Archives for May 2016

FDA Approves Monthly Zinbryta Injection For Patients With Multiple Sclerosis

Patients with multiple sclerosis (MS) can now get monthly Zinbryta injections as the U.S. Food and Drug Administration approved its use.

The FDA approved on May 27 the use of Zinbryta (daclizumab) for adults suffering from worsening forms of MS. Zinbryta is a self-administered long-acting monthly injection manufactured by Biogen, Inc.

Cancer Drugs Are The Least Likely to Receive FDA Approval

A massive new study of drug candidates sheds light on which experimental therapies are most likely to eventually reach the market.

Safety Troubles in Hospital Compounding Pharmacies

We wrote yesterday about contamination at the pharmacy of the NIH Clinical Center in Bethesda. Other big hospitals, judging by media reports, also may need to look at their pharmacy operations, especially when they compound ingredients together into custom drugs for patients.

FDA issues safety alert for fluoroquinolones

Agency warns that serious adverse effects generally outweigh benefits for patients with sinusitis, bronchitis, and uncomplicated UTIs.

FDA announced that it will require drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated with new safety information. FDA is warning that serious adverse effects with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections (UTIs) who do not have other treatment options.

FDA Requests Compounding Pharmacy Recall Products

The FDA is warning health care professionals and patients about products intended to be sterile that were compounded by Medaus Inc.

The administration has formally requested that the compounding pharmacy, which is based in Birmingham, Alabama, recall products due to sterility concerns.

Administering nonsterile products that are supposed to be sterile may cause serious infections or death.

The FDA recommended that health care facilities check their supplies and quarantine products from Medaus that are intended to be sterile. The products were distributed both nationwide and internationally.

Many of the affected products are hormone replacement drugs, such as injectables and implantable pellets. Others are injectable nutritional products, such as vitamins, minerals, and amino acids.

“Patient safety is our top priority and patients deserve drugs that are made under safe conditions,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a press release. “We are deeply concerned about the safety of the products made by Medaus and the risks associated with them.”

During a March 2016 inspection at a Medaus facility, the FDA claimed that there were insanitary conditions, which could affect the sterility of drugs.

The FDA recommended on March 29, 2016, that the company recall all non-expired lots of drugs intended to be sterile, but the company refused.

On April 1, 2016, the FDA issued a formal statement advising against the use of “sterile” Medaus products.

Thus far, the FDA has not received reports of adverse events stemming from these products. Patients and health care professionals may report adverse reactions through the MedWatch Adverse Event Reporting program.

SOS Telecom, Inc. Recalls New Unapproved Drugs Marked as Dietary Supplements

SOS Telecom, Inc. of Bayside, NY is voluntarily recalling all lots of the following products to the consumer level because these products were tested by the FDA and found to contain Sildenafil, and analogs of Sildenafil. Sildenafil is a PDE-5 Inhibitor which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED), making this tainted dietary supplement and unapproved drug.

PharMEDium Recalls Compounded Bupivacaine Products

PharMEDium Services, LLC, of Lake Forest, Illinois, has voluntarily recalled hundreds of sterile preparations compounded with a single recalled lot of Fresenius KabiSensorcaine-MPF (bupivacaine HCl) to the hospital level.

The complete 81-page list of recalled products can be found on the PharMEDium website.

Federal Judge Enters Order of Permanent Injunction Against Compounding Pharmacy Owner

A federal judge has entered an order of permanent injunction on behalf of FDA against Paul W. Franck, the owner and operator of numerous compounding pharmacies in Florida over the past 20 years, FDA said in an April 29, 2016 press announcement. Franck allegedly “manufactured and distributed drug products that were adulterated and misbranded in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act),” FDA said. The order issued by the US Department of Justice prohibits Franck from distributing sterile drug products until he complies with the FD&C Act.

New Compounding Policies from FDA May Affect Hospital and Health System Pharmacy Operations

Last month, FDA released three draft guidance documents that are expected to have significant implications for traditional pharmacy-based compounding and the distribution of those drug products.