On September 30th 2004, the pharmaceutical giant Merck announced to the world that they would stop marketing the pain medication Vioxx because it increased the risk of heart attack and strokes in patients who were taking it for long periods of time. One estimate showed that as much as 100,000 people taking Vioxx might have had a heart attack or stroke and some might have died.
There is anger against Merck with charges that the company had known all along that this might happen, yet aggressively marketed the drug as a safer alternative to older pain medications.
There is anger against the Food and Drug Administration (FDA), the government agency that is supposed to certify that a drug is safe, for not looking closely into the safety data of Vioxx.
And there is anger against some physicians for not looking out for their patients and falling prey to the fierce marketing attacks from drug companies.
The case of Vioxx is just one example of what happens when medicines can kill rather than heal. The issue of side effects, which is what happened in the case of Vioxx, is nothing new.
On October 15, 2004 the “FDA directed the manufacturers of all antidepressant medications to add a “black box” warning that describes the increased risk of suicidality in children and adolescents given antidepressant medications and notes what uses the drugs have been approved or not approved for in these patients. A “black box” warning is the most serious warning placed in the labeling of a prescription medication.
One FDA scientist said before Congress that there are five other drugs out there in the market that can become the next Vioxx and yet the FDA is allowing them to be used by patients. The drugs he mentioned are;
- Accutane, an acne-fighting drug which could cause birth defects
- Bextra, an arthritis pain-relieving drug just like Vioxx, which could increase the chance of a heart attack
- Crestor, a cholesterol-lowering drug, which could cause kidney failure and serious muscle problems
- Meridia, a weight-loss drug, which could cause an increase in blood pressure
- Serevent, an asthma drug, which could worsen asthma and increase asthma-related deaths
As these stories grab the headlines, it is easy to see how a lot of individuals can feel helpless. There are, however, a number of things you can do. The first place to start is to ask five questions and demand to know the answers. They are;
1. Is this drug for long-term use and how long has it been around?
Most serious side effects that are only discovered later are usually from drugs that people take for long periods of time. This is because these side effects usually do not show up with short tern use and only as the drug builds up in the body do the side effects manifest themselves. The longer the drug has been around the more we know about its effects and side effects.
2. Do the reported side effects occur at least twice as much on people who take the drug as in those who take a sugar pill?
The side effects you hear mentioned on TV are side effects that occurred in at least 5% of the people who took the drug or appeared in at least twice the number of people on the drug than on those taking placebos. This is how you know that the side effects are actually caused by the drug.
3. Are there other alternatives that are just as effective?
If you are taking a drug and it is causing a side effect that you do not want to live with, the next question is “are there other drugs that can do the job and are safer?” If the answer is yes, then this is a no brainer. Asking to get off Vioxx is no big loss because there are other drugs that are equally effective and still give you the safety profile that Vioxx promised, all without increasing your risk for a heart attack.
4. What is the Risk-Reward Ratio?
What if there are no safer alternatives? Then you must decide if the benefits are worth the risks. Remember the drug Lotronex for irritable bowel syndrome in women that had such horrible side effects that some women actually died? It was taken off the market. However, because there were women for whom the drug was a God-sent, they were willing to take the risk because they felt the reward was worth it and they had no alternative.
5. Will I have careful monitoring?
As you make the decision to stick with a drug that has the potential to cause serious side effects, it is important to institute careful monitoring from your provider. Drugs with serious side effects like cancer drugs require very close supervision and the more harmful the drug can be the tighter the monitoring. If you feel your drug is causing you side effects or has the potential to cause you serious side effects be sure your provider carefully monitors the situation and is ready, able and willing to intervene as soon as it is warranted.
For more information on what you can do to protect yourself or a loved one from being injured or killed by prescription drugs, log on to my web site at www.rxhelpdoc.com
Dr. David Nganele
