New Iloperidone (FANAPT) Is Not as Effective as Older Drugs For Schizophrenia Treatment

Iloperidone (FANAPT) was ap­proved by the Food and Drug Administration (FDA) in May 2009 for the acute treatment of schizophre­nia in adults and is the ninth atypical or second-generation antipsychotic on the market.

This new schizophrenia drug is not as effective as older, tested drugs used for the same purpose, such as haloperidol (HALDOL) or risperi­done (RISPERDAL). These results are found in the summary review of clinical trials that led to iloperidone’s approval.

New drugs might seem appeal­ing because consumers often assume that a new product offers some new benefit; this is frequently not the case with pharmaceuticals.

There is no law or regulation that says a new drug must be either safer or more effective, or even equally as effective, than older drugs already on the market. In fact, too often, new drugs turn out to be less safe than older drugs. Underscoring this point is the fact that 20 new drugs have been withdrawn from the market in the U.S. for safety reasons since 1992.

The FDA examined several clinical trials before approving iloperidone, but the long-term trials were too poorly done to be useful. Some of the short-term trials tested iloperidone against both a placebo and risperi­done. In several of these studies, ris­peridone was superior to iloperidone.

Another study compared iloperi­done to both a placebo and another, older, atypical antipsychotic called ziprasidone (GEODON). Iloperidone performed better than the placebo but about the same as ziprasidone.

FDA documents also demonstrate that three long-term clinical trials showed no difference between iloperi­done and the older first-generation antipsychotic haloperidol.

Special considerations before using iloperidone

There are at least two important issues that patients and their caregiv­ers should be aware of before making a decision to use iloperidone.

First, iloperidone is associated with electrical changes in the heart called prolongation of the QTc interval. This can lead to heart rhythm dis­turbances that can result in sudden death. It may be a good idea to check the electrocardiogram of patients us­ing the drug.

Second, the dose of iloperidone must be slowly adjusted to an ef­fective level. Thus, the control of symptoms may be delayed during the first one to two weeks of treatment compared with some other antipsy­chotic drugs that do not require a similar dosage adjustment. This is an important consideration for the acute treatment of schizophrenia.

What You Can Do

You should not use iloperidone. The Medical Letter concluded that, because of the heart rhythm prob­lems and the risk of fainting that, “Older drugs with longer records of efficacy and safety are preferred.” In clinical trials, this drug offers no greater benefit than the older drugs.

You should not discontinue the use of any antipsychotic medica­tion, including iloperidone, without consulting the prescribing health care provider.

Read the Medication Guide for iloperidone, available on the FDA’s website at http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm or from your local pharmacist.

Consumers may report serious adverse events or product quality problems with the use of iloperi­done or other products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

Online: https://www.accessdata.fda.gov/scripts/medwatch/med­watch-online.htm 
Regular Mail: Use postage-paid FDA form 3500 and mail to Med­Watch, 5600 Fishers Lane, Rock­ville, MD 20852-9787
Fax: (800) FDA-0178
Phone: (800) FDA-1088