We saw a TV commercial recently for the drug Otezla® (generic apremilast), from Celgene Corporation, which was approved by the FDA in 2014 for the treatment of symptoms of moderate to severe plaque psoriasis (skin lesions) and psoriatic arthritis.
Our attention was caught by the statement that Otezla is associated with an increase in adverse reactions of depression, suicidal thoughts, or suicidal behavior. We wondered why, since this drug is not used for psychiatric diagnoses, and psychiatric drugs all have such potential side effects.
The drug inhibits the enzyme phosphodiesterase 4 (PDE4), but the exact way in which it is supposed to work “isn’t completely understood”.
The estimated wholesale price is $22,500 for a year of treatment.
Digging deeper, we find that apremilast is an analog of thalidomide which was primarily prescribed as a psychotropic sedative or hypnotic and which was banned in 1961 for causing disastrous birth defects. Depression is also a common side effect of thalidomide.
In 1998 thalidomide was approved again by the FDA for use in multiple myeloma, a type of cancer, because it apparently had some kind of anti-inflammatory effect. It still is not known how it is supposed to work. Analogs of thalidomide were then developed to try to limit the side effects; an analog is a compound having a chemical structure similar to that of another one, but differing from it in respect of a certain component. Analogs are developed to see if they can improve upon the function of the base drug.
Well, apparently this one side effect — depression — did not get eliminated in the transformation from thalidomide to apremilast.
If someone has been given the full range of pros and cons for a drug or other treatment (i.e. full informed consent), with all applicable alternatives and even the alternative of no treatment, and then decides to take the drug or treatment, they made a fully informed decision. But we know that such informed consent is rarely, if ever, obtained prior to a psychiatrist or other doctor writing a prescription for a psychotropic drug. Click here to learn more about informed consent.