Postmarket Safety

FDA Probe Into Plan B Effectiveness May Prompt Label Changes

The FDA is investigating reports that emergency contraceptives such as Teva’s Plan B One-Step lose effectiveness in women over 165 lbs. and don’t work at all for women over 175 lbs. Based on its review, labeling changes for the drugs may be forthcoming. Read More

FDA Relaxes Avandia Restrictions

Three years after placing heavy restrictions on GlaxoSmithKline’s type 2 diabetes drug Avandia, the FDA said Monday it is relaxing those restrictions in line with its advisers’ recommendations. Read More

Roche Escapes EMA Rebuke on Drug Safety

The European Medicines Agency (EMA) has concluded a review of adverse event reporting deficiencies at Roche, concluding the company’s failure last year to report adverse events for 19 drugs did not cause any additional risks to consumers. Read More