Archive for August, 2007

Drug Safety Update

admin August 15th, 2007

The MHRA have published the first issue of the replacement for Current Problems in Pharmacovigilance, Drug Safety Update. Drug Safety Update is planned to be a monthly publication, which will mean that the MHRA will be providing a much higher rate of publications than in previous years. Hopefully this service will be of use to practitioners. The MHRA are also asking for feedback about their new publication via a web survey – so do let them know what you like and how it might be improved.

The first issue includes information about:

  • Gadolinium-containing MRI contrast agents: nephrogenic systemic fibrosis
  • Cabergoline: cardiovalvulopathy
  • Antidepressants: suicidal behaviour
  • Yellow Card scheme: reporting trends and latest data
  • Smoking-cessation aids
  • Isotretinoin for severe acne
  • Extraneal and products that contain (or are metabolised to) maltose, xylose, or galactose: false glucose reading
  • α1-adrenoreceptor antagonists and intraoperative floppy iris syndrome
  • Linezolid: restriction of indication
  • Dopamine agonists and pathological gambling, increased libido, and hypersexuality

Thiazolidinediones and heart failure

admin August 15th, 2007

The FDA strengthen warnings about thiazolidinediones:

After a review of postmarketing adverse event reports, FDA determined that an updated label with a boxed warning on the risks of heart failure was needed for the entire class of antidiabetic drugs.

These drugs are used in conjunction with diet and exercise to improve blood sugar control in adults with type 2 (non-insulin-dependent) diabetes. Manufacturers of certain drugs have agreed to the upgraded warning.

The strengthened warning advises healthcare professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered. People who have questions should contact their healthcare providers to discuss alternative treatments.