Most people realize that drug medications can play an essential role in preventing disease and improving their lives. The problems with drugs include adverse medication reactions1 and medication recalls. Jay Harold wrote this post, “Drug Recalls: Definition, Classifications & Reports,'” so you can be aware of another type of recall; a non-drug one.
The Food and Drug Administration (FDA) is informing health care providers and patients of the potential risk of serious or life-threatening infections with the use of fecal microbiota for transplantation2 (FMT). The agency is now aware of bacterial infections caused by multi-drug resistant organisms (MDROs) that have occurred due to the transmission of an MDRO from use of investigational FMT.
Summary of the Issue
- Two immunocompromised adults who received investigational FMT developed invasive infections caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E.coli). One of the individuals died.
- FMT used in these two individuals were prepared from stool obtained from the same donor.
- The donor stool and resulting FMT used in these two individuals were not tested for ESBL-producing gram-negative organisms prior to use. After these adverse events occurred, stored preparations of FMT from this stool donor were tested and found to be positive for ESBL-producing E. coli identical to the organisms isolated from the two patients.
Information for Health Care Providers and Patients
In July 2013, FDA issued guidance stating that it intends to exercise enforcement discretion under limited conditions regarding the IND requirements for the use of FMT to treat Clostridium difficile (C. difficile) infection in patients who have not responded to standard therapies. The guidance states that the FDA intends to exercise enforcement discretion provided that the treating physician obtains adequate consent for the use of FMT from the patient or his or her legally authorized representative. The consent should include, at a minimum, a statement that the use of FMT to treat C. difficile is investigational and a discussion of its potential risks. FDA is informing members of the medical and scientific communities and other interested persons of the potential risk of transmission of MDROs by FMT and the resultant serious adverse reactions that may occur.
Patients considering FMT to treat C. difficile infection should speak to their health care provider to understand the potential risks associated with the product’s use.
Additional Protections for Investigational Use of FMT
- Because of these serious adverse reactions that occurred with investigational FMT, FDA has determined that the following protections are needed for any investigational use of FMT:
- Donor screening with questions that specifically address risk factors for colonization with MDROs, and exclusion of individuals at higher risk of colonization with MDROs.
- MDRO testing of donor stool and exclusion of stool that tests positive for MDRO. FDA scientists have determined the specific MDRO testing and frequency that should be implemented.
- Donor screening with questions that specifically address risk factors for colonization with MDROs, and exclusion of individuals at higher risk of colonization with MDROs.
Reporting Adverse Events
FDA encourages all health care providers administering FMT products to report suspected adverse events to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
FDA’s Role in Drug Recalls3
A drug recall4 is the most effective way to protect the public from a defective or potentially harmful product. A recall is a voluntary action taken by a company to remove a defective drug product from the market. Drug recalls may be conducted on a company’s own initiative or by FDA request. FDA’s role in a recall is to oversee a company’s strategy, assess the adequacy of the recall, and classify the recall.
Recall Classification
- Class I: A dangerous or defective product that could cause serious health problems or death.
- Class II: A product that might cause a temporary health problem, or pose a slight threat of a serious nature.
- Class III: A products that are unlikely to cause any adverse health reaction, but that violates FDA labeling or manufacturing laws.
Alerting the Public
Not all recalls are announced on FDA.gov or in the news media. Public notification is generally issued when a product that has been widely distributed or poses a serious health hazard is recalled. However, if a company does not issue public notification of a recall, FDA may do so if the agency determines it is necessary to protect patients. Patients also may learn that their medicine has been recalled through n
otification from the manufacturer, their health care professional or pharmacist.
If you have a medicine that has been recalled, talk to your health care professional about the best course of action for your health, including the possibility of returning the product to the store in which you purchased it.
Stores generally have a return and refund policy when a company has announced a recall of its products. Generally, Class I recall notifications provide instructions with actions for patients. FDA recommends that patients follow the instructions provided by the recalling company.
Weekly Enforcement Report
All recalls are posted weekly in the FDA enforcement report. Recalls that are classified will have a classification of Class I, Class II or Class III based on the level of hazard. Ongoing recalls that have not been classified are also published in the enforcement report as “not yet classified” in the classification field. After the recall classification has been determined, the recall is updated in the enforcement report with its appropriate classification.
Determining the Effectiveness of the Recall
FDA evaluates the effectiveness of a recall by evaluating a company’s efforts to properly notify customers and remove the defective product from the market. If a recall is determined to be ineffective FDA will request the company take additional actions.
| Date | Brand Name(s) | Product Description | Recall Reason Description | Company Name |
|---|---|---|---|---|
| 10/05/2017 | Baxter | INTRALIPID 20% IV Fat Emulsion, 100 mL | Product exposed to subfreezing temperatures | Baxter International Inc. |
| 10/19/2017 | A1 | Dietary Supplement A1 Slim | Unapproved new drug; tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine | Kiriko, LLC |
| 10/19/2017 | A1 Slim | Dietary Supplement A1 Slim | Unapproved new drug; tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine | Kiriko, LLC |
| 10/20/2017 | SCA Pharmaceuticals LLC | Injectable drugs | SCA Pharmaceuticals LLC | |
| 12/29/2017 | AuroMedics | Linezolid Injection | White particulate matter that has been identified as mold | AuroMedics Pharma |
| 12/29/2017 | AuroMedics Pharma LLC | Pantoprazole Sodium for Injection 40 mg per vial | Contains glass particles | AuroMedics Pharma LLC |
| 12/29/2017 | Marmex Corp | Male Enhancement | Unapproved new drug | Marmex Corp |
| 12/29/2017 | Pharmacist Choice | Alcohol Prep Pads | Simple Diagnostics | |
| 12/29/2017 | Sun Pharma | Riomet® (Metformin Hydrochloride Oral Solution), 500 mg/5mL | Microbial Contamination (Scopulariopsis brevicaulis) | Sun Pharmaceutical Industries Ltd |
| 12/29/2017 | Greenstone LLC | diphenoxylate hydrochloride and atropine sulfate tablets, USP | Greenstone LLC, a wholly owned subsidiary of Pfizer Inc. |
Jay Harold hopes you enjoyed this post, “Drug Recalls: Definition, Classifications & Reports.” Please Share it and read more about Jay Harold here. Please take this advice from Muhammad Ali and give back to others. “Service to others is the rent you pay for your room here on earth.”
Bibliography
- https://medlineplus.gov/drugreactions.html
- https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/important-safety-alert-regarding-use-fecal-microbiota-transplantation-and-risk-serious-adverse
- https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls
- https://www.fda.gov/drugs/drug-recalls/fdas-role-drug-recalls
