Drug News
FDA issues alert, revisions for prescribing ceftriaxone
The FDA has revised information about ceftriaxone (Rocephin®) regarding its interaction with calcium-containing products.
Here are the FDA's recommendations:
- Concomitant use of ceftriaxone and intravenous calcium-containing products is contraindicated in neonates of 28 days of age or younger. Ceftriaxone should not be used in these neonates if they are receiving or are expected to receive calcium-containing intravenous products.
- In patients older than 28 days of age, ceftriaxone and calcium-containing products may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid.
- Ceftriaxone must not be administered simultaneously with intravenous calcium-containing solutions via a Y-site in any age group.
- The FDA now recommends that ceftriaxone and calcium-containing products may be used concomitantly in patients older than 28 days, using the precautionary steps above because the risk of precipitation is low in this population. The FDA had previously recommended, but no longer recommends, that in all age groups ceftriaxone and calcium-containing products should not be administered within 48 hours of one another.
Also, the FDA reiterates three of its previous recommendations from September, 2007:
- Do not reconstitute or mix ceftriaxone with a calcium-containing product, such as Ringer's or Hartmann's solution or parenteral nutrition containing calcium, because particulate formation can result.
- There are no data on interactions between intravenous ceftriaxone and oral calcium-containing products or between intramuscular ceftriaxone and intravenous or oral calcium-containing products.
- Report patients who have adverse events following ceftriaxone administration to the FDA's MedWatch program.
To report any unexpected adverse or serious event associated with the use of this drug, please contact FDA MedWatch program and complete a form on-line at www.fda.gov/medwatch/report/hcp.htm, or report by fax to 1-800-FDA-0178.
Company recalls 39 lots of transdermal patches
Shire Pharmaceutical Group of Philadelphia, PA, has announced a voluntary market withdrawal/recall of thirty-nine (39) lots of the ADHD patch methylphenidate transdermal (Daytrana®).
Shire is taking this action because some methylphenidate transdermal patches no longer meet their release liner removal specification, and as a result, patients and caregivers could have difficulties removing the liners.
Pharmacists who have questions about the recall should call Shire's Daytana customer service line at 1-888-202-3822.
FDA has updated labeling for antiepileptic drugs treating epilepsy
The FDA notified health care professionals in May that it approved updated labeling for antiepileptic drugs used to treat epilepsy, psychiatric disorders, and other conditions (e.g., migraine and neuropathic pain syndromes).
The FDA also required development of a medication guide, to be issued to patients each time the product is dispensed. Since issuing safety alerts on Dec. 16, 2008, and Jan. 31, 2008, the FDA has been working with the manufacturers of drugs in this class to better understand the suicidality risk. Eleven antiepileptic drugs were included in a pooled analysis of placebo-controlled clinical studies in which these drugs were used to treat epilepsy as well as psychiatric disorders and other conditions. The increased risk of suicidal thoughts or behavior was generally consistent among the 11 drugs, with varying mechanisms of action and across a range of indications. This observation suggests that the risk applies to all antiepileptic drugs used for any indication.
Based on the outcome of this review, FDA is requiring that all manufacturers of drugs in this class include a Warning in their labeling and develop a Medication Guide to be provided to patients prescribed these drugs to inform them of the risks of suicidal thoughts or actions.
In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the 11 drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.
Health care professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.
Although 11 drugs were included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly.
For more information, visit the FDA's web site at www.fda.gov.
FDA warns consumers to stop using Hydroxycut®
The FDA warned consumers in May 2009 to immediately stop using Hydroxycut products by Iovate Health Sciences, Inc. of Oakville, Ontario, Canada, because they are associated with serious liver injuries. Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.
In May, the FDA sent out a "Dear Healthcare Professional Colleague" letter about the recall.
The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplants and death.
One death due to liver failure has been reported to FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.
The injuries reported to FDA occurred in persons between 21 and 51 years of age. No other cause for liver disease was identified. In the majority of cases, no preexisting medical condition that would predispose the consumer to liver injury was identified.
In some cases, discontinuation of Hydroxycut usage resulted in recovery of liver function.
Although the liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risk.
Hydroxycut products bear the Iovate or Muscletech brand name and are multi-ingredient dietary supplements marketed for weight loss, as fat burners, energy enhancers, as low carb diet aids, and to promote water loss.
The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to Hydroxycut products. FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.
The FDA urges health care professionals to review their cases of hepatitis in order to determine if any may be related to the use of dietary supplements in these patients. Adverse events associated with the use of dietary supplements should be reported as soon as possible to FDA's MedWatch program by telephone (1-800-332-1088) or Internet (www.fda.gov/medwatch).
For additional information, see www.cfsan.fda.gov.
The FDA has revised information about ceftriaxone (Rocephin®) regarding its interaction with calcium-containing products.Subscribe Now for Access
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