Caveat Emptor!

It seems that once a week the FDA reports a worrying adverse effect of a previously approved therapy — not infrequently, a drug that has been used successfully for 10 or more years. These concerns tend to make the front page of major newspapers and our patients start to panic.

It is hard to find fault with the FDA doing its job.

My problem is that there is usually no filter between a patient getting the information and making a hasty decision to stop their medicine. There is a huge difference between the FDA removing a product from the market for safety reasons and frightening the community by broadcasting that they are looking into a possible adverse effect from an already approved drug. This is particularly a problem for patients taking a medicine for asymptomatic preventive therapy, such as hypertension or low bone mass, with 6-month intervals between clinic visits.

Despite their good intentions, the pharmacist may aggravate the situation as patients seek their advice about the need to stop therapy. As clinicians, we tend to feel comfortable with a relatively small number of drugs — certainly small in comparison to the exhaustive listing in Physicians’ Desk Reference (PDR). The pharmacist, in contrast, must be prepared to answer questions about any drug in the PDR; that is an impossible task. Pharmacists typically rely heavily on information provided by the head office and pass on information to the customer. In general, these label attachments have a lot to say about possible harmful effects of the drug, but very little — sometimes nothing — about the indications for use and the likely benefits.

Two cases come quickly to mind.

A patient was prescribed raloxifene (Evista, Eli Lilly) and the label attachment said the drug may affect cholesterol levels. A true statement, but the pharmacist had no idea that the major effect of raloxifene on cholesterol is to lower it.

Another patient picked up a prescription for clomiphene citrate only to read that it may cause vaginal bleeding. Are you surprised that the male patient was stunned? I explained, obviously not well enough, that this drug is used primarily for fertility in women but also improves testosterone levels in some men with hypogonadotropic hypogonadism.

There is no question that the patient has a right to know about a newly recognized, possible adverse effect of any drug providers prescribe. The FDA is correct to keep a watchful eye on possible adverse effects of approved therapies. Equally, the print, TV, radio and Internet media should report the information, but somewhere along the line the opportunity for an expert clinician to put these very preliminary observations/warnings into perspective.

As it now stands, within 24 hours of any such announcements by the FDA there are many attorneys who advertise for persons who might have taken one of the drugs and suffered a “serious side effect,” saying, “You may be entitled to compensation! Please call us immediately at 1-800 … !”

What can we do about this? I don’t profess to know, but can provide several suggestions:

Listen to the news on the radio on your drive to or from work. An FDA warning is likely to be included in the broadcast.
Be comfortable with the medications you prescribe/use regularly, particularly those that have been on the market for a few years.
Be prepared to point out that your patient has received clinical benefit from your prescription; that the association with a late finding of a possible newly recognized adverse effect is extremely uncommon; and the odds of your patient experiencing this adverse reaction are minimal.
Be prepared to prescribe a different therapy with similar benefits, preferably from a different class of drugs.