Medication Monitor

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  • April 17, 2018

    FDA issued new guidance to clarify that dietary supplements containing pure or highly concentrated caffeine in powder or liquid forms are dangerous and present a significant or unreasonable risk of illness or injury. 

    In 2015 and 2016, FDA issued warning letters to seven distributors of pure powdered caffeine. Since that time, FDA has continued to see a proliferation of similar products being sold online.

    Highly concentrated and pure caffeine, often sold in bulk packages, has been linked to at least two deaths in otherwise healthy individuals.

    A one-half cup of highly concentrated liquid caffeine can contain approximately 2,000 mg of caffeine, and just a single teaspoon of a powdered pure caffeine product can contain approximately 3,200 mg of caffeine. This is equivalent to about 20 to 28 cups of coffee, a potentially toxic dose. 

    The recommended safe serving of highly concentrated or pure caffeine products is often 200 mg of caffeine, which equates to 1/16 of a teaspoon of pure powder or approximately 2.5 teaspoons of a liquid.

    When formulated and marketed appropriately, such as in premeasured packets or containers, in solid dosage forms such as tablets or capsules, or when in formulations that are not highly concentrated, caffeine can be a safe ingredient in a dietary supplement  

    The guidance does not affect other types of products that might also contain caffeine, such as prescription or OTC drugs or conventional foods such as traditionally caffeinated beverages.

  • April 17, 2018

    FDA is alerting health professionals to a voluntary recall of all nonexpired products marketed as sterile that were made by Coastal Meds, of Biloxi, MI. During a recent inspection, FDA investigators observed visible particulates and poor sterile production practices in products intended for injection.

    Injection of a drug product containing particulate matter may result in serious and potentially life-threatening adverse events, such as infection, allergic reaction, toxicity, or other reactions. Health professionals should immediately check their medical supplies, quarantine any sterile drug products intended for injection from Coastal Meds, and not administer them to patients.

    On April 5, 2018, Coastal Meds initiated a voluntarily recall of all products intended to be sterile. FDA requested the compounder inform the public, but the company has not done so.

    To date, FDA is not aware of any reports of adverse events associated with drug products produced by Coastal Meds. Patients who have received drug products produced by Coastal Meds and have concerns should contact their health professional.

  • April 13, 2018

    Premier Pharmacy Labs is voluntarily recalling specific sterile injectable product lots because they lack sterility assurance.

    Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper-evident container closure. This may introduce microorganisms into the products.

    Administration of nonsterile injection products that are intended to be sterile may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant morbidity (permanent organ damage), or a fatal outcome.

    The product can be identified by the product description in the table on FDA's website and beyond-use date (BUD) on the individual product or shipping bag. The listed product lots were distributed nationwide to hospital pharmacy, clinic, and health care facilities.

    To date, Premier Pharmacy Labs has not received any reports of adverse events related to this issue.

  • April 12, 2018

    FDA continues to monitor the safety of Essure. FDA stated that it continues to believe the benefits of the device outweigh its risks, and that Essure’s updated labeling and the sales restriction will ensure that women are appropriately informed of the risks.

    Some women have received the Essure device without being adequately informed of its risks. FDA has taken steps, including labeling changes in 2016 adding a boxed warning and patient decision checklist, to better inform health care providers and patients about these risks. For this device to meet reasonable assurance of safety and effectiveness, all women considering Essure should receive this important information.

    On April 9, 2018, FDA restricted sales of the Essure device to only doctors and health care facilities who use the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement,” which is part of the patient information booklet. It includes key items about the device, its use, and safety and effectiveness outcomes. Sale and distribution of Essure is limited to health care providers who agree to review this checklist with patients, and give them the opportunity to sign it, before Essure implantation.

    FDA also approved Bayer's new labeling that includes the following statement: “The sale and distribution of this device are restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Bayer.”

  • April 4, 2018

    FDA is alerting consumers of a voluntary recall of a topical drug product, Pasta De Lassar Andromaco zinc oxide diaper rash treatment, made by Industria Farmacéutica Andrómaco, Toluca, Mexico, and distributed by MarcasUSA LLC, El Segundo, CA.

    FDA laboratory analysis confirmed that Pasta De Lassar Andromaco is contaminated with high levels of yeast, mold, and bacteria. This is especially concerning because Pasta De Lassar Adromoca is labeled for use to relieve diaper rash, where irritated skin can become infected. Therefore, consumers and caregivers should not use this product because possible microbial contamination may cause infections.

    Consumers who have Pasta De Lassar Andromaco should stop using it and dispose of it immediately. Consumers also should contact their doctor or health professional if they have concerns or if they develop an infection following the use of topical drug products made by Industria Farmacéutica.

    Pasta De Lassar Andromaco and other topical drug products made by Industria Farmacéutica are available online and in retail stores. Additionally, the company donated its Pasta De Lassar Andromaco product to a charity in California.