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CDER News Items 2008
• December 24. ETHEX and FDA notify heathcare professionals of a nationwide recall of a single lot of Hydromorphone HCl 2 mg Tablets due to potential for oversized tablets. MedWatch Safety Information
• December 22. FDA warns consumers about tainted weight loss pills. FDA News
• December 16. FDA is requiring that all manufacturers of antiepileptic drugs include a Warning in their labeling and develop a Medication Guide to be provided to patients to inform them of the risks of suicidal thoughts or actions. MedWatch Safety Information
• December 16. FDA releases a study that finds much of private-sector consumer medication information is not consistently useful. Information
• December 10. FDA requires new safety measures for oral sodium phosphate products to reduce risk of acute kidney injury. Information
• December 8. Hospira, Inc. recalls one lot of 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP. MedWatch Safety Information
• December 2. Innohep (tinzaparin): Clinical study stopped early because of interim finding of increased all-cause mortality in patients who received drug. Information
• December 2. FDA issues questions and answers on medication guides for erythropoiesis-stimulating agents (ESAs). Information
• November 24. Phenytoin and Fosphenytoin Sodium associated with potential increased risk of serious skin reactions. Information for Healthcare Professional
• November 18. CSI USA Inc. and FDA inform consumers and healthcare professionals of a nationwide recall of all lots of 1 ounce tubes of 10% Benzoyl Peroxide Acne Cream. MedWatch Safety Information
• November 12. FDA updates the Early Communication about the Ongoing Safety Review of Bisphosphonates. Information
•November 10. Ethex Corp and FDA notify healthcare professionals of a voluntary recall of five generic products due to the potential for oversized tablets. MedWatch Safety Information
• October 28. FDA issues warning letters to Bayer HealthCare for illegally marketing two unapproved drugs. FDA News
• October 16. Ethex Corp and FDA notify healthcare professionals of a voluntary recall of three lots of dextroamphetamine sulfate 5mg tablets. MedWatch Safety Information
• October 16. FDA creates a consolidated web page with drug safety information for patients and health care professionals. FDA News
• October 9. FDA issues statement following CHPA's announcement on nonprescription over-the-counter cough and cold medicines in children. FDA Statement
• October 7. FDA issues an updated Early Communication about an Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler). Information
• September 26. FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke. MedWatch Safety Information
• September 18. FDA releases its fourth issue of the FDA Drug Safety Newsletter.
• September 18. Covidien and Mallinckrodt Inc. inform healthcare professionals of important new safety information in prescribing Phosphocol P 32. MedWatch Safety Information
• September 16. FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India. Drug Information.
• September 12. Genentech informs healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoencephalopathy (PML). MedWatch Safety Information
• September 5. FDA posts quarterly report of potential safety issues. FDA News
• September 4. FDA announces that manufacturers of TNF-blocker drugs (Cimzia, Enbrel, Humira, and Remicade) must highlight the risk of fungal and serious opportunistic infections. FDA News
• August 25. FDA updates the Information for Healthcare Professionals sheet for Tysabri (natalizumab). Drug Information
• August 21. FDA issues an Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia). Drug Information
• August 18. FDA updates the Information for Healthcare Professionals sheet for Byetta (exenatide). Drug Information
• August 21. FDA issues an Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia). Drug Information
• August 18. FDA updates the Information for Healthcare Professionals sheet for Byetta (exenatide).
• August 13. Watson Pharmaceuticals, Inc. issues a voluntary recall of one lot of 75mcg/hr Fentanyl Transdermal System patches. MedWatch Safety Information
• August 12. FDA issues an Information for Healthcare Professionals sheet for Naltrexone. Drug Information.
• August 8. FDA issues an Information for Healthcare Professionals sheet for Amiodarone and Simvastatin. Drug Information.
• July 31.Viapro 375mg Capsules recalled since it contained a potentially harmful analog of Sildenafil. MedWatch Safety Information
• July 30. FDA issues Complete Response letters ordering Safety Labeling Changes under FDAAA for Aranesp, Epogen, and Procrit. Drug Information
• July 29. FDA reminds health care professionals who treat patients with mitoxantrone about recommendations that left ventricular ejection fraction (LVEF) be evaluated before initiating treatment and prior to administering each dose of mitoxantrone. MedWatch Safety Information
• July 24. FDA informs healthcare professionals that serious and sometimes fatal hypersensitivity reactions (HSR) caused by abacavir therapy are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*5701. MedWatch Safety Information
• July 17. FDA updates healthcare professionals about recent changes made to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information for micro-bubble contrast agents. MedWatch Safety Information
• July 17. Roxane Laboratories informs healthcare professionals of the recall of two lots of Sodium Polystyrene Sulfonate Suspension, a product used to treat hyperkalemia. MedWatch Safety Information
• July 14. Genentech informs healthcare professionals of reports of several cases of microangiopathic hemolytic anemia (MAHA) in patients with solid tumors receiving Avastin in combination with sunitinib malate. MedWatch Safety Information
• July 9. Genentech reports that it received an increased number of complaints regarding damaged and broken vials of Herceptin 440 mg and BWFI (bacteriostatic water for injection) diluent. MedWatch Safety Information
• July 9. FDA revises its process for responding to drug applications. FDA News
• July 8. FDA issues an Information for Healthcare Professionals sheet for fluoroquinolone antimicrobial drugs. Drug Information
• June 30. Sage Products voluntary recalls limited lots of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation product. MedWatch Safety Information
• June 30. Novartis changes sections of Myfortic prescribing information based on postmarketing data regarding cases of Progressive Multifocal Leukoencephalopathy (PML) in patients treated with Myfortic. MedWatch Safety Information
• June 30. FDA approves the first generic versions of Risperdal (risperidone) tablets to treat schizophrenia, bipolar disorder, and other psychiatric conditions. FDA News
• June 17. FDA warns individuals and firms to stop selling fake cancer "cures" FDA News
• June 16. FDA issues an Information for Healthcare Professionals sheet for antipsychotics. Drug Information
• June 12. FDA releases its third issue of the FDA Drug Safety Newsletter.
• June 11. ETHEX Corporation voluntarily recalls a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. MedWatch Safety Information
• June 6. FDA issues a Follow-up to the March 27, 2008 Communication about the Ongoing Safety Review of Regranex (becaplermin). Information
• June 4. FDA issues an Early Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia). Information
• May 30. FDA has issued a public health advisory to switch to hydrofluoroalkane (HFA)-propelled albuterol inhalers because chlorofluorocarbon (CFC)-propelled inhalers will not be available in the United States after Dec. 31, 2008. FDA News | Public Health Advisory | Podcast | Availability
• May 28. FDA proposes a new rule to provide updated information on the use of prescription drugs and biological products during pregnancy and breast-feeding. FDA News
• May 20. FDA approves Entereg (alvimopan) to help restore bowel function following surgery. FDA News
• May 16. FDA approves new Medication Guide and Label for Varenicline (marketed as Chantix). Drug Information.
• May 16. FDA issues an FDA Alert and Information for Healthcare Professional sheet for Mycophenolate Mofetil (marketed as CellCept) and Mycophenolic Acid (marketed as Myfortic). Drug Information.
• May 14. Aprotinin Injection (marketed as Trasylol): Manufacturer Removes Remaining Stocks of Trasylol. FDA News and Information.
• May 14. Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass. Information.
• May 14. FDA releases a Follow-up to the November 14, 2007, Communication about the Ongoing Safety Review of Cefepime (marketed as Maxipime). Information
• May 12. FDA requests that health professionals and facilities review and examine all drug/device storage areas to ensure that all recalled heparin products have been removed and are no longer available for patient use. MedWatch Safety Information
• May 2. The prescribing information for Enbrel (etabercept) is revised to include a boxed warning about infections. MedWatch Safety Information.
• April 29. FDA approves Amitiza (lubiprostone) for the treatment of irritable bowel syndrome with constipation in adult women aged 18 and over. FDA News
• April 28. Actavis Totowa LLC recalls all strengths of Digitek (digoxin tablets, USP), a drug used to treat heart failure and abnormal heart rhythms. MedWatch Safety Information
• April 25. FDA approves Relistor (methylnaltrexone bromide) for opioid-induced constipation.
• April 22. FDA approves Cimzia (certolizumab pegol) to treat Crohn's disease
• April 16. FDA issues "Review of Therapeutic Equivalence Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg."
• April 10. FDA issues a Communication About an Ongoing Safety Review of CellCept and Myfortic. Drug Information
• April 9. Schwarz Pharma recalls Neupro, a transdermal delivery system used to treat early stage Parkinson’s disease, at the end of April. MedWatch Safety Information
• April 9. Pfizer informs healthcare professionals and patients of updated safety information in the labeling for Exubera, a short-acting insulin. MedWatch Safety Information
• April 9. Cubist Pharmaceuticals, Inc. informs healthcare professionals that a potentially significant impurity has been isolated from reconstituted Cubicin stored in with ReadyMED elastomeric infusion pumps manufactured by Cardinal Health, Inc. MedWatch Safety Information
• April 2. GlaxoSmithKline informs healthcare professionals of changes to the prescribing information for Relenza regarding information from postmarketing reports. MedWatch Safety Information
• March 27. FDA issues a Communication about an Ongoing Safety Review Regranex (becaplermin). Information
• March 27. FDA issues an Early Communication about an Ongoing Safety Review of Ziagen (marketed as Abacavir) and Videx (marketed as Didanosine). Information
• March 27. FDA issues an Early Communication about an Ongoing Safety Review of Montelukast (marketed as Singulair). Information
• March 26. FDA releases information on Risk Evaluation and Mitigation Strategies (REMS).
• March 21. B. Braun Medical Inc. was notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). MedWatch Safety Information
• March 21. FDA issues an FDA Alert and Information for Healthcare Professionals Sheet for Prezista (darunavir ethalolate). Drug Information
• March 18. FDA issues an Early Communication about an Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler). Information
• March 18. FDA releases its second issue of the FDA Drug Safety Newsletter.
• March 18. FDA releases a progress report on the New Molecular Entities (NME) Post-Marketing Safety Evaluation Pilot Program. Information
• March 12. Amgen and FDA notify healthcare professionals of changes to the Boxed Warnings/Warnings for increased mortality and/or tumor progression section of the Aranesp and Epogen/Procrit labeling. MedWatch Information
• March 12. FDA and Tibotec Therapeutics notify healthcare professionals of changes to the Warnings section of the prescribing information for Prezista (darunavir) tablets regarding the risk of hepatotoxicity. MedWatch Information
• March 11. FDA issues an Information for Healthcare Professionals sheet and Public Health Advisory for Tussionex Pennkinetic Extended-Release Suspension, a long-acting hydrocodone-containing cough product. Drug Information
• March 6. FDA releases information on two tests that manufacturers and regulators can use to screen heparin for contaminants. Information
• March 5. FDA updates safety information for long acting beta agonists (LABA). Information
• February 29. FDA issues a Public Health Advisory highlighting the correct use of Spiriva (tiotropium bromide inhalation powder) and Foradil (formoterol fumarate inhalation powder) capsules. Public Health Advisory
• February 28. Baxter Healthcare Corporation has voluntarily recalled all of their multi-dose and single-use vials of heparin sodium for injection, and their heparin lock flush solutions. Information
• February 28. FDA approves Nexium (esomeprazole magnesium) for use in children ages 1-11 years. Drug Information
• February 15. PriCara and Sandoz Inc. recall all lots of 25 mcg/hr Duragesic 25 mcg/hr (fentanyl transdermal system) CII Pain Patches sold in the United States. MedWatch Safety Information.
• February 11. FDA announces that Baxter Healthcare Corp. has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension. FDA News
• February 6. FDA approves the first generic versions of Fosamax (alendronate sodium tablets), used to treat osteoporosis. FDA News
• February 6. FDA takes action to stop the marketing of unapproved injectable drugs containing colchicine. FDA News
• February 1. FDA issues a Public Health Advisory and Information for Healthcare Professional sheet for Chantix (varenicline). Drug Information
• January 31. FDA issues an FDA Alert and Information for Healthcare Professional sheet for suicidality and antiepileptic drugs. Information
• January 25. FDA issues an Early Communication about an Ongoing Data Review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor). FDA Statement
• January 25. Clarification of Recent FDA Initiatives Affecting OTC Drugs. Information
• January 24. Bayer and FDA inform healthcare professionals of the market withdrawal of the current liquid formulation of Leukine (sargramostim) MedWatch Information
• January 18. FDA approves additional changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label. FDA News
• January 17. FDA issues a Public Health Advisory recommending that over-the-counter (OTC) cough and cold products should not be used to treat infants and children less than 2 years. FDA News | Public Health Advisory
• January 16. FDA issues a Public Health Advisory on edetate disodium (marketed as Endrate and generic products). Drug Information
• January 15. FDA approves Tysabri (natalizumab) to treat moderate-to-severe Crohn's Disease. FDA News
• January 9. FDA takes action against compounded menopause hormone therapy drugs. FDA News
• January 7. FDA issues an FDA Alert and Information for Healthcare Professionals sheet for bisphosphonates. Drug Information
• January 3. FDA receives new data on risks of anemia drugs known as erythropoiesis-stimulating agents, or ESAs. FDA News | Communication about an Ongoing Safety Review
News Items 2008
News Items 2007
News Items 2006
News Items 2005
News Items 2004
News Items 2003
News Items 2002
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Date updated: December 24 2008 |
