FDA MedWATCH

Angiotensin Receptor Blockers (ARBs): Drug Safety Communication - Drug Safety Review Completed

[UPDATED 06/02/2011] FDA’s meta-analysis of 31 randomized controlled trials comparing ARBs to other treatment found no evidence of an increased risk of incident (new) cancer, cancer-related death, breast cancer, lung cancer, or prostate cancer in patients receiving ARBs.

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm219185.htm

Thermographic Imaging Systems for Breast Cancer Screening: FDA Safety Communication

[Posted 06/02/2011]

AUDIENCE: Consumers, Patients

ISSUE: FDA notified consumers, women who participate in breast cancer screening and healthcare professionals that thermography is not a replacement for screening mammography and should not be used by itself to diagnose breast cancer. Thermographic systems use an infrared camera to produce images (thermograms) that show the patterns of heat and blood flow on or near the surface of the body. The FDA is not aware of any valid scientific data to show that thermographic devices, when used on their own, are an effective screening tool for any medical condition including the early detection of breast cancer or other breast disease. The FDA is concerned that women will believe these misleading claims about thermography and not receive needed mammograms.

BACKGROUND: Certain facilities, websites, and mobile units are promoting the use of thermography as a stand-alone evaluation tool for screening and diagnosing breast cancer, claiming that is a substitute for or superior to mammography. They also claim that thermography can detect pre-cancerous abnormalities and diagnose breast cancer long before mammography and that compressing the breast during mammography will cause or spread cancer by pushing cancer cells into additional locations in the body.

RECOMMENDATION: Woman should have regular mammograms according to screening guidelines or as recommended by a health care provider. Patients should follow a health care provider's recommendations for additional breast diagnostic procedure which could include thermography, clinical breast exam, breast ultrasound, MRI or biopsy.

Read the MedWatch safety alert, including links to the FDA Safety Communication, News Release, Consumer Update and other resources at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257707.htm
Aidapak Services Repackaged Pharmaceuticals: Recall - Potential Cross Contamination with Beta Lactam Products


AUDIENCE: Pharmacy, Risk Manager

ISSUE: FDA and Aidapak Services notified healthcare professionals and hospital pharmacies of a nationwide recall of multiple repackaged drug products after learning of the potential cross contamination of non-penicillin drug products that were repackaged in the same facility. There is the potential for serious anaphylactic reaction in patients with known hypersensitivity to beta-lactam or penicillin products that could result from using these recalled products.

BACKGROUND: Please click on the link in the firm press release to view a complete listing of products affected by this recall. All products affected by this recall are stamped with Aidapak's packaging stamp.

RECOMMENDATION: Hospitals, Emergency rooms, clinics and other healthcare facilities should stop distributing these products immediately and quarantine the products, and then contact Aidapak Services for return instructions.

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257723.htm