Sixteen years ago, the Health Research Group of Public Citizen published a report in its Worst Pills, Best Pills News regarding the heartburn drug Reglan and the link to tardive dyskinesia-often an incurable and irreversible disorder. But the FDA didn’t slap a black box warning on this treatment for heartburn until last February, 2009. Talk about closing the barn door after the horse has bolted…
When you consider how many people are prescribed Reglan–dispensed 6.5 million times in 2008–it’s mind-boggling that the FDA didn’t act sooner.
My friend suffers from tardive dyskinesia and it’s not a pretty sight. His eye is constantly twitching and he can barely control his jaw when he’s talking-like he’s grimacing all the time. Some people think he has Parkinson’s disease. Because of this disorder, he lost a job in retail and now works as a line cook in a chain restaurant-a job that doesn’t suit him.
My friend is 50. He doesn’t know how he got this disorder and neither does his doctor, but he does remember taking a med for heartburn years ago…
The FDA approved metoclopramide, the generic name, way back in June 1985. I wonder how many people have tardive dyskinesia and took Reglan years ago and haven’t connected the dots?
This is how Reglan works: it stimulates the muscles of the gastrointestinal tract including the muscles of the lower esophageal sphincter, stomach, and small intestine . That in turn stimulates more rapid emptying of the stomach as well as decreasing the reflux of stomach acid into the esophagus. Some patients, particularly those with diabetes, have nerve damage in the stomach and that causes delayed emptying of the stomach, resulting in heartburn and other symptoms.
I’d take heartburn over tardive dyskinesia any time. Or take another drug for heartburn!
Getting back to Public Citizen, I’m a big fan. When my doctor prescribes a new med, Worst Pills, Best Pills is my bible. You can subscribe to their website and get more current news than the FDA provides, or biased information from the drug companies.
And what about your doctor? Most of us trust our physicians to prescribe the right meds and think it unfathomable that we could be given a harmful drug. Yesterday I asked health expert Judy Norsigian of Our Bodies Ourselves to shed some light on the doctor dilemma with drugs.
She told me that many doctors don’t keep track of the latest findings and what happens with post-marketing surveillance. “Reports from the medical community usually become one of the key ways we find out about low level effects of any drugs, and not all the information from clinical trials, because there are not enough [people] involved in the trials to collect data,” Norsigian explained. ” And doctors are not always paying attention, so they aren’t even aware that there is a problem…”
All the more reason to do your own research, both online and by talking to your doctor and pharmacist about possible side effects. Another great source is the online Physicians’ Desk Reference. Just keep in mind that you can’t rely on the FDA (the “Foot Dragging Administration” as columnist Herb Denenberg calls it) to protect you.
Pregnant women are understandably cautious about what drugs and supplements they take-and this can be a problem for many women who suffer from debilitating morning sickness. What can you take that’s safe?
The New England Journal of Medicine (NEJM) published a new study this week, “The Safety of Metoclopramide Use in the First Trimester of Pregnancy“; Metoclopramide may sound familiar—it’s the name of the drug more commonly known as Reglan.
The results of the study are getting attention because the study, which was carried out in Israel, was apparently one of the largest of its kind to date. The results of the study were as follows:
There were 113,612 singleton births during the study period. A total of 81,703 of the infants (71.9%) were born to women registered in Clalit Health Services; 3458 of them (4.2%) were exposed to metoclopramide during the first trimester of pregnancy. Exposure to metoclopramide, as compared with no exposure to the drug, was not associated with significantly increased risks of major congenital malformations (5.3% and 4.9%, respectively).
Given that Reglan—which is typically prescribed for acid reflux (GERD)—was given a black box warning by the FDA earlier in the year for its connection to Tardive Dyskinesia (characterized by involuntary, repetitive movements of the extremities, lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering, pursing of the lips, or impaired movement of the fingers), it’s hard to imagine taking such a drug while pregnant.
So it will be interesting to see what, if anything, the FDA will do based on the results of this latest study. For now, Reglan remains classified by the FDA as a Pregnancy Category B drug-meaning they don’t have enough information to determine if it does cause problems.
So you’re pregnant, you’re heavy, you’re tired, and you’re suffering from indigestion and nausea quite badly. This is typically a situation beyond the ability of Alka-Seltzer to remedy. One of the medicines currently available to treat acid reflux (GERD) and nausea is Reglan, and it may be recommended to pregnant women in some instances, in the tablet formulation. The only problem is there’s a chance, slim perhaps, but still a chance your indigestion might be replaced by tardive dyskinesia—a movement disorder syndrome. And there’s also the question of what it could do to the fetus. So what should you do?
1. Approved for 12-week use. Reglan is only approved to be taken for up to 12 weeks, though it’s often prescribed for longer time periods.
2. Generic name is Metoclopramide. Check your prescription label as you may in fact be taking a generic version of Reglan, but not be aware that you are.
3. Prescribed for more than Acid Reflux (GERD). Reglan is a gastrointestinal stimulant, but it’s also an anti-nauseant. It’s prescribed for Gastroesophageal Reflux Disease, Diabetic Gastroparesis (Diabetic Gastric Stasis), and Renal or Hepatic Impairment.
4. Linked to Tardive Dyskinesia. Reglan has been linked to Tardive Dyskinesia, which involves abnormal and involuntary repetitive movement. Tardive dyskinesia is often permanent, and there is no known effective treatment.