Don't use PPIs with clopidogrel, FDA warns


Warnings, recalls

A warning that clopidogrel (Plavix) and omeprazole (Prilosec/Prilosec OTC) should not be used together based on new manufacturer data showing that when the drugs are taken together, the effectiveness of clopidogrel is reduced. Separating the dose of clopidogrel and omeprazole in time will not reduce this drug interaction. Other drugs that are expected to have a similar effect and should be avoided in combination with clopidogrel include cimetidine, fluconazole, ketoconazole, voriconazole, etravirine, felbamate, fluoxetine, fluvoxamine and ticlopidine.

Art 1

A class 1 recall of CardioVations EndoClamp Aortic Catheter, Model Numbers EC1001 and EC65, manufactured from August 2008 through August 2009 and distributed from November 2008 through September 2009, because the balloon catheters may spontaneously rupture during surgery.

A recall of Liposyn II and III and Propofol Injectable Emulsion because some may contain particulate matter that impedes blood flow, which could lead to stroke, respiratory failure, kidney failure, liver failure, heart attack and/or death. The recall comprises 85 lots of Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, and Liposyn III 30%, and 73 lots of Propofol Injectable Emulsion 1% that begin with the lot numbers 79 and 80 and were distributed between July and October of 2009.

A warning that five medications for rare diseases made by Genzyme Corporation may be contaminated by foreign particles. The affected medications include all of the following products with lot numbers that start with “A” (e.g., Lot A12345): imiglucerase (Cerezyme), agalsidase beta (Fabrazyme), alglucosidase alfa (Myozyme), laronidase (Aldurazyme), and thyrotropin alpha (Thyrogen).

A voluntary recall of three lots of Vicks Sinex Nasal Spray because the bacteria B. cepacia was found in a small amount of product. There have been no reports of illness.

A class 1 recall of 23 Operating Room System II Surgical Navigation Systems distributed by Stryker Corporation (Catalog numbers 7700-100-000 and 7700-101-201) because there is a potential for the navigation component to stop working, which could result in the screen freezing, the system updating at a slow rate, or not responding at all.

Approvals

Romidepsin (Istodax) to treat patients with cutaneous T-cell lymphoma (CTCL). The drug is meant to be used when CTCL gets worse or comes back after at least one other type of chemotherapy has been used. Side effects of romidepsin may include nausea, fatigue, infections, vomiting, decreased appetite and decreased red blood cell count.

Tranexamic acid tablets (Lysteda), the first non-hormonal product to treat menorrhagia. The drug was approved by the FDA in 1986 as an injection to reduce or prevent bleeding during and following tooth extraction in patients with hemophilia. Use of the drug while taking hormonal contraceptives may increase the risk of blood clots, stroke or heart attack, so women using hormonal contraception should take it only if there is a strong medical need.

A medicated skin patch containing capsaicin (Qutenza 8%) to treat pain from post-herpetic neuralgia in patients with shingles. The most frequently reported adverse drug reactions included pain, swelling, itching, redness and bumps at the application site.

An additional seasonal influenza vaccine, Agriflu, for people ages 18 years and older to prevent disease caused by influenza virus subtypes A and B. The vaccine was approved using the FDA's accelerated approval pathway which requires the manufacturer to conduct further studies to verify that the vaccine induces levels of antibodies in the blood that are effective in preventing seasonal influenza.

Miscellaneous

An investigation of energy levels in external biphasic defibrillators with shocks <200 J due to 14 reports of the devices being ineffective. In the 14 events, a 200 J biphasic defibrillator was ineffective in providing defibrillation/ cardioversion therapy to a patient, whereas a subsequent shock from a different 360 J biphasic defibrillator resulted in immediate defibrillation/cardioversion. The agency doesn't recommend any changes to clinical practice at this time.