Lilly and FDA notified healthcare professionals of changes to the Prescribing Information for Zyprexa related to its indication for use in adolescents (ages 13-17) for treatment of schizophrenia and bipolar I disorder [manic or mixed episodes]. The revised labeling states that: Section 1, Indications and Usage: When deciding among the alternative treatments available for adolescents, […]
Videx/Videx EC (didanosine): Labeling Revision – Risk of Non-Cirrhotic Portal Hypertension
FDA notified healthcare professionals and patients about a rare, but serious, complication in the liver known as non-cirrhotic portal hypertension in patients using Videx or Videx EC (didanosine), a medication used to treat human immunodeficiency virus (HIV) infection. FDA became aware of cases of non-cirrhotic portal hypertension through adverse event reports submitted to FDA’s Adverse […]
Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall
FDA notified healthcare professionals of a Class I recall of Hettich Centrifuges with 2050 and 2076 plastic rotors, used in combination with the Mikro 12-24, Mikro 20, Haematokrit 20 and Haematokrit 24 bench top plastic centrifuges. The recall was initiated because the plastic centrifuge rotor may crack, break apart and be forcefully ejected through the […]
Edwards Lifesciences Aquarius Hemodialysis System: Recall
FDA and Edwards Lifesciences notified healthcare professionals of a Class I recall of the Aquarius Hemodialysis System due to reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm. This could result in a decrease or increase in the volume of the circulating blood, which may result in […]
Infusion Set Needles [Manufactured by Nipro for Exelint]: Recall
FDA notified healthcare professionals of a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation due to ‘coring’, the cutting or dislodging of silicone cores or slivers from the ports into which they are inserted. Huber needles […]
Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment
Patients with moderate or severe hepatic impairment should be treated with reduced starting doses and closely monitored. SOURCE
Nipro GlucoPro Insulin Syringes: Recall
Nipro Medical Corporation and FDA notified healthcare professionals of a voluntary nationwide recall of all GlucoPro Insulin Syringes. These syringes may have needles that detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the […]
Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review
FDA notified healthcare professionals that the review of additional data indicates an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using sibutramine. Based on the serious nature of the review findings, FDA requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label stating […]
Alli 60 mg capsules (120 count refill kit): Counterfeit Product
FDA notified consumers and healthcare professionals about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit). The counterfeit version contained the controlled substance sibutramine and did not contain orlistat, the active ingredient. Sibutramine is a drug that should not be used in certain patient populations or without physician oversight. […]
MuscleMaster.com Products Sold on Internet as Dietary Supplements: Recall
MuscleMaster.com, Inc. and FDA notified consumers and healthcare professionals of the voluntary nationwide recall of all lots and expiration dates of the seventeen dietary supplements listed in the firm press release, sold between June 1, 2009 and November 17, 2009. FDA informed MuscleMaster.com that it believes that the recalled products contain ingredients that are steroids. […]