The FDA Is Watching These 14 Drugs for Serious Side Effects

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Every three months, the FDA reviews and publishes reports of adverse reactions from medications they’ve received through the FDA Adverse Event Reporting System (FAERS). The FDA has been posting these quarterly updates since 2007, due to an update to the Food and Drug Administration Amendments Act that requires the FDA to publish a new list of potential signals of serious risks/new safety information identified every 3 months (see our overview of the previous list here).

Should I be worried if my prescription is on the list?

The FDA does emphasize that just because a medication appears this list, it doesn’t mean that the they have determined that the drug actually carries a risk. Following the quarterly update, the FDA will complete an evaluation of each potential safety issue and make additional announcements if they find anything further.

At the end of June 2017, the FDA released the list of medications for the first quarter (January – March) that potentially carry serious risks.

So which prescriptions is the FDA monitoring this quarter?

  1. Alli and Xenical (orlistat) are prescribed for weight loss. They are on the list due to reports of neuropsychiatric side effects (like mild cognitive impairment).
  2. Cubicin and Cubicin RF (daptomycin) are antibacterials (antibiotics) that appear on the list because of reports that confusion around the similar names causes prescribing and filling errors. To resolve the issue, the external package labeling has been updated, and the “Dosage and Administration” section of the labeling was updated to better differentiate the two formulations.
  3. Exjade and Jadenu (deferasirox) are prescribed for chronic iron overload, and they are on the list due to reports of fever and dehydration in children.
  4. Lupron (leuprolide), Lupron Depot PED (leuprolide), Supprelin LA (histrelin), and Synarel (nafarelin) are all used to treat central precocious puberty (CPP), a condition where girls under 8 years old and boys under 9 begin puberty too early. These prescriptions appear on the list due to reports of musculoskeletal and connective tissue pain and discomfort.
  5. Keppra (levetiracetam) products are typically used to treat seizures. They appear on the list due to reports of acute kidney injury and interstitial nephritis—a kidney condition characterized by swelling inside of the kidney. The “Adverse Reactions; Postmarketing Experience” section of the labeling for Keppra and Keppra XR was updated to include acute kidney injury.
  6. Keytruda (pembrolizumab), Opdivo (nivolumab), and Yervoy (ipilimumab) are used to treat certain cancers, and are on the list because of reports of adverse effects on the eye, including vision loss and retinal detachment.
  7. Kybella (deoxycholic acid) treats double chin by destroying fat cells under the chin. It’s on the list due to reports of injection site reactions and tissue death.
  8. Methimazole is typically used to treat overactive thyroid. It’s on the list due to reports of rhabdomyolysis, the breakdown of muscle tissue which can lead to kidney damage. The FDA decided no action is necessary at this time, based on available information.
  9. Neulasta (pegfilgrastim) is typically used the day after chemotherapy to boost your white blood cell count and help lower your risk for infection. It appears on the list for reports of device failure—the delivery device is applied to your skin at your chemo appointment and is designed to deliver Neulasta automatically the next day.
  10. Ofev (nintedanib) is used to treat a lung disease called pulmonary fibrosis, and it appears on the list due to reports of liver dysfunction.
  11. Farxiga (dapagliflozin), Glyxambi (empagliflozin/linagliptin), Invokana (canagliflozin), Invokamet (canagliflozin/metformin), Invokamet XR (canagliflozin/metformin), Jardiance (empagliflozin), Synjardy (empagliflozin/metformin), Synjardy XR (empagliflozin/metformin), and Xigduo XR (dapagliflozin/metformin) are all prescribed for the treatment of type 2 diabetes. Reports of kidney stones landed these diabetes meds on the list, but the FDA decided no action is necessary at this time, based on available information.
  12. Stelara (ustekinumab) is used to treat plaque psoriasis, psoriatic arthritis, and Crohn’s disease. Interstitial pneumonia (a form of lung disease) has been reported by patients using Stelara.
  13. Tanzeum (albuglutide) and Trulicity (dulaglutide) are used for the treatment of type 2 diabetes, and appear on the list due to reports of serious hypersensitivity reactions.
  14. Uloric (febuxostat) is prescribed to treat gout. It appears on the list due to reports of reactions to the drug, including an increase in disease-fighting white blood cells, eosinophils, as well as various symptoms in other parts of the body.

What is the FDA doing about all of these reports?

Unless otherwise noted, the FDA is currently evaluating the need for further action on all of the medications on the list.

What should I do if I take one of these medications?

First, don’t stop taking your prescription without speaking to your doctor—this can cause more problems than it solves. If you have any concerns or if you think you’re experiencing one of these side effects, talk to your prescriber or pharmacist.

How can I report a problem with a drug to the FDA?

If you need to report a serious problem with a medication to the FDA, you can do so through their MedWatch website. The MedWatch website allows you to voluntarily report a serious adverse event, product quality problem, product use error, or therapeutic inequivalence/failure that you suspect is associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic. You can report suspected counterfeit medical products here as well.

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