February 14, 2009Venom HYPERDRIVE 3.0 Venom HYPERDRIVE 3.0
Product marketed as dietary supplement contains undeclared sibutramine, a controlled substance with risks for abuse or addiction, and can substantially increase blood pressure and heart rate. Source: www.fda.gov FDA Public Health Advisory Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammography and Other Medical Tests and Conditions FDA Public Health Advisory Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammography and Other Medical Tests and Conditions
Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammography and Other Medical Tests and Conditions: Overview Version Source: www.fda.gov Food Allergies: Reducing the Risks FDA is working to ensure that allergens in food are clearly and accurately labeled. Source: www.fda.gov Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2008 Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2008 Source: www.fda.gov February 13, 2009Drug Shortages: Current Drug Shortages: Azactam 1 gram and 2 gram (aztreonam for injection) Drug Shortages: Current Drug Shortages: Azactam 1 gram and 2 gram (aztreonam for injection)
Elan estimates availability of Azactam 1 gram vials (NDC 51479-0041-15), and 2 gram vials (NDC 51479-0042-15)in March/April time frame. For additional information call Elan at 1-800-859-8586, and Baxter has 1 gram (NDC 51479-0048-01) and 2 gram (NDC 51479-0049-01) frozen aztreonam available on allocation. For additional information call Baxter at 1-888-229-0001. Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Nimotop (nimodipine) capsules See Web site for additional information Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Albuterol Metered Dose Inhalers and Levalbuterol Metered Dose Inhalers The transition from albuterol CFC MDIs to albuterol HFA MDIs is now complete and supplies of albuterol HFA and levalbuterol HFA MDIs continue to meet total market demand. Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Vinblastine Sulfate Injection See Related information section Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Foscavir (foscarnet sodium) injection See Web site for additional information Source: www.fda.gov Recalls and Safety Alerts: Serious Complications with Surgical Mesh for Gynecologic Surgery Recalls and Safety Alerts: Serious Complications with Surgical Mesh for Gynecologic Surgery
The FDA is alerting healthcare professionals about rare but serious complications associated with the surgical mesh used to treat pelvic organ prolapse and stress urinary incontinence. The mesh is usually placed transvaginally using minimally invasi... Source: www.accessdata.fda.gov Patients Are Asking: New Labels for Non-prescription Cough and Cold Medications Most makers of nonprescription cough and cold medicines are voluntarily changing the labels on these products to say "do not use" for children under 4 years of age. New child resistant packaging and measuring devices are also being introduced. ... Source: www.accessdata.fda.gov Xigris (Drotrecogin alfa (activated)) - Early Communication about an Ongoing Safety Review FDA is evaluating a study showing increased incidence of serious bleeding events and mortality in patients who received Xigris. Source: www.fda.gov February 12, 2009Kidney Risk Spurs Warning on Bowel Cleansers Kidney Risk Spurs Warning on Bowel Cleansers
FDA requires new safety measures for products used as bowel cleansers before colon examinations. Source: www.fda.gov Drug Shortages: Current Drug Shortages; Leucovorin See web site for additional information Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Fentanyl transdermal patch See Related information section Source: www.fda.gov FDA Warns Bayer About Two Unapproved Aspirin Products FDA has sent warning letters to Bayer HealthCare regarding two over-the-counter products that combine aspirin with a dietary supplement into a single pill. Source: www.fda.gov Generic Drug Roundup: February 2009 Here are some of the noteworthy generic drug approvals of 2008. Source: www.fda.gov Beware of Extortion Scam by FDA Impersonators As part of a fraudulent scheme to extort money, callers have falsely identified themselves as "FDA special agents" or other FDA officials. Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated See additional information in Related Information section. Source: www.fda.gov FDA Web Page on Salmonella and Peanut Butter Visit FDA's Web page on Salmonella Typhimurium for the latest product recalls and advice for consumers. Source: www.fda.gov Drug Shortages: Current Drug Shortages; Leucovorin Drug Shortages: Current Drug Shortages; Leucovorin
Please call 1-888-TevaUSA for additional information. Teva is manufacturing at full capacity. Bedford Customer Service 1-440-232-3320 Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Nimotop (nimodipine) capsules See Web site for additional information Source: www.fda.gov Drug Shortages: Current Drug Shortages: Nitrostat sublingual tablets (0.3 mg, 0.4 mg, and 0.6 mg) See Related Information section Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Foscavir (foscarnet sodium) injection See Web site for additional information Source: www.fda.gov Innohep (tinzaparin sodium injection) [UPDATE] Dear Healthcare Professional letter issued re: increased risk of death in elderly patients with renal insufficiency Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Vinblastine Sulfate Injection See Related information section Source: www.fda.gov Drug Shortages: Current Drug Shortages; Levoleucovorin (Fusilev) 50 mg single use vials See Web site for additional information Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) See Web site for additional information. Source: www.fda.gov February 11, 2009The Adverse Event Reporting System (AERS) Latest Quarterly Data Files The Adverse Event Reporting System (AERS) Latest Quarterly Data Files
3rd quarter 2008 data is now available. Source: www.fda.gov Follow-up to the March 27, 2008, Communication about the Ongoing Safety Review of Montelukast (Singulair) Follow-up to the March 27, 2008, Communication about the Ongoing Safety Review of Montelukast (Singulair) Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Albuterol Metered Dose Inhalers and Levalbuterol Metered Dose Inhalers The transition from albuterol CFC MDIs to albuterol HFA MDIs is now complete and supplies of albuterol HFA and levalbuterol HFA MDIs continue to meet total market demand. Source: internet-dev Drug Shortages: Resolved Drug Shortages; Fentanyl transdermal patch See Related information section Source: www.fda.gov Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2008 Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2008 Source: www.fda.gov Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov BPCA/Pediatric Exclusivity Statistics BPCA/Pediatric Exclusivity Statistics (updated) Source: www.fda.gov Drug Shortages: Current Drug Shortages; Leucovorin Please call 1-888-TevaUSA for additional information. Teva is manufacturing at full capacity. Bedford Customer Service 1-440-232-3320 Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated See information in Related Information section. Source: www.fda.gov February 10, 2009Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the FDA (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA) Source: www.fda.gov Mexican Vanilla With Coumarin: No Bargain Beware of Mexican vanilla that contains coumarin, a toxic substance banned in the United States. Source: www.fda.gov Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book (updated) Source: www.fda.gov FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop, April 23, 2009 FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop, April 23, 2009 Source: www.fda.gov List of Authorized Generic Drugs Office of Generic Drugs: List of Authorized Generic Drugs (updated) Source: www.fda.gov Prescription Drug Leaflets Need Improvement Improvement is needed for the printed consumer medication information (CMI) that accompanies new prescriptions. Source: www.fda.gov Preventing Medical Errors: More Mix-ups between Propylthiouracil and Purinethol The Institute for Safe Medication Practices (ISMP) is warning about mix-ups between the trade name of one drug and the generic name of another. Purinethol® (mercaptopurine), is the trade name of a potent antimetabolite used in oncology. Propylthiou... Source: www.accessdata.fda.gov Guidance for Industry Comprehensive List of Guidance Documents Source: www.fda.gov Botulism Risk From Ungutted, Salt-Cured Alewives Fish Consumers should not eat this product because it may contain Clostridium botulinum toxin. Source: www.fda.gov Paragraph IV Patent Certifications Office of Generic Drugs: Paragraph IV Patent Certifications (updated) Source: www.fda.gov February 9, 2009Ethex Corporation Product Recall Ethex Corporation Product Recall
UPDATE - Nationwide recall expanded to include various prescription prenatal vitamin and iron supplement products. Source: www.fda.gov Beware of Extortion Scam by FDA Impersonators As part of a fraudulent scheme to extort money, callers have falsely identified themselves as "FDA special agents" or other FDA officials. Source: www.fda.gov Singulair (montelukast) FDA provided updated information to its March 2008 Early Communication. Source: www.fda.gov Improper Use of Decorative Contacts May Haunt You Improper Use of Decorative Contacts May Haunt You
Halloween is a good time to remind people that improper use of non-prescription decorative contact lenses may harm your vision Source: www.fda.gov Botulism Risk From Ungutted, Salt-Cured Alewives Fish Consumers should not eat this product because it may contain Clostridium botulinum toxin. Source: www.fda.gov Safety Concerns and Labeling Changes for Psoriasis Drug Raptiva FDA has received reports of serious infections leading to hospitalizations and deaths in people who use Raptiva. Source: www.fda.gov Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated) Updated letter on this current drug shortage Source: www.fda.gov February 8, 2009Food Safety Tips for Healthy Holidays Food Safety Tips for Healthy Holidays
FDA gives consumers practical food safety tips to help prevent foodborne illness. Source: www.fda.gov Guidance for Industry Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Source: www.fda.gov Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov Tainted Weight Loss Pills Flagged as Health Risks FDA has alerted consumers not to buy or use more than 25 weight-loss products. Source: www.fda.gov Paragraph IV Patent Certifications Office of Generic Drugs: Paragraph IV Patent Certifications (updated) Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Nimotop (nimodipine) capsules See Web site for additional information Source: www.fda.gov |
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