Monday, April 16, 2012

Do YOU Know How To Check The FDA's Website For Recalls?

I am certainly not the only blogger to note how easy it is to become complacent with diabetes care. After all, with 35 years of type 1 under my belt, the never-ending nature of this disease makes it easy to want to forget. But unlike some fellow d-bloggers or preachy diabetes educators, today I'm NOT referring to self-care. As Americans, we tend to PRESUME that the drugs, biotech products, and medical devices we rely on to keep us healthy will be usually be safe.

And for the most part, that's been a safe presumption. The U.S. Food and Drug Administration's job is supposed to keep us safe. And for the most part, that organization does it's job reasonably well.

When things go wrong, it's our fault, right?

Not always.

In recent years, the number of recalls issued by the FDA has gone from next-to-nothing to quite an astonishing number if I do say so myself.

Perhaps it's because the FDA finally has new leadership that has decided to crack down on it's loosey-goosey policy enforcement that became so prevalent under the leadership of former FDA chief Andrew von Eschenbach. Or maybe it's because the companies that provide these products have become too damn big and complex thanks to relentless mergers and acquisitions and cannot catch things as quickly as they used to, or maybe drug and medical device companies have simply put profits before patients in recent years.

For example, Johnson & Johnson has had an almost weekly stream of recalls since the beginning of 2011, and the law has caught up with that shareholder-first behavior. Last June (2011), a judge in South Carolina named Roger Crouch ordered the company to pay more than $327 million in penalties for deceptively marketing the antipsychotic drug Risperdal as safer and better than competing medicines, which is a violation of that state's consumer-protection laws.

Johnson and Johnson's execs had "allowed the profit-at-all-costs mentality to cloud" their judgment in connection with the drug's marketing campaign and its labeling, Couch said in a particularly egregious, 17-page ruling (see HERE for the ruling) against the company. Judge Crouch added that J&J exhibited what he called a "callous disregard to a patient's right to have all information available, and in the hands of their physician, before deciding to use or continue to use the drug. Further, I find that the defendants allowed the 'profits at all costs' mentality to cloud the vision of their own responsibilities as acknowledged in their credo." [that famous credo can be seen HERE] He concluded that bad faith was considerable when it came to labeling matters.

Ironically, in spite of an astonishing number of recalls in the past year from J&J alone. J&J's diabetes care products (so far, anyway) have NOT really been among it's numerous recalls. But several of it's rivals have had recalls in 2011, including Abbott Diabetes Care, Roche and others.

Were you aware of any of those, and if so, how did you hear about them?

In December 2011, the FDA mandated a recall for some of Abbott's Glucose Test Strips (as many as 359 million test strips according to the FDA) made by that company could give false low Bbood glucose results (see HERE).

March 2011 brought us a recall from Roche for that company's ACCU-CHEK FlexLink Plus Infusion Set as having the potential for under-deliver insulin (see HERE).

Then, at the beginning of June 2011, the FDA required a recall of Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks which are commonly used to disinfect prior to an injection (although truth be told, many diabetes veterans have given up on doing that). Many distributors such as CCS Medical provide these with most orders. The reason for that recall: "potential microbial contamination" from those products (see HERE).

Also, in 2010, there were FDA safety alerts for several type 2 diabetes drugs, including Actos and Avandia (see HERE and HERE).

Also in 2010, an FDA mandated recall on Nipro GlucoPro Insulin Syringes because the syringes may have needles that detach from the syringe. If the needle becomes detached from the syringe during use, it could become stuck in the insulin vial, push back into the syringe, or remain in the skin after injection. (see HERE).

Let's not forget the FDA fines against Eli Lilly and Company's Puerto Rico manufacturing facility of Humalog for a dirty ("adulterated") facility (see HERE).

If it seems like the number of warnings, recalls and safety alerts has increased, that's because it does seem to be the case. I can remember reading about a rare recall in Diabetes Health (formerly Diabetes Interview) magazine (often for brands of syringes and the like which I had never heard of), but those seemed to be relatively rare until the last few years.

However, nobody bothers telling you about these things until you hear them on the six o'clock news, or read it online. Your local pharmacist might share this information if he/she knows about it. However, because many for-profit insurance companies are effectively forcing patients to use mail-order with tiered pricing arrangements and in the name of "efficiency", do you really think Medco's massive mail-order pharmacy will do robocalls to advise you of a recall? I wouldn't hold my breath waitng for that to happen. I'll bet Adam Fein probably doesn't have an answer to that (since he's such a huge fan of mail-order pharmacies), either!

All of this makes me wonder. Scott's Web Log has long had a widget from the FDA containing links to check for recalls for readers (or report adverse events to the FDA), yet I haven't personally checked them for myself for a while.

Would you know where to look? I didn't think so!

Hence today's writeup.

Do YOU know where to find news of FDA-mandated recalls, warnings and safety alerts? Merely visiting the FDA's poorly organized website might not make that an easy task. Incidentally, the FDA was cited by the U.S. Government Accountability Office in 2006 for a need to better communicate these issues (see HERE) on postmarket analysis and communications, and again in 2009 for the need to establish a plan to modernize their antiquated information systems (see HERE for that report).

In any event, you can indeed find warnings, recalls and the like for the FDA by visting:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/default.htm

I'm including the widget (which normally appears towards the bottom of my blog's right-hand margin) here for reference:



For my Canadian readers, know that issues impacting U.S. drugs and medical devices are not necessarily relevant in Canada. However, the regulatory agency (Health Canada) also has a website for these issues.

Health Canada Advisories, Warnings and Recalls can be visited at:
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/index-eng.php

For my readers in Europe, Australia and New Zealand or Asia, I don't have a ready place to refer you, but I can say that the European Medicines Agency does have a nicely organized website (which frequently has far more info. on medicines sold than the FDA ever seems to publish) so finding this may not be the challenge it is in the U.S. Oceania or Asian residents should check with their local regulatory authorities to determine if there are comparable sources for recalls, warnings and safey information.

In a small way, I hope this little tidbit of information will help you be better advised of product recalls in the future.

3 comments:

Jonah said...

Thank you, Scott.

One of my local drug stores taped up a piece of paper with a notice about th alcohol wipes.


I also this year heard about one of the pump makers getting reprimanded for not reporting adverse effects enough.

I hadn't heard about the dirty Humalog.

Michael Hoskins said...

Scott: Thank you for this. What an incredibly valuable post, my friend. You're abolutely right - so many don't know about these. I occasionally check in just to get a feel for what's going on, but not for myself. More in that journalism watchdog role. It is somewhat alarming how these big mergers and acquisitions, and partnerships creating huge medical supply companies, are taking away that local "pharmacy talk" - kind of like the relationship with your local barber where everyone goes to hear all the latest community news and gossip. At least, that's how it used to be. Not anymore. We need to write more about these resources to let people know about them. Thanks for providing this service, bud.

Bridget Hall said...

I think this has been a major discussion at any online pharmacy reviews forum, considering how they've also featured some of these meds before and considered them quite safe.