FDA Updates Watch List With Xofluza and Other Drugs

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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 below:

Abatacept (Orencia)

Baloxavir marboxil (Xofluza)

Benralizumab (Fasenra)

Cinacalcet hydrochloride (Sensipar) and generics

Clobazam (Onfi) and generics

Dimethyl fumarate (Tecfidera)

Ferumoxytol (Feraheme)

Sodium ferric gluconate (Ferrlecit) and generics

Iron dextran (INFeD)

Ferric carboxymaltose (Injectafer)

Iron sucrose (Venofer)

Fingolimod (Gilenya)

Gamunex-C [Immune Globulin (Human), 10% Caprylate/Chromatography Purified]

Glecaprevir and pibrentasvir (Mavyret)

HMG-CoA reductase inhibitors

Ixazomib (Ninlaro)

Mecasermin (Increlex)

Naltrexone hydrochloride (Vivitrol)

Oritavancin diphosphate (Orbactiv)

Pegfilgrastim, CHS- 1701 (Udeynca)

Pegfilgrastim, CHS- 1701 (Udeynca)

Pentostatin (Nipent) and generics

Pitavastatin (Livalo)

Pitavastatin magnesium (Zypitamag)

Sucroferric oxyhydroxide (Velphoro)

Sulfamethoxazole and trimethoprim (Bactrim DS, Septra) and generics

Trabectedin (Yondelis)

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.

By Benjamin Duong

Benjamin Duong is a medical student and freelance writer based in Dothan, Alabama. He has a Masters of Public Health from the George Washington University and majored in microbiology and political science at the University of Florida. He has worked on advocacy for issues ranging from medical education to global maternal and infant mortality.

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