The US Food and Drug Administration (FDA) has flagged 19 drugs or drug classes — including 7 cancer treatments — as generating possible signals of serious risk or new safety information in its watch list for the second quarter of 2017.
The watch list, posted October 6 on the FDA website, is derived from the FDA Adverse Event Reporting System (FAERS).
A drug's appearance on a quarterly FAERS watch list, the FDA states, does not mean that the agency has determined a causal relationship between that product and the adverse event. Nor does it mean that physicians should stop prescribing the drug and patients stop taking it. If further study determines that there is a causal link, the agency can collect more data to better describe the risk, revise the drug's label, order a risk evaluation and mitigation strategy, or pull the product from the market.
The seven cancer drugs on the latest watch list are imiquimod cream, alemtuzumab, imatinib (Gleevec, Novartis), pomalidomide (Pomalyst, Celgene), docetaxel, and two programmed cell death 1 (PD-1) inhibitors: pembrolizumab (Keytruda, Merck) and nivolumab (Opdivo, Bristol-Myers Squibb). For two of these drugs, the FDA already has dealt with reports of adverse events. The agency updated the label for imatinib to warn about renal toxicity. Likewise, the label for pembrolizumab has been revised to warn about Stevens-Johnson syndrome and toxic epidermal necrolysis.
The regulatory jury is still out, however, on pembrolizumab regarding another reported adverse event: complications of allogenic hematopoietic stem cell transplantation. Nivolumab made the watch list for the same reason. The agency said it would evaluate the need for further action on this potential risk signal for these PD-1 inhibitors.
Three other cancer drugs on the list also will undergo scrutiny for a possible causal link to reported adverse events: vitiligo-like depigmentation for imiquimod cream, acute acalculous cholecystitis for alemtuzumab, and enterocolitis for docetaxel.
In contrast, the agency decided that the available information about pomalidomide, listed on account of ischemic colitis, warrants no action at this time.
The new watch list cited proton-pump inhibitors, prescribed for gastroesophageal reflux disease, for two different potential adverse events: polyps of the stomach and duodenum, and chronic kidney disease and acute kidney injury. The agency said it would investigate the former adverse event but not take any action on the latter one, based on the information at hand.
| Product Name: Trade (Active Ingredient) or Product Class | Potential Signal of a Serious Risk/New Safety Information | Additional Information (as of September 30, 2017) |
|---|---|---|
Adrenalin (epinephrine injection), for intramuscular and subcutaneous use
|
Adrenalin (epinephrine) injection and wrong drug errors
|
FDA published a Dear Healthcare Provider letter on its website to communicate the change in formulation and removal of the mydriasis indication for Adrenalin.
The carton/container labeling for Adrenalin was updated to remove the mydriasis indication.
|
|
Drug-induced vitiligo-like depigmentation
|
FDA is evaluating the need for regulatory action.
|
Ameluz (aminolevulinic acid hydrochloride) gel, 10%, for topical use
|
Transient global amnesia
|
The "Warnings and Precautions," "Adverse Reactions," and "Patient Counseling" sections of the labeling for Ameluz were updated to include transient amnestic episodes.
|
|
Acute acalculous cholecystitis
|
FDA is evaluating the need for regulatory action.
|
Carafate (sucralfate) oral suspension
|
Medication error: administration error
|
The labeling for Carafate was updated to revise the name of the drug from "Carafate suspension" to "Carafate oral suspension."
The labeling for Carafate was changed to include warnings of fatal complications with inappropriate intravenous administration of Carafate oral suspension.
|
Coartem (artemether/lumefantrine) tablets
|
Hemolytic anemia
|
FDA is evaluating the need for regulatory action.
|
|
Device failure
|
FDA issued a warning letter to Meridian Medical Technologies Inc summarizing significant violations of current good manufacturing practice requirements for combination products
|
Dipeptidyl peptidase-4 inhibitors
|
Rhabdomyolysis
|
FDA is evaluating the need for regulatory action.
|
Gilenya (fingolimod) capsules, for oral use
|
Rebound multiple sclerosis upon discontinuation of fingolimod
|
FDA is evaluating the need for regulatory action.
|
Gleevec (imatinib mesylate) tablets, for oral use
|
Decline in renal function
|
The "Warning and Precautions" section of the labeling for Gleevec was updated to include renal toxicity.
|
|
Necrolytic migratory erythema
|
FDA is evaluating the need for regulatory action.
|
|
Complications of allogeneic hematopoietic stem cell transplantation
|
FDA is evaluating the need for regulatory action.
|
Keytruda (pembrolizumab) injection, for intravenous use
|
Stevens-Johnson syndrome and toxic epidermal necrolysis
|
The "Warning and Precautions" section of the labeling for Keytruda was updated to include Stevens-Johnson syndrome and toxic epidermal necrolysis.
|
Pomalyst (pomalidomide) capsules, for oral use
|
Ischemic colitis
|
FDA decided that no action is necessary at this time based on available information.
|
Proton-pump inhibitors
|
Polyps of stomach and duodenum
|
FDA is evaluating the need for regulatory action.
|
Proton-pump Inhibitors
|
Chronic kidney disease/acute kidney injury
|
FDA decided that no action is necessary at this time based on available information.
|
Repatha (evolocumab) injection, for subcutaneous use
|
Skin and subcutaneous tissue bacterial infections
|
FDA is evaluating the need for regulatory action.
|
Taxotere (docetaxel) injection concentrate, intravenous infusion
|
Docetaxel and neutropenic enterocolitis
|
FDA is evaluating the need for regulatory action.
|
Uvadex (methoxsalen) injection, solution
|
Embolism and thrombosis
|
FDA is evaluating the need for regulatory action.
|
Source: FDA
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