How do you know what side effects your drug can cause? If you ask doctors or pharmacists, they often will consult the official prescribing information sanctioned by the Food and Drug Administration. This is considered the ultimate authority on how to use the medicine and what to expect from it.
Sadly, this resource is flawed. The trouble is that it can take years, or even decades, for significant drug problems to emerge. For example, fluoxetine (Prozac) was launched in the U.S. in 1988 as the first of a new type of antidepressant called a selective serotonin reuptake inhibitor (SSRI).
Within a few years, it had become a best-seller that spawned many similar drugs, from citalopram (Celexa) and paroxetine (Paxil) to sertraline (Zoloft) and venlafaxine (Effexor). Side effects such as weird dreams, drowsiness, fatigue, dizziness, nausea and diarrhea were noticed right away.
Sexual problems took longer to be detected, although well more than half of the people taking such medicines report low libido, inability to achieve orgasm or erectile dysfunction when questioned.
Just last month, a new side effect surfaced. SSRIs are widely prescribed for many conditions other than depression or anxiety. They can be helpful for the hot flashes and night sweats of menopause, and may be prescribed to help control them. One drug, paroxetine (Brisdelle), has been specifically approved for this purpose.
A study covering 137,031 perimenopausal women with no diagnosis of depression found that those taking SSRI medications were significantly more likely to suffer a bone fracture during the 12 years from 1998 to 2010 (Injury Prevention online, June 25, 2015).
The comparison group was 236,294 women matched for age, but taking heartburn pills instead of SSRIs.
Is there a way to discover such complications sooner, so that doctors and patients alike could be aware of them? This would help doctors decide if a specific drug might be a good choice for a particular patient, and it would certainly help patients decide if they want to chance the risks inherent in taking the drug.
The FDA is testing a way to let patients help. The agency is partnering with a patient network called PatientsLikeMe.com. On this website, more than 350,000 members trade information about symptoms and treatments for the 2,500 or so conditions that they suffer. This is a much larger number of people than the relative handful – a few hundred to a few thousand – who participate in clinical trials of a new drug.
PatientsLikeMe gives its members an easy way to report their experience to the FDA. Since patients have the most “skin in the game,” they are likely to take more time than doctors or pharmacists to give reports of potential drug reactions.
Readers of this newspaper column have been reporting adverse drug reactions for decades. Through them we learned that SSRIs cause a high rate of sexual side effects, and that was before the FDA recognized the problem. We also heard about blood-sugar elevations with statin-type cholesterol-lowering drugs. Our readers have reported rebound hyperacidity and horrible heartburn upon stopping acid-suppressing drugs such as omeprazole.
We, too, report these signals to the FDA. Anyone wishing to share his experience can do so at PeoplesPharmacy.com.