MRSA test and warfarin recalled, new tests for HIV and hepatitis C


Recalls, warnings

Mylotarg (gemtuzumab ozogamicin) was voluntarily withdrawn from the market due to new concerns about safety and benefits. The drug had been approved under an accelerated program for patients with acute myeloid leukemia.

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A class I recall of LIFEPAK 20 and LIFEPAK 20e external defibrillator/monitors due to power supply failures. Customers are advised to keep the defibrillators in service while updates are scheduled.

A class I recall of Cepheid Xpert methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) blood culture assay due to a potential for false negative MRSA results, which could result in incorrect treatment or delay of care for patients with MRSA infection.

A warning against the use of Qualaquin (quinine sulfate) to treat nighttime leg cramps. This unapproved use of the malaria drug has resulted in serious side effects, including thrombocytopenia and death, and prompted the manufacturer to develop a risk management plan.

A warning that certain stolen Advair Diskus inhalers have been found in pharmacies and their safety and effectiveness cannot be assured.

A warning that a product represented as generic Tamiflu is being sold over the Internet and could potentially harm patients who are allergic to penicillin. Tests revealed that the fraudulent product does not contain oseltamivir, but contains cloxacillin, an ingredient in the same class of antibiotics as penicillin.

A boxed warning on leflunomide (Arava) highlighting the risk of severe liver injury (including 14 reports of fatal liver failure). Patients taking other drugs known to cause liver injury and patients with pre-existing liver disease are at highest risk, and the warning includes treatment recommendations regarding these patients.

A recall of physician sample and hospital unit dose blister packs of Coumadin (warfarin) 1 mg because the active ingredient may be below or above therapeutic levels.

A recall of Procter & Gamble's 4 Hour Decongestant Nasal Spray because the product formulation may not meet the expiration dates on the package.

Approvals

The Implantable Miniature Telescope to improve vision in patients with end-stage age-related macular degeneration. Implanted in one eye, the telescope comes in two models: 2.2 times magnification or 2.7 times. In a trial, 90% of patients achieved at least a 2-line gain in vision. Risks of implantation include extensive loss of corneal endothelial cells and chronic endothelial cell loss.

The first assay to detect both antigen and antibodies to human immunodeficiency virus (HIV). This assay is approved for use as an aid in the diagnosis of HIV-1/HIV-2 infection in adults including pregnant women and can be used to diagnose HIV infection prior to the emergence of antibodies. It is also the first assay for use as an aid in the diagnosis of HIV-1/HIV-2 infection in children as young as two years old.

Cabazitaxel (Jevtana), a chemotherapy drug used in combination with prednisone to treat prostate cancer. It is the first treatment for advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel. In a trial, the median overall survival for patients receiving cabazitaxel was 15.1 months versus 12.7 months for mitoxantrone patients.

A new indication for nilotinib (Tasigna). Under the FDA's accelerated approval program, use of the drug has been expanded to earlier stages of Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML).

The first rapid blood test for antibodies to the hepatitis C virus (HCV) for individuals 15 years and older. The test strip does not require an instrument for diagnosis and takes about 20 minutes to provide results.

The first generic version of venlafaxine hydrochloride extended-release capsules (Effexor XR) to treat major depressive disorder. The capsules will be sold in 37.5 milligram, 75 milligram and 150 milligram strengths and will have the same safety warnings as Effexor XR.

Miscellaneous

The FDA is reviewing the safety of angiotensin receptor blockers (ARBs) after a recently published study suggested they may be associated with a small increased risk of cancer. While the review is ongoing, the FDA recommends these drugs continue to be used as recommended and advises that the benefits of these medicines appear to continue to outweigh their potential risks.