Following recent complaints that the prescription drug Accutane may be linked to depression and suicidal tendencies, the Food and Drug Administration has taken new strides to ensure that patients are fully aware of the effects of the drug.
Accutane, prescribed for cases of severe nodular cystic acne after other acne treatments have failed to work, has been scientifically proven to cause a range of birth defects in the fetuses of women taking the drug.
To ensure that patients are fully aware of these side effects, the FDA has approved a revised informed consent agreement all users are required to sign before receiving a prescription from their doctors.
“It will be helpful,” said Donna Chen, a pharmacist at Decker Drugs on South State Street. “Acne is so common, especially with teenagers.”
“It”s a medicine with pretty serious side effects, and this will certainly raise some attention,” she said.
According to a press release from Roche Pharmaceuticals, the drug”s manufacturer, “the form has 12 statements for the patient to read and initial, including risks associated with being pregnant while on Accutane and the potential for psychiatric events.” The form is reviewed by both male and female patients with their doctors.
In addition to the revised informed consent agreement, there are two other methods in place to ensure that users are educated about their risks.
A second form is signed only by female patients and focuses exclusively on the side effects concerning pregnancy. The second is a medication guide given to all patients by their pharmacists.
Carrie Coselman, a pharmacist at Village Apothecary on South University Avenue, said prior to the distribution of the new medication guide, pharmacists distributed a patient information sheet.
“The new guide is actually distributed by Roche Pharmaceuticals and goes into more detail. The other one was pretty general, and this is very extensive,” Coselman said.
Chen added that some pharmacies do even more.
“We usually print out the monograph and give that to the patient as well when they pick up their medication,” Chen said.
A monograph is a standard print-out that pharmacies issue upon filling a prescription. It explains proper usage of the drug.
The decision to revise the consent form and to add the medication guide were the result of a meeting last September by an FDA advisory committee. The committee recommended that because of the great risks associated with the drug, further efforts should be made to ensure the safety and education of patients. Among these was the drug”s possible relation of depression and suicidal tendencies.
Though the FDA confirms there is no clear causal link between the drug and incidences of psychotic events, the agency says there is enough evidence to cause suspicion of an association between the two.
As part of the effort to ensure safe use of the drug, the advisory committee has recommended the FDA work with several organizations, including the National Institutes of Health, to design a study to examine the possible link between Accutane and suicide.