FDA Studying 27 Drugs, Drug Classes for Potential Safety Issues

February 20, 2010

February 20, 2010 — Twenty-seven drugs and drug categories have landed on the watch list of the US Food and Drug Administration (FDA) based on potential signs of serious risks or new safety information identified in the agency's Adverse Event Reporting System (AERS) last year.

The key word here is potential. The FDA states that the appearance of a drug on the AERS list does not mean that the agency has determined that the drug actually poses the listed risk. While the FDA evaluates whether there is a casual relationship between a listed drug and a possible risk, it is not suggesting that physicians stop prescribing these drugs, or that patients stop taking them.

Drugs coming under surveillance include oseltamivir (Tamiflu), used to treat influenza, and cisplatin (Platinol), a staple in cancer chemotherapy. Oseltamivir made the list due to reports of hypothermia, while cisplatin is there based on reports of leukoencephalopathy.

Yet another chemotherapy agent on the watch list is imatinib mesylate (Gleevec). The FDA will evaluate whether hearing disorders and hearing loss are possible adverse effects.

In the case of dexlansoprazole (Kapidex), prescribed for gastroesophageal reflux disease and erosive esophagitis, the possible problem is alphabetical in nature. FDA is wondering if physicians and patients are confusing the brand name Kapidex with Casodex, the brand name for the prostate cancer drug bicalutamide.

Some Safety Issues Have Already Been Addressed

The 27 drugs and drug categories appear on quarterly reports generated by AERS for the second and third quarters of 2009; the reports were made public on Wednesday. AERS is a database for adverse drug events and medication errors reported by clinicians, patients, drug manufacturers, and others.

Because the reports cover the second and third quarters of 2009, the FDA and drug manufacturers have had time since then to address some of the possible safety issues. For example, the antihypertensive agent aliskiren (Tekturna and Tekturna HCT) surfaced in AERS because of reports of angioedema so severe that it required intubation. In November, the warnings and precautions section of aliskiren's labeling was revised to include angioedema as a possible adverse effect.

Potential Signals of Serious Risks/New Safety Information Identified by AERS, Second Quarter 2009

Product Name: Active Ingredient (Brand Name) or Product Class Potential Signal of a Serious Risk/New Safety Information Additional Information as of December 31, 2009
Aliskiren (Tekturna, Tekturna HCT) Angioedema requiring intubation FDA approved Valturna (an aliskiren-containing product) on September 16, 2009. Risk for angioedema was included in the Warnings and Precautions section of the labeling for Valturna.
The Warnings and Precautions section of the labeling for Tekturna was updated in November 2009 to include angioedema requiring intubation.
Antipsychotics Agranulocytosis FDA has requested class labeling to add agranulocytosis to the Precautions section of the labeling for all antipsychotics. Refer to the July 2009 Drug Safety Labeling Changes summary page, listing products with "labeling for the entire class of antipsychotic drugs," on the MedWatch Web site.
Bumetanide (Bumex) Serious skin reactions (Stevens-Johnson Syndrome, toxic epidermal necrosis) FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Cisplatin (Platinol) Leukoencephalopathy Under FDA study
Deferasirox (Exjade) Deaths FDA issued an Early Communication about an Ongoing Safety Review on this issue in September 2009.
FDA Issues Early Communication Regarding Deferasirox Safety in MDS, Sept. 2009
New Boxed Warning for Deferasirox, Feb. 2010
Under FDA study
Gabapentin (Neurontin) Drug reaction with eosinophilia and systemic symptoms (DRESS) Under FDA study
Imatinib mesylate (Gleevec) Hearing disorders and hearing loss Under FDA study
Immunosuppressants (transplant) BK virus nephropathy An FDA alert was issued in July 2009 about labeling changes for immunosuppressant drugs for this event.
FDA Adds Infection Warnings to Immunosuppressant Labels
Natalizumab (Tysabri) Herpes virus infections FDA evaluated case reports in AERS and determined that the current labeling, which addresses herpes virus infections in the Warnings and Precautions and Adverse Reactions sections of the labeling, is adequate.
Natalizumab (Tysabri) Pericarditis Under FDA study
Oseltamivir phosphate (Tamiflu) Hypothermia Under FDA study
Riluzole (Rilutek) Interstitial lung disease The Warnings section of the labeling was updated November 2009 to include interstitial lung disease.
Simvastatin (Zocor) and Diltiazem (Cardizem) Myopathy due to drug interaction FDA is evaluating this issue to determine if simvastatin labeling, which includes myopathy, is adequate.
Ticlopidine Disseminated intravascular coagulopathy Under FDA study

Potential Signals of Serious Risks/New Safety Information Identified by AERS, Third Quarter 2009

Product Name: Active Ingredient (Brand Name) or Product Class Potential Signal of a Serious Risk/New Safety Information Additional Information as of December 31, 2009
Alvimopan (Entereg) Gastrointestinal perforation FDA is studying this issue to determine the need for regulatory action
Bendamustine (Treanda) Infusion site extravasation Under FDA study
Dexlansoprazole (Kapidex) Name confusion with Casodex The FDA/CDER medication error division works closely with the Institute for Safe Medication Practices (ISMP) on some issues. Both FDA and ISMP have been evaluating this issue. The ISMP discussion of the issue is available on the ISMP Web site.
Doripenem (Doribax) Seizure events, hepatic events, thrombocytopenia, serious skin reactions Under FDA study
Enoxaparin (Lovenox) Catheter thrombosis, splenic rupture Under FDA study
HMG-CoA reductase inhibitors (Statins) Cognitive effects Under FDA study
Lamotrigine (Lamictal) Central nervous system infection, aseptic meningitis Under FDA study
Neuromuscular blocking agents Anaphylactic reactions and potential for cross-reactivity Under FDA study
Ramipril (Altace) Angioedema (requiring intubation) Under FDA study
Sirolimus (Rapamune) Progressive multifocal leukoencephalopathy (PML) Under FDA study
Tumor necrosis factor (TNF)-alpha blockers Demyelinating neuropathy Under FDA study
Valsartan-containing products Angioedema (requiring intubation) Under FDA study
Zonisamide (Zonegran) Rhabdomyolysis, pancreatitis Under FDA study


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