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FDA Safety Alerts
  • Breast Implants: Update - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

    Tuesday, March 21, 2017 12:00:00 PM CST
    BIA-ALCL is a rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma. [...] Read More..
  • Absorb GT1 Bioresorbable Vascular Scaffold (BVS) by Abbott Vascular: Letter to Health Care Providers - FDA Investigating Increased Rate of Major Adverse Cardiac Events

    Saturday, March 18, 2017 9:00:00 AM CST
    Increased rate of major adverse cardiac events observed in patients receiving the BVS, when compared to patients treated with metallic XIENCE drug-eluting stent. [...] Read More..
  • Viberzi (eluxadoline): Drug Safety Communication - Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder

    Wednesday, March 15, 2017 11:02:00 AM CST
    Patients who do not have a gallbladder should not take Viberzi. Developing pancreatitis could result in hospitalization or death. [...] Read More..
  • SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps by Medtronic: Class I Recall - Failure of Priming Bolus

    Tuesday, March 14, 2017 12:20:00 PM CST
    Patients may receive a drug overdose or under dose which can lead to serious adverse health consequences such as respiratory depression, coma or death. [...] Read More..
  • Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action - Immediately Remove and Reinstall Battery

    Thursday, March 09, 2017 1:23:00 PM CST
    Device has shut down unexpectedly during patient treatment, which may expose patients to the risk of serious harm or death. Posted 01/14/2017 [...] Read More..
  • Herbal and Dietary Supplement Products by Regeneca Worldwide: Recall - Not Manufactured in Compliance with Current Good Manufacturing Practices

    Thursday, March 09, 2017 12:40:00 PM CST
    Nationwide recall of Regeneca's entire line of herbal and dietary supplement products. [...] Read More..
  • SPS-1 Static Preservation Solution distributed by Organ Recovery Systems: Safety Communication - FDA Warns Of Potential Contamination

    Thursday, March 09, 2017 10:00:00 AM CST
    Laboratory results confirmed contamination with Pantoea and Enterococcus (intrinsically vancomycin-resistant) bacteria. [...] Read More..
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  • Balloon angioplasty devices to treat autonomic dysfunction: FDA Safety Communication - FDA concern over experimental procedures

    Wednesday, March 08, 2017 12:30:00 PM CST
    Procedure may put patients at risk because is being promoted as treatment for a variety of conditions even though it has not been formally studied in clinical trials [...] Read More..
  • Dietary Supplements for Male Sexual Enhancement by A and H Focal: Recall - Undeclared Drug Ingredient

    Tuesday, March 07, 2017 7:00:00 PM CST
    PDE-5 Inhibitors may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. [...] Read More..
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  • Edex (alprostadil for injection) 10 mcg 2 Pack by Endo Pharmaceuticals: Recall - Potential Lack of Sterility Assurance

    Monday, February 27, 2017 12:00:00 PM CST
    Loss of container closure integrity could impact the product’s sterility assurance and may lead to serious adverse events such as infections, both localized at the site of injection and systemically. [...] Read More..
  • Avella Specialty Pharmacy Unexpired Sterile Injectable Products Labeled “Latex Free”: Recall - Products May Contain Synthetic or Natural Latex

    Friday, February 24, 2017 7:00:00 PM CST
    Risk of potential adverse events can range from local site reactions including swelling and inflammation, to allergic reactions which could be life-threatening to users who are sensitive to latex. [...] Read More..
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  • XtraHRD Natural Male Enhancement Capsules by Organic Herbal Supply, Inc.: Recall - Undeclared Drug Ingredient

    Wednesday, February 22, 2017 7:00:00 AM CST
    Undeclared tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. [...] Read More..
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Avoiding Drug Interactions

Avoiding Drug Interactions
People often combine foods. For example, chocolate and peanut butter might be considered a tasty combination. But eating chocolate and taking certain drugs might carry risks. In fact, eating chocolate and taking monoamine oxidase...
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