Archive for December 20, 2018

FDA warns about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patients

December 20, 2018 – A U.S. Food and Drug Administration (FDA) review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta.

These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death.  They can occur with fluoroquinolones for systemic use given by mouth or through an injection.

Fluoroquinolones should not be used in patients at increased risk unless there are no other treatment options available.

People at increased risk include those with a history of blockages or aneurysms (abnormal bulges) of the aorta or other blood vessels, high blood pressure, certain genetic disorders that involve blood vessel changes, and the elderly.

We are requiring that a new warning about this risk be added to the prescribing information and patient Medication Guide for all fluoroquinolones.

Fluoroquinolone antibiotics are approved to treat certain bacterial infections and have been used for more than 30 years.  They work by killing or stopping the growth of bacteria that can cause illness.  Without treatment, some infections can spread and lead to serious health problems (see List of Currently Available FDA-Approved Systemic Fluoroquinolones).

Health care professionals should avoid prescribing fluoroquinolone antibiotics to patients who have an aortic aneurysm or are at risk for an aortic aneurysm, such as patients with peripheral atherosclerotic vascular diseases, hypertension, certain genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome, and elderly patients.

Prescribe fluoroquinolones to these patients only when no other treatment options are available.  Advise all patients to seek immediate medical treatment for any symptoms associated with aortic aneurysm.

Stop fluoroquinolone treatment immediately if a patient reports side effects suggestive of aortic aneurysm or dissection.

Patients should seek medical attention immediately by going to an emergency room or calling 911 if you experience sudden, severe, and constant pain in the stomach, chest or back.

Be aware that symptoms of an aortic aneurysm often do not show up until the aneurysm becomes large or bursts, so report any unusual side effects from taking fluoroquinolones to your health care professional immediately.

Before starting an antibiotic prescription, inform your health care professional if you have a history of aneurysms, blockages or hardening of the arteries, high blood pressure, or genetic conditions such as Marfan syndrome or Ehlers-Danlos syndrome.

If you have been prescribed a fluoroquinolone to treat an infection, do not stop the antibiotic without first talking to your health care professional.

We reviewed cases reported to FDA* and four published observational studies1,2,3,4 that showed an increased risk of aortic aneurysm or dissection associated with fluoroquinolone use (see Data Summary).

How some of the studies were designed or carried out, and the ways the data were analyzed could affect the study findings; however, taken together, the results of all four studies provide consistent evidence of an association between fluoroquinolone use and aortic aneurysm or dissection.

The underlying mechanism for this risk cannot be determined from these studies, and the background risk of aortic aneurysm can vary depending on the population.

The background risk has been estimated from nine aortic aneurysm events per 100,000 people per year in the general population to 300 aortic aneurysm events per 100,000 people per year in individuals at highest risk.

Because multiple studies showed higher rates of about twice the risk of aortic aneurysm rupture and dissection in those taking fluoroquinolones, FDA determined the warnings were warranted to alert health care professionals and patients.

We communicated safety information associated with fluoroquinolones in July 2018 (significant decreases in blood sugar and certain mental health side effects), July 2016 (disabling side effects of the tendons, muscles, joints, nerves, and central nervous system), May 2016 (restricting use for certain uncomplicated infections), August 2013 (peripheral neuropathy), and July 2008 (tendinitis and tendon rupture).

To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving fluoroquinolones or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

https://www.fda.gov/Drugs/DrugSafety/ucm628753.htm

December 20, 2018 at 9:27 pm

Culture-Negative Periprosthetic Joint Infection: An Update on What to Expect.

JB JS Open Access. 2018 July 12, 2018 V.3 N.3 e0060.

doi: 10.2106/JBJS.OA.17.00060. eCollection 2018 Sep 25.

Tan TL1, Kheir MM1, Shohat N1, Tan DD1, Kheir M1, Chen C1, Parvizi J1.

1 Rothman Institute at Thomas Jefferson University, Philadelphia, Pennsylvania.

Abstract

BACKGROUND:

Culture-negative periprosthetic joint infection (PJI) is a challenging condition to treat. The most appropriate management of culture-negative PJI is not known, and there is immense variability in the treatment outcome of this condition. The purpose of this study was to elucidate the characteristics, outcomes, and risk factors for failure of treatment of culture-negative PJI.

METHODS:

A retrospective review of 219 patients (138 hips and 81 knees) who had undergone surgery for the treatment of culture-negative PJI was performed utilizing a prospectively collected institutional PJI database. PJIs for which the results of culture were unavailable were excluded. An electronic query and manual review of the medical records were completed to obtain patient demographics, treatment, microbiology data, comorbidities, and other surgical characteristics. Treatment failure was assessed using the Delphi consensus criteria.

RESULTS:

The prevalence of suspected culture-negative PJI was 22.0% (219 of 996), and the prevalence of culture-negative PJI as defined by the Musculoskeletal Infection Society (MSIS) was 6.4% (44 of 688). Overall, the rate of treatment success was 69.2% (110 of 159) in patients with >1 year of follow-up. Of the 49 culture-negative PJIs for which treatment failed, 26 (53.1%) subsequently had positive cultures; of those 26, 10 (38.5%) were positive for methicillin-sensitive Staphylococcus aureus. The rate of treatment success was greater (p = 0.019) for patients who had 2-stage exchange than for those who underwent irrigation and debridement.

CONCLUSIONS:

The present study demonstrates that culture-negative PJI is a relatively frequent finding with unacceptable rates of treatment failure. Every effort should be made to isolate the infecting organism prior to surgical intervention, including extending the incubation period for cultures, withholding antibiotics prior to obtaining culture specimens, and possibly using newly introduced molecular techniques.

LEVEL OF EVIDENCE:

Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

PDF

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6242327/pdf/jbjsoa-3-e0060.pdf

 

December 20, 2018 at 7:27 pm

Culturing Periprosthetic Joint Infection: Number of Samples, Growth Duration, and Organisms.

J Arthroplasty. November 2018 V.33 N.11 P.3531-3536.e1.

doi: 10.1016/j.arth.2018.06.018. Epub 2018 Jul 11.

Kheir MM1, Tan TL1, Ackerman CT1, Modi R1, Foltz C1, Parvizi J1.

Abstract

BACKGROUND:

Owing to the difficulty isolating microorganisms in periprosthetic joint infection (PJI), current guidelines recommend that 3-5 intraoperative samples be cultured and maintained for 3-14 days. We investigated (1) the optimal number of culture samples and growth duration to diagnose PJI and (2) the microbiology profile at our institution.

METHODS:

A retrospective review of 711 patients (329 hips, 382 knees) with PJI that met Musculoskeletal Infection Society criteria from 2000 to 2014 was performed. Two thousand two hundred ninety aerobic and anaerobic cultures were analyzed. A manual chart review collected demographic, surgical, and microbiological data. Microbiology profiles were trended. Logistic regression analysis was performed to determine statistical significance.

RESULTS:

Obtaining 5 samples provided the greatest yield positive cultures for diagnosing PJI. The percentage of positive cultures overall was 62.6% and stratified by organism type: antibiotic resistant (80.0%), Staphylococcus aureus (76.0%), gram negative (58.9%), Pseudomonas (52.0%), variant PJI organisms (28.2%), Propionibacterium acnes (20.0%), and Escherichia coli (8.0%). Although most organisms were cultured in 5 days or less, 10.8 days were needed for Propionibacterium acnes, 6.6 for variant PJI organisms, and 5.2 for coagulase-negative Staphylococcus. At 3 days, only 42.2% of cultures turned positive compared with 95.0% at 8 days. There was a significant decrease in time in gram-positive PJIs and an increase in culture-negative PJIs.

CONCLUSION:

The optimal number of cultures and growth duration depended on the type of organism. This study provides evidence that 5 samples should be obtained and held for at least 8 days given that the type of organisms is likely to be unknown at the time of surgery.

PDF

https://www.arthroplastyjournal.org/article/S0883-5403(18)30588-6/pdf

 

December 20, 2018 at 7:25 pm


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