In countries where the cost of health care is high and the prices of medications a burden, many people are happy to received free drug samples from their health care providers.

A survey in the US which involved 10,295 children and adolescents (age below 18) gives the following information:

• 4.9% of all children received at least 1 free drug sample.
• 10% of children who were prescribed drugs also got at least 1 free drug sample.
• Free drug sample distribution was not dependent on socioeconomic status. All children received samples regardless of income or health insurance coverage

So what’s the big deal? Who doesn’t want freebies?

The problem lies in the fact that some of these free drugs actually have safety problems – major safety problems in some cases. Among the top 15 most commonly distributed free samples are

• 2 drugs classified as schedule II controlled medications, drugs which are closely monitored by the US FDA because they can be addictive and are prone to abuse.
• 4 drugs with the so-called “black box warnings” issued by the US FDA, the most serious type of safety warning in prescription drug labeling.
• Some drugs indicated for attention deficit hyperactivity disorder (ADHD).

Freebies are used as marketing tools by big pharmaceutical companies. It has always been thought that doctors tended to distribute free drug samples to needy patients. The survey results indicate otherwise. So, what is the motivation behind the doctors’ act of giving free drug samples? Is it simply to clear out the clutter and reduce the inventory? Or are there greedy motives behind the act? Are they aware of the safety issues concerning the drugs they are giving away?

What do you think?

What do all of these conditions have in common? Morning sickness, eclampsia and pre-eclampsia, gestational diabetes? They all affect pregnant women, no-one knows what causes them, and medical science has no way to medicate or treat them.

Morning sickness is normal and some doctors believe it is a sign of a healthy pregnancy, it’s unpleasant for many, and debilitating for some. Morning sickness affects around 80% of pregnant women, with around 10% having their lives seriously affected by their morning sickness, and many women suffer throughout their pregnancies. The only cure is time, and for mothers who suffer all through their pregnancies, is delivering the baby.

Pre-eclampsia, dangerously high blood pressure in a pregnant woman, is a very serious condition, affecting around 5% of pregnant women, and can be fatal to mother and baby. The disease can be managed somewhat, but the only cure is to deliver the baby.

Gestational diabetes, GD, affects about 8% of mothers, and while it can be managed to some extent with diet, exercise, and insulin treatments in some cases, mothers and babies with GD are at risk of complications and birth defects. The only cure is to deliver the baby.

The only cure is to deliver the baby? Have we moved on from medieval times? When millions of people suffer worldwide from non-pregnancy high blood pressure and diabetes, and drug companies are spending billions of dollars on research and bringing out new drugs to treat them, why is there next-to-nothing for pregnant women?

In defense of the researchers and doctors, care and treatment for pregnant women has improved drastically in the last generation.

And to bring a new drug to the market, it must be tested on real patients, and pregnant women are understandably reluctant to try experimental drugs. Everyone has heard of the horrific birth defects caused by Thalidomide. This untested-on-pregnant-women drug was prescribed to thousands of women as a treatment for morning sickness in the 1950s and 1960s.

Still, as we know, it’s 2008. Medical science is light years ahead of where it was in the era of Thalidomide, in the 1950s.

So why are common, and serious conditions, like pre-eclampsia and GD, so poorly understood? Why is research into them so underfunded? And why are there no effective treatments for them today?

I was inspired to write this post by this article in USA Today.

We are all wary of taking drugs during pregnancy and nursing. But there are many among us who – for medical reasons – have to take medications, pregnant or not. I have to take thyroid replacement hormone everyday for the rest of my life. Others take pills for a wide range of pre-existing conditions such as asthma, allergies, epilepsy, or diabetes. It is estimated that in the US, pregnant women take on the average, 3 to 5 prescription drugs during pregnancy.

This is the reason why the US FDA has recent proposed to update the rules of labeling prescription drugs to give better and more detailed information of the effects of drugs to the unborn child or the nursing baby.

“Under the proposal, drug labeling would explain, based on available information, the potential benefits and risks for the mother and the fetus, and how these risks may change during the course of pregnancy.”

The new labels would contain a special sections on pregnancy and lactation. The “fetal summary risk” section should give all available information, be it on animals or humans, regarding this topic. The label should also reveal whether the drug has a pregnancy exposure registry, a registry which collects data on the effects of drugs prescribed to pregnant women.

In the lactation section, information about the amount of drug that is passed into the milk and possible effects to the nursing baby should also be given.

It is hoped that with the new labels, expecting and nursing mothers are better informed and protected.

Source:

FDA News 28 May 2008

I can’t count the number of times that I have popped a couple of Tylenols while drinking my morning coffee. Sometimes I wake up with a little headache – not surprisingly, this usually happens when the kids wake up crying in the middle of the night repeatedly – and every morning I enjoy a nice cup of coffee to start my day. Putting the two of them together was more for the logistical ease instead of being something I did intentionally, but I never imagined that it might put my health at risk.

Then I read an article about the dangers of mixing acetaminophen and coffee. The specific reason why the combination of the two things is so bad boils down to this: Apparently, the coffee makes the acetaminophen three times as toxic to the human liver. Yikes!

This got me to thinking…how many things do I do to myself or my kids that might be endangering us? I mean, who would think that taking a Tylenol with a cup of coffee would be a potentially harmful event? I wonder if some of the other combinations I encounter throughout the day are wrecking my internal organs too. Does my multi-vitamin clash with the orange juice I have with breakfast? Does my allergy medicine become deadly when I take it with hot cocoa? My kids take allergy medicine too…what horrible drug interactions am I exposing them too?

Honestly, it makes my head spin.

I guess I have to keep in mind that the caffeine is a drug, after all, and so that means it can have contraindications to other drugs. I guess I’ll also have to pay better attention to the combinations or drugs that I expose myself and my kids to.

Researchers are learning that alot of the pharmecutical drugs that we take on a day-to-day basis are not being filtered properly from our water and waste water treatment facilities. Some of the active ingredients in things like cholesterol fighters, tranquilizers and anti-epileptic medications actually resist our current treatment processes. These chemicals are finding their way, albeit in low doses, into the tap water faucets of millions of families across the U.S.

Scientists are unsure of the effect that prolonged low-dose exposure to these drugs will cause in people and admit that more research needs to be done. But you may think twice before taking another sip.

Read more about this story here.

E! News reports that Cedars-Sinai Medical Center has been given by the California Department of Public Health (CDPH) ten days to respond to a 20-page deficiency report concerning the medical mix up involving the drug heparin.

The incident transpired last November when nurses gave 1,000 times the needed dosage to three patients, two of whom were Dennis Quaid and Kimberly Buffington’s newborn twins. Though the twins and another patient did not suffer adversely from the mix up, it still resulted in a prolonged confinement for fraternal twins Zoe Grace and Thomas Boone, who were born on November 8.

Heparin is a blood thinner generally used when patients receive fluids through a central line to avoid clots forming in that line which can result in death. Too much blood thinner, however, could lead to life-threatening bleeding, or hemorrhages.

Cedars Sinai was quick to acknowledge preventable errors made by their staff in following standard procedures in the administration of a high-alert medication. The infants required only a 10 unit/milliliter dosage but were given a 10,000 unit/milliliter solution by nurses who failed to double check the labels. It was fortunate that a doctor noticed blood oozing from the twins’ IVs in time for the mishap to be corrected. The twins were given protamine to reverse the effects of heparin.

This is not the first time heparin featured in a medical mix up. Back in 2006, nurses at an Indianapolis hospital also made the same mistake which affected six patients and killed three. It could be two incidences too much for actor Dennis Quaid, who has filed a case against heparin-maker Baxter Health Care Corp. for creating a dangerous situation by using nearly identical labels for the 10 unit/milliliter and 10,000 unit/milliliter solution.

Cedars Sinai has already undertaken measures to re-train their medical staff, segregate the high-concentration heparin and review all policies and practices involving all high-risk medications. CDPH will decide on a course of action against the hospital pending their response.

Remember those reports by the Philadelphia Medical Examiners Office about 15 infantile deaths which might be related to cold and cough medications? It is well-known that pseudoephedrine is one of those drugs to be wary of. However, other active ingredients in many over-the-counter medications may be involved as well. These substances are dextromethorphan, acetaminophen, brompheniramine, carbinoxamine, chlorpheniramine, ethanol, doxylamine, phenobarbital, and phenytoin. All of these may be found in the common cold drops you can buy almost anywhere. In addition, acetaminophen, also called paracetamol, is present many anti-fever medications. Phenobarbital and phenytoin are anticonvulsants used to manage epileptic seizures.

The report concludes that the giving OTC cold and cough medications to babies may actually be unsafe and potentially fatal. Parents, as well as doctors, should therefore, be extra careful when using these drugs in very young patients.

Sources:
Wingert WE, Mundy LA, Collins GL, Chmara ES. Possible role of pseudoephedrine and other over-the-counter cold medications in the deaths of very young children. J Forensic Sci. 2007 Mar;52(2):487-90.
Centers for Disease Control and Prevention (CDC). Infant deaths associated with cough and cold medications–two states, 2005. Morb Mortal Wkly Rep. 2007 Jan 12;56(1):1-4.