FDA notified healthcare professionals of clinical trial data that suggest increased mortality in stable liver transplant patients after conversion from a calcineurin inhibitor (CNI)-based immunosuppressive regimen to sirolimus (Rapamune). The trial was conducted by sirolimus manufacturer, Wyeth. The Agency will continue to examine the data on mortality and other adverse events in this study, and [...]

The FDA is warning consumers to not use any Clarcon products. Consumers should not use any Clarcon products and should throw these products away in household refuse. Analyses of several samples of over-the-counter topical antimicrobial skin sanitizer and skin protectant products revealed high levels of various bacteria, including some associated with unsanitary conditions. Some of [...]

ZOLL Medical Corporation and FDA notified healthcare professionals of a Class 1 recall of ZOLL AED Plus Defibrillators distributed from May, 2004 through February 9, 2009. The recall was initiated because the device may fail to deliver a defibrillation shock, which could result in failure to resuscitate a patient during treatment of sudden cardiac arrest. [...]

By June 8, 2009, Raptiva will no longer be available in the United States.
Genentech and FDA notified healthcare professionals of the voluntary, phased withdrawal of Raptiva, a medication for treatment of psoriasis, from the U.S. market due to a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML).
On 02/19/2009 the FDA issued [...]

The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as [...]

Say no to cold meds for kids Under 4
Following the trail of growing evidence, and potential liability, of the dangers to children of over-the-counter (OTC) cold medications sold for children, drug companies said Tuesday that the medicines should not be given to children younger than 4 years old. The companies say they are acting from [...]

According to the New York Times, the U.S. Food and Drug Administration is raising the alarm about a new blood test called OvaSure that is claimed to detect early-stage ovarian cancer.
In an Aug. 7 letter to LabCorp, the test distrinutor and one of the largest U.S. clinical laboratory firms, the FDA said, “We believe you [...]

FDA is notifying healthcare professionals of the risk of adverse injection site reactions in patients receiving naltrexone (Vivitrol).
Physicians should instruct patients to monitor the injection site and contact them if they develop pain, swelling, tenderness, induration, bruising, pruritus, or redness at the injection site that does not improve or worsens within two weeks. Physicians should [...]

The interaction between cholesterol and heart medication can cause a “muscle injury called rhabdomyolysis, which can lead to kidney failure or death”, says FDA warning.
Patients are at risk of the life threatening condition when taking the anti-cholesterol drugs containing simvastatin are taken with the drug amiodarone, used to manage heart arrhythmias (irregular heartbeat).
The widely used drugs [...]

The agency rejects anesthesia recovery drug sugammadex, adding to the list of several rejections this year of drugs that were expected to gain approval.
The decision to reject approval of the the drug sugammadex was a surprise because the expert review committee had recommended approval of the drug.  Th drug is supposed to help patients recover [...]