DRUG SAFETY COMMUNICATION

Drug update By Shamna.M

DRUG SAFETY COMMUNICATION

·                  Samsca (tolvaptan): Drug Warning - Potential Risk of Liver Injury

The manufacturer 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 patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and its open-label extension trial, 3 patients treated with the drug developed significant increases in serum alanine aminotransferase (ALT) with concomitant, clinically significant increases in serum total bilirubin. In the trials the maximum daily dose of Samsca administered (90 mg in the morning and 30 mg in the afternoon) was higher than the maximum 60 mg daily dose approved for the treatment of hyponatremia.   

·                  Incretin Mimetic Drugs for Type 2 Diabetes: Early Communication - Reports of Possible Increased Risk of Pancreatitis and Pre-cancerous Findings of the Pancreas

FDA is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics such as exenatide (Byetta, Bydureon),liraglutide (Victoza), sitagliptin (Januvia,Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina,Kazano, Oseni), and linagliptin (Tradjenta,Jentadueto). These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes. FDA has asked the researchers to provide the methodology used to collect and study these specimens and to provide the tissue samples so the Agency can further investigate potential pancreatic toxicity associated with the incretin mimetics. These drugs work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. They are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

DRUG RECALLS

§   Night Bullet: Undeclared Drug Ingredient

Analytical tests conducted by the FDA found that the dietary supplement product Night Bullet contains trace amounts of Sulfohydroxyhomosildenafil and Aminotadalafil, which are analogues of sildenafil. Sildenafil is the active pharmaceutical ingredient in an FDA-approved drug that is used to treat erectile dysfunction (ED), making this product an unapproved drug.

§   Maxiloss Weight Advanced Softgels:  Undeclared Drug Ingredient

FDA testing found that the Maxiloss Weight Advanced product to contain Sibutramine. Sibutramine was a previously approved controlled substance for the treatment of obesity that was removed from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.

§   Omontys (peginesatide) Injection by Affymax and Takeda: Recall of All Lots - Serious Hypersensitivity Reactions

U.S. Food and Drug Administration (FDA) and the manufacturer are informing the public of a voluntary recall of all lots of OMONTYS® (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal.

§   Vistide (Cidofovir Injection) by Gilead:  Presence of Particulate Matter

§   Triaminic, Theraflu Cough/Cold Syrups Recalled Due to Safety Cap Problems