Category Archives: FDA Warning

Methylphenidate ADHD Medications Drug Safety Communication

Share

Methylphenidate ADHD Medications: Drug Safety Communication – Risk of Long-lasting Erections Including Concerta, Daytrana, Focalin/Focalin XR, Metadate CD/Metadate ER, Methylin/Methylin ER, Quillivant XR, Ritalin/Ritalin LA/Ritalin SR AUDIENCE: Psychiatry, Family Medicine, Consumer ISSUE: FDA is warning that methylphenidate products, one type … Continue reading

Share
Posted in Consumer Products, Family Practice, FDA 2013, FDA Warning, Psychiatry | Tagged , , , , , , , , , , , , , , , , , | Comments Off on Methylphenidate ADHD Medications Drug Safety Communication

OxyElite Pro Health Advisory

Share

OxyElite Pro: Health Advisory – Acute Hepatitis Illness Cases Linked To Product Use AUDIENCE: Health Professional, Consumer ISSUE: The FDA, along with the Centers for Disease Control and Prevention (CDC) and the Hawaii Department of Health (DOH), are investigating a … Continue reading

Share
Posted in Consumer Products, FDA 2013, FDA Warning, Healthcare Professionals | Tagged , , , , , , , , | Comments Off on OxyElite Pro Health Advisory

Ortiga Public Notification

Share

Ortiga: Public Notification – Contains Hidden Drug Ingredient   AUDIENCE: Consumer, Patient, Health Professional ISSUE: The Food and Drug Administration (FDA) is advising consumers not to purchase or use Ortiga, an unapproved product promoted for a variety of health conditions … Continue reading

Share
Posted in Consumer Products, FDA 2013, FDA Warning, Healthcare Professionals | Tagged , , , , , , , , | Comments Off on Ortiga Public Notification

Healthy Life Chemistry By Purity First B50

Share

Healthy Life Chemistry By Purity First B-50: FDA Health Risk Warning – Undeclared Ingredients AUDIENCE:  Consumer, Health Professional ISSUE:  FDA is warning consumers that they should not use or purchase Healthy Life Chemistry By Purity First B-50, marketed as a … Continue reading

Share
Posted in Consumer Products, FDA 2013, FDA Warning, Healthcare Professionals | Tagged , , , , , , , , | Comments Off on Healthy Life Chemistry By Purity First B50

Magnesium Sulfate Recommendation Drug Safety Communication

Share

Magnesium Sulfate: Drug Safety Communication – Recommendation Against Prolonged Use in Pre-term Labor AUDIENCE: OB/GYN, Nursing, Risk Manager ISSUE: FDA is advising health care professionals against using magnesium sulfate injection for more than 5-7 days to stop pre-term labor in … Continue reading

Share
Posted in FDA 2013, FDA Safety Communication, FDA Warning, Nursing, OBGYN, Risk Manager | Tagged , , , , , , , , , , , | Comments Off on Magnesium Sulfate Recommendation Drug Safety Communication

Neptune 1 Silver and Neptune 2 Ultra Safety Communication

Share

Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra): Safety Communication – Reports of Serious Tissue Damage and Patient Death [UPDATE 03/15/2012] In the past 6 months, the FDA has become … Continue reading

Share
Posted in FDA 2013, FDA Safety Communication, FDA Warning | Tagged , , , , , | Comments Off on Neptune 1 Silver and Neptune 2 Ultra Safety Communication

Incretin Mimetic Drugs for Type 2 Diabetes

Share

Incretin Mimetic Drugs for Type 2 Diabetes: Early Communication – Reports of Possible Increased Risk of Pancreatitis and Pre-cancerous Findings of the Pancreas    AUDIENCE: Gastroenterology, Endocrinology, Oncology, Patient ISSUE: FDA is evaluating unpublished new findings by a group of … Continue reading

Share
Posted in Endocrinology, FDA 2013, FDA Warning, Gastroenterology, Oncology, Patients | Tagged , , , , , , , , | Comments Off on Incretin Mimetic Drugs for Type 2 Diabetes

Hamilton Medical Inc HAMILTON T1 Ventilators

Share

Hamilton Medical, Inc., HAMILTON-T1 Ventilators with Software Versions 1.1.2 and Lower AUDIENCE: Anesthesiology, Risk Managers ISSUE: During ventilation of small pediatric patients with high airway resistance and low lung function, there may be unexpected high internal oxygen consumption by HAMILTON-T1 … Continue reading

Share
Posted in Anesthesiology, FDA 2013, FDA Safety Communication, FDA Warning, Risk Manager | Tagged , , , , , , , , , | Comments Off on Hamilton Medical Inc HAMILTON T1 Ventilators

Samsca tolvaptan Drug Warning

Share

Samsca (tolvaptan): Drug Warning – Potential Risk of Liver Injury AUDIENCE: Gastroenterology, Nephrology, Pharmacy ISSUE: Otsuka and FDA notified healthcare professionals of significant liver injury associated with the use of Samsca. In a double-blind, 3-year, placebo-controlled trial in about 1400 … Continue reading

Share
Posted in FDA 2013, FDA Warning, Gastroenterology, Nephrology, Pharmacy | Tagged , , , , , , , , , , | Comments Off on Samsca tolvaptan Drug Warning

Pradaxa dabigatran etexilate mesylate Drug Safety Communication

Share

Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication – Should Not Be Used in Patients with Mechanical Prosthetic Heart Valves AUDIENCE: Cardiology, Patient ISSUE: The U.S. Food and Drug Administration (FDA) is informing health care professionals and the public that the … Continue reading

Share
Posted in Cardiology, FDA 2012, FDA Notice, FDA Warning, Patients | Tagged , , , | Comments Off on Pradaxa dabigatran etexilate mesylate Drug Safety Communication