Nationwide recall includes Rx prenatal vitamins
ETHEX Corporation and Ther-RX Corporation expanded the companies' previous recall notices to include prescription prenatal vitamins and iron supplement products. Both companies are subsidiaries of KV Pharmaceutical Corporation, which has issued a voluntary nationwide recall of these products at a wholesale level. The action is being taken as a precaution because the products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practice.
For a complete list of products that have been recalled, visit http://www.fda.gov/oc/po/firmrecalls/therrx02_09.html.
New depression indication for Symbyax
Eli Lilly's Symbyax (olanzapine and fluoxetine HCl capsules) is now approved for the acute treatment of treatment-resistant depression (TRD). It is the first drug to receive FDA approval for this indication. Symbyax was the first drug approved by the FDA in 2003 for the acute treatment of bipolar depression in adults.
The new Symbyax TRD indication is for acute treatment of adult patients with major depressive disorder who have not responded to two separate trials of different antidepressants of adequate dose and duration in their current episode.
Weight gain, increased appetite, dry mouth, somnolence, and fatigue were adverse events reported in 5% or more of patients treated with Symbyax in clinical trials.
Consult product labeling for safety information and specific dosing instructions.
Transdermal patches may present burn risk
The FDA has notified healthcare professionals and patients that certain transdermal patches containing aluminum or other metals in the backing of the patches can overheat during a magnetic resonance imaging (MRI) scan, causing skin burns in the immediate area of the patch.
The patches include both brand name and generic products, as well as over-the-counter patches. The FDA issued the public health advisory after learning that a warning was missing on some patches that contain aluminum or other metals in their nonadhesive backing. The metal may not be visible and the product labeling may not disclose the presence of metal.
The FDA is reviewing the labeling and composition of all medicated patches-including nicotine patches-to ensure that those made with materials containing metal provide a warning to patients undergoing MRIs; the FDA will alert the public when this information has been added.
The agency advises patients to alert MRI facilities that they are using a patch when they call to schedule their appointments and should repeat this information after arriving for their appointments.
Medication Update alerts readers to new drug approvals and other timely drug information. Healthcare providers should not make clinical decisions from these announcements, as they are not comprehensive.
FDA approves medication for COPD
AstraZeneca's budesonide/formoterol fumarate dihydrate 160/4.5 mcg (Symbicort) has been approved by the FDA for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
The FDA based its approval on the results of two studies (6 months and 12 months) that found Symbicort significantly improved lung function within 5 minutes of the first dose, and sustained that function improvement for the duration of the studies.
Symbicort was generally well tolerated over the 12-month study and the incidence of pneumonia was no different for patients taking Symbicort versus placebo. The most common drug-related adverse events reported were nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory infection.
Consult product labeling for detailed prescribing directions and contraindications.