Telavancin (Vibativ)
An antibiotic used to treat complicated skin and skin-structure infections caused by susceptible gram-positive organisms
Special considerations
• Women of childbearing age should have a pregnancy test before therapy.
• Monitor renal function before and during therapy.
• Rapid I.V. infusion may cause “red man syndrome,” flushing of the upper body, urticaria, pruritus, or rash.
• Watch for signs and symptoms of superinfection, such as continued fever, chills, and increased pulse.
AVAILABLE FORMS
Lyophilized powder for injection: 250-mg, 750-mg single-use vials
INDICATIONS AND DOSAGES
Complicated skin and skin-structure infections caused by susceptible gram-positive organisms, such as Staphylococcus aureus, methicillin-resistant Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group, or Enterococcus faecalis (vancomycin-susceptible isolates only)—
Adults: 10 mg/kg I.V. infusion every 24 hours for 7 to 14 days.
ADVERSE REACTIONS
CNS: dizziness.
GI: abdominal pain, decreased appetite, diarrhea, nausea, taste disturbance, vomiting.
GU: foamy urine.
Skin: generalized pruritus, infusion site pain, infusion site erythema, rash.
Other: rigors.
Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE-THREATENING.
www.vibativ.com
acetaminophen (Tylenol Arthritis Pain Caplet)
Recall announced for various 100-count bottles due to “uncharacteristic smell”
clevidipine butyrate (Cleviprex)
Recall of 11 lots announced due to visual particulate matter
diclofenac sodium, topical gel (Voltaren Gel)
Prescribing information revised to address risk associated with liver test results
valproic acid (Depakene, Stavzor), valproate sodium (Depacon),
divalproex sodium (Depakote, Depakote CP, Depakote ER)
Labeling to be revised to reinforce risk of birth defects in neonates
exposed to these drugs during pregnancy
orlistat
Alli
Pharmaceutical company:
GlaxoSmithKline
www.gsk.com
NEW WARNING
The Food and Drug Administration is warning consumers about a counterfeit, possibly harmful version of the OTC weight-loss product Alli 60 mg capsules. Preliminary laboratory tests conducted by GlaxoSmithKline (GSK), the product’s manufacturer, revealed that the counterfeit product didn’t contain orlistat, the active ingredient in Alli. The counterfeit product contained the controlled substance sibutramine instead. Sibutramine is a drug that shouldn’t be used in certain patient populations or without physician supervision. Sibutramine can also interact dangerously with other medications the consumer may be taking.
Beginning early December 2009, consumers began reporting suspected counterfeit Alli, which was sold over the Internet, to GSK. There is no evidence that this product was sold in retail stores. The counterfeit product has a similar appearance to the authentic product with a few notable differences, including:
* The “Lot” code is missing from the outside cardboard package.
* The expiration date contains the month, day, and year. (The authentic product contains only the month and year.)
* Plain foil seals the plastic bottle. (The foil sealing the authentic bottle contains the printing “SEALED for YOUR PROTECTION.”)
* The plastic container is taller and has a wider cap with coarser ribbing than the authentic product.
* The capsules are larger and contain a white powder. (The authentic product contains small white pellets.)
If you believe you have received the counterfeit product, contact the FDA’s Office of Criminal Investigations (OCI) by calling 800-551-3989.
Health care professionals and consumers should report adverse events that may be associated with the use of these counterfeit products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program online, by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
sibutramine hydrochloride
Meridia
Pharmaceutical company:
Abbott Laboratories
www.abbott.com
NEW WARNING
After reviewing data, the Food and Drug Administration (FDA) notified health care professionals about an increased risk of MI and stroke in patients with a history of cardiovascular disease who are being treated with sibutramine (Meridia). Sibutramine is indicated for treatment of obesity in conjunction with a reduced-calorie diet. The FDA requested that the manufacturer add a new contraindication to prescribing information stating that the drug shouldn’t be used in patients with a history of cardiovascular disease, including coronary artery disease, stroke, transient ischemic attack, arrhythmias, heart failure, peripheral arterial disease and uncontrolled hypertension. Patients currently prescribed sibutramine should consult with their health care provider to determine when they should continue treatment with the drug.
Brought to you by Lippincott Williams & Wilkins.
