Captain's Quarters Blog

« Once Around the Axis, and Others | Main | My Political Compass »

November 2, 2003
Off-label drug use growing

If you take prescription medication, you should read this entire article on "off-label" prescriptions:

A six-month Knight Ridder investigation has found that patients nationwide are being injured and killed as doctors routinely prescribe drugs in ways the FDA never certified as safe and effective.

Moreover, these unapproved prescriptions are soaring. In the past year, 115 million such prescriptions were written, nearly double the number of five years ago, a Knight Ridder analysis of prescriptions for the country's top-selling drugs found.

The practice, called off-label prescribing, often is driven by questionable research, aggressive drug company marketing and cavalier doctors, and condoned by tepid regulators.

The story details the practice of giving medications for conditions not specifically targeted by the medicine, such as anti-depressants for premature ejaculation, even if no studies exist to validate such use. Doctors aren't prepared for the possible damage these off-label prescriptions cause:

Victims of off-label prescribing whom Knight Ridder interviewed have suffered heart attacks and strokes, had permanent nerve damage or lost their eyesight. Most said they never were told the FDA hadn't approved their treatments.

Based on the FDA's own data, Knight Ridder estimates at least 8,000 people became seriously ill last year after taking some of the nation's most popular drugs for off-label uses. The true number is likely to be many times higher.

The First Mate has several chronic health conditions and takes a number of medicines for these, but even when used as intended, certain medications can be harmful if taken for longer than designed. One example given is Reglan, which the First Mate just began using for diabetic gastroparesis:

In 2001, Glenna Baker, a loan officer from Burke, Va., came down with a debilitating stomach disorder that was suspected to be diabetic gastroparesis. She vomited repeatedly, prompting a specialist to prescribe Reglan. The FDA has approved the drug to be used for less than three months at a time, but studies have found that it's frequently prescribed improperly and that long-term use exposes patients to unnecessary side effects.

One of the worst is tardive dyskinesia, a condition that causes relentless body tremors and facial tics. Baker, now 55, said she was never told about this, so when she moved into her fourth month on the drug she didn't realize what was happening when she began to twitch every now and then. ... Today, Baker is out of work; the tremors make holding a job impossible. She can sit only for short spells; her right leg constantly bounces, and she endlessly wrings her hands.

That opened my eyes, and we will discuss this treatment immediately with her physicians. How many people take Reglan without knowing these consequences? My advice to all is this: when prescribed any new medication, Google it immediately, or failing that, ask the pharmicist when you buy it about any potential consequences. Read the entire article; there are several other medications discussed in detail.

IMHO, the Pioneer Press outclasses its competition, the Star Tribune, by a country mile. I just wish they would design a better website in order for people to realize it.

Sphere It Digg! View blog reactions
Posted by Ed Morrissey at November 2, 2003 3:37 PM

Trackback Pings

TrackBack URL for this entry is

Design & Skinning by:
m2 web studios

blog advertising


Proud Ex-Pat Member of the Bear Flag League!