America’s Unsafe Medical Products

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The U.S. Food and Drug Administration (FDA) has issued six new safety alerts since mid-July, four related to product recalls and two safety communications, one of which is related to patient risk for certain breast implants.

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 July 31. 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.

FDA Requests Recall of Textured Breast Implants
> Issue date: July 31, 2019
> Type of alert: Safety communication

The FDA has requested that Allergan recall all its Biocell textured breast implants and tissue expanders due to increased risk of breast implant-associated anaplastic large cell lymphoma. Allergan has agreed to the recall and has begun removing the products from global markets.

Higher Risk of Blood Clots Among Patients Using Xeljanz to Treat Ulcerative Colitis
> Issue date: July 26, 2019
> Type of alert: Safety communication

The FDA has approved new box warnings related to an increased risk of blood clots and of death with the 10 mg twice daily dose of Xeljanz XR (tofacitinib) used to treat patients with ulcerative colitis. The FDA noted that patients should not stop taking the drug before talking to their health care provider, “as doing so can worsen your condition.”

Herbal Products Marketed Without FDA Approval
> Issue date: July 24, 2019
> Type of alert: Recall

Herbal Doctor Remedies is voluntarily recalling all drug products. All have been marketed without FDA approval and manufactured outside required controls. The products were intended to be used as Chinese herbal medicines.

Oral Contraceptive’s Effectiveness May Be Compromised
> Issue date: July 23, 2019
> Type of alert: Recall

Jubilant Cadista Pharmaceuticals is voluntarily recalling one lot of its oral contraceptive for women Drospirenone and Ethinyl Estradiol tablets, USP, 3 mg/ 0.02mg in 28×3 blister pack/carton packaging. Product efficacy may be decreased due to decreased absorption of the active ingredients.

Intra-Aortic Balloon Pumps May Stop Unexpectedly
> Issue date: July 23, 2019
> Type of alert: Recall

The Maquet/Datascope balloon pump is used to assist patients during certain kinds of surgery or to treat those with acute coronary syndrome or complications from heart failure. The recalled pump’s battery may fail to hold a charge and stop working when used on battery power only. Five patients have died since March 2016, although the company has not concluded that the deaths were due solely to a malfunctioning device.