America’s Unsafe Medical Products

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The U.S. Food and Drug Administration (FDA) on Monday issued five safety alerts related to medical products sold in the United States. Three alerts were voluntary recalls of medicines, one warned of unapproved use of a drug and the fourth was a warning regarding a medical device used to screen for breast cancer.

Notably, the FDA warned against the use of thermography as a stand-alone diagnostic tool to screen for breast cancer. In a warning letter to a distributor that misbrands its thermography package as a stand-alone screener, the FDA said that there is no valid scientific data showing that thermography devices, either used in conjunction with another device or by itself, “are an effective screening tool for any medical condition.” Mammography, the FDA reiterated, “is the most effective breast cancer screening method and the only method proven to increase the chance of survival through earlier detection.”

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 since the beginning of 2019. 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, with the most recent listed first. Included are the type of alert and the issue date.

Golean Detox Capsules
> Issue date: February 25, 2019
> Type of Alert: Recall

Golean Detox USA voluntarily has issued a recall of all lots of its capsules following an FDA analysis that the capsules are tainted with substances that have been withdrawn by the agency from the U.S. market. The company said it has received no reports of adverse effects related to the recall.

Macleod’s Pharmaceuticals Losartan 100mg/25mg Tablets
> Issue date: February 25, 2019
> Type of Alert: Recall

The company is voluntarily recalling of two types of losartan tablets used to treat hypertension. One lot of losartan potassium and hydrochlorothiazide tablets has been found to have trace amounts of an unexpected carcinogen in tablets manufactured by Hetero Labs. The company has received no reports of adverse events related to this recall.

Pfizer Xeljanz and Xeljanz XR
> Issue date: February 25, 2019
> Type of Alert: Safety alert

The FDA is alerting patients, health care professionals, pharmacists and rheumatologist that Pfizer’s Xeljanz and Xeljanz XR increase the risk of blood clots in the lungs and death for patients with rheumatoid arthritis taking a twice-daily 10mg dose of the drug.

Total Thermal Imaging Inc. (TTI) Thermography Business Package
> Issue date: February 25, 2019
> Type of Alert: Warning

TTI has failed to take promised steps to replace misleading marketing messages for its thermography package. The company has mischaracterized the product as a stand-alone screening device for diagnosing breast cancer. The FDA has approved thermography only for use with another diagnostic tool. TTI faces severe sanctions if it fails to respond within 15 days to the FDA’s warning letter.

ICU Medical’s 20mm ChemoLock Vial Spike
> Issue date: February 25, 2019
> Type of alert: Recall

The company is recalling 2,050 units of its CL-80S ChemoLock Vial Spike due to the potential for plastic particles to break off the protective cap, potentially entering the drug delivery system and infused into a patient’s intravenous line resulting in “serious injury or death.” ICU Medical has received no reports of adverse effects related to this issue. The devices are commonly used in pharmacies that compound their own medicines and by healthcare facilities.

Takeda Uloric
> Issue date: February 21, 2019
> Type of alert: Safety announcement

Uloric is prescribed to treat gout and was approved by the FDA in 2009 on condition of conducting a post-release study. The results of that study found “an increased risk of death” from heart-related problems or deaths from any cause among patients using Uloric (febuxostat) compared to another treatment, allopurinol (brand name Zyloprim). The FDA is now requiring Takeda to include a Boxed Warning for Uloric and restricting approved use of the drug only to those patients for whom allopurinol is not effective or who suffer severe side effects from allopurinol.