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FDA tarafından incelenmeye alınan,ciddi yan etkileri olan ilaçlar

Product Name: Trade (Active Ingredient) or Product Class
Potential Signal of a Serious Risk/New Safety Information
Additional Information (as of June 30, 2017)
Alli (orlistat) capsules
Xenical (orlistat) capsules, for oral use
Orlistat and neuropsychiatric adverse events
FDA is evaluating the need for regulatory action.
Cubicin (daptomycin for injection) for intravenous use
Cubicin RF (daptomycin for injection) for intravenous use
Medication error
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
Pediatric fever and dehydration
FDA is evaluating the need for regulatory action.
Gonadotropin-releasing hormone agonists
Lupron (leuprolide acetate) injection
Lupron Depot PED (leuprolide acetate for depot suspension), injection, powder, lyophilized, for suspension
Supprelin LA (histrelin acetate) subcutaneous implant
Synarel (nafarelin acetate) nasal solution
Musculoskeletal and connective tissue pain and discomfort
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
Keppra (levetiracetam) injection, for intravenous use
Acute kidney injury and interstitial nephritis
The "Adverse Reactions; Postmarketing Experience" section of the labeling for Keppra and Keppra XR was updated to include acute kidney injury.
Keppra XR labeling
Keppra labeling (tablets and  oral solution)
Keppra labeling (injection)
Keytruda (pembrolizumab) for injection, for intravenous use
Opdivo (nivolumab) injection, for intravenous use
Yervoy (ipilimumab) injection, for intravenous use
Ocular toxicities, including vision loss and retinal detachment
FDA is evaluating the need for regulatory action.
Kybella (deoxycholic acid) injection, for subcutaneous use
Injection site infection and necrosis
FDA is evaluating the need for regulatory action.
Methimazole tablets
Rhabdomyolysis in methimazole
FDA decided that no action is necessary at this time, based on available information.
Neulasta Onpro kit (pegfilgrastim) injection, for subcutaneous use
Device failure
FDA is evaluating the need for regulatory action.
Ofev (nintedanib) capsules, for oral use
Liver dysfunction
FDA is evaluating the need for regulatory action.
SGLT-2 inhibitors
Farxiga (dapagliflozin) tablets, for oral use
Glyxambi (empagliflozin and linagliptin) tablets, for oral use
Invokamet (canagliflozin and metformin hydrochloride) tablets, for oral use
Invokamet XR (canagliflozin and metformin hydrochloride extended-release) tablets, for oral use
Invokana (canagliflozin) tablets, for oral use
Jardiance (empagliflozin) tablets, for 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 (dapagliflozin and metformin hydrochloride extended-release) tablets, for oral use
Nephrolithiasis
FDA decided that no action is necessary at this time, based on available information.
Stelara (ustekinumab) injection, for subcutaneous use
Interstitial pneumonia
FDA is evaluating the need for regulatory action.
Tanzeum (albiglutide) for injection, for subcutaneous use
Trulicity (dulaglutide), injection, for subcutaneous use
Serious hypersensitivity reactions
FDA is evaluating the need for regulatory action.
Uloric (febuxostat) tablets, for oral use
Drug reaction with eosinophilia and systemic symptoms
FDA is evaluating the need for regulatory action.