If finding the right medication feels a bit like a minefield lately, it’s no wonder.
It’s not been a banner time for Pharma—these past few years. So many drugs and medical products in general seem to be linked with serious, if not life-threatening adverse events. You may recognize some of the names on the hit parade: drugs such as Accutane and a possible link with inflammatory bowel disease (IBD); proton pump inhibitors (antacid drugs) and increased risk for hip fractures; Reglan and its link with Tardive Dyskinesia; Byetta—a diabetes medication linked with kidney failure…
And of course no list would be complete without Avandia—another diabetes medication—and its infamous association with serious, sometimes fatal cardiovascular events.
Oh—there’s also allegations surrounding the class of antidepressants known as SSRIs and links with newborn heart defects. In fact the list is exhaustive.
And to be clear, it’s not just drugs. Products such as the DePuy metal hip replacement are also in trouble. DePuy is currently facing a class action lawsuit over failure rates seen with its ASR acetabular cup. DePuy, which is owned by Johnson & Johnson, has also had global product recalls.
Gadolinium is another one. It’s a clear, non-radioactive chemical compound used with patients undergoing magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA). In 1988 the FDA approved gadolinium as a contrast agent to provide a clearer picture of organs and tissues. Since that time, more than 200 cases of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) have been linked to the product.
This week, news out on Bloomberg indicates that the powers that be at Pfizer Inc, ‘failed to properly warn doctors and consumers that its Prempro menopause drug could cause Read the rest of this entry »
A news article in today’s NY Daily News has this for a headline:
“Breastfeeding could save many babies’ lives, billions of dollars: Pediatrics Journal”
Fine. Those of us who’ve been pregnant at some point in the last few decades would need to have lived in a cave on Mars to have missed the “Breastfeeding is good for your baby!” memo.
And so, yes, here we have another study that’s been done to tout breast milk.
Translation: another study to lend more ammunition to those who would like to see formula feeding labeled as a punishable crime.
I stress here that I agree that breast-feeding is beneficial to babies—I don’t argue that.
But as I had posted about breastfeeding and Reglan, it’s the guilt-trip that those who deem themselves as the arbiters of baby’s health and well-being impose upon moms-to-be and moms who are just hours post-delivery.
This barrage of breast milk goodliness, while well-intentioned, sends mothers—many of whom simply cannot breast feed when left to their own bodily devices—into a state of panic: I’m not lactating…am I producing enough?…how do I know if baby is getting enough nutrition?…
And they turn to drugs—like off-label Reglan—and homeopathy, massage techniques, pumps—you name it Read the rest of this entry »
Use of Reglan for babies with GERD issues—particularly premature babies—as well as using Reglan to stimulate milk production for breastfeeding are hot topics on mommy message boards all over the internet. Boards about colic, GERD, low milk production, premature births, and even morning sickness debate the pro’s and con’s of using Reglan to provide relief—or help things get moving properly.
But it’s also a well-known fact that Reglan can only be prescribed off label for the above uses, and that no studies have been done on the effects of Reglan on infants. All we know is that Reglan carries a black box warning for Tardive Dyskinesia and that there’s a mixed bag of anecdotal experiences on all the mommy message boards and forums out there.
So why is this what’s written about Reglan use in infants with regurgitation, reflux or GER on the California Pacific Medical Center’s website?…
Medications
When basic measures fail to control symptoms, medication may be indicated. Usually, two types of medication are used. Acid-blocking medications (famotidine/Pepcid, ranitidine/Zantac, cimetidine/Tagamet, omeprazole/Prilosec and lansoprazole/ Prevacid) suppress stomach acid and prevent it from doing damage to the esophagus and lungs. Pro-motility agents (bethanechol, metoclopramide/Reglan, cisapride/ Propulsid) help to strengthen the tone of the lower sphincter and increase gastric emptying. For children these medications are by prescription only.
All of these medications are safe in infants and children [my bolding] and have only minor side effects. If your child experiences side effects, we will adjust the dose or change medication.
No qualifying statements or footnotes. No references to use of Reglan in this capacity being off-label. No mentions of the info you’ll see on rxlist.com (run by webmd.com) for Reglan use in children, which reflects Reglan’s monograph:
Pediatric Use
Safety and effectiveness in pediatric patients have not been established (see OVERDOSAGE).
Care should be exercised in administering metoclopramide to neonates since prolonged clearance may produce excessive serum concentrations (see CLINICAL PHARMACOLOGY – Pharmacokinetics). In addition, neonates have reduced levels of NADH-cytochrome b5 reductase which, in combination with the aforementioned pharmacokinetic factors, make neonates more susceptible to methemoglobinemia (see OVERDOSAGE).
The safety profile of metoclopramide in adults cannot be extrapolated to pediatric patients. Dystonias and other extrapyramidal reactions associated with metoclopramide are more common in the pediatric population than in adults. (See WARNINGS and ADVERSE REACTIONS – Extrapyramidal Reactions.)
What gives California Pacific Medical Center?
There are women who breastfeed, and there are women who don’t. I’m not going into pro’s and con’s here (or a debate on breastfeeding 4 year olds, or public displays of breasts)—but suffice to say, if you’ve been pregnant, you have undoubtedly found yourself signed up for two things associated with the letter “L”: Lamaze and La Leche League training—otherwise known as breastfeeding 101. You may have your own opinions about both practices surrounding the joy of childbirth, but no matter. You will be highly “encouraged” to attend these classes.
Encouragement to be a “good mother” is always good; but unfortunately if you decline attendance—or worse—attend but voice some reservations or lack of desire to follow the script, you feel yourself being labelled…identified…duly noted…as the dissenter in class. Other moms-to-be will cast disparaging glances in your direction like you JUST. DON’T. GET IT. And you begin to internalize the negative vibes and start to question yourself.
God bless Cindy Crawford and her at-home, no meds deliveries. I am not Cindy. And I knew that no amount of huff-huff-puff-puff timed breathing while tightly gripping a pillow was going to delude me into thinking I could breathe through the pain. Nurse!! Where’s that &#@%ing epidural I ordered up!??
Breastfeeding was a different story. So many studies done to back up its healthiness. The benefits of bonding. The primal back-to-nature, this-is-what-it’s-all-about thing. Reduced rates of viral infection. Smart babies. On and on. Throw some Baby Einstein in and we’ll be off the WISC IQ scoring charts! Ok, sign me up! Pump for $200? Sure—I’ll take one!
Then…uh-oh…baby’s here and…NA-DA.
All the planning gone to hell. Why? A little thing called “complications”. (Not epidural-related for you Lamaze lovers out there). And so begins the guilt. The what-ifs. The what-now’s? Is my baby already underweight??
La Leche will offer you a figurative shoulder to cry on, along with some resources and guidance. And some well-meaning websites will share with you your “options” to get that milk flowing. One option: Reglan. Reglan’s called a “prescription galactagogue”. Funny thing about Reglan though (and Read the rest of this entry »
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.