Fracture Risk and Acid Blocking Medications: What Should You Do?

Yesterday, the FDA released a Drug Safety Communication warning about a possible risk of increased fractures with acid blocking medications called proton pump inhibitors or PPI's.

PPI's have been a major advance in medical science. Prior to these and ealier medications, the treatment for severe gastroesophageal reflux disease (GERD) was major surgery. PPI's are now commonly prescribed for GERD and less serious heart burn, many are generic, and some are now sold over the counter. The popular PPI's include Nexium (esomeprazole), Prilosec (omeprazole), Prevacid (lansoprazole), and Protonix (pantoprazole) which are available by prescription. Prilosec OTC and Prevacid 24HR are sold over-the-counter (OTC). Given the use and popularity of these medications, this warning may cause great concern among patients who rely on these medications.

What did the FDA find?
The FDA analyzed the data from several epidemiologic studies in thousands of patients studied for several years and in 6/7 studies found a greater risk for certain kinds of fractures when patients took PPI's. These risks seemed to be the greatest when patients were taking the medications regularly, for a long time, and at a high dose.

So is this a real problem?
Maybe. It is important to know that the gold standard of studies is the randomized clinical trial (RCT). Only RCT's can prove a cause and effect. None of the RCT's with PPI's thus far have shown and increase fracture risk with PPI's. The problem with RCT's is that they are hard to do and are usually limited in time (6 months) and have fewer patients. So a rare but serious side effect is unlikely to be picked up in an RCT. The epidemiologic studies are useful, but have limitations (which the FDA readily points out). These studies are case-control, meaning they look for people who had fractures, find similar people who didn't have fractures, and then see how common PPI use was in each group. Though the studies show that people with fractures were more likely to take PPI's than people without fractures, this doesn't mean that PPI's cause fractures. Maybe the folks who took PPI's had stomach troubles and were less likely to take things that prevent fractures like Calcium or Bisphosphates (drugs which prevent fractures but are relatively contraindicated in those patients with GERD). In addition, these studies use claims databases. This means that to get the data, doctors never examined or interviewed patients, rather the investigators looked at insurance claims for fractures, medication use, etc. For example, we don't know what the bone density scores (DEXA) were for the patients in this study. It is very possible (and even likely) that the patients in the fracture group had lower DEXA scores, and this more than the PPI use accounted for fracture. Also, if you have ever received a bill or claim notification from your insurance company, you problem know that the information they contain is not always 100% accurate. That said, the number of patients studied and the consistency of this relationship suggests that there may indeed be a cause and effect.

What should you do?
It is unlikely that short term use of PPI's substantially increase risk of fractures. So if you need an occasional Prilosec OTC (like after a big barbecue this Memorial Day weekend), this is probably fine. If you need to take PPI's, either prescription or over the counter, on a daily basis and have symptoms when you do not take them regularly, this could be a sign of more serious disease and should be investigated by a physician (regardless of a fracture risk). For those patients who have had an extensive medical work up for a stomach condition and told by a physician that taking a PPI on a daily basis for years to come is the recommended treatment, then they should discuss the risks and benefits of PPI's as it relates to fractures. This would be particularly important if you have an increased risk for fracture such as a previous fracture, family history of osteoporosis, or low bone density.

What every medicine cabinet needs

Here in D.C., we are slowly starting to thaw from what my friends on Facebook have been calling "snowmageddon" or the "snowpocolypse." We haven't had this much snow in DC for over 100 years!
Today's Washington Post had an interesting article entitled "What Every Medicine Cabinet Needs." Because traffic around the Beltway is normally horrible, we in the DC Metro area run to raid the local grocery store at the first sign of snow. However, a stop at the pharmacy isn't usually considered since it generally doesn't snow that much here. However, this latest winter blast found many stuck in their houses for days, unable to get to a store or pharmacy. Some pharmacies shut down. All of this leading to the Post's question in preparation for the next blizzard. They asked a few local docs and here's what they came up with:
Neosporin
Bandages
Hydrogen peroxide
Benadryl
Tylenol
Aspirin
Thermometer
Robitussin
Neti Pot
Vicks VapoRub
Plan B

While I think the list is a good start, I might change or get rid of some and add a few. Here's my list.
Neosporin and Bandages- both useful in case of cuts and scrapes
Rubbing alcohol -prefer this over hydrogen peroxide, but either probably OK
Benadryl - a life saver in case of a severe allergic reaction. Also, before Ambien, this is what we used for insomnia.
Tylenol-good for fever, headache
Naproxen (Alleve)- though also good for fever and pain, slightly better than Tylenol for menstrual cramps and muscle pain (that one might get from shovelling 2 feet of snow). Also, for high fevers, you can take both naproxen and Tylenol. Aspirin is not a great pain reliever because at true anti-inflammatory doses, it can cause side effects, which is why it's not on my list. Though aspirin can prevent heart attacks, if you are at high risk (diabetes, high blood pressure) you should be on a baby aspirin every day, and this would be part of your regular meds and not something in the back of the cabinet.
Decongestant- I would ditch the Robitussin and Vaporub from the Post's list. These do absolutely nothing. Neti pots are OK for allergies, but unless you are a regular user, no need to keep one around. If you get a cold or congestion, or even a cough which is usually caused by post nasal drip and congestion, decongestants work great. If you can, get the pseudoephredrine that's behind the counter.
Dextromethorphan. Robitussin or guaifenessin doesn't do much, but dextromethorphan which is the DM in Robitussin DM works great on coughs. Delsym is DM strait up and tastes good too!
Antacids- Tums are OK, but now that Prilosec is OTC, I would have some of these on hand. That frozen pizza you are stuck eating during a snowstorm could cause bad heartburn.
Laxatives- constipation can be quite uncomfortable. Though increased fluids and high fiber foods might help, it's always good to have a laxative on hand. My preference is Miralax.
Hydrocortisone cream 1%-eczema is common in the winter, and lots of things can irritate the skin, which a cortisone cream will fix.