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FDA Update

Boxed warning for metoclopramide, alert for zonisamide

From the April ACP Hospitalist, copyright © 2009 by the American College of Physicians

By Jessica Berthold

Recalls, alerts and warnings

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.

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.

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.

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 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 prefilled 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.

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.

Approvals

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.

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

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

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

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

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© 2010 ACP Hospitalist and American College of Physicians

ACP Hospitalist provides news and information for internists about the practice of medicine and reports on the policies, products and activities of ACP. All published material, which is covered by copyright, represents the views of the contributor and does not reflect the opinion of the American College of Physicians or any other institution unless clearly stated