Safety Alerts & Recalls

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FDA Updates Safety Review For Recombinant Human Growth Hormone (Somatropin)
The U.S. Food and Drug Administration (FDA) has provided an update about its ongoing safety review of recombinant human growth hormone (somatropin) and possible increased risk of death when recombinant human growth hormone (somatropin) is used in certain kinds of short stature during childhood. This review was first described in a December 2010 Drug Safety Communication announcement. The FDA has reviewed the results from a study conducted in France—the Santé Adulte GH Enfant (SAGhE) study—and other available information on this potential risk. At this time, the FDA has determined that there is not enough evidence to support a definitive link between recombinant human growth hormone and an increased risk of death. The FDA advises that healthcare professionals and patients should continue to prescribe and use recombinant human growth hormone according to the labeled recommendations. The FDA is continuing to review this safety issue and expects to receive additional data from the SAGhE study in Spring 2012. FDA will update the public when new information is available. Recombinant human growth hormone is a protein that is manufactured to be nearly identical to the main form of the naturally occurring human growth hormone. This hormone can stimulate tissue growth, linear growth (height), and protein, carbohydrate, lipid, and mineral metabolism. It has approved indications in both the adult and pediatric populations. Recombinant human growth hormone, also known as somatropin [rDNA origin] injection, is marketed under the following brand names in the United States: Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, and Tev-Tropin. For more information, please visit:
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Corepharma Recalls Several Lots of Potassium Citrate Extended-Release Tablets
Corepharma LLC has recalled several lots of Potassium Citrate Extended-Release Tablets, 5 and 10 mEq. This recall was issued because the recalled lots failed the manufacturer routine tests that measure the tablets’ ability to dissolve. Potassium Citrate is a potassium supplement used in the treatment of low potassium level in the body. This recall alert only applies to the single lot of the generic Potassium Citrate Extended-Release Tablets, 5 and 10 mEq made by Corepharma LLC. No other potassium supplements were involved in this recall. To view the FDA notice about this recall and to see a list of recalled lot numbers please visit:
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Date Published Title Drug Source
2011-08-05 FDA Updates Safety Review For Recombinant Human Growth Hormone (Somatropin) Somatropin FDA
2011-08-16 Corepharma Recalls Several Lots of Potassium Citrate Extended-Release Tablets Potassium Citrate FDA
2011-08-16 Novartis Pharmaceuticals Recalls Single Lot of Enablex Darifenacin FDA
2011-08-16 Hi-Tech Pharmacal Recalls Single Lot of Chlorhexidine Gluconate Oral Rinse, 0.12% Chlorhexidine FDA
2011-08-16 Kimberly-Clark Corp. Recalls Several Lots of KimVent Oral Care Kits with Chlorhexidine Gluconate Solution 0.12% Chlorhexidine FDA
2011-08-16 Teva Pharmaceuticals Recalls Several Lots of Risperidone 0.25 mg, 0.5 mg, 1 mg, 2 mg and 3 mg Tablets Risperidone FDA
2011-08-16 Dr. Reddy's Laboratories Inc. Recalls Simvastatin Tablets Due To Musty Smell Simvastatin FDA
2011-08-16 Taro Pharmaceuticals Recalls Select Lots of Fluorouracil Topical Cream, 5% Fluorouracil FDA
2011-08-16 McNeil Recalls Tylenol Cold Multi-Symptom Nighttime Rapid Release Gelcaps Tylenol Cold Multisymtom Plus Coug Manufacturer
2011-08-27 Abnormal Heart Rhythms Associated with High Doses of Citalopram (Celexa) Citalopram FDA
2011-09-01 FDA Adds Warning of Risk of Kidney Failure With Use of Reclast (Zoledronic Acid) Zoledronic Acid FDA
2011-09-01 FDA Warns: Serious Allergic Reactions Reported with the Use of Saphris (Asenapine Maleate) Asenapine FDA
2011-09-07 FDA Warns of Infection Risk from Repackaged Avastin Injections For Eye Disease Bevacizumab FDA
2011-09-07 FDA Updates Labels for Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab) Etanercept FDA
2011-09-08 Pure Encapsulations, Incorporated Recalls Prenatal Nutrients Products Prenatal Vitamins FDA
2011-09-16 FDA Warns: Abnormal Heart Rhythms May Be Associated with Use of Zofran (Ondansetron) Ondansetron FDA
2011-09-16 Qualitest Pharmaceuticals Recalls Birth Control Pills Due To Packaging Error that May Increase Risk of Unintended Pregnancies Desogestrel with Ethinylestradiol Manufacturer
2011-09-22 Users of Primatene Mist Will Need a Prescription Product to Treat Their Asthma Epinephrine FDA
2011-09-26 The FDA Continues to Be Concerned about the Increase Risk of Blood Clots with YAZ (generics – Gianvi and Loryna), Yasmin (generics – Ocella, Syeda, and Zarah), Beyaz, and Safyral Drospirenone with Ethinyl Estradiol FDA
2011-10-03 Online Guide For Using Pain Relievers Safely Acetaminophen FDA