FDA News: Warning Issued for Ziprasidone; Saxenda Approved for Weight Loss

syringeThe FDA is advising providers to warn their patients that the antipsychotic ziprasidone (Geodon) in rare cases can cause a severe, potentially deadly, skin reaction.

A federal Drug Safety Communication, released in December 2014, reported recent data connecting ziprasidone to DRESS—Drug Reaction with Eosinophilia and Systemic Symptoms.

DRESS is a medication reaction that begins with a rash, but can progress to fever, swollen lymph nodes, excess white blood cells, and possible systemic complications such as inflammation of the liver (hepatitis), kidneys (nephritis), lungs (pneumonitis), pancreas (pancreatitis) or the heart (myocarditis, pericarditis). There is no specific treatment for the condition; treatment is mostly focused on managing symptoms. DRESS can be fatal.

Patients on ziprasidone with a rash accompanied by fever or swollen glands should seek immediate medical attention and health care providers should have patients with these symptoms stop taking ziprasidone, according to the FDA.

A recent review of six patients on ziprasidone who developed DRESS prompted the FDA to release this warning. The drug labeling has been edited to include this adverse effect, as well. All six of the patients studied—who developed symptoms of DRESS between 11 and 30 days of starting ziprasidone—survived the reaction. Three of the patients were taking other medications that also carry the risk of DRESS.

Other medications associated with DRESS include lamotrigine (Lamictal), carbamazepine (Tegretol), phenytoin (Dilantin), phenobarbital, sulfasalazine, the HIV drug nevirapine (Viramune), and the gout medication allopurinol.

The warning can be read here.

FDA Approves Saxenda for Weight Management

In December 2014, the FDA approved Novo Nordisk’s Saxenda (liraglutide [rDNA origin] injection) for chronic weight management.

Saxenda is for adults with a body mass index (BMI) of 30 or greater or adults with a BMI of 27 or greater, who also have at least one weight-related condition such as hypertension, type 2 diabetes, or high cholesterol.

Saxenda should not be used in people with a personal or family history of certain types of thyroid disease, or in those already taking glucagon-like peptide-1 (GLP-1) receptor agonists, such as the type 2 diabetes drugs Victroza and Byetta, as these medications contain the same active ingredients as Saxenda.

In a clinical trial, patients taking Saxenda lost an average of 4.5% body weight. All patients also received counseling on a healthy diet and exercise plan. The most common side effects of Saxenda are GI-related, but serious side effects can include suicidal thoughts, pancreatitis, gallbladder disease, and renal impairment.

Saxenda joins a growing market: the weight loss drug Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release) was approved earlier in 2014, and both Belviq (lorcaserin) and Qsymia (phentermine and topiramate extended-release) were approved in 2012. Before that, it had been 13 years since a new weight loss drug had been approved by the FDA.

More information on Saxenda can be found on the FDA website.

Photo courtesy of Victor on Flickr 

FDA News: Warning Issued for Ziprasidone; Saxenda Approved for Weight Loss