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.

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.

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.

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).

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.

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.

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).

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 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).

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.