FDA Lists Product Faults

Just go to the product problem site of the FDA and reads some examples. For instance:

• A physician reported to her hospital pharmacist that she suspected the epoetin alfa administered to a patient might be counterfeit due to unusual local reaction to the injection. The pharmacist, after inspecting the vial, label, and packaging, noted differences in the quality of the packaging between the suspect sample and other lots. A MedWatch report was submitted to FDA. Subsequent investigations determined that the product was counterfeit and contaminated with bacteria.

What gets me about this report is they don't tell you what the "unusual local reaction " was. Did she get a rash. I could live with that. Did all her teeth fall out? That would certainly qualify under "unusual reaction". Did she start growing hair on her chest, start having delusions like the Cubs had a chance of winning, that the English live in a good climate or that comprehensive health care plan untainted by special interests could eventually be passed. These would also would be "unusual reactions."

• A pharmacist observed that a 5cc unit bottle of diphenhydramine syrup made a rattling noise when shaken. After removing the seal, it became obvious that the noise was caused by loose glass fragments floating in the syrup. Recognizing the life-threatening nature of this product if swallowed, FDA was contacted. An FDA investigator picked up the samples and initiated an investigation at the manufacturer. The results revealed a problem with the production of glass bottles. This report resulted in a nationwide recall of the product.

What gets me about the report is that it is actually funny. There are "loose glass fragments" floating in the syrup and the FDA uncovers " a problem with the production of glass bottles." Amazing! Who would have figured that out? It is like wondering why Killer Whales kill? Hmm, let me work on that for a while. Could there be a clue in the name KILLER Whale?

• A customer returned to the pharmacy after purchasing a bottle of a liquid antacid and complained about the foul odor coming from the product when it was opened. The pharmacist took note of the terrible odor and also observed that the plastic bottle container was distended. The customer was given a similar product to replace this antacid. Next, the pharmacist checked the storeroom stock and checked the lot numbers of the affected product. Then the FDA was contacted to relay this drug product quality concern and to provide the necessary facts to investigate this production lot.

Okay - what bothers you about the report, Could it be that that "The customer was given a SIMILAR product to replace this antacid." If I just got a tainted bottle with a foul odor, would I want a SIMILAR product? Hmm, no THANKS! And the FDA could have used similar in a funny way. They could have written into the report "The pharmacist took note of the terrible odor, similar to the odor coming from Congress when they are working on a bill. .."

I must end now, as the FDA will soon call me seeking help writing their reports.

http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053091.htm