Breaking News

  • Fluoroquinolone Antibacterial Drugs: Risk for possibly permanent nerve damage
    FDA has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy. This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent.
  • DePuy Orthopaedics - LPS Lower Extremity Dovetail Intercalary Component: Class 1 Recall - Potential for Fracture of Device
    FDA and DePuy Orthopaedics notified healthcare professionals of the class 1 recall of the LPS Lower Extremity Dovetail Intercalary Component due to the potential for fracture of the female component, at the dovetail, when exposed to normal physiologic loads while walking. This may also lead to additional pain, infection, loss of function, loss of limb, neurovascular injury or need for revision surgery. Patients greater than 200 pounds and/or those with high levels of activity are at higher risk of fracture.
  • Nizoral (ketoconazole): Drug Safety Communication - Potentially Fatal Liver Injury, Risk of Drug Interactions and Adrenal Gland Problems
    FDA is taking several actions related to Nizoral (ketoconazole) oral tablets, including limiting the drug’s use, warning that it can cause severe liver injuries and adrenal gland problems, and advising that it can lead to harmful drug interactions with other medications. FDA has approved label changes and added a new Medication Guide to address these safety issues. As a result, Nizoral oral tablets should not be a first-line treatment for any fungal infection. Nizoral should be used for the treatment of certain fungal infections, known as endemic mycoses, only when alternative antifungal therapies are not available or tolerated.
  • $750,000 Pennsylvania Fracking Settlement Made Public
    Overruling a fracking company’s request to keep the details private, a Pennsylvania judge has unsealed records related to a $750,000 settlement of a suit alleged water contamination near Marcellus shale fracking in southwestern Pennsylvania.
  • Jury Awards $8.35M in DePuy ASR Hip Replacement Lawsuit
    A jury in Los Angeles on Friday ordered Johnson & Johnson to pay more than $8.3 million in damages to a Montana man in the first of more than 10,000 lawsuits pending against the medical products maker in connection with a now-recalled artificial hip.
  • Metal-on-Metal Hip Implants: Safety Communication - Updated Safety Recommendations
    FDA notified healthcare professionals that it is providing updated safety information and recommendations to patients and health care providers, based on the FDA’s current assessment of metal-on-metal hip implants, including the benefits and risks, the evaluation of the published literature, and the results of the June 2012 Orthopedic and Rehabilitation Devices Advisory Panel meeting.
  • FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised - Update [Update 10/18/2012] CDC and FDA have confirmed the presence of a fungus known as Exserohilum rostratum in unopened medication vials of preservative-free methylprednisolone acetate (80mg/ml) from one of the three implicated lots from NECC. The laboratory confirmation further links steroid injections from these lots from NECC to the multistate outbreak of fungal meningitis and joint infections. Testing on the other two implicated lots of methylprednisolone acetate and other NECC injectables continues.CDC and state health departments estimate that approximately 14,000 patients may have received injections with medication from three implicated lots of methylprednisolone and nearly 97% of these patients have been contacted for further follow-up.
  • Massachusetts Pharmacy Linked to Meningitis Outbreak: A rare form of fungal meningitis has killed five people and sickened 30 across six states, and more are expected, health officials said. The steroid came from the New England Compounding Center in Framingham, Mass., a specialty pharmacy that has recalled three lots of the drug and shut down operations. Twenty-five of the meningitis cases -- three of them lethal -- have been in Tennessee, where more than 900 residents received the drug in the past three months.

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FDA Consumer Health Information Updates

  • Children and Asthma: The Goal Is Control Though asthma in children is being diagnosed more frequently, FDA-approved drugs and devices used to treat it, as well as awareness of the conditions that trigger symptoms, can help kids with asthma to lead more active, independent lives.
  • MedWatch Safety Alerts, May 2012 The Food and Drug Administration (FDA) announces safety alerts and reviews for some widely used medications. A counterfeit ADHD drug has the wrong active ingredients, some hepatitis C and HIV drugs are less effective when used together, one manufacturer’s dietary supplements have been recalled due to an undeclared ingredient, and FDA is reviewing cases involving possible deaths from an antibiotic and a drug for multiple sclerosis.
  • Benzocaine and Babies: Not a Good Mix Parents should avoid using benzocaine products to relieve teething pain for children under 2. They are at risk for the disease methemoglobinemia.
  • Consumer Update Analytics This page contains links to all past Consumer Update Analytics web pages.
  • Database Is One-Stop Resource on Kids' Medications A new FDA database pulls the science on drug labels for kids into one place.

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