New Drugs Approved by the FDA Agents Pending FDA Approval Supplemental Applications Filed by Manufacturer Significant Labeling Changes

Long-term administration of nonsteroidal anti-inflammatory drugs (NSAIDs) has resulted in renal papillary necrosis and other renal injury. Renal toxicity was also seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, and the elderly.

Concomitant use in patients taking MAOIs is contraindicated due to the risk of serious, sometimes fatal, drug interactions with serotonergic drugs. These interactions may include hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. These reactions have also been reported in patients who have recently discontinued serotonin reuptake inhibitors and are then started on an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome.

Fetal/neonatal morbidity and mortality; Avalide can cause fetal harm when administered to a pregnant woman.

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Do not administer Optison to patients with known or suspected:

Right-to-left, bi-directional, or transient right-to-left cardiac shunts, Worsening or clinically unstable congestive heart failure, Acute myocardial infarction or acute coronary syndromes, Serious ventricular arrhythmias or high risk for arrhythmias due to prolongation of the QT interval, Respiratory failure, as manifest by signs or symptoms of carbon dioxide retention or hypoxemia, Severe emphysema, pulmonary emboli, or other conditions that cause pulmonary hypertension due to compromised pulmonary arterial vasculature, Hypersensitivity to perflutren, blood, blood products, or albumin (see WARNINGS).

Do not administer Optison by intra-arterial injection.

WARNINGS

Serious cardiopulmonary reactions

Anaphylactoid reactions patients with cardiac shunts

High ultrasound mechanical index

Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported

Because another drug in this class passes into breast milk, and because HMG-CoA reductase inhibitors have the potential to cause serious adverse reactions in breast-feeding infants, women who require Crestor treatment should be advised not to breast-feed their infants.

Liver enzyme abnormalities and monitoring In a pooled analysis of placebo-controlled trials, increases in serum transaminases to > 3 times the upper limit of normal occurred in 1.1% of patients taking Crestor versus 0.5% of patients treated with placebo.

Hypersensitivity reactions including rare cases of urticaria and angioedema as well as very rare cases of anaphylactic reaction/shock have been reported.

Zometa contains the same active ingredient as found in zoledronic acid (Reclast). Patients being treated with Zometa should not be treated with Reclast.

Osteonecrosis of the jaw - revised text