Category: Drug Safety Alerts
-
Analyst Report Forecasts Some Choppy Waters for Return of Tysabri
FDA Adverse Event Reports Show Tysabri May Be Tied To Other Serious Side Effects On August 29, 2005 The Wall Street Journal ("WSJ") reported that a list of adverse event reports made to the…
-
Adderall: Health Canada Allows Shire’s ADHD Drug Back on Market
Sudden Cardiac Death and Stroke Case Reports Had Caused Health Canada to Recall Adderall in February 2005 Health Canada announced on August 24, 2005 that Adderall XR, an attention deficit hyperactivity disorder ("ADHD") drug,…
-
Scios / J&J to Educate Doctors Regarding Which Patients Should, and Should Not, Receive Natrecor
Guidance to Doctors Prompted by Natrecor Expert Panel or US DOJ Investigation of Sales Tactics? Johnson & Johnson’s Scios unit announced on August 22, 2005 the launch of a new program intended to educate…
-
Patients Discharged From Hospital Often Lack Sufficient Knowledge About Their Medications
Drug-safety Issue: Prescription Medication Noncompliance Due to Patient Misunderstanding In the August 2005 issue of Mayo Clinic Proceedings (Mayo Clin Proc 2005;80:991-994) a small study report suggests that poor communication with patients when being…
-
Abbott’s Weight-loss Drug Meridia Gets a Confidence Vote by FDA
FDA Denies Public Citizen’s Petition to Remove Meridia from Market The FDA has decided that the benefits of Abbott Laboratories’ prescription weight-loss drug Meridia continue to outweigh the drug’s risks for select obese…
-
Health Canada Not in Any Rush to Return Vioxx to Pharmacies
Expert Panel Finds That Vioxx is Safe Enough — But is it, Really? Health Canada is balking, so to speak, at the recommendation of an expert panel it appointed to consider the issue of…
-
Johnson & Johnson Attempts to Restrict Prescribing Of Heart-failure Drug Natrecor
Drug Company Warns Doctors Against "Off Label" Use of Natrecor at Clinics Johnson & Johnson is apparently acting on some two-month old advice from an expert panel of cardiologists in attempting to restrict the…
-
Celebrex “Black Box” Label Warning About Increased Cardiovascular Risks
"Class Effect": Like Bextra and Vioxx, Celebrex Can Cause Heart Attacks and Strokes The pharmaceutical company Pfizer Inc. announced on August 1, 2005 that the FDA had finalized a new label for the arthritis…
-
Hormonal Menopausal Therapy Classified as Carcinogenic by IARC
U.N. Research Agency Determines Hormone Therapy Regimen Slightly Raises Risk of Some Cancers In late July 2005, the International Agency for Research on Cancer — the United Nations’ cancer agency — announced its new…
-
Health Canada Issues Warning About Vision Loss Related to Viagra, Cialis, and Levitra
Two Case Reports of NAION in Canada Prompt Drug-safety Alert on ED Drugs On July 26, 2005 Health Canada advised users of the erectile dysfunction drugs Viagra, Cialis, and Levitra to seek "immediate medical…