MedWatch - September 2004 Safety-Related Drug Labeling Changes

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Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2004

The detailed view includes drug products with safety labeling changes to the CONTRAINDICATIONS, BOXED WARNING, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS sections. The prescribing information may be accessed by clicking on the drug name.

Summary View

Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Canasa (mesalamine) Suppository (click product name to read prescribing information)	CONTRAINDICATIONS	Canasa 500 mg and 1000 mg Suppositories are contraindicated in patients who have demonstrated hypersensitivity to mesalamine (5-aminosalicylic acid) or to the suppository vehicle [saturated vegetable fatty acid esters (Hard Fat, NF)], or to salicylates (including aspirin).

Humatrope (somatropin [rDNA origin] for Injection) (click product name to read prescribing information)	CONTRAINDICATIONS WARNINGS	CONTRAINDICATIONS Growth hormone is contraindicated in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment. Unless patients with Prader-Willi syndrome also have a diagnosis of growth hormone deficiency, Humatrope is not indicated for the long term treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome. WARNINGS There have been reports of fatalities after initiating therapy with growth hormone in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. Patients with Prader-Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment with growth hormone. If, during treatment with growth hormone, patients show signs of upper airway obstruction (including onset of or increased snoring) and/or new onset sleep apnea, treatment should be interrupted. All patients with Prader-Willi syndrome treated with growth hormone should also have effective weight control and be monitored for signs of respiratory infection, which should be diagnosed as early as possible and treated aggressively. Unless patients with Prader-Willi syndrome also have a diagnosis of growth hormone deficiency, Humatrope is not indicated for the long term treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.

NegGram (nalidixic acid) Caplets (click product name to read prescribing information)	SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant bacteria. CONTRAINDICATIONS WARNINGS Peripheral neuropathy Tendon Effects PRECAUTIONS General Information for Patients Drug Interactions Other Bacterial Substances Probenecid Melphalan Nursing Mothers Usage in Patients Under 18 Years of Age ADVERSE REACTIONS Allergic Anaphylactic Shock Other Peripheral Neuropathy	CONTRAINDICATIONS NegGram is contraindicated in patients with known hypersensitivity to nalidixic acid or to related compounds, infants less than three months of age, and in patients with porphyria or a history of convulsive disorders. NegGram is contraindicated in patients undergoing concomitant therapy with melphalan or other related cancer chemotherapeutic alkylating agents because of serious gastrointestinal toxicity such as hemorrhagic ulcerative colitis or intestinal necrosis. WARNINGS Peripheral Neuropathy Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones, including nalidixic acid. Nalidixic acid should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness, or is found to have deficits in light touch, pain, temperature, position sense, vibratory sensation, and/or motor strength in order to prevent the development of an irreversible condition. Tendon Effects Ruptures of the shoulder, hand, Achilles tendon or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including nalidixic acid. Post-marketing surveillance reports indicate that this risk may be increased in patients receiving concomitant corticosteroids, especially in the elderly. Nalidixic acid should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendonitis or tendon rupture has been excluded. Tendon rupture can occur during or after therapy with quinolones, including nalidixic acid.

NegGram (nalidixic acid) Oral Suspension (click product name to read prescribing information)	SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant bacteria. CONTRAINDICATIONS WARNINGS Peripheral Neuropathy Tendon Effects PRECAUTIONS General Information for Patients Drug Interactions Other Bacterial Substances Probenecid Melphalan Nursing Mothers Usage in Patients Under 18 Years of Age ADVERSE REACTIONS Allergic Anaphylactic Shock Other Peripheral Neuropathy	CONTRAINDICATIONS NegGram is contraindicated in patients with known hypersensitivity to nalidixic acid or to related compounds, infants less than three months of age, and in patients with porphyria or a history of convulsive disorders. NegGram is contraindicated in patients undergoing concomitant therapy with melphalan or other related cancer chemotherapeutic alkylating agents because of serious gastrointestinal toxicity such as hemorrhagic ulcerative colitis or intestinal necrosis. WARNINGS Peripheral Neuropathy Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones, including nalidixic acid. Nalidixic acid should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness, or is found to have deficits in light touch, pain, temperature, position sense, vibratory sensation, and/or motor strength in order to prevent the development of an irreversible condition. Tendon Effects Ruptures of the shoulder, hand, Achilles tendon or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including nalidixic acid. Post-marketing surveillance reports indicate that this risk may be increased in patients receiving concomitant corticosteroids, especially in the elderly. Nalidixic acid should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendonitis or tendon rupture has been excluded. Tendon rupture can occur during or after therapy with quinolones, including nalidixic acid.

Nitrolingual Pumpspray (nitroglycerin lingual spray) (click product name to read prescribing information)	CONTRAINDICATIONS WARNINGS PRECAUTIONS Information for Patients Drug Interactions Phosphodiesterase Inhibitors Information for Patients	CONTRAINDICATIONS Allergic reactions to organic nitrates are rare. Nitroglycerin is contraindicated in patients who are allergic to it. Nitrolingual Pumpspray is contraindicated in patients taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), as their concomitant use can cause severe hypotension. The time course and dose-dependency of this interaction are not known. WARNINGS Amplification of the vasodilatory effects of Nitrolingual Pumpspray by certain drugs (phosphodiesterase inhibitors) used to treat erectile dysfunction can result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion. The use of any form of nitroglycerin during the early days of acute myocardial infarction requires particular attention to hemodynamic monitoring and clinical status.

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Advair Diskus (fluticasone propionate and salmeterol xinafoate inhalation powder) (click product name to read prescribing information)	BOXED WARNINGS WARNINGS	BOXED WARNINGS Data from a large placebo-controlled US study that compared the safety of salmeterol (Servent Inhalation Aerosol) or placebo added to usual asthma therapy showed a small but significant increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 patients treated for 28 weeks) versus those on placebo (3 of 13,179). WARNINGS Results of Serevent Multi-Center Asthma Research Trial updated. Please see prescribing information.

Combivir (lamivudine/zidovudine) Tablets (click product name to read prescribing information)	BOXED WARNING PRECAUTIONS Information for Patients	Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and HIV and have discontinued lamivudine, which is one component of combivir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue combivir and are co-infected with HIV and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Epivir (lamivudine) Tablets and Oral Solution (click product name to read prescribing information)	BOXED WARNING PRECAUTIONS Information for Patients	Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and HIV and have discontinued Epivir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue Epivir and are co-infected with HIV and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Epivir-HBV (lamivudine) Tablets and Oral Solution (click product name to read prescribing information)	BOXED WARNING PRECAUTIONS Information for Patients	Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy (including Epivir-HBV). Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Forteo [teriparatide (rDNA origin)] Injection (click product name to read prescribing information)	BOXED WARNING WARNINGS ADVERSE REACTIONS Postmarketing Reports	BOXED WARNING Teriparatide should not be prescribed for patients who are at increased baseline risk for osteosarcoma (including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, open epiphyses, or prior external beam or implant radiation therapy involving the skeleton). WARNINGS The following categories of patients have increased baseline risk of osteosarcoma and therefore should not be treated with Forteo: Prior external beam or implant radiation therapy involving the skeleton. Forteo should not be given to such patients.

Serevent Diskus (salmeterol xinafoate inhalation powder) (click product name to read prescribing information)	BOXED WARNING WARNINGS	BOXED WARNING Data from a large placebo-controlled US study that compared the safety of salmeterol (Servent Inhalation Aerosol) or placebo added to usual asthma therapy showed a small but significant increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 patients treated for 28 weeks) versus those on placebo (3 of 13,179). WARNINGS Results of Serevent Multi-Center Asthma Research Trial updated. Please see prescribing information.

Serevent Inhalation Aerosol (salmeterol xinafoate) (click product name to read prescribing information)	BOXED WARNING WARNINGS	BOXED WARNING Data from a large placebo-controlled US study that compared the safety of salmeterol (Servent Inhalation Aerosol) or placebo added to usual asthma therapy showed a small but significant increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 patients treated for 28 weeks) versus those on placebo (3 of 13,179). WARNINGS Results of Serevent Multi-Center Asthma Research Trial updated. Please see prescribing information.

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Factive (gemifloxacin mesylate) Tablets (click product name to read prescribing information)	WARNINGS QT Effects Peripheral Neuropathy Tendon Effects PRECAUTIONS Information for Patients	QT Effects Fluoroquinolones may prolong the QT interval in some patients. Peripheral Neuropathy Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones. Tendon Effects Ruptures of the shoulder, hand, Achilles tendons or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones. Post-marketing surveillance reports indicate that this risk may be increased in patients receiving concomitant corticosteroids, especially the elderly. Gemifloxacin should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendonitis or tendon rupture has been excluded. Tendon rupture can occur during or after therapy with quinolones.

Floxin (ofloxacin tablets) Tablets (click product name to read prescribing information)	WARNINGS Peripheral Neuropathy Tendon Effects PRECAUTIONS Torsades de Pointes Information for Patients Geriatric Use	Peripheral Neuropathy Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones, including ofloxacin. Ofloxacin should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation in order to prevent the development of an irreversible condition. Tendon Effects Ruptures of the shoulder, hand, Achilles tendon or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including ofloxacin. Post-marketing surveillance reports indicate that the risk may be increased in patients receiving corticosteroids, especially the elderly. Ofloxacin should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendonitis or tendon rupture has been confidently excluded. Tendon rupture can occur during or after therapy with quinolones, including ofloxacin.

Infant's Advil (50 mg ibuprofen per 1.25 ml) oral suspension) (click product name to read prescribing information)	WARNINGS Stomach Bleeding Warning Ask a Doctor Before Use if the Child has High blood pressure, heart or kidney disease or is taking a diuretic Ulcers Bleeding problems Stomach problems that last or come back, such as heartburn, upset stomach or pain Ask a Doctor or Pharmacist Before Use if the Child is Taking a prescription product for anticoagulation (blood thinning)	Taking more than recommended may cause stomach bleeding.

Levaquin (levofloxacin) Tablets and Injection (click product name to read prescribing information)	WARNINGS Peripheral Neuropathy Tendon Effects PRECAUTIONS General Torsades de Pointes Information for Patients Geriatric Use ADVERSE REACTIONS Post-Marketing Adverse Reactions Peripheral Neuropathy Rhabdomyolysis	Peripheral Neuropathy Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones, including levofloxacin. Levofloxacin should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation in order to prevent the development of an irreversible condition. Tendon Effects Ruptures of the shoulder, hand, Achilles tendon, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including levofloxacin. Post-marketing surveillance reports indicate that this risk may be increased in patients receiving concomitant corticosteroids, especially the elderly. Levofloxacin should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendonitis or tendon rupture has been confidently excluded. Tendon rupture can occur during or after therapy with quinolones, including levofloxacin.

Orudis KT (12.5 mg ketoprofen) Tablets (click product name to read prescribing information)	WARNINGS	Stomach bleeding warning: Taking more than recommended may cause stomach bleeding.

Sarafem (fluoxetine hydrochloride) Pulvules (click product name to read prescribing information)	WARNINGS Clinical Worsening and Suicide Risk PRECAUTIONS General Abnormal Bleeding Discontinuation of Treatment with Sarafem Information for Patients Drug Interactions Drugs that Interfere with Hemostasis (NSAIDs, Aspirin, Warfarin, etc.) Pregnancy Nonteratogenic Effects	Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Although there has been a long-standing concern that antidepressants many have a role in inducing worsening of depression and the emergence of suicidality in certain patients, a causal role for antidepressants in inducing such behaviors has not been established. Nevertheless, patients being treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse or whose emergent suicidality is severe, abrupt in onset, or was not part of the patient's presenting symptoms.

Tequin (gatifloxacin) Injection and Tablets Tequin (gatifloxacin in 5% dextrose) Injection (click product name to read prescribing information)	WARNINGS QTc Interval Prolongation Tendon Effects Peripheral Neuropathy PATIENT PACKAGE INSERT	QTc Interval Prolongation Gatifloxacin has the potential to prolong the QTc interval of the electrocardiogram in some patients. QTc prolongation may lead to an increased risk for ventricular arrhythmias including torsades de pointes. Rare cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving quinolones, including gatifloxacin. Nearly all of these rare cases were associated with one or more of the following factors: age over 60, female gender, underlying cardiac disease, and/or use of multiple medications....(More - see prescribing information.) Peripheral Neuropathy Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones. Tendon Effects Ruptures of the shoulder, hand, Achilles tendon, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including levofloxacin. Post-marketing surveillance reports indicate that this risk may be increased in patients receiving concomitant corticosteroids, especially the elderly. Levofloxacin should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendonitis or tendon rupture has been confidently excluded. Tendon rupture can occur during or after therapy with quinolones, including levofloxacin.

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Brand (Generic) Name	Sections Modified
Abilify (aripiprazole) Tablets (click product name to read prescribing information)	PRECAUTIONS General Orthostatic Hypotension Seizure Potential for Cognitive and Motor Impairment Geriatric Use ADVERSE REACTIONS Initial paragraph Adverse Findings Observed in Short-Term, Placebo-Controlled Trials of Patients with Bipolar Mania Adverse Events Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled Trials Commonly Observed Adverse Events in Short-Term Placebo-Controlled Trials of Patients with Bipolar Mania Adverse Events Occurring at an Incidence of 2% or More Among Aripiprazole-Treated Patients and Greater than Placebo in Short-Term, Placebo-Controlled Trials Table 2 Dose-Related Adverse Events Extrapyramidal Symptoms Laboratory Test Abnormalities ECG Changes Other Adverse Events Observed During the Premarketing Evaluation of Aripiprazole Other Events Observed During the Postmarketing Evaluation of Aripiprazole

Actiq (oral transmucosal fentanyl citrate) (click product name to read prescribing information)	PRECAUTIONS Information for Patients and their Caregivers ADVERSE REACTIONS Post Marketing Experience PATIENT PACKAGE INSERT

Aldomet (methyldopa) Tablets (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Anafranil (clomipramine hydrochloride) Capsules (click product name to read prescribing information)	PRECAUTIONS Geriatric Use ADVERSE REACTIONS Leading to Discontinuation of Treatment

Aromasin (exemestane tablets) (click product name to read prescribing information)	PRECAUTIONS Carcinogenesis, Mutagenesis, Impairment of Fertility

Augmentin XR (amoxicillin/clavulanate potassium) Extended Release Tablets (click product name to read prescribing information)	SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant bacteria. PRECAUTIONS General Information for Patients

Avodart (dutasteride) Soft-Gelatin Capsules (click product name to read prescribing information)	PRECAUTIONS Effects on PSA and Prostate Cancer Detection ADVERSE REACTIONS Post-Marketing Experience

Claforan Sterile (cefotaxime for injection, USP) Claforan Injection (cefotaxime injection, USP) (click product name to read prescribing information)	SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant bacteria. PRECAUTIONS General Information for Patients

Cordarone (amiodarone hydrochloride) Intravenous (click product name to read prescribing information)	PRECAUTIONS Proarrhythmia Drug Interactions Other Reported Interactions with Amiodarone Fluoroquinolones, Macrolide Antibiotics, and Azoles

5% Dextrose in Lactated Ringer's Injection (click product name to read prescribing information)	PRECAUTIONS Laboratory Tests Carcinogenesis, Mutagenesis and Impairment of Fertility Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use

Dextrose and Sodium Chloride Injections, USP (click product name to read prescribing information)	PRECAUTIONS Laboratory Tests Carcinogenesis, Mutagenesis and Impairment of Fertility Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use

Diuril (chlorothiazide sodium) Intravenous (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Diuril (chlorothiazide) Oral Suspension and Tablets (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Erythrocin Lactobionate - IV (erythromycin lactobionate for injection, USP) (click product name to read prescribing information)	SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant bacteria. PRECAUTIONS General Information for Patients

Erythrocin Lactobionate - IV (sterile erythromycin lactobionate, USP) Please contact Abbott Laboratories at 1-800-633-9110 for prescribing information.	SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant bacteria. PRECAUTIONS General Information for Patients

Halog (halcinonide cream, USP) (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Halog-E Cream (halcinonide cream, USP) (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Halog Ointment (halcinonide ointment, USP) (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Halog Solution (halcinonide topical solution, USP) (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Helidac Therapy (bismuth subsalicylate/metronidazole/tetracycline hydrochloride) (click product name to read prescribing information)	SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant bacteria. PRECAUTIONS General Information for Patients

Indium DTPA in 111 (pentetate indium disodium In 111) Please contact GE Healthcare at 1-800-682-5327 for prescribing information.	PRECAUTIONS Geriatric Use Clinical studies of Indium DTPA In 111 did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the lower end of the dosing range, reflection the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken or other drug therapy.

Omnicef (cefdinir) Capsules Omnicef (cefdinir) for Oral Suspension (click product name to read prescribing information)	SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant bacteria. PRECAUTIONS General Information for Patients

0.15% Potassium Chloride in 0.9% Sodium Chloride Injection, USP (click product name to read prescribing information)	PRECAUTIONS Laboratory Tests Carcinogenesis, Mutagenesis and Impairment of Fertility Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use

Potassium Chloride in 5% Dextrose Injections, USP (click product name to read prescribing information)	PRECAUTIONS Laboratory Tests Carcinogenesis, Mutagenesis and Impairment of Fertility Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use

Potassium Chloride in Dextrose and Sodium Chloride Injections, USP (click product name to read prescribing information)	PRECAUTIONS Laboratory Tests Carcinogenesis, Mutagenesis and Impairment of Fertility Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use

Rocephin (ceftriaxone Injection) (click product name to read prescribing information)	SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant bacteria. PRECAUTIONS General Information for Patients

Rocephin (ceftriaxone sodium) for Injection (click product name to read prescribing information)	SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant bacteria. PRECAUTIONS General Information for Patients

Rythmol SR (propafenone hydrochloride) Extended Release Capsules (click product name to read prescribing information)	PRECAUTIONS Drug Interactions

Tenuate (diethylpropion hydrochloride USP) Immediate Release Tablets Tenuate Dospan (diethylpropion hydrochloride USP) Controlled-Release Tablets (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

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Brand (Generic) Name	Sections Modified
Caduet (amlodipine besylate/atorvastatin calcium) Tablets (click product name to read prescribing information)	ADVERSE REACTIONS The Atorvastatin Component of Caduet Clinical Adverse Experiences Table 10

Cancidas (caspofungin acetate) for Injection (click product name to read prescribing information)	ADVERSE REACTIONS Empirical Therapy

Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules (click product name to read prescribing information)	ADVERSE REACTIONS Diabetic Peripheral Neuropathy Adverse Events Reported as Reasons for Discontinuation of Treatment in Placebo-Controlled Trials Diabetic Peripheral Neuropathic Pain Adverse Events Occurring at an Incidence of 2% or More Among Cymbalta-Treated Patients in Placebo-Controlled Trials Diabetic Peripheral Neuropathic Pain Table 2 Other Adverse Events Observed During the Premarketing Evaluation of Cymbalta for MDD and the Pain of DPN

Malarone (atovaquone and proguanil hydrochloride) Tablets Malarone (atovaquone and proguanil hydrochloride) Pediatric Tablets (click product name to read prescribing information)	ADVERSE REACTIONS See Description of Third Active-Controlled Study Post-Marketing Adverse Reactions Central Nervous System

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