Warnings on Celexa, Zofran; new use of Botox for incontinence

Recalls, warnings, and approvals.

Recalls and warnings

A warning on the antidepressant citalopram hydrobromide (Celexa) against doses greater than 40 mg/d, due to the potential for prolongation of the QT interval and abnormal heart rhythm (including torsade de pointes). The drug label previously stated that certain patients may require a dose of 60 mg/d.


A warning on antinausea drug ondansetron (Zofran) about the risk of prolongation of the QT interval of the electrocardiogram, which can lead to abnormal and potentially fatal arrhythmias, including torsade de pointes. Physicians should avoid the use of ondansetron in patients with congenital long QT syndrome and ECG monitoring is recommended in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, and bradyarrhythmias or patients taking concomitant medications that prolong the QT interval.

A voluntary recall of Povidone Iodine Swabsticks, Povidone Iodine Prep Solutions, Povidone Iodine Scrub Solutions, and Povidone Iodine Prep Gel manufactured by H&P Industries, Inc. due to insufficient precautions against microbial contamination during manufacturing. No adverse events have been reported.

An update to the boxed warning for Tumor Necrosis Factor-alpha (TNFa) blockers to include the risk of infection from two bacterial pathogens, Legionella and Listeria. The FDA has identified cases of both infections in patients taking the medications.

A warning on psychiatric drug asenapine maleate (Saphris) about the risk of type I hypersensitivity reactions (including anaphylaxis, angioedema, low blood pressure, rapid heart rate, swollen tongue, difficulty breathing, wheezing, or rash). In several cases, the reactions occurred after the first dose. Physicians should counsel patients receiving the drug about how to recognize the signs and symptoms of a serious allergic reaction.

An update to the drug label for zoledronic acid (Reclast) regarding the risk of kidney failure. Cases of acute renal failure requiring dialysis or having a fatal outcome following use of the drug have been reported. The revised label states that the medication is contraindicated in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment and recommends that healthcare professionals screen patients prior to administering it.

A Class I recall of the SynchroMed II Infusion system due to reduced battery performance resulting from formation of a film within the pump battery, which can lead to the sudden loss of therapy and the return of underlying symptoms and/or therapy withdrawal symptoms.


Vemurafenib (Zelboraf) to treat patients with metastatic or unresectable melanoma. It is specifically indicated for patients whose tumors express the BRAF V600E gene mutation and was approved with a companion diagnostic test that will help determine if a patient's melanoma cells have the BRAF V600E mutation. Safety and effectiveness were established in a single international trial of 675 patients in which survival on the drug exceeded that with dacarbazine.

Brentuximab vedotin (Adcetris) to treat Hodgkin's lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL). It is to be used in patients with HL whose disease has progressed after autologous stem cell transplant, or after two prior chemotherapy treatments for those who cannot receive a transplant. It may also be used in patients with ALCL whose disease has progressed after one prior chemotherapy treatment. The drug, which was approved under the accelerated approval program, is the first new treatment for HL since 1977 and the first specifically indicated to treat ALCL.

A new indication for onabotulinumtoxinA (Botox) injection to treat urinary incontinence in people with neurologic conditions, such as spinal cord injury and multiple sclerosis, who have overactivity of the bladder. The treatment consists of injections into the bladder. Two clinical studies involving 691 patients showed statistically significant decreases in the weekly frequency of incontinence episodes in the active treatment group compared with placebo.

Icatibant (Firazyr) injection for the treatment of acute attacks of hereditary angioedema (HAE) in people ages 18 years and older.