (NECC) is at the center of this quite horrific tragedy that has affected the lives of many with fourteen already dead. I cannot personally fathom such a loss over something so seemingly accidental. As a pharmacist my thoughts immediately go to sterile technique and the FDA's regulation of our industry. You see, the states oversee the pharmacies compounding and normally that should be enough. However, something went terribly wrong here. But what is coming out lately is the role of compounding pharmacies and how in this case, there was a grey area they were working in. Basically compound pharmacies can make patient specific medications, what is not allowed is these compounding pharmacies acting as manufacturing and bulk shipping repackaged medications without FDA oversight.

It's all about the dollar, but in this case many priceless lives have been lost.

There are two fungi involved: aspergillus and Exserohilum rostratum.

In the past, these pharmacies have been the heroes making things like bioidentical hormones and other specialty concoctions.

Under the FDA's definition, compounding pharmacies are supposed to mix drugs to order only on a specific patient in response to a prescription from a doctor. Under this definition NECC was not operating as a compounding pharmacy but as a large-scale production of a drug. The FDa should have stepped in before these lives were lost.

You never know what you are going to get...

U.S. health officials have identified a contaminant in batches of the blood thinner heparin associated with 19 deaths and are trying to determine how the chemical got into the drug.

The lots of heparin, whose key ingredient was imported from China, were recalled Feb. 28, and Food and Drug Administration officials said Wednesday that no new deaths have been reported since that time.

Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, said the contaminant is oversulfated chondroitin sulfate, a chemical that does not occur naturally.

Chondroitin sulfate is a natural compound that occurs widely and is used as a dietary supplement but the oversulfated version has not been widely studied.

''We cannot rule in or out whether this was accidentally or deliberately introduced into the product,'' Woodcock said, ''We are investigating how it got in.''

Baxter Recalls Heparin Products

Baxter International recently announced a voluntary recall of all remaining lots and doses of its heparin sodium injection multidose and single-dose vials and HEP-LOCK heparin flush products.

The FDA has received 448 reports of adverse events associated with heparin products, but some of these may be duplicate reports. In 389 of these cases, Baxter was named as the source of the product. The reports included 215 “events of interest” and 21 deaths. Most of the events occurred last year.

The FDA has launched a “far-reaching investigation” of a Chinese firm, Changzhou SPL, which made the active pharmaceutical ingredient (API) for Baxter, Michael Rogers, director of the FDA’s Division of Field Investigations, said. Two FDA inspectors were sent to China to carry out that investigation and related investigations of two “consolidators” associated with the API manufacturer. They also may inspect workshops and farms associated with the manufacture of the product, which uses pig intestines.

The agency has posted on its website a redacted version of the Form 483 observations that its investigators issued after inspecting the API plant. It can be accessed at www.fda.gov/ora/frequent/483s/Changzhouspl_heparin_20080226_483.html.

--------------------------

It's the backdoor method of the Chinese trying to kill us.  Just kidding.  Seriously though this recall does affect the hospitals where I work pretty severely.  When do you think we'll stop relying on foreign countries to make a medicine that can be trusted?

Avandia

The Food and Drug Administration (FDA) issued an alert on May 21, 2007 informing healthcare providers of a potential cardiovascular safety issue raised by a recent meta-analysis (Nissen, 2007). Nissen and Wolski reviewed 42 randomized, controlled studies (each >6 months duration) in patients with type 2 diabetes or impaired glucose tolerance. Each study included compared rosiglitazone (as monotherapy or in combination regimens that include a sulfonylurea, metformin, and/or insulin) to a control group (another diabetic agent or placebo). The meta-analysis tabulated the number of myocardial infarctions and cardiovascular deaths from each trial. Of the 42 studies, 38 reported at least 1 MI and 22 reported at least 1 CV related death. The meta-analysis evaluated 15,560 patients who received regimens that included rosiglitazone and 12,283 patients in the group without rosiglitazone. In comparing the rosiglitazone group to the control group, the odds ratio for myocardial infarction was 1.43 (95% CI 1.03 to 1.98; p=0.03). The odds ratio for death from cardiovascular disease was 1.64 (95% CI, 0.98 to 2.74; p=0.06). Rosiglitazone was associated with a significant risk of myocardial infarction in this pooled analysis. The clinical significance of these initial results is unclear and the data has not been reviewed by the FDA. The agency is currently assessing the information. Healthcare providers should be aware of these developments and await further information as more becomes available.