The Food and Drug Administration (FDA) added about four dozen drugs and drug classes to its watch list for potential new safety risks. There are several notable warnings from this release, which is listed current as of Sept. 30, 2019. 

In the April to June 2019 update, the FDA added new drugs to its watch list, which flags medications that may pose risks of serious illness. A notable addition is a range of iron supplements used to address iron deficiency in the blood, which was marked for an increased risk of miscarriage.

HMG-CoA reductase inhibitors (aka statins), which are used to lower bad cholesterol and improve cardiovascular health, were marked for an increased risk of necrotizing myopathy. Necrotizing myopathy can lead to muscle weakness and a sense of fatigue as muscle cells die.

Xofluza, the first FDA-approved flu treatment, was marked for an increased risk of anaphylaxis (severe, life-threatening allergic reaction). Additionally, Mavyret, used to treat hepatitis C, and Bactrim DS, an antibiotic prescribed for urinary tract infections, may cause hypersensitivity reactions.

The full list can be found in the table below:

  • Angioedema
  • Anaphylaxis and angioedema
  • Medication error - Labeling confusion (wrong dose errors)
  • Flu-like illness
  • Risk of Herpes zoster
  • Chondrocalcinosis pyrophosphate
  • Drug rash with Eosinophilia and Systemic Symptoms (DRESS)
  • Serious herpes infection
  • Fetal death (miscarriage)
  • Fetal death (miscarriage)
  • Fetal death (miscarriage)
  • Fetal death (miscarriage)

Fetal death (miscarriage)

  • Tumefactive multiple sclerosis
  • Thrombocytopenia
  • Increased hypersensitivity reactions in patients receiving certain product lots
  • Hypersensitivity: angioedema and anaphylaxis
  • Immune-mediated necrotizing myopathy
  • Thrombotic microangiopathy (TMA)
  • Malignancies
  • Medication Error - Patient self-administration errors
  • Anaphylaxis
  • Medication error – Labeling confusion (wrong drug errors)
  • Medication error – Labeling confusion (wrong drug errors)

Thrombotic microangiopathy (TMA)

  • Drug hypersensitivity
  • Drug hypersensitivity
  • Hemoglobin increased
  • Hypersensitivity
  • Acute respiratory failure
  • Interstitial lung disease and mucositis

The FDA utilizes its Adverse Event Reporting System (FAERS) to aggregate reports of previously unknown side effects from patients, and they release quarterly reports on trends they see with drugs available in U.S. markets. This system is how the FDA catches side effects not discovered during trial studies, or notes new side effects from off-label or inappropriate uses of drugs. 

With these new warnings, the FDA is considering a range of potential regulatory actions including updating drug labels, communication of risks to the public, limiting use, and removal from the market.   

If you are feeling any adverse side effects from drugs you are prescribed, report them IMMEDIATELY to your physician. 

If you are experiencing a side effect not listed on the label of your prescription, you can either report them to your physician to send to the FDA or visit MedWatch to learn more about your options for reporting adverse effects.

Report an adverse event.

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