Which Drugs Do You Consider “Safe?”
FDA Provides Perspective on Drug Risks
The U.S. Food and Drug Administration (FDA) helps protect the public from potentially harmful drugs by monitoring the risks of marketed drugs. The FDA’s approach to determining whether a drug should be recalled is consistent with how clinicians decide whether a drug should be prescribed: it always involves a risk/benefit analysis. If the potential risk of prescribing a drug is greater than the potential benefit, it should not be prescribed.
Looking at which drugs have required FDA intervention provides an interesting perspective into how we think about “safe” and “harmful” drugs.
The FDA can remove a drug from the market for two reasons:
● If they feel the risks of the drug outweighs its potential benefits
● If a manufacturer violates FDA labeling or manufacturing laws
An interim step before removal is a drug recall which may happen when a manufacturer voluntarily removes their product or when the FDA forces the drug to be temporarily removed. A drug recall may or may not lead to its eventual permanent removal from the market.
Of course, any of these events can create financial disaster for a company. The ability to pull a drug from the market gives the FDA enormous power over manufacturers as it protects consumers from harm.
Four Anti-Inflammatory Drugs Removed From the Market
In the July 25 issue of MDLinx Internal Medicine, Dr. Naveed Saleh reports on ten drugs that were removed from the market due to safety concerns over the last 30 years. It is interesting, and perhaps surprising, that four of them were anti-inflammatory drugs because most people presume these drugs are relatively safe.
Most nonsteroidal anti-inflammatories (NSAIDs) are available without a prescription. The ease of purchasing these anti-inflammatories can lead to the false assumption that NSAIDs are safe enough to use for everyday aches and pains ranging from menstrual cramps to headaches. That’s not necessarily the case. In fact, the FDA requires all over-the-counter NSAIDs to provide a warning about the elevated risk of heart attack or stroke after just one week of use.
Rofecoxib (Vioxx) and Valdecoxib (Bextra) were popular NSAIDs that were supposedly safer than other NSAIDs because they caused fewer gastrointestinal complications. These two drugs required a prescription. However, both were eventually shown to pose significantly greater risks of causing heart attacks and strokes than more commonly used NSAIDs. Both were on the market around the turn of the century for four or five years before they were recalled. Merck withdrew Rofecoxib due to potentially increased risk of cardiovascular disease. Similarly, Pfizer voluntarily withdrew Bextra from the market because it could cause “heart, stomach, and skin problems,” according to WebMD.
A third recalled drug, Bromfenac (Duract), also required a prescription and was considered an NSAID. It was on the market for only about a year in the late 1990s. In that short time, it was blamed for four deaths and multiple liver failures.
Troglitazone (Rezulin), the fourth recalled prescribed anti-inflammatory, was marketed in the late 1990s as a treatment for diabetes and inflammation. As with Vioxx, there were tens of thousands of lawsuits filed against the manufacturer (Pfizer) by people who developed hepatic failure or lost family members because of the drug.
The stories of these four drugs illustrate that anti-inflammatories may not present less risk for some patients than an opioid.
NSAIDs, Like All Medications, Carry Risks
The FDA has removed one opioid from the market, but not because it caused too great a risk for the population for which the drug was intended.
Despite the major concern about opioids in America, reformulated oxymorphone hydrochloride (Opana ER) was the first and only opioid to be removed from the market by the FDA. Unlike the anti-inflammatories mentioned above, the FDA determined that oxymorphone hydrochloride posed an unacceptable risk to society.
The FDA determined that the drug could be easily crushed and injected by drug abusers. Due its high potency, a small amount of the drug prepared for injection could be shared with other drug users. This contributed to the spread of HIV and hepatitis, and that’s why the FDA acted.
All medications are potentially harmful. To people who oppose prescribing opioids for pain patients, it may come as a surprise that NSAIDs, too, are risky — in some cases, they are even more dangerous than opioids.
There must be a common denominator to these NSAIDs that make then attack the heart and GI. With my heart medicine for the atrophy and failure I now have, I believe for the loss of 12 years of success with opiates now withdrawn, I am not suppose to take ibuprofen OR aspirin, the last two pain meds I have left of any effect. Can’t they decide the NSAID is too dangerous for OTC BEFORE they release them?
I’m wondering if within another year or 2 we might see an epidemic of strokes, heart attacks and stomach bleeds because of the increased use of NSAIDs by pain patients? I had always taken an occasional Ibuprofen along with my opioid medications, but ever since my opioid meds were cut SO drastically I’ve been eating Ibuprofen like candy. It’s the only NSAID that helps at least a little. I don’t even look at the clock anymore to see when I last took 1-2 because when the pain has me in tears I just don’t care–I HAVE to do something! I don’t really care if I leave this world because I no longer have any semblance of a life ever since the opioids and doses that I was on (with no problems or abuse) for 15+ years were cut. I always tell my family that I’m either going to die from choking because of all the “metal” in my neck or because my stomach is going to burst because of all the Ibuprofen I’ve been using for almost 3 years now. Actually, suicide would probably be less painful! Please don’t think that I take using an NSAID as much as I do lightly–I honestly don’t–but I’ve got to do SOMETHING to try and relieve even just a tiny bit of this pain. It may only drop my pain level from a 10 to a 9, but I’ll take that. I’ve tried medical marijuana and other alternatives with no positive results. I don’t know what else to do?
As a chronic pain patient, I am worried about the effects of taking long term NSAIDS. My pain was adequately covered by opiate meds. I am actually taking more meds now, than ever before. I do not understand, why they want people, to be mixing so many drugs instead of taking the meds, that actually work. Acute pain can be handled with NSAIDS. I have Fibromyalgia.