America’s Unsafe Medical Products

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Macleod’s Pharmaceuticals Losartan 100 mg/25 mg 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 10 mg 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 health care 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.