A word of wisdom on all the latest FDA pharmaceutical warnings.

[Liberal Veteran]

Keep in mind that nearly ALL medicine is a risk to benefit equation. I am hard pressed to think of ANY medication that doesn't pose some risk either in the short-term or long term. Does it make the drug worthless? Not at all. It just says you need to know what risks there are and if the risk are small enough when compared to the benefit.

While we should all promote INFORMED consent and disclosure of possible side-effects, we also need to not panic everytime something comes down the pike we didn't expect like the naproxen warning.

Take my own case for example: I have HIV. I am currently taking three drugs.

Here is the list of possible side-effects (and not all of them):

Headache, high-blood pressure, nausea, vomitting, fatigue, neutropenia, myopathy, anemia, psychiatric issues, rash, insomia, ataxia, convulsions, tinnitus, alopecia, eczema, asthma, hepatitis, liver dysfunction, increased cholesterol, amnesia, neuropathy, vertigo, pancreatitis, tachychardia....

Pretty scary, huh?

In the five years that I have been on the drugs, I have experienced fatigue and insomnia only in passing and I don't even know if those are attributed to the drugs themselves.

On the other hand, I went from having one foot in the grave and an immune system that was almost non-existant to not even having to take prophylaxis anymore to prevent opportunistic infections.

That's risk to benefit analysis in the extreme.

But the same logic must hold true with others drugs.

Yes, there is a chance of a fatal reaction to immunizations, but returning to the age of millions of children dying every year from polio and other diseases is unthinkable.

Yes, there is a slightly higher risk of cardiac issues with naproxen, but the drug has also been on the market for almost 30 years and is effective for some people.

I guess what I am saying is don't go over the top whenever there is a warning. Those warning are sensational, but for the most part, if the drug is really dangerous, it will most likely be pulled from the market (like mercurochrome that our moms dished out on us in abundance for every scrape and was pulled off the shelves permanently in 1998). The warnings are there to help us recognize that we might be experiencing a symptom as a result of a drug we are taking. It doesn't mean that all or even a most people will experience said effect.

[ayeshahaqqiqa]

1. wise words

I think each person must check their own reactions to drugs. And I hope your HIV stays in remission and is someday cured.

[HuckleB]

2. A wonderful, thoughtful post.

Thank you. I worry about the severity of hype that surrounds some reports, and wonder how many people will forgo treatment that would have improved their lives dramatically. I suspect that number will far outweigh the risks. Your post clearly focuses on making the choice an individual one and an informed one. Thank you for sharing.

[Patiod]

3. Thanks for the post

I interview doctors for a living, and they always joke that "the FDA wouldn't approve aspirin if it came up for a review these days". What they're saying isn't that aspirin is bad, but that aspirin has side effects.

Hope the HIV stays in remission until less-toxic solutions are found.

[slutticus]

4. More like Acetaminophen (Tylenol)

That stuff is bad news for your liver.

I knew some people in college who would pop a few tylenols before a drinking binge in order to stave off a hangover. I told them to start saving up for a liver transplant now...

[Liberal Veteran]

5. Yeah...APAP has a very low liver toxicity threshold and taking it with...

...alcohol makes it even worse.

[slutticus]

6. I think that most of the people who over-react to these types of warnings..

...are the ones who are not on these drugs (I'm thinking of lawyers specifically). I have taken drugs for medical problems that have been known for very serious side effects (like hepatic failure and seizures). I was well aware of the possible side effects, even though they were stated as being very rare. If they pulled that drug from the market tomorrow, I would not freak out.

Now, if I found that the company was deliberately withholding possible problems with the drugs, then that would be a different issue.

However, with the recent problems with the COX-2 inhibitor drugs (like Vioxx, Celebrex), I believe that cardiac problems were always listed in the informational pamphlets that are included with the medications. Just because it isn't plastered on the front of the bottle doesn't mean that it isn't going to happen. If you have a condition that requires you to take a med, you should read the information provided for you. I would never trust the doctor and I would especially not trust the pharma companies to take care of me.

But there is a very fine line between negligence on the part of big pharma, and the responsibility that falls on each person who is taking meds (as well as the docs who are prescribing them).

[Liberal Veteran]

7. True...I tend to be forgiving of doctors to a great extent on this.

Doctors are given 15 minutes with you most of the time and they also have to consider whether going into too much detail about the rarer side-effects will scare the hell out of the person they are trying to help.

[HuckleB]

9. Exactly on both accounts.

It's actually a bit of a miracle that doctors will prescribe at all, given the short period of time they have to do patient education and the apparent culture of blaming someone else whenever something goes wrong. That's an ugly, scary combination. It's a good thing docs can put it out of mind and do their jobs.

[Liberal Veteran]

8. Bump...back to page 1.

I feel people should read this so I am shamelessly bumping my own post.

[CHIMO]

10. Can the FDA Protect the Public?

Can the FDA Protect the Public? Agency Accused Of Approving Unsafe Drugs Under Pressure From Pharmaceutical Industry

The pharmaceutical industry is still reeling from one of its most devastating couple of days in recent history. On Sunday, drug giant Pfizer announced that it was pulling all advertisements for its popular pain reliever Celebrex. This came two days after the company admitted that studies showed high doses of the drug led to an increased risk of heart attacks. But Pfizer said it was keeping the drug on the market and the company says it will continue to market the drug to doctors. In addition to Pfizer's announcement about Celebrex, drug companies AstraZeneca and Eli Lilly also disclosed serious problems with drugs of their own.
AstraZeneca admitted that tests show that its lung cancer drug, Iressa, did not prolong lives. And Eli Lilly warned doctors that, Strattera, its drug to fight attention deficit disorder drug has caused severe liver injury in at least two patients. The announcements resulted in the three companies losing a total of $30 billion in stock value. Then early this week, the Food and Drug Administration announced that yet another painkiller drug on the market might increase people's risk of having a heart attack or stroke. The drug is manufactured by Bayer and is known as Aleve when sold over the counter and naproxen when sold by prescription.

http://www.democracynow.org/article.pl?sid=04/12/22/151224

[Liberal Veteran]

11. Not entirely..

The FDA will never be able to totally control the drug manufacturers, nor will they ever be able to completely certify a new drug as 100% safe, nor will they ever be able to protect people who don't use the drugs properly. That is why INFORMED consent and patients taking some responsibility for themselves as well is as necessary as federal oversight.

Take efavirenz. It's kept my viral load under control as part of my combination therapy.

It's been around 6 years now. Who knows what the effects of LONG-TERM usage are? That is why we need to continue to do studies.

As I said, it's a risk to benefit analysis with ALL medications.

[Jesus H. Christ]

12. There's a lot of scaremongering going on.

Not enough people are willing to get to the facts.

[HuckleB]

13. Kick.

[slutticus]

14. Kick

[Sara Beverley]

15. Exclusive licensing is almost up. Time for new drugs.

My tin foil hat is so tight it is giving me a headache.:tinfoilhat: