The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products

AUDIENCE: Pharmacy, Healthcare Professionals, Patients
ISSUE: The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that the FDA’s preliminary findings of practices at The Compounding Shop of St. Petersburg, Fla., raise concerns about a lack of sterility assurance for sterile drugs produced at and distributed from this site. Therefore, these products should not be administered to patients. If a drug product marketed as sterile has microbial contamination, it potentially places patients at risk of serious infection.
The FDA has advised the firm that it is in the best interest of public health to take action to remove all sterile products from the market. The Compounding Shop has informed the FDA that it is recalling sterile products and is in the process of notifying customers.
BACKGROUND:  The FDA is basing this warning on a recent inspection of The Compounding Shop. The investigators observed poor sterile production practices that raise concerns about a lack of sterility assurance of The Compounding Shop’s sterile drug products.
RECOMMENDATION: Health care providers and hospital staff should immediately check their medical supplies, quarantine any sterile products from The Compounding Shop, not administer them to patients, and await further instructions from the company regarding the recalled products. Patients who have received any product produced by The Compounding Shop and have concerns should contact their health care provider.

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Samsca (Tolvaptan): Limits Duration and Usage Due To Possible Liver Injury Leading to Organ Transplant or Death

Samsca (Tolvaptan): Drug Safety Communication - FDA Limits Duration and Usage Due To Possible Liver Injury Leading to Organ Transplant or Death

AUDIENCE: Pharmacy, Health Professional, Patient
ISSUE: FDA has determined that the drug Samsca (tolvaptan) should not be used for longer than 30 days and should not be used in patients with underlying liver disease because it can cause liver injury, potentially leading to liver transplant or death. FDA has worked with the manufacturer to revise the Samsca drug label to include new limitations.
BACKGROUND: Samsca is a selective vasopression V2-receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia, including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH). An increased risk of liver injury was observed in recent large clinical trials evaluating Samsca for a new use in patients with autosomal dominant polycystic kidney disease (ADPKD).
RECOMMENDATION: Samsca treatment should be stopped if the patient develops signs of liver disease. Treatment duration should be limited to 30 days or less, and use should be avoided in patients with underlying liver disease, including cirrhosis. Patients should be aware that Samsca may cause liver problems, including life-threatening liver failure, and should contact their health care professional to discuss any questions or concerns about Samsca.

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Med Prep Consulting Inc. Compounded Products: Recall - Potential Mold Contamination

AUDIENCE: Risk Manager, Pharmacy, Family Practice
ISSUE: Med Prep Consulting, Inc. notified the public that it is recalling all lots of all products compounded at its facility, due to lack of sterility assurance. The level of recall is to the user: regional hospital pharmacies and related departments, and physician’s office practices. The recall resulted from the pharmacy being notified by a Connecticut hospital that it observed visible particulate contaminants in 50 ml bags of MAGNESIUM SULFATE 2GM IN DEXTROSE 5% IN WATER, 50ML FOR INJECTION intravenous solution, confirmed to be mold. These were unique and distinct lots compounded and dispensed by the pharmacy to the Connecticut hospital. At this time a total of five (5) contaminated bags were discovered. See the Med Prep Press Release for a list of affected products.
Administration of an intravenous product found to be contaminated with mold could result in a fatal infection in a broad array of patients.
BACKGROUND: The affected products are used for a wide range of therapeutic uses for hospitalized inpatients and outpatients, and, patients directly treated by a health care professional at a physician’s office practice facility or clinic. None of these products are dispensed directly to patients from retail pharmacies or to home care patients for either self-administration or nursing administration.
All products are packaged in plastic infusion bags, plastic infusion devices, plastic syringes and glass vials. Products packaged in plastic infusion bags, plastic infusion devices, plastic syringes and glass vials were distributed directly to regional hospital pharmacies located in New Jersey, Pennsylvania, Connecticut, and Delaware. Products packaged in plastic syringes only, were distributed nationwide to physician’s office practice facilities and clinics. All of these products were distributed to the described users through March 13, 2013, from Tinton Falls, New Jersey to both regional and nationwide locations.
RECOMMENDATION: All facilities that received any product compounded by Med Prep Consulting, Inc. have been notified by telephone fax, electronic mail and regular mail of the recall and have been instructed to remove and return the product to the pharmacy. Facilities with questions may contact the company at 732-493-3390, Monday through Friday, between 10:00 a.m. and 5:00 p.m. EST.
Read the MedWatch safety alert, including a link to the Press Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm344259.htm

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Azithromycin: risk of potentially fatal heart rhytms

Azithromycin (Zithromax or Zmax): Drug Safety Communication - Risk of Potentially Fatal Heart Rhythms

AUDIENCE: Family Practice, Patient, Pharmacy, Health Professional
ISSUE: FDA is warning the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. Patients at particular risk for developing this condition include those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms, or arrhythmias.  FDA has issued a Drug Safety Communication today as a result of our review of a study by medical researchers as well as another study by a manufacturer of the drug that assessed the potential for azithromycin to cause abnormal changes in the electrical activity of the heart.
FDA previously released a Statement on May 17, 2012, about a study that compared the risks of cardiovascular death in patients treated with the antibacterial drugs azithromycin, amoxicillin, ciprofloxacin (Cipro), and levofloxacin (Levaquin), or no antibacterial drug. The study reported an increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug. The risks of cardiovascular death associated with levofloxacin treatment were similar to those associated with azithromycin treatment.
BACKGROUND: Azithromycin is marketed under the brand names Zithromax and Zmax. Change to “FDA-approved indications for azithromycin include: acute bacterial exacerbations of chronic obstructive pulmonary disease, acute bacterial sinusitis, community-acquired pneumonia, pharyngitis/tonsillitis, uncomplicated skin and skin structure infections, urethritis and cervicitis, genital ulcer disease
RECOMMENDATION: Health care professionals should consider the risk of torsades de pointes and fatal heart rhythms with azithromycin when considering treatment options for patients who are already at risk for cardiovascular events.  FDA notes that the potential risk of QT prolongation with azithromycin should be placed in appropriate context when choosing an antibacterial drug: Alternative drugs in the macrolide class, or non-macrolides such as the fluoroquinolones, also have the potential for QT prolongation or other significant side effects that should be considered when choosing an antibacterial drug.

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Florida Suspends A Compounding Pharmacy

In the wake of the meningitis outbreak and controversy over compounding pharmacies, the Florida Department of Health late last week suspended a compounder in Boca Raton after determining the pharmacy had violated a number of statutes and rules. The move came following an inpsection earlier this month.

Florida Suspends A Compounding Pharmacy

octubre 29, 2012 under Compound Pharmacy, Rejuvi Pharmaceuticals

In reaching its decision, the department cited problems with cleanliness, dispensing and compounding medications, and record keeping. A review of previous inspections also found that Rejuvi Pharmaceuticals had previously been notified of the violations, but failed to correct them, according to a statement.
The suspension, which will be followed by a hearing, is the latest fallout from the scandal surrounding the New England Compounding Center – which has been identified as the source of contaminated vials of injectable steroids traced to the meningitis outbreak – and the role of regulators in overseeing compounding pharmacies.
Since the outbreak emerged this month, there has been a mixture of confusion and outrage over the extent to which the FDA and state regulators are responsible for enforcing regulations, and whether the appropriate actions were taken. NECC, for instance, received an FDA warning letter in 2006 and Massachusetts regulators had received complaints.
Although debate remains over FDA powers and whether Congress should clarify agency authority with additional legislation, the FDA last Friday issued the results of an inspection of NECC that found the compounding pharmacy had serious problems keeping its facilities free of mold and bacteria, notably in so-called clean rooms used for production (see this).
Meanwhile, state regulators are facing mounting pressure to ensure that compounders are adhering to local laws, a development reflected in the suspension in Florida. The state has, so far, tallied 22 cases of meningitis, including three deaths, accoring to the state health department (read here).
And in Massachusetts, regulators closed yet another compounder. In addition to shuttering NECC and a related operation called Ameridose, which voluntarily closed earlier this month, Infusion was closed after inspectors last week found “significant issues” and “expressed concerns for the sterility of products,” according to Madeleine Biondolillo, director of the Bureau for Health Care Safety and Quality.
In addition, “there was an adjacent space set up for giving patients intravenous medications onsite. Infusion Resource does not have an appropriate clinic license to conduct these activities, which is a violation of state regulations.” The pharmacy has now surrendered its license (here is the statement).
On a broader scale, the state is filing regulations to require compounding pharmacies in Masschusetts to submit frequent reports of production, volume and distribution of sterile, injectable medications. And a commission is being formed to examine best practices in other states and potential changes to state law or regulations.

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