by The GoodRx Pharmacist

The FDA is watching these 14 drugs for serious side effects.

Every 3 months, the FDA reviews and publishes reports of adverse reactions from medications they have 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 U.S 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.

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

The FDA does emphasize that just because a medication appears this list, it doesn’t mean that 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 the June 2017, the FDA released the list of medications for the first quarter (January-March) that potentially carries serious risks.

So which prescription is the FDA monitoring this quarter???

PRODUCT NAME: ALLI (OSLISTAT) CAPSULES, XENICAL (ORLISTAT) CAPSULES FOR ORAL USE

POTENTIAL RISK: Orlistat and neuropsychiatric adverse events

ADDITIONAL INFORMATION: FDA is evaluating the need for regulatory action

PRODUCT NAME: CUBICIN (DAPTOMYCIN FOR INJECTION) FOR INTRAVENOUS USE, CUBICIN RF (DAPTOMYCIN FOR INJECTION) FOR INTRAVENOUS USE

POTENTIAL RSIK: Medication error

ADDITIONAL INFORMATION: The container labels and carton labeling were revised. In addition the dosage and administration section of the labeling was updated to better differentiate the two formulations. Cubicin labeling, Cubicin RF labeling.

EXJADE (DEFERASIROX) TABLETS, FOR ORAL SUSPENSION,JADENU (DEFERASIROX) TABLETS,FOR ORAL USE

POTENTIAL RISK: Pediatric fever and dehydration

ADDITIONAL INFORMATION: FDA is evaluating the need for regulatory action.

Gonadotropin releasing hormone (Gnrh) Agonist

>>LUPRON (LEUPROLIDE ACETATE) INJECTION,LUPRON DEPOT PED (LEUPROLIDE ACETATE FOR DEPOT SUSPENSION),INJECTION,POWDER,LYOPHLIZED,FOR SUSPENSION,SUPPRELIN LA( HISTRELIN ACETATE) SUBCUTANEOUS IMPLANT,SYNAREL(NAFARELIN ACETATE)NASAL SOLUTION

POTENTIAL RISK: Musculoskeletal and connective tissue pain and discomfort

ADDITIONAL INFORMATION: FDA is evaluating the need for regulatory action.

>>KEPPRA (LEVETIRACETAM) TABLETS FOR ORAL USE

>>KEPPRA (LEVETIRACETAM) EXTENDED RELEASE TABLETS FOR ORAL USE

>>KEPPRA (LEVETIRACETAM) ORAL SOLUTION

R>>KEPPRA (LEVETIRACETAM) INJECTION, FOR INTRAVENOUS USE

POTENTIAL RISK: Acute kidney injury and interstitial nephritis

ADDITIONAL INFPRMATION: The adverse reactions, post marketing experience section of the labeling for Keppra and keppra XR was updated to include acute kidney injury.

KEYTRUDA (PEMBEOLIZUMAB) for injection for intravenous use, OPDIVO (NIVOLUMAB) for injection, for intravenous use, YERVOY (IPILIMUMAB) injection, for intravenous use.

POTENTIAL RISK: Ocular toxicities including vision loss and retinal detachment

ADDITIONAL INFORMATION: FDA is evaluating the need for regulatory action.

KYBELLA (DEOXYCHOLIC ACID) injection, for subcutaneous use

POTENTIAL RISK: Injection site infection and necrosis

ADDITIONAL INFORMATION: FDA is evaluating the need for regulatory action.

METHIMAZOLE TABLETS:

POTENTIAL RISK: Rhabdomyolysis in methimazole

ADDITIONAL INFORMATION: FDA decided that no action is necessary at this time, based on available information.

NEULASTA ONPRO KIT (PEGFILGRASTIM) injection, for subcutaneous use

POTENTIAL RISK: Device failure

ADDITIONAL INFORMATION: FDA is evaluating the need for regulatory action.

OFEV (NINTEDANIB) capsules, for oral use

POTENTIAL RISK: Liver dysfunction

ADDITIONAL INFORMATION: FDA is evaluating the need for regulatory action.

SODIUM GLUCOSE COTRANSPORTER- 2(SGLT-2) INHIBITORS

>>>FARXIGA (DAPAGLIFLOZIN) tablets, for oral use

>>>GLYXAMBI (EMPAGLIFLOZIN AND LINAGLIPTIN) tablets, for oral use

>>>INVOKAMET XR (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE) tablets, for oral use

>>>INVOKANA (CANAGLIFLOZIN) tablets, for oral use

>>>JARDAINCE (EMPAGLIFLOZIN) tablets, oral use

>>>SYNJARDY (EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) tablets, for oral use

>>>SYNJARDY XR (EMPAGLIFLOZIN and METFORMIN HYDROCHLORIDE EXTENDED-RELEASE) tablets, for oral use

>>>XIGDUO XR (DAOAGLIFLOZIN and METFORMIN HYDROCHLORIDE EXTENDED-RELEASE) tablets, for oral use

POTENTIAL RISK: Nephrolithiasis

ADDITIONAL INFORMATION: FDA decided that no action is necessary at this time, based on available information.

STELARA (USTEKINUMAB) injection, for subcutaneous use

POTENTIAL RISK: Interstitial pneumonia

ADDITIONAL INFORMATION: FDA is evaluating the need for regulatory action.

>>>TANZEUM (ALBIGLUTIDE) for injection, foe subcutaneous use

>>>TRULICITY (DULAGLUTIDE) injection, for subcutaneous use

POTEBTIAL RISK: Serious hypersensitivity reactions.

ADDITIONAL INFORMATION: FDA is evaluating the need for regulatory action.

ULORIC (FEBUXOSTAT) tablets, for oral use

POTENTIAL RISK: Drug reaction with Eosinophilia and systemic symptoms.

ADDITIONAL INFORMATION: FDA is evaluating the need for regulatory actions.

 

Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS): January – March 2017