New FDA Watch List Flags More Drugs

July 03, 2017

The US Food and Drug Administration (FDA) spotted possible safety blips on its radar for 14 drugs or drug classes in the first 3 months of 2017, which put them on the agency's latest watch list.

The watch list, posted last week on the FDA website, reflects potential signals of serious risk or new safety information gathered by the FDA Adverse Event Reporting System (FAERS).

In the case of four drugs or drug classes, the agency already has reached a regulatory resolution. The FDA decided that on the basis of available information, no action was needed right now regarding reports of kidney stones in patients with type 2 diabetes who took sodium-glucose cotransporter-2 (SGLT-2) inhibitors to lower blood glucose levels. It took the same stance on reports of rhabdomyolysis — a breakdown of muscle tissue that can lead to kidney damage — in patients who took methimazole tablets for hyperthyroidism, Graves disease, thyrotoxic crisis, and other disorders.

With two other drugs, the FDA already has revised the labels. In the case of the anticonvulsant medicine levetiracetam (Keppra, UCB), the label's section on adverse reactions reported after approval was updated to include the risk for acute kidney injury. The change also applies to the extended-release version of the drug.

The FDA revised the label of two forms of the antibiotic daptomycin (Cubicin and Cubicin RF, Merck) to warn not about an inherent risk but a medication error that clinicians could commit. The labels now state that each drug is reconstituted from powder differently — a sodium chloride solution for Cubicin and either sterile or bacteriostatic water for injection for Cubicin RF. Differences also extend to how the drugs are stored.

The FDA notes that a drug's appearance on a quarterly FAERS watch list does not mean that the agency has determined a causal relationship between the drug and the adverse event. What it does mean is further study. If the FDA concludes that there is a causal link, it can collect more data to better describe the risk, change the drug's label, order a risk evaluation and mitigation strategy, or pull the product from the market.

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.

 

More information about FAERS and its quarterly watch lists are available on the FDA website.

Follow Robert Lowes on Twitter @LowesRobert

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