FDA’nın izlem listesine 3 ilaç eklendi. Söz konusu ilaçlar olası risk işaretleri taşıdıkları için bu listeye eklenmekteler (İng)
Three Drugs Added to FDA Watch List
Robert Lowes, Feb 12, 2013
- Administration (FDA) has added 3 drugs to its list of products to monitor because of possible signs of serious risks or new safety information.
The FDA also put an over-the-counter sunscreen — which was voluntarily pulled from the market — on its watch list, released today.
The agency received reports of possible adverse events for these 4 products in the FDA Adverse Event Reporting System (FAERS) database during the third quarter of 2012. A drug’s appearance on the list, which grows quarter by quarter, does not mean that the FDA has concluded that the drug actually poses the health risk reported through FAERS. Instead, the agency is studying whether there is indeed a causal link. If it establishes one, the FDA then would consider a regulatory response such as gathering more information to better describe the risk, changing the drug’s label, or mandating a risk evaluation and mitigation strategy.
The FDA says it is not suggesting that clinicians should stop prescribing watch list drugs or that patients should stop taking them while the jury is out.
One of the drugs on the most current quarterly watch list — lacosamide (Vimpat, UCB), indicated for epilepsy as well as liver and kidney impairment — also appeared on the list for the first quarter of 2012. During that earlier period, FAERS received reports of toxic epidermal necrolysis. In the third quarter of 2012, the reports were for neutropenia.
Another drug on the list for the third quarter of 2012 underwent a label change during that time. FAERS received reports of anaphylaxis for dalfampridine (Ampyra, Acorda Therapeutics), indicated for both improving gait in patients with multiple sclerosis and treating kidney and liver impairment. In July 2012, the agency revised dalfampridine’s label to warn of the risk for seizures (already a known adverse event) at the recommended dose and often during the first week of treatment.
Potential Signals of Serious Risks/New Safety Information Identified by FAERS, July to September 2012
|
Product Name: Active Ingredient (Trade) or Product Class |
Potential Signal of a Serious Risk/New Safety Information |
Additional Information* |
|
Ofatumumab (Arzerra, GlaxoSmithKline) |
Viral infections |
FDA is continuing to evaluate this issue to determine whether the current labeling, which contains information about viral infections, is adequate. |
|
Lacosamide (Vimpat, UCB) |
Neutropenia |
|
|
Dalfampridine (Ampyra, Acorda Therapeutics) |
Anaphylaxis |
|
|
Banana Boat Sunscreen Spray (Energizer Holdings) |
Flammability |
The manufacturer, Energizer Holdings, announced on October 19, 2012, that it was voluntarily withdrawing its continuous-spray Banana Boat sun care products from the market because they could ignite on the skin if they come into contact with a source of ignition before they are completely dry. |
*Unless otherwise noted, the FDA is continuing to evaluate these issues to determine the need for any regulatory action.
More information on FAERS and its quarterly watch list is available on the FDA Web site.