FDA updates oral nizoral label to reflect safety concerns

FDA updates oral nizoral label to reflect safety concerns
The U.S. Food and Drug Administration has approved label changes for Nizoral (ketoconazole) oral tablets and added a Medication Guide detailing various associated safety concerns.

(HealthDay)—The U.S. Food and Drug Administration has approved label changes for Nizoral (ketoconazole) oral tablets and added a Medication Guide detailing various associated safety concerns.

Nizoral tablets can cause , potentially necessitating transplantation or resulting in death. The Boxed Warning has been revised to include a strong recommendation against its use in patients with liver disease, and new recommendations for assessing and monitoring for . Nizoral can cause adrenal insufficiency by decreasing production of corticosteroids; should monitor adrenal function in patients taking Nizoral who have existing adrenal problems or who are under prolonged periods of stress. The precautions section of the drug label has been updated to include information of potential drug interactions. The FDA has also approved a Medication Guide with information on the potential risks linked with oral Nizoral use. Topical formulations of Nizoral have not been associated with liver damage, adrenal problems, and drug interactions.

Oral Nizoral tablets should no longer be a first-line treatment for any fungal infection, and should only be used for endemic mycoses when alternative antifungal therapies are unavailable or not tolerated. Use of Nizoral tablets should be limited by removing indications where the risks outweigh the benefits of treatment.

"[We] will continue to evaluate the safety of Nizoral tablets and will communicate with the public again if additional information becomes available," according to the FDA.

More information: More Information

add to favorites email to friend print save as pdf

Related Stories

FDA reports Samsca may cause liver damage

May 02, 2013

(HealthDay)—After reviewing data from recent large clinical trials, the U.S. Food and Drug Administration has determined that Samsca (tolvaptan) should not be used for longer than 30 days and should not ...

FDA: Samsca may cause irreversible liver damage

Jan 26, 2013

(HealthDay)—Patients who take Samsca (tolvaptan) may be at elevated risk for significant liver injury, according to a Jan. 25 safety alert issued by the U.S. Food and Drug Administration.

Signifor approved for Cushing's disease

Dec 17, 2012

(HealthDay)—Signifor (pasireotide diaspartate) has been approved by the U.S. Food and Drug Administration to treat Cushing's disease in cases that cannot be treated by surgery.

Aubagio approved for multiple sclerosis

Sep 13, 2012

(HealthDay)—Aubagio (teriflunomide) has been approved by the U.S. Food and Drug Administration to treat adults with relapsing forms of multiple sclerosis (MS).

Recommended for you

Health care M&A leads global deal surge

16 hours ago

In a big year for deal making, the health care industry is a standout. Large drugmakers are buying and selling businesses to control costs and deploy surplus cash. A rising stock market, tax strategies and ...

US approves new, hard-to-abuse hydrocodone pill (Update)

Nov 20, 2014

U.S. government health regulators on Thursday approved the first hard-to-abuse version of the painkiller hydrocodone, offering an alternative to a similar medication that has been widely criticized for lacking ...

Soaring generic drug prices draw Senate scrutiny

Nov 20, 2014

Some low-cost generic drugs that have helped restrain health care costs for decades are seeing unexpected price spikes of up to 8,000 percent, prompting a backlash from patients, pharmacists and now Washington ...

Only half of patients take their medications as prescribed

Nov 20, 2014

The cost of patients not taking their medications as prescribed can be substantial in terms of their health. Although a large amount of research evidence has tried to address this problem, there are no well-established ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.