News Briefs: Clinical Practice Updates

This roundup includes the following brief clinical practice updates:

The FDA is warning consumers to stop using three Zicam intranasal products. The warning comes after the agency said it had received more than 130 reports linking the cold medications to the loss of sense of smell. FDA officials said that the loss of sense of smell may be long-lasting or even permanent in some people.

The three OTC products involved, along with each product's unit size and product number, are

FDA officials clarified that the children's product already has been discontinued but may still be on consumers' medicine cabinet shelves.

The FDA said it sent a letter to the products' manufacturer, Matrixx Initiatives, based in Scottsdale, Ariz., advising the manufacturer that these products cannot be marketed without FDA approval and stating that they do not include adequate warnings about the risk of anosmia. The agency also said the products have not been shown to be effective in reducing the duration or severity of cold symptoms.

The FDA recommends that consumers who have used the products contact their physician if they experience loss of sense of smell or other problems. The agency asks physicians and consumers to report problems to the FDA's MedWatch program either online or by calling (800) FDA-1088.

The FDA is advising patients and physicians to be aware of the potential for neuropsychiatric events with the use of the leukotriene modifiers montelukast, which is marketed as Singulair; zafirlukast, which is marketed as Accolate; and zileuton, which is marketed as Zyflo and Zyflo CR. The agency also has requested that manufacturers include precautions in the drugs' prescribing information.

Montelukast and zafirlukast are leukotriene receptor antagonists, and zileuton is a leukotriene synthesis inhibitor. All three medications are used for the prophylaxis and chronic treatment of asthma; montelukast also is used to treat the symptoms of allergic rhinitis and to prevent exercise-induced bronchoconstriction.

FDA officials said neuropsychiatric events reported include agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior, and tremor.

The agency said that consumers who use these drugs should talk with their physicians if these events occur, and physicians should consider discontinuing use of the medications if patients develop any of the reported signs or symptoms.

Serious adverse events associated with the drugs should be reported to the FDA online or by calling (800) FDA-1088.

Three stolen lots of the long-acting insulin Levemir have resurfaced in the U.S. market, and the FDA is advising consumers to check their personal supplies to ensure their insulin is not from the affected lots, which are XZF0036, XZF0037 and XZF0038.

Lot numbers are printed on the side of the product box and also on the side of the insulin vial.

FDA officials said in a June 13 news release that a total of 129,000 10-ml vials had been stolen. The agency is concerned that the stolen product may not have been stored and handled properly and may be unsafe to use. The agency said it has received one report of a patient who suffered an adverse event after using a vial from one of the lots.

In addition to checking lot numbers, the FDA offered the following advice for consumers who use Levemir:

The FDA has approved Caldolor, the first injectable form of ibuprofen, to treat pain and fever.

In a June 11 news release, FDA officials said that Caldolor, which is manufactured by Nashville, Tenn.-based Cumberland Pharmaceuticals Inc., will be available for in-hospital use only.

For acute pain, the medication may be administered in 400- to 800-mg doses, given as a 30-minute course every six hours. To treat fever, an initial 400-mg dose should be administered as a 30-minute course, followed by 400 mg every four to six hours, or 100-200 mg every four hours, as necessary.

The FDA release reported that in a clinical trial involving more than 300 women who had undergone an abdominal hysterectomy, patients were less likely to need morphine for pain when administered Caldolor.

The agency said Caldolor should be used with caution in patients who have congestive heart failure, kidney impairment or a history of ulcers or gastrointestinal bleeding, as well as those who are at risk for developing blood clots. Although use of the drug has
been associated with high blood pressure, skin reactions and allergic reactions, the most common adverse reactions reported in clinical trials were nausea, flatulence, vomiting and headache.

The FDA is reminding physicians and consumers that syncope may occur after vaccination with the quadrivalent human papillomavirus, or HPV, vaccine, which is sold as Gardasil, and patients should remain seated or lying down for 15 minutes after receiving the vaccine to prevent falls and injuries.

The agency said Gardasil recipients should be closely monitored for warning signs of syncope, such as pallidity, sweating, dizziness, ringing in the ears or vision changes. If a vaccine recipient faints, and especially if seizure-like activity occurs, the individual should be placed in a position, such as lying down, that helps restore blood flow to the brain.

The FDA said June 9 that it had approved new labeling for Gardasil to emphasize the risk of syncope and how to avoid it, because even though this information was added to Gardasil's label in October 2007, the agency continues to receive reports of syncope and traumatic injuries resulting from it. In addition to placing the information about syncope in the Warnings and Precautions section of the label so that it is more prominent, new information noting that individuals who faint may demonstrate tonic-clonic movements and seizure-like activity also has been added.

FDA officials also said that syncope has been reported after administration of other adolescent and adult vaccines, and the agency is evaluating whether label changes are needed for other vaccine products.