Warning on an antipsychotic; generic rosuvastatin approval

This update covers new warnings on the entire class of opioids and approval of the first leadless pacemaker approved to treat heart rhythm disorders.


Recalls, safety alerts, and warnings

A warning and label change for fluoroquinolones, stating that their serious side effects generally outweigh benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections. In patients with these conditions, fluoroquinolones should be reserved for those without alternative treatment options. When used systemically, fluoroquinolones are associated with disabling and potentially permanent side effects involving the tendons, muscles, joints, nerves, and central nervous system.

Photo by ThinkStock
Photo by ThinkStock

A warning that aripiprazole (Abilify, Abilify Maintena, Aristada, and generics) may be associated with compulsive or uncontrollable urges. These behaviors (e.g., urges to gamble, eat, shop, and have sex) were reported to have stopped upon discontinuation or a reduction in dose. Clinicians should ask patients who are taking aripiprazole about any new or increasing urges and closely monitor those at higher risk for impulse-control problems.

A warning reminding that ketoconazole (Nizoral) oral tablets should not be prescribed to treat fungal infections of the skin and nails. These indications were removed in 2013 because the benefits were outweighed by serious risks, such as liver damage, adrenal gland problems, and harmful interactions with other medicines. Topical forms of the medication have not been associated with these side effects. Since the labeling change, 1 patient death due to liver failure associated with oral ketoconazole prescribed to treat a fungal nail infection has been reported. The tablet form should be used to treat serious infections caused by fungi only if other therapy is not available or tolerated.

A safety alert recommending cautious prescribing of oral fluconazole (Diflucan) in pregnancy, due to a Danish study finding a possible increased risk of miscarriage with the use of the drug for yeast infections. After a full review of the study is complete, the FDA will communicate final conclusions and recommendations.

A warning that a counterfeit version of the cancer drug carmustine for injection (BiCNU), 100 mg, has been detected in other countries. There is no indication that the counterfeit products have entered the U.S. drug supply chain. However, clinicians should carefully inspect the vials to ensure that the product is authentic before administering to patients.

A statewide recall in Nevada of all unexpired sterile products compounded by Well Care Compounding Pharmacy due to lack of sterility assurance. The recall, which was initiated after an FDA inspection, applies to all sterile compounded products distributed between Jan. 1 and April 29, 2016.

A warning not to use drugs intended to be sterile that were produced by Medaus Inc. due to lack of sterility assurance. The FDA requested that the compounding pharmacy recall all nonexpired lots of drug products intended to be sterile, but the company has refused to do so.

Approvals

The first generic version of rosuvastatin tablets, approved for the following uses: in combination with diet for the treatment of hypertriglyceridemia or hyperlipoproteinemia type III and either alone or in combination with other cholesterol treatments for adults with homozygous familial hypercholesterolemia. Common side effects include headache, myalgia, abdominal pain, asthenia, and nausea. This drug should not be used in women who are pregnant or may become pregnant, as it may cause fetal harm.

Pimavanserin (Nuplazid) tablets to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson's disease. A 6-week clinical trial of 199 participants showed the drug to be superior to placebo in decreasing the frequency and/or severity of hallucinations and delusions without worsening primary motor symptoms. As with other atypical antipsychotics, the medication contains a boxed warning about the increased risk of death associated with the use of these drugs to treat older people with dementia-related psychosis. The most common side effects are peripheral edema, nausea, and confused state.

Miscellaneous

An alert that an ongoing clinical trial found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with canagliflozin (Invokana, Invokamet). The FDA continues to investigate and has not determined whether the diabetes drug increases the risk of leg and foot amputations. Clinicians should continue to follow recommendations in the drug labels.

An approved brand-name change for the antidepressant Brintellix (vortioxetine) to help avoid prescribing and dispensing errors resulting from name confusion with the blood-thinning medication Brilinta (ticagrelor). The new brand name is Trintellix.

A request for clinicians to report more adverse events related to cosmetic products to the FDA. Manufacturers of these products are not required to report adverse events, so the agency relies heavily on information from clinicians, who submit only 1% to 3% of all related reports. Clinicians can report adverse events through MedWatch or by contacting their local FDA district office consumer complaint coordinator.