Boxed warning for metoclopramide, alert for zonisamide

A summary of approvals, recalls, warnings and alerts.

Recalls, alerts and warnings

A boxed warning for metoclopramide (Reglan) that chronic use has been linked to tardive dyskinesia, even after the drug is no longer taken. Chronic use should be avoided in all but rare cases where benefit is thought to outweigh risk. Those at highest risk are the elderly—particularly elderly women, and people who have taken the drug for a long time.


A safety alert that zonisamide (Zonegran) can cause metabolic acidosis in some patients. Patients may be at greater risk if they have predisposing conditions or therapies, including renal disease, severe respiratory disorders, diarrhea, surgery and ketogenic diet. The risk may also be more frequent and severe in younger patients. Providers should measure serum bicarbonate before and during treatment, even in the absence of symptoms.

An advisory about possible serious adverse events connected with efalizumab (Raptiva). There have been at least three confirmed reports of progressive multifocal leukoencephalopathy (PML) in patients who took the psoriasis drug for more than three years. Physicians should carefully monitor for signs of PML in patients who are taking, and have taken, efalizumab.

A recall of prenatal vitamins and iron supplements by ETHEX Corp. and Ther-Rx Corp, subsidiaries of KV Pharmaceutical Co., because they may have been made under conditions that didn't comply with Good Manufacturing Practices. Prescription prenatal vitamin brands affected by the recall include Advanced NatalCare, NatalCare, NataTab, PreCare and PrimaCare, among others. Affected iron supplement brands include Anemagen, Conison, Chromagen, Encora and Niferex, among others.

A request to return five lots of FLUVIRIN vaccine due to a minor deviation in the potency of the A/Brisbane (H1N1) component. Customers should stop using and return any remaining doses of FLUVIRIN Influenza vaccine Luer-Lok pre-filled syringes with lot numbers 878771P, 878772P, 878773P, 878775P and 878776P. The vaccine met all specifications when it was released, and has been monitored monthly during its shelf life. In early January 2009, a minimal decrease in H1N1 antigen content was found. Patients vaccinated with affected lots don't need to be revaccinated.

A required Risk Evaluation and Mitigation Strategy for certain opioid drugs to make sure the benefits of use outweigh the risks. The affected drugs are those formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone. Rates of misuse, abuse, and accidental overdose of opioids have risen in the past decade.

A safety review of drotrecogin alfa (Xigris) due to a study that found a higher risk of serious bleeding events and death in patients with sepsis and bleeding risk factors who took the drug. The study, published in the January Critical Care Medicine, retrospectively reviewed the medical records of 73 patients who took drotrecogin alfa. Results showed serious bleeding events in 35% of patients who had a bleeding risk factor compared with 3.8% of patients with no bleeding risk factors. The review may take several months.

An expanded recall of generics by ETHEX Corp., to include more than 60 drugs which may not comply with Good Manufacturing Practices. The retail drugs under recall are hydromorphone HCl tables in 2 mg, 4 mg and 8 mg doses; and metoprolol succinate ER tablets in 25 mg, 50 mg, 100 mg and 200 mg doses. Wholesale drugs being recalled include benazepril, diltiazem HCl, morphine sulfate, oxycodone and potassium chloride in various doses. Some of the products already had specific lots recalled in 2008 due to defects such as oversized tablets that delivered higher doses than the label indicated.


The NaviStar ThermoCool saline irrigated radio-frequency ablation catheter and the EZ Steer ThermoCool Nav, the first ablation catheters to treat atrial fibrillation. The devices, which create small scars in heart tissue to block irregular electrical waves, should only be used after drug treatment has failed.

ATryn, an anticoagulant, the first approved biological product made from genetically engineered animals. The orphan drug is used to prevent blood clots during medical interventions in patients with hereditary antithrombin (AT) deficiency, a rare disease. ATryn, a therapeutic protein, is derived from the milk of goats that were genetically engineered by introducing recombinant DNA or rDNA construct with instructions for the goat to produce human antithrombin in its milk.

Febuxostat (Ulloric), a prescription drug for gout, in 40 mg and 80 mg doses.

A new medication guide with safety information for mycophenolate mofetil (CellCept) which pharmacists are required to give to all patients who fill a prescription.

Calcitriol (Vectical), a topical treatment for mild-to-moderate psoriasis in adults.

Oxybutynin chloride (Gelnique), a topical gel to treat overactive bladder, expected to be available in the second quarter of 2009.