FDA, ciddi risk işaretleri taşıyan tıbbi ürünler ya da Advers Olay Raporlama Sistemi’nde yeni bir güvenlik bilgisinin tanımlanmasının ardından yaptığı üzere yeni izleme listesini yayımladı.

FDA’nın son izleme listesinde nöbetler, pospartum kan kaybı, astım ve bağışıkık sistemi düzensizliklerini tedavi etmeye yönelik 4 ilaç ile X-ray kontrast madde bulunmakta.


FDA Puts 4 Drugs, X-Ray Contrast Agent on Watch List

Robert Lowes

July 17, 2012 — The US Food and Drug Administration (FDA) has published its latest quarterly list of drugs to monitor after having identified possible signs of serious risks or new safety information in the agency’s Adverse Event Reporting System (AERS) database during the first 3 months of 2012.

The latest FDA watch list consists of 4 drugs that treat seizures, postpartum hemorrhaging, asthma, and immune system disorders, as well as an X-ray contrast agent.

The appearance of a drug on the list does not mean that the FDA has determined that the drug actually poses the health risk reported through AERS. Instead, watch-list status means that the agency will study the drug to determine whether there is indeed a causal link. If a link is proven, the FDA then would consider a regulatory response such as collecting more information to better characterize the risk, amending the drug’s label, or requiring a risk evaluation and mitigation strategy.

The FDA also cautions that it is not suggesting that clinicians should stop prescribing any drugs on the watch list or that patients should stop taking them.

Potential Signals of Serious Risks/New Safety Information Identified by AERS, January to March 2012

Product Name: Active Ingredient (Trade) or Product Class

Potential Signal of a Serious Risk/New Safety Information

Additional Information (as of May 1, 2012)*

Immune globulin intravenous (human), 10% liquid (Privigen, CSL Behring)

Hemolysis, hemolytic anemia. The majority of cases reported have occurred in patients with non-O blood type and/or receiving doses of ≥2g/kg.

The labeling for Privigen was modified in April 2012 to include information on risk factors for hemolysis.
The FDA is continuing to evaluate this issue to determine the need for any further regulatory action.

Iodinated contrast agent products

Thyroid dysfunction (hyperthyroidism and hypothyroidism)

The FDA is continuing to evaluate these issues to determine whether the current labeling, which contains information about thyroid dysfunction, is adequate.

Lacosamide (Vimpat, UCB)

Toxic epidermal necrolysis


Methylergonovine maleate tablets and injection (Methergine, Novartis)

Myocardial ischemia and infarction associated with methylergonovine-induced vasospasm.
Medication errors involving neonates and adults.


Montelukast (Singulair, Merck)

Stevens-Johnson syndrome


* Unless otherwise noted, the FDA is continuing to evaluate these issues to determine the need for any regulatory action.

More information on AERS and its quarterly watch list is available on the FDA’s Web site.

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