Study Says FDA Could Be Doing Better At Publicizing Drug Recalls

Although the U.S. Food and Drug Administration recalls drugs that could be harmful around once a month, a new study says the agency has room for improvement when it comes to publicizing those recalls and informing doctors and patients about them.

Researchers found that over a period of eight years, the FDA didn’t send notifications for one in five of the most serious recalls it issued, using two electronic systems used to alert the public as well as doctors, reports Reuters.

These are what the FDA calls Class 1 recalls — drugs that if taken, could potentially cause “serious adverse health consequences or death.”

Included in one of these Class 1 recalls was the blood thinner heparin, which was contaminated in2008 and was reported for resulting in serious reactions and some deaths in dialysis patients.

Some experts suggest that any Class 1 recall should be communicated, while perhaps leaving out less important Class II and Class III recalls.

Researchers found more than 1,700 drug recalls listed in the FDA’s enforcement reports between 2004 and 2011, with 91 of those being serious Class 1 recalls. In that same time period, the FDA issued around 2,900 announcements through its Recall Alert System, but the system only sent alerts for 55 of the Class 1 recalls.

Another system, MedWatch, sent out alearts for 18 of the remaining recalls, which left 18 more recalls that never had alerts sent out about them at all.

“Despite recent efforts by the FDA to address the drug recall burden, health care providers may be inadequately informed about clinically important recalls that threaten patient safety,” wrote the authors of the study in a letter to the Archives of Internal Medicine on Monday.

An FDA spokesperson told Reuters the agency uses many ways to communicate with doctors, but wasn’t able to say why those 18 cases never had an alert sent out.

Researchers suggested that there should be an active tracking system for drugs, so that all pharmacists know which bottles the recalled products come from. In the meantime, drug companies could also send letters directly to doctors about the recalls.

For the FDA’s automatic email notices about recalls, check out or on Twitter: @FDArecalls.

U.S. drug recalls common, not well publicized: study [Reuters]


Edit Your Comment

  1. GuyGuidoEyesSteveDaveâ„¢ says:

    I know Target was damn good at sending me alerts when something was amiss with one of the scripts I had with them. Maybe instead of blanketing the public with warnings that we will eventually become desensitized to, mandate that the people who fill our prescriptions contact us when something that directly affects us comes out. Think about all of those commercials you see for law firms warning you if you took drug X or had implant Y or procedure Z that you may have been in danger. Can you think of a single drug name they mentioned in those adverts, or do you just blow past them on your Tivo or tune them out?

  2. ScandalMgr says:

    The FDA is to Drugs, what the EPA is to Brawndo.

    In other words, if Brawndo is what plants want…

  3. ScandalMgr says:

    The Drugs I Need, by the Austin Lounge Lizards.

  4. catastrophegirl chooses not to fly says:

    i work in pharma and i get better updates about drug recalls from a google alert i set up than i do from being on the FDA’s email list

  5. lovemypets00 - You'll need to forgive me, my social filter has cracked. says:

    Express Scripts leaves me voice mail messages on my home phone about everything, from “you have a prescription that could be refilled” to “we’re filling your prescription, shipping it, it should arrive by, blah blah blah”. You’d think they’d at least be able to send an email or leave a message and say “your prescription med was recalled, please contact us”.

    • catastrophegirl chooses not to fly says:

      you should be able to set up email alerts from express scripts in your preferences on their website

      • lovemypets00 - You'll need to forgive me, my social filter has cracked. says:

        I looked and looked – can’t find it. Calling them is a nightmare. So I just ignore their calls, and I’m happy to have prescription drug coverage. I really would prefer it if they’d just email me, though.

        • catastrophegirl chooses not to fly says:

          i haven’t had them in years but i know i had set it up on the website. i might have removed my phone number to make it happen though

  6. Talmonis says:

    Oh oh oh I know! It’s ineffecient, and things fall through the cracks. So instead of having some oversight, lets throw it ALL out! That will sure get corporations to police themselves for some contrived and insane reason!

  7. sirwired says:

    What would any consumer do with such a recall alert? They are inevitably tied to specific lot numbers, which a consumer with a pill bottle usually has no knowledge of.

    The dispensing pharmacy should be the one tasked with alerting consumers.

  8. Lisa W says:

    They needed a study to figure that out?