Three Invanz lots recalled
Merck & Co., Inc. is voluntarily recalling three lots of ertapenem sodium (Invanz) 1 gram as a precautionary measure due to the possibility that glass pieces could be present in some vials within these lots.
The lots that are being recalled are numbers 0803930, 0803940, and 0803950. No other lots are affected by this recall. All lots have an expiration date of October 2008.
A statement from Merck notes that while the company believes the incidence of Invanz vials that could contain glass particles is extremely low, in the event that a dose of Invanz was administered and did contain glass particles, the risk of associated medical harm is unlikely.
Medical questions can be directed to Merck's National Service Center at 1-800-672-6372.
Extended-release asthma medication approved
The FDA approved an extended-release 600-mg tablet formulation of zileuton (Zyflo CR) for the prophylaxis and long-term treatment of asthma in patients age 12 and over. The new formulation is a product of Critical Therapeutics and is copromoted with Dey LP.
Zileuton isn't indicated for use in treating bronchospasms in acute asthma attacks. The recommended dosage of extended-release zileuton is two 600-mg tablets twice daily, taken within 1 hour after morning and evening meals.
The most common adverse events reported in studies included sinusitis, nausea, and pharyngolaryngeal and abdominal pain. Prescribing instructions note that the dose of concomitantly administered theophylline should be reduced by 50%. Patients also taking propranolol or warfarin should be monitored and dosage adjustments made as needed. Monitoring liver enzyme levels is recommended prior to starting therapy and at regular intervals thereafter. Use of zilueton is contraindicated in patients with active liver disease or persistent hepatic enzyme level elevations greater than three or more times the normal upper limits.
Rimantadine may interfere with FluMist
The FDA has made alterations in the labeling of rimantadine HCl (Flumadine tablets and syrup) to warn of a potential interaction with FluMist (influenza virus vaccine live, intranasal). According to the agency, there's a potential for interference when the two products are administered concurrently because rimantadine may inhibit the replication of live vaccine virus.
The FDA advises that a 48-hour period elapse between the end of antiviral therapy and the administration of the vaccine. A 2-week lapse is advised after vaccination and before initiation of antiviral therapy.
Pulmonary arterial hypertension treatment available
The FDA has approved ambrisentan (Letairis) for the treatment of pulmonary arterial hypertension (PAH). The medication is a product of Gilead Sciences. Ambrisentan is similar to an existing medication but offers the potential for fewer drug interactions, according to the FDA. The drug is approved for patients with PAH who are in World Health Organization symptom class II or III. Ambrisentan is available in 5-mg and 10-mg once-daily tablets.
The safety and effectiveness of ambrisentan was shown in two clinical trials involving 393 patients. Ambrisentan significantly improved physical activity capacity compared with placebo and delayed the worsening of PAH. The most common side effects associated with the medication were ankle edema, nasal congestion, sinusitis, and flushing.
This medication shouldn't be used by women who are pregnant or can become pregnant because it has the potential to cause birth defects. Patients taking ambrisentan must also have monthly blood tests to monitor for liver damage.