Healthcare Professional Sheets

Information for Healthcare Professionals: This information from FDA is for doctors, pharmacists, nurses, and other healthcare professionals. It contains an "alert" (a summary of the new safety information), detailed information about the safety issue, factors to consider when making treatment decisions, information for healthcare professionals to discuss with patients about their roles in reducing the risks from the drug, and a summary of the facts or data that serve as the basis for the information in the page.

 

Abacavir (marketed as Ziagen) and Abacavir-Containing Medications

Angiotensin-Converting Enzyme Inhibitor (ACE Inhibitor) Drugs and Pregnancy 

Adderall and Adderall XR (amphetamine)

Alemtuzumab (marketed as Campath)

Amiodarone (marketed as Cordarone)

Suicidality and Antiepileptic Drugs

Antipsychotics

Atomoxetine (marketed as Strattera)

Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa)

OnabotulinumtoxinA (marketed as Botox/Botox Cosmetic), AbobotulinumtoxinA (marketed as Dysport) and RimabotulinumtoxinB (marketed as Myobloc) (8/3/2009)

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, and generics)

Cefepime (marketed as Maxipime)

Ceftriaxone (marketed at Rocephin)

Citalopram (marketed as Celexa) 

Clarithromycin (marketed as Biaxin)

Use of Codeine Products in Nursing Mothers

Colchicine (marketed as Colcrys) (7/30/2009)

Colistimethate (marketed as Coly-Mycin M and generic products)

Darunavir Ethalolate (marketed as Prezista)

Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray)

Diazepam Rectal Gel (marketed as Diastat AcuDial)

Duloxetine (marketed as Cymbalta)

Erythropoiesis Stimulating Agents (ESA)

Escitalopram (marketed as Lexapro)

Reports of Altered Kidney Function in patients using Exenatide (Marketed as Byetta) (11/2/2009)

Exenatide (marketed as Byetta) (8/2008)

Fentanyl Buccal Tablets (marketed as Fentora)

Fentanyl Transdermal System (marketed as Duragesic and generics)

Fluoroquinolone Antimicrobial Drugs [ciprofloxacin (marketed as Cipro and generic ciprofloxacin), ciprofloxacin extended-release (marketed as Cipro XR and Proquin XR), gemifloxacin (marketed as Factive), levofloxacin (marketed as Levaquin), moxifloxacin (marketed as Avelox), norfloxacin (marketed as Noroxin), and ofloxacin (marketed as Floxin and generic ofloxacin)]

Fluoxetine (marketed as Prozac)

Fluvoxamine

Galantamine hydrochloride (marketed as Razadyne, formerly Reminyl)

Gatifloxacin (marketed as Tequin)

Gefitinib (marketed as Iressa)

Haloperidol (marketed as Haldol, Haldol Decanoate and Haldol Lactate)

Long-Acting Hydrocodone-Containing Cough Product (marketed as Tussionex Pennkinetic Extended-Release Suspension)

Concomitant Use of Ibuprofen and Aspirin

Immunosuppressant Drugs: Required Labeling Changes (7/14/2009)

Insulin Pens - Risk of Transmission of Blood-borne Pathogens from Shared Use of Insulin Pens

Interferon gamma-1b (marketed as Actimmune)

Isotretinoin (marked as Accutane)

Lamotrigine (marketed as Lamictal)

Linezolid (marketed as Zyvox)

Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection)

Mifepristone (marketed as Mifeprex)

Mycophenolate Mofetil (marketed as CellCept) and
Mycophenolic Acid (marketed as Myfortic)

Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)*

Olanzapine/fluoxetine (marketed as Symbyax)

Omalizumab (marketed as Xolair)

Oral Sodium Phosphate (OSP) Products for Bowel Cleansing

Paroxetine (marketed as Paxil)

Pemoline Tablets and Chewable Tablets (marketed as Cylert)

Mandatory Adverse Event Reporting for Emergency Use of Peramivir Under EUA (10/23/2009)

Pioglitazone HCl (marketed as Actos, Actoplus Met, and Duetact)

Promethazine (marketed as Phenergan and generic products) (4/2006)

Intravenous Promethazine and Severe Tissue Injury, Including Gangrene (9/16/2009)

Propofol (marketed as Diprivan and as generic products)

Propylthiouracil-Induced Liver Failure

Rituximab (marketed as Rituxan) Information

Rosuvastatin Calcium (marketed as Crestor)

Selective Serotonin Reuptake Inhibitors (SSRIs)

Selective Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs)

Sertraline (marketed as Zoloft)

Sildenafil (marketed as Viagra and Revatio) Vardenafil (marketed as Levitra) Tadalafil (marketed as Cialis)

Sirolimus (marketed as Rapamune)

Acute pancreatitis and sitagliptin (marketed as Januvia and Janumet) (9/25/2009)

Tamiflu: Authorization of Use of Expired Tamiflu for Oral Suspension (10/2/2009)

Tiagabine hydrochloride (marketed as Gabitril) (2/18/2005)

5-Hydroxytryptamine Receptor Agonists (Triptans) (7/2006)

Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) (8/4/2009)

Valdecoxib (marketed as Bextra) (4/7/2005)

Varenicline (marketed as Chantix) (2/1/2008)

Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics) (7/1/2009)

Venlafaxine (marketed as Effexor) - Selective Serotonin Reuptake Inhibitors (SSRIs), Selective Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs), 5-Hydroxytryptamine Receptor Agonists (Triptans) (7/2006)

Zonisamide (marketed as Zonegran) (2/23/2008)