Drug Safety Alerts and Recalls

Tysabri labeling to include safety information on risk of progressive multifocal leukoencephalopathy

February 05, 2010

The FDA has notified healthcare professionals and patients that the risk of developing progressive multifocal leukoencephalopathy (PML) increases with the number of Tysabri (natalizumab, from Biogen Idec) infusions received.
 

Zyprexa Prescribing Information updated for use in adolescents

February 01, 2010

Lilly and the FDA had notified healthcare professionals of changes to the Prescribing Information for Zyprexa (olanzapine) related to its indication for use in adolescents (13-17 years of age) for the treatment of schizophrenia and bipolar I disorder.
 

Videx and Videx EC labeling revised to include risk of non-cirrhotic portal hypertension

January 29, 2010

The FDA has notified healthcare professionals and patients that the use of Videx or Videx EC (didanosine, from Bristol-Myers Squibb) may cause non-cirrhotic portal hypertension, a rare but serious complication.
 

Exel/Exelint infusion set needles recalled

January 26, 2010

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 due to 'coring,' the cutting or dislodging of silicone cores or slivers from the ports into which they are inserted).
 

Updated warning on counterfeit Alli dosing

January 25, 2010

The FDA is updating its warning about a counterfeit version of Alli (orlistat caps, from GlaxoSmithKline) that does not contain orlistat, rather sibutramine, a prescription product indicated as an adjunct to diet in the management of obesity.
 

Nipro GlucoPro insulin syringes recalled

January 22, 2010

The FDA and Nipro Medical Corporation have notified healthcare professionals of a voluntary nationwide recall of all GlucoPro insulin syringes because they may have needles that detach from the syringe.
 

Meridia cardiovascular safety review update

January 21, 2010

The FDA has 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 Meridia (sibutramine HCl tablets, from Abbott).
 

MuscleMaster.com dietary supplement products recalled

January 19, 2010

The FDA and MuscleMaster.com have notified healthcare professionals and consumers of a voluntary nationwide recall of all lots and expiration dates of 17 dietary supplements sold between June 1, 2009 and November 17, 2009.
 

McNeil Consumer Healthcare recalls certain over-the-counter (OTC) products

January 15, 2010

McNeil Consumer Healthcare and the FDA have announced a voluntary recall of certain lots of over-the-counter products, including Tylenol (acetaminophen), Motrin IB (ibuprofen), St. Joseph Aspirin (aspirin), Simply Sleep (diphenhydramine), and Rolaids (calcium carbonate and magnesium hydroxide).
 

Spiriva HandiHaler safety update

January 15, 2010

The FDA announced that data from a recent review of Spiriva HandiHaler (tiotropium dry powder for inhalation, from Boehringer Ingelheim) do not support an increased risk of stroke, heart attack, or death.
 

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