... Betterchem Health Drug Information DMFs Portal 21CFR Search Site Map FDA News Archive [index page] February 11, 2008_Baxter's Multiple-dose Vial Heparin Linked to Severe Allergic Reactions The U.S. Food and Drug Administration announced today that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high" bolus" doses of the drug. Serious reactions to the drug have included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that can lead to life-threatening shock. Four people have died after receiving heparin, although the relationship to the drug is unclear. Heparin sodium is derived from pig intestines and has been marketed in the United States since the 1930s. Millions of patients benefit from the intravenous administration of this drug every year to avoid potentially life-threatening blood clots in the veins, arteries, and lungs." FDA concurs with Baxter's decision to halt manufacture of heparin sodium in multiple-dose vials ," said Janet Woodcock, M.D, FDA's ...

... Betterchem Health Drug Information DMFs Portal 21CFR Search Site Map FDA News Archive [index page] November 6, 2008_FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer As part of the U.S. Food and Drug Administration's ongoing efforts to ensure that heparin for patients remains safe, the government today seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio. The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS ), a substance that mimics heparin's anticoagulant activity. “ This action will help prevent this contaminated heparin from finding its way into the marketplace ," said Mike Chappell, acting associate commissioner for regulatory affairs, FDA. 2010 Betterchem.com ...

... in the power supply connector can cause potentially dangerous overheating … http :// www.accessdata.fda.gov / psn / transcript.cfm? show = 65 #5 Warning about Tracheoesophageal Fistula with Avastin Cases of tracheoesophageal (TE) fistulae reported in clinical study when treating patients with small cell lung cancer … http :// www.accessdata.fda.gov / psn / transcript.cfm? show = 65 #6 New Guidelines on MRI Safety MR-associated accidents, many life-threatening or fatal, are still occurring … http :// www.accessdata.fda.gov / psn / transcript.cfm? show = 65 #7 Avoiding Dangerous Mix-ups between Insulin and Heparin Severe and sometimes fatal hypoglycemia has occurred when insulin is used instead of heparin … http :// www.accessdata.fda.gov / psn / transcript.cfm? show = 65 #8 New Food Safety Education Kit for Moms-to-Be Free video, slide show and poster are part of FDA kit to teach pregnant women about food borne risks and steps to preventing food borne illnesses … http :// www.accessdata.fda.gov / psn / transcript.cfm? show = 65 #9 ...

... Betterchem Health Drug Information DMFs Portal 21CFR Search Site Map CDER News Archive [index page] April 14, 2004 Inactive Ingredient Database (updated) New and Generic Drug Approvals Colgate Total Toothpaste, Colgate-Palmolive Company Heparin Sodium in 5 %Dextrose Injection, B. Braun Medical Inc. Heparin Sodium in 0.9 %Sodium Chloride Injection, B. Braun Medical Inc. Lovenox (enoxaparin sodium) Injection, Aventis Pharmaceuticals Terconazole Vaginal Cream, Taro Pharmaceuticals Tylenol Arthritis Pain (650 mg acetaminophen) extended release tablets, McNeil Consumer Patent Term Extension and New Patents Docket Number*95S-0117 (updated) April 30, 2004 is the last day New and Generic Drug Approvals 1998-2004, will be updated. Starting May 1, 2004, please use Drugs @FDA for all drug approval information. April 13, 2004 FDA requests that a warning be added to the prescribing information for all atypical antipsychotics regarding the risk of hyperglycemia and diabetes. MedWatch Safety Info 2009 Betterchem.com ...

... may have an increased risk of being born with a cleft lip or palate. http :// www.accessdata.fda.gov / psn / transcript.cfm? show = 58 #4 Roche Diagnostics Recalls CoaguChek PT Test Strips A possible defect in the test strips may cause falsely elevated test results. http :// www.accessdata.fda.gov / psn / transcript.cfm? show = 58 #5 Severe Tissue Injury with IV Promethazine ISMP warns that administering promethazine parenterally may cause more severe tissue injuries than previously recognized. http :// www.accessdata.fda.gov / psn / transcript.cfm? show = 58 #6 Preventing Fatal Heparin Overdoses ISMP cites a case in which three premature infants died after receiving an overdose of heparin. http :// www.accessdata.fda.gov / psn / transcript.cfm? show = 58 #7 ...

... Betterchem Health Drug Information DMFs Portal 21CFR Search Site Map FDA News Archive [index page] January 25, 2008_FDA Warns Public of Contaminated Syringes The U.S. Food and Drug Administration (FDA) today announced a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc, of Angier, N.C. Two lots have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death. These syringes are manufactured by AM2 PAT under the brand names Sierra Pre-filled, Inc. and B. Braun. They are sold in fill sizes of 3mL, 5mL and 10mL and syringe sizes of 6mL and 12mL. Consumers and health care facilities with any of the recalled, pre-filled Heparin Lock or Normal Saline IV Flush syringes should stop using the product immediately. Health care facilities should immediately quarantine the products in their inventory and return them to their distributor. Individual consumers should return them to the location from which they were received, such as a pharmacy or hospital. They should also let their ...

... cyclobenzaprine hydrochloride) Extended-Release Capsules, Anesta AG, Labeling Revision Depakote (divalproex sodium) Sprinkle Capsules, Abbott Labs, Patient Population Altered Depakote ER (divalproex sodium) Extended-Release Tablets, Abbott Labs, Patient Population Altered INVANZ (ertapenem sodium) Injection, Merck & Co, Labeling Revision Tigan (trimethobenzamide hydrochloride) Capsules, King Pharma, Labeling Revision Warning Letters PDF] On March 21, 2008, 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 New and Generic Drug Approvals Fioricet w / Codeine Capsules, Watson Labs, Labeling Revision Gabapentin Tablets, Zydus Pharma, Tentative Approval Glycopyrrolate Tablets, Indicus Pharma, Approval Ondansetron Injection, Taro Pharma, Approval Phentermine Hydrochloride Capsules, KVK-Tech, Approval Prozac (fluoxetine HCl) Capsules, Eli Lilly & Co, Labeling Revision Prozac (fluoxetine HCl) Solution, Eli Lilly & Co, Labeling Revision Prozac (fluoxetine HCl) Delayed Release Capsules, Eli Lilly & Co, Labeling ...

... ) for the treatment of irritable bowel syndrome with constipation in adult women aged 18 and over. Postmarketing Study Commitments (updated) April 29, 2008 Actavis Totowa LLC recalls all strengths of Digitek (digoxin tablets, USP ), a drug used to treat heart failure and abnormal heart rhythms Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated) April 28, 2008 Drug Master Files (updated) | Search FDA approves Relistor (methylnaltrexone bromide) for opioid-induced constipation FDA updates information to healthcare facilities and healthcare professionals about heparin and heparin-containing medical products New and Generic Drug Approvals Dipyridamole Tablets, Lannett, Approval Epoprostenol Sodium Injection, Teva Parenteral, Approval Ondansetron Injection, Akorn-Strides, Approval Paragraph IV Patent Certifications (updated) Postmarketing Study Commitments: Introduction (updated) April 24, 2008 New and Generic Drug Approvals Actonel (risedronate sodium) Tablets, Procter & Gamble, Labeling Revision Actonel (risedronate sodium) Tablets, Procter & Gamble, New Dosage Regimen Declomycin (demeclocycline hydrochloride) Tablets, Stiefel Labs, Labeling Revision Vyvanse (lisdexamfetamine dimesylate) Capsule, New ...

... Bleeding in IUD Users The U.S. Food and Drug Administration today approved Mirena (levonorgestrel intrauterine system) to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention. This is the first intrauterine device approved by the FDA for this additional indication. Mirena was approved as a contraceptive by the FDA in 2000. It is a small, flexible hormone-releasing device inserted into the uterus to prevent pregnancy. The device should be inserted by a trained health care professional. FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common anti-clotting drug. To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP ), a nonprofit standards-setting organization, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug ’ s unit dose. 2010 Betterchem.com ...

... alert about certain Lifepak 500 automatic external defibrillators because in some cases, these devices may not recognize that the electrodes are connected to the patient, and thus may not defibrillate those patients. The company is also recalling certain Medtronic implanted defibrillators because some of their batteries can develop internal short circuits. If this happens, the device can quickly become inoperative. http :// www.accessdata.fda.gov / psn / transcript.cfm? show = 38 #3 Alert on IV Flush Syringes-FDA has issued nationwide alerts that warn against using certain preloaded syringes that contain heparin or saline flushes for IV catheters. The syringes are not approved by FDA and in fact, the flushes may have caused Pseudomonas fluorescens (P. fluorescens) infections in a number of patients. The syringes are manufactured by IV Flush, LLC and distributed by Pinnacle Medical Supply, of Rowlett, Texas. http :// www.accessdata.fda.gov / psn / transcript.cfm? show = 38 #4 Injuries from Improper Use of U.S. Surgical Helical Tacks A recent report from ECRI warns that serious patient injuries have occurred from helical tacks used with the Auto ...