America’s Unsafe Medical Products

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The U.S. Food and Drug Administration (FDA) has issued five new safety alerts, three related to product recalls, one regarding a stent system and one warning of dangers related to some prescription insomnia medicines.

The FDA issues safety alerts to provide timely new safety information on human drugs, medical devices, vaccines and other products including biologics, dietary supplements and cosmetics. The alerts are publicly available at the agency’s MedWatch website and contain “actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient.”

The following list includes all MedWatch alerts for 2019 through May 3.There are several types of alerts, including letters to health care providers, warnings to users, drug safety notices and recalls. The 2019 alerts are listed in reverse chronological order, so the most recent are listed first. Included are the type of alert and the issue date.

Recall of Anti-Inflammatory Drug Ketorolac Tromethamine Injection
> Issue date: May 3, 2019
> Type of alert: Recall

Sagent Pharmaceuticals is voluntarily recalling one lot of its non-steroidal anti-inflammatory drug (NSAID) due to the possibility that the drug may not be sterile.

Blood Pressure Medication Losartan May Be Tainted
> Issue Date: May 3, 2019
> Type of alert: Recall

Vivimed is recalling 19 lots of Losartan potassium tablets in 25mg, 50mg and 100mg dosages following detection of an impurity in the drug. The tablets were made in India and distributed in the United States by Heritage Pharmaceuticals.

Glass Fragment Found in Medication to Fight Against Organ Transplant Rejection
> Issue date: May 3, 2019
> Type of alert: Recall

Endo International’s Par Pharmaceuticals is voluntarily recalling one lot of its Mycophenolate Mofetil for Injection after one vial of the product was found to contain a fragment of glass. The drug is used for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.

New Box Warning on Some Insomnia Medicines
> Issue date: April 30, 2019
> Type of alert: Advisory

The FDA is advising patients, health care professionals and pharmacies of rare but serious injuries related to commonly used insomnia medicines such as Lunesta, Sonata, Ambien, Ambien CR, Edluar, Intermezzo and Zolpimist. Patients may exhibit such behaviors as sleepwalking or sleep driving while not fully awake. According to the FDA, complex sleep behaviors have led to serious injury or death.