New Drugs Approved by the FDA;New Dosage Forms and Indications Approved by the FDA;Agents Pending FDA Approval;New Drug/Biologics License Applications Filed by Manufacturer;Supplemental Applications Filed by Manufacturer;Significant Labeling Changes or “Dear Health Professional” Letters Related to Safety

von Willebrand factor/coagulation factor VIII complex (human)

Wilate (Octapharma USA)

Injection 450 IU VWF:RCo and 450 IU FVIII activities in 5 mL

900 IU VWF:RCo and 900 IU FVIII activities in 10 mL

BOXED WARNING: Avoid Use in Pregnancy

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When pregnancy is detected, discontinue Tekturna as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

WARNINGS AND PRECAUTIONS

Fetal/Neonatal Morbidity and Mortality

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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.

Impaired Renal Function

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Consider periodic determinations of serum electrolytes to detect possible electrolyte imbalances particularly in patients with severe renal impairment.

Head and Neck Angioedema (section revised)

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Discontinue Tekturna immediately in patients who develop angioedema, and do not readminister.

DRUG INTERACTIONS

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Patients receiving furosemide could find its effect diminished after starting aliskiren.

USE IN SPECIFIC POPULATIONS

Pregnancy

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When pregnancy is detected, Tekturna should be discontinued as soon as possible.

CONTRAINDICATIONS

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Patients with a history of angioedema with or without previous ACE inhibitor treatment.

CONTRAINDICATIONS

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Patients with a history of angioedema with or without previous ACE inhibitor treatment

ADVERSE REACTIONS: Skin

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Erythema multiforme including Steven-Johnson syndrome, exfoliative dermatitis, including toxic epidermal necrolysis

WARNINGS AND PRECAUTIONS: New Onset or Worsening Renal Impairment

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Routine monitoring of calculated creatinine clearance and serum phosphorus should be performed

ADVERSE REACTIONS: Postmarketing Experience

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Angioedema

WARNINGS and PRECAUTIONS: Acute Pancreatitis

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Based on postmarketing data, Byetta has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis.

Renal Impairment

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Byetta should not be used in patients with severe renal impairment (creatinine clearance < 30 mL/min) or end-stage renal disease and should be used with caution in patients with renal transplantation. In patients with end-stage renal disease receiving dialysis, single doses of Byetta 5 mcg were not well-tolerated due to gastrointestinal side effects. Because Byetta may induce nausea and vomiting with transient hypovolemia, treatment may worsen renal function.

Following statements added to the BOXED WARNING:

The substitution of Actiq for any other fentanyl product may result in fatal overdose.

When prescribing, do not convert patients on a mcg per mcg basis to Actiq from other fentanyl products.

When dispensing, do not substitute an Actiq prescription for other fentanyl products. Substantial differences exist in the pharmacokinetic profile of Actiq compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl. As a result of these differences, the substitution of Actiq for any other fentanyl product may result in fatal overdose.

Potential association with the development of myocardial infarction and dyslipidemia in HIV-infected adults

Testing for triglyceride and cholesterol levels should be done prior to the start of therapy and periodically throughout therapy.

PRECAUTIONS: Hemolytic Anemia

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Treatment of patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency with sulfonylurea agents can lead to hemolytic anemia. Caution should be used in patients with G6PD deficiency and a non-sulfonylurea alternative should be considered. In postmarketing reports, hemolytic anemia has also been reported in patients who did not have known G6PD deficiency.

WARNINGS AND PRECAUTIONS: Ophthalmologic Disorders

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Ribavirin is used in combination therapy with alpha interferons. Decrease or loss of vision, retinopathy including macular edema, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots, optic neuritis, papilledema, and serous retinal detachment.

Dental and Periodontal Disorders

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Patients should brush their teeth thoroughly twice daily and have regular dental examinations. If vomiting occurs, they should be advised to rinse out their mouth thoroughly afterwards.

Impact on Growth - Pediatric Use

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Data on the effects of Peg-Intron (peginterferon alfa-2b) plus Rebetol on growth come from an open-label study in subjects 3 through 17 years of age, and weight loss and growth inhibition was noted.

WARNINGS: Interstitial Lung Disease

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Cases of interstitial lung disease have been reported, some of them severe and many of these cases were hypersensitivity pneumonitis. If respiratory symptoms develop such as dry cough and/or dyspnea, chest radiography should be performed; in case of findings suggestive of interstitial lung disease or hypersensitivity pneumonitis (eg, bilateral diffuse lung opacities), riluzole should be discontinued immediately. In the majority of the reported cases, symptoms resolved after drug discontinuation and symptomatic treatment.

CONTRAINDICATIONS

Addition: PDE5 enzyme inhibitor: Sildenafil (Revatio) only when used for the treatment of pulmonary arterial hypertension

PRECAUTIONS

Established and Other Potentially Significant Drug Interactions: Alteration in Dose or Regimen Recommended Based on Drug Interaction Studies or Predicted Interaction

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Concomitant use of fluticasone propionate and Norvir. Norvir increases plasma concentrations of fluticasone propionate, resulting in significantly reduced serum cortisol concentrations. Co-administration of fluticasone propionate and Norvir is not recommended unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects.

WARNINGS AND PRECAUTIONS: Hemolytic Anemia

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Treatment of patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency with sulfonylurea agents can lead to hemolytic anemia. Because glimepiride, a component of Avandaryl, belongs to the class of sulfonylurea agents, caution should be used in patients with G6PD deficiency and a non-sulfonylurea alternative should be considered. In postmarketing experience, hemolytic anemia has also been reported in patients receiving sulfonylureas who did not have known G6PD deficiency

TNF-blockers – Class Labeling Change

Adalimumab – Humira (Abbott)

Certolizumab pegol – Cimzia (UCB)

Etanercept – Enbrel (Amgen)

Golimumab – Simponi (Centocor Ortho Biotech)

Infliximab – Remicade (Centocor)

BOXED WARNINGS

Malignancy

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Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers.

WARNINGS and PRECAUTIONS

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Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy ~ 18 years of age).

ADVERSE REACTIONS

Adverse Reaction Information from Other Sources

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Skin: new or worsening psoriasis (all subtypes including pustular and palmoplantar) has been identified during postapproval use of TNF blockers.

MEDICATION GUIDE

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Reflect new safety information about malignancies in pediatric patients, leukemia in adults, and psoriasis-like skin lesions associated with use of products within the class of TNF-blockers.