How long does it take for a drug regulator to act after receiving alarming reports from doctors about a drug? A few weeks? Perhaps a few months? How about seven years.
That is the time it has taken the US drug regulator, the Food and Drug Administration (FDA), to respond to reports about the acne drug Roaccutane (isotretinoin), marketed in the US as Accutane.
Concerns about the drug were first raised in Australia in 1993 after a woman gave birth to a severely malformed baby. She had been using the drug before conception and for the first five weeks of gestation.
This soon became such a concern that the drug manufacturer tried to educate users to take contraception before starting the drug. Despite this, a large number of babies in the womb were put at risk because women started the treatment while pregnant. And doctors were blissfully prescribing the drug when they really should have known better.
The drug has also caused miscarriage, premature birth or the death of the baby. The Center for Drug Evaluation and Research in the US says that “there is an extremely high risk that a baby will be deformed or will die” if the patient is pregnant when taking the drug.
Another concern is that the drug might trigger depression and other serious mental problems, including suicidal thoughts. Some patients have actually taken their own lives.
So, finally, the FDA has decided to act. It has issued a letter to all health practitioners, alerting them to the dangers. It is also changing the warning on the product label. All this after seven years of reports of something being seriously wrong.
Now all we have to do is get the doctor to read it.