Tag Archives: FDA

pembrolizumab (KEYTRUDA) in Patients with Multiple Myeloma: FDA Statement – Two Clinical Trials On Hold

Keytruda (pembrolizumab) in Patients with Multiple Myeloma: FDA Statement – Two Clinical Trials on Hold
AUDIENCE: Oncology
ISSUE: Based on data from two recently halted clinical trials, the U.S. Food and Drug Administration today is issuing this statement to inform the public, health care professionals, and oncology clinical investigators about the risks associated with the use of Keytruda (pembrolizumab) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma. Keytruda (pembrolizumab) is not approved for treatment of multiple myeloma.
The FDA statement is based on review of data from two clinical trials (KEYNOTE-183 and KEYNOTE-185) evaluating the use of Keytruda (pembrolizumab) combined with other treatments in patients with multiple myeloma. On July 3, 2017, the FDA required that all patients in these trials be discontinued from further investigation with this drug, because interim results from both trials demonstrated an increased risk of death for patients receiving Keytruda (pembrolizumab) when it was combined with an immunomodulatory agent as compared to the control group (see statistical analysis section below). Merck & Co., Inc. was made aware of the issue through an external data monitoring committee recommendation and suspended the trials to enrollment on June 12, 2017. Continue reading

UPDATE: Smith & Nephew Wound Vac Conversion

Due to an FDA hold on the Renasys wound vac product we are currently on hold for a conversion. We will continue to utilize KCI for our patient’s wound vac needs.

Smith & Newphew Front Page

Doripenem has increased risk of death from pneumonia on ventilated patients

The FDA announced that Doripenem is not approved for an type of pneumonia. It is still considered safe and effective in treating intrabdominal infections and urinary tract infections.

Tygacil safety alert – FDA

Health care professionals should reserve Tygacil for use in situations when alternative treatments are not suitable.

This analysis showed a higher risk of death among patients receiving Tygacil compared to other antibacterial drugs: 2.5% (66/2640) vs. 1.8% (48/2628), respectively. The adjusted risk difference for death was 0.6% with corresponding 95% confidence interval (0.0%, 1.2%). In general, the deaths resulted from worsening infections, complications of infection, or other underlying medical conditions.

Reference:

Tygacil (tigecycline): Drug Safety Communication – Increased Risk of Death, Sept 27th 2013

Nationwide Voluntary Recall of All Products for Sterile Use from Compounding Pharmacy located in Cedar Park, Texas – FDA

Summary

The U.S. Food and Drug Administration (FDA) is alerting health care providers and patients of a voluntary nationwide recall of all products produced and distributed for sterile use by Specialty Compounding, LLC, Cedar Park, Texas. There have been recent reports of bacterial bloodstream infections potentially related to the company’s calcium gluconate infusions.

CDC and the FDA are working with Texas state officials to determine the scope of the contamination. According to the FDA, information provided by the firm stated that the recalled products (i.e., all products produced and distributed for sterile use by Specialty Compounding) were distributed directly to patients nationwide, with the exception of North Carolina, which received no products. The full text of the recall is available on the FDA website. Also according to the FDA, information provided by the firm stated that recalled products were also distributed to hospitals and physician offices in Texas.

Background

The Texas Department of State Health Services has reported bacterial bloodstream infections in 15 patients from two Texas hospitals who received an infusion of calcium gluconate 2 grams in Sodium Chloride 0.9 percent for Injection, supplied by Specialty Compounding. According to Texas state officials, most infections were caused by Rhodococcus equi and are thought to be related to the infusions. Two of the 15 patients have died. CDC does not have information that the deaths are related to recalled product. Also according to Texas state officials, cultures from an intact sample of calcium gluconate compounded by Specialty Compounding show growth of bacteria that are consistent with Rhodococcus species. Isolates are being evaluated by CDC to confirm the identification.

Reference

FDA recall of Specialty Compunding LLC

FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection

The U.S. Food and Drug Administration (FDA) has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy. This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent.

The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection. Approved fluoroquinolone drugs include levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive). The topical formulations of fluoroquinolones, applied to the ears or eyes, are not known to be associated with this risk.

If a patient develops symptoms of peripheral neuropathy, the fluoroquinolone should be stopped, and the patient should be switched to another, non-fluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk.

Reference

FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection

Victories in Infectious Diseases – Video of lecture

This lecture was presented at the July 2013 Centegra summer symposium. Continue reading

FDA approves new drug to reverse effects of warfarin

The FDA recently approved a new drug for the reversal of vitamin K anticoagulation in adults with acute major bleeding. The drug is Prothrombin Complex Concentrate (KCENTRA), and contains the vitamin K dependent clotting Factors II, VII, IX, and X, as well as antithrombotic Proteins C and S. The only other product approved for this use in the United States is plasma. A caution with the use of this product is that it is associated with blood clots when used as indicated. The product comes with a Boxed Warning on this subject.

Reference

  1. FDA approval of KCENTRA
  2. Kcentra product page

Zolpidem auto substitution

The FDA recently issued as recommendation that bedtime doses of zolpidem (AMBIEN) be lowered because new data show that blood levels in some patients may be high enough in the morning after use to impair activities that require alertness, including driving. Based on this recommendation orders written will be substituted as follows:

AMBIEN 10 mg → AMBIEN 5 mg

AMBIEN CR 12.5 mg → AMBIEN CR 6.25 mg

All pre-printed order sets are being changed to the lower dose as well. If physicians choose to keep their patients on the higher doses of zolpidem, they need to indicate “no substitution”.

Doxycycline shortage

Due to manufacturing issues there is a national shortage of doxycycline. The following recommendations for patient care were issues by the CDC.