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Which Drug Side Effects Should Your Doctor Tell You About?

Once when my mother was visiting me, we went to a dollar store and she bought something that surprised me — a book about pills that discussed which medicines are for what conditions and what their side effects are. As soon as we got home, she pulled out the book and a pill bottle and searched the pages.

She nearly wept when she read that a very common side effect of a drug she had just started taking was depression. She had been hiding very sad feelings, lethargy and a lack of happiness. She now knew what was happening, and a simple phone call to her doctor got her a new prescription for a drug less likely to have that effect.

Since then, I’ve discovered that there are doctors who believe it’s better for a patient to not know the minor or less common side effects of medicines. Research has shown that simply by being aware that a drug you take might have a particular side effect — fatigue, for example — makes it more likely that you will feel tired when taking that medicine.

A 2003 study in the European Heart Journal enrolled 96 men with newly diagnosed cardiovascular disease that received a beta blocker, atenolol, for high blood pressure. Erectile dysfunction (ED) is a known side effect of beta blockers, though none of the men in the study complained of it prior to starting the study. Those who were told that ED might be a side effect of the drug were twice as likely to report experiencing it compared to those who were not informed about the side effect.

Many would say this is related to the nocebo effect. The more correct definition refers to being given a placebo (a harmless sugar pill) and then believing you have developed one or more side effects caused by being warned about those effects. Some doctors feel that by withholding information about side effects they are protecting their patients from a nocebo-like response to medicine they need. If patients aren’t told about a side effect, they won’t get it. Or if the patient has that side effect, then knowing about it might magnify the discomfort.

More commonly known is the placebo effect — when a patient is given a pill that can’t possibly cure their illness but yet it does, presumably because the patient believes in it.

Withholding pertinent information without a patient’s knowledge or consent is paternalistic and violates the concept of informed consent. Patients have the right to know what drug they are being prescribed, for what reason, what the anticipated outcome will be and what all the risks are of taking it.

Experiencing symptoms without understanding their possible cause can create considerable distress, as it did with my mother. She suspected that something was “really wrong,” in her words, and she feared this new, unmanageable psychological distress. Her anxiety mounted, but she was hesitant to call her doctor about something as vague and seemingly unrelated to her original diagnosis as depression. When she saw the reference book mentioning side effects, she connected the drug to her depression and felt justified in calling her doctor.

People are different, and doctors are called upon to use judgment all the time. Even doctors who try to relay all possible side effects are challenged to know when to stop. Listing all the rare adverse events could scare the patient out of getting needed care. Which side effects are common enough to be mentioned, and which are rare enough to be left unsaid?

This is a good discussion to have with your doctor. You might not want to know all the possible minor irritations that could be caused by a medicine. A warning of the most significant possible adverse events and a general comment that any new symptoms are probably from the medicine might be all the information you want.

Others might want to discuss the drug in detail and have a strategy for coping with side effects. It’s your body, your appointment, and the doctor is your consultant. Ask for the information you want and know when to say, “Enough.”

4 Drugs With Annoying Side Effects You Should Put Up With

Some really useful drugs have irksome side effects, but not all of those persist. Soldier through one or more unpleasant initial symptoms for a few days, weeks or months, and they may subside. What is left is an effective, tolerable treatment.

Norman Tomaka, a clinical consultant pharmacist in Melbourne, Fla., says initial side effects are to be expected when you incorporate any new drug into your body as it physically adjusts to the medication. However, in most cases, the body returns to normal functioning, and side effects subside.

“It’s just the way our bodies defend their normal patterns,” says Tomaka.

Here are common drugs that each have at least one major off-putting side effect that will likely go away:

  1. Metformin, a first-line drug for type 2 diabetes, causes diarrhea and other gastric distress with each change of dosage; typically goes away in a few days.
  2. Nexplanon, a progestin-only birth control implant, is 99% effective, but heavy or irregular bleeding can be a particularly off-putting side effect. It usually abates after 3 to 6 months.
  3. Zoloft (sertraline), a veteran treatment for depression, obsessive-compulsive disorder, panic attacks and social anxiety disorder, causes gastrointestinal distress that generally subsides within a few months.
  4. Ritalin (methylphenidate) is a common treatment for attention deficit/hyperactivity disorder. Common side effects include appetite suppression, which may go away but needs to be attended to while it persists, as it can lead to weight loss.

1. Metformin

Marie Brown, MD, a suburban Chicago internist, treats many type 2 diabetics. Her drug of choice for the condition is metformin, an old, inexpensive, first-line drug. Diet and exercise work best at controlling diabetes, says Brown, but as an effective treatment, “metformin stands alone.” It costs pennies a day, and Brown says it doesn’t cause weight gain, which can make diabetes worse.

There’s just one hitch with this miracle drug: Metformin almost always causes diarrhea. It typically goes away in 2 to 6 days, but will likely return for a few days with every dosage increase.

“It almost invariably resolves,” Brown says, but physicians should always warn their patients about metformin. “They will have loose stools. They should begin the medicine when they’re going to be near a bathroom.”

To minimize diarrhea, take a low dose, as low as 250 mg, with a meal, and persevere through those few days of diarrhea, says Brown. A week after the diarrhea stops, go up to the next dose, brace for a new bout of diarrhea, and repeat the process until you’ve reached the full dose the doctor has prescribed, a process that could take weeks or even months. Even resuming the maintenance dose after a drug holiday of 2 to 3 days may bring on diarrhea, Brown says.

Maryann Collins of Oak Park, Ill., now a patient of Dr. Brown’s, has been on metformin for her type 2 diabetes for more than 20 years. She takes the maximum dose — 1,000 mg — twice a day, a total of 2,000 mg, as part of her regimen. In the beginning, she recalls, she was surprised and distressed by the bouts of diarrhea, especially since at the time she was commuting 35 miles to work.

“It was only for about a week, but I felt like, ‘Ooh, am I going to make it?’ After that week, though, it was not a significant issue,” Collins says, although she still tends “to want to be near a bathroom in the morning.”

Brown says many providers don’t walk their patients through the process of adjusting to metformin, don’t tell them what to expect and don’t tell them the diarrhea is only temporary. Many patients conclude they’ll have to stay close to a bathroom for the duration, and stop taking metformin, possibly moving on to a less effective, more expensive drug with its own side effects. Sometimes patients don’t even mention to their doctors why they’ve stopped, she notes.

The truth is, many providers don’t know that diarrhea is only temporary with metformin, Brown says. She knows this because she often speaks about drug adherence at medical conferences.

“Metformin has been around so long, it’s not taught in detail like the newer drugs that are coming out,” Brown says.

2. Nexplanon

Another effective drug with a distressing side effect is Nexplanon, a birth control implant. A rod the size of a matchstick inserted under the skin of a woman’s upper arm releases etonogestrel, a type of progestin, a hormone that helps prevent pregnancy. Placed by a trained physician or other provider, Nexplanon works for 3 years and has a 99% success rate.

That’s why Emily Gregory, an obstetrics-gynecology resident at the University of Tennessee Graduate School of Medicine in Knoxville, uses Nexplanon. “It’s more effective than a tubal ligation but completely reversible,” she says. Gregory also likes that, in her case, Nexplanon controls the pain and mood swings that can accompany menstrual periods.

If a Nexplanon user decides she wants to have children, she can have the implant removed and expect to return to her normal fertility pattern within days, says Nikki Zite, MD, a Knoxville ob-gyn and a professor at the school of medicine there. That’s a popular benefit, too.

The problem with Nexplanon is that patients typically experience, among other symptoms, irregular and often heavy bleeding. This side effect usually goes away after 3 to 6 months, but in the interim, for the patient, the bleeding can seem like a continual period, interfering with sexual relations and other aspects of daily life.

Gregory experienced spotting for a few weeks about a month after the implant was placed, “then nothing,” she says. However, 10 to 15% of women who get the Nexplanon implant have it removed because of bleeding, Zite says.

“Give it 3 to 6 months,” Zite says. If women can take daily birth control pills in addition, the estrogen in those pills can help. Ibuprofen (Advil, Motrin), an over-the-counter NSAID (nonsteroidal anti-inflammatory drug), may ease bleeding, too. Sometimes, “reassurance and time” are all a woman needs, Zite says.

3. Zoloft

Tomaka says that another effective drug with troublesome temporary side effects is the depression treatment Zoloft (sertraline). This antidepressant, also used for anxiety, can cause gastrointestinal distress. However, the common nausea, diarrhea and stomach pain ordinarily go away after a few weeks, he says.

4. Ritalin

Ritalin (methylphenidate), the popular stimulant prescribed for ADHD (attention deficit/hyperactivity disorder), may cause decreased appetite, a common symptom that may resolve with time. Meanwhile, eat plenty of healthy foods to prevent weight loss. If the patient is a child, offer fruit, whole grains and appealing proteins (don’t forget about peanut butter!), and try providing a bedtime snack. If a child’s appetite doesn’t return, re-evaluate the use of methylphenidate.

More Than One-Third of Adults Take Meds That Have Depression Risk

An estimated 37% of adults use medications where depression is a potential side effect, according to a new study. Researchers looked at 26,192 adults who participated in a national survey between 2005-2014.

Results, published in JAMA, indicated that more than one-third (37.2%) of adults use medications that have depression as a possible side effect. Over time, the percentage of people using these medications has steadily increased, going from 35% in 2005-2006 to 38.4% in 2013–2014. People were more likely to experience depression while using multiple medications that listed depression as a side effect.

Additionally, the percentage of people using medications that are associated with suicidal symptoms increased from 17.3% in 2005-2006 to 23.5% in 2013-2014.

Overall, adults reported using more than 200 medications that have been associated with depression or suicidal behavior as adverse effects, including anti-hypertensives (blood pressure meds), proton pump inhibitors (used to control acid reflux), pain medications and hormonal contraceptives.

Can Google Influence Your Perception of Negative Side Effects?

If you have the tendency to Google the negative side effects associated with your medications, you may have a greater chance of experiencing them, a study published in the International Journal of Cardiology suggests.

Researchers evaluated patient intolerance to statins — 1 of the common cholesterol-lowering drugs — in 13 countries across 5 continents. They then compared the rate of intolerance to the number of websites available in each country that discuss the adverse effects of statins.

Interestingly, the results showed that patients in English-speaking countries, including Canada, the United States, United Kingdom, and Australia, reported negative side effects at a higher rate than in the other countries. Researchers suggest that this may be partly because people in English-speaking countries have greater access to websites detailing the side effects of statins.

Lead researcher Dr. Baiju Shah, MD, PhD, an endocrinologist at Sunnybrook Health Sciences Centre in Toronto, referred to this concept as the “nocebo effect.” That’s when a medication may actually be effective and beneficial but the person taking it believes that the drug will harm them, and as a result, they may experience the negative side effects instead.

What You Need to Know About Drug-Induced Disease

Did you know that aspirin can cause asthma in some people? Or that as many as 90 different medications may cause lupus erythematosus, a chronic autoimmune disease characterized by fatigue and joint pain?

The fact that prescription medications can cause side effects is well-known. The idea that they can cause disease is not. Yet the difference between a drug-induced disease and an adverse drug reaction isn’t as great – or as dramatic – as it might seem.

“Really, it’s a matter of semantics,” says B. Joseph Guglielmo, PharmD, Dean of Pharmacy at the University of California, San Francisco. “The bottom line is, if a drug creates a complication of a normal body function, that’s a disease.”

Dangerous Drugs

Every prescription and over-the-counter medication has the potential to cause harm, particularly if used incorrectly. However, there are certain medications which are more likely to cause harm. Some of these include:

  • High-powered antibiotics, such as tobramycin and vancomycin. These medications can be life-saving in some cases. However, they are also known to cause hearing loss and kidney damage, and that damage may persist even after the medication is stopped. These potentially irreversible side effects are one reason healthcare providers rarely prescribe these drugs as a first-line treatment.
  • Steroids, including prednisone and cortisol. These drugs, which are used to treat everything from asthma to organ rejection, “have a very large spectrum of side effects, and the longer you’re on them, the more likely you are to have them,” Guglielmo says. Potentially serious, long-lasting adverse effects include hypothyroidism, glaucoma, cataracts and diabetes. Healthcare providers try to decrease the risk of drug-induced disease related to steroids by only prescribing them if necessary – and at the lowest effective dose, for the shortest possible time. Steroid treatment is also tapered over time, rather than stopped abruptly.
  • Anti-cancer drugs. Chemotherapy and immunotherapy medications can kill cancer, but in many people, they also cause lingering damage, including damage to the nerves of the hands and feet, heart disease and secondary cancers.

Factors That Increase the Risk of Drug-Induced Disease

Two patients of the same age, gender and weight, and in similar health, can take the same medication at the same dose for the same amount of time. One may develop a drug-induced disease, while the other only experiences positive effects.

At present, it’s next to impossible to predict with much accuracy who will develop a drug-induced disease. Increasingly, scientists are untangling the genetic differences that likely account for at least some of the variation in response to drugs. For instance, healthcare providers now know that people with a gene called HLA-B*1502 have an increased risk of developing Stevens-Johnson syndrome, a serious disorder characterized by blistering and peeling skin, if they take carbamazepine, an anti-seizure drug .

But the ability to pinpoint susceptibility is still the exception, not the norm. That said, healthcare providers know that these 3 variables increase the risk of developing drug-induced disease:

  1. Age. “Every year you get older, you are at a greater risk for side effects,” Guglielmo says. In part, that’s because the body’s functioning changes over time. Most medications are metabolized by the kidneys or liver, and in general, these organs don’t work as efficiently as we age.
  2. Overall health. A person with multiple chronic diseases – say, diabetes and heart disease – is more likely to develop a drug-induced disease. The risk increases with each additional diagnosis.
  3. Medication usage. “The more drugs you are on, the greater the likelihood of adverse events,” Guglielmo says. That’s partly because each drug has its own side effect profile, and because more medications also means an increased risk of drug interactions. But it’s also because medications alter bodily function. Chemotherapy, for instance, is therapeutic, but also tough on the body – which “sets people up to be at risk for other diseases,” Guglielmo says.

Treating Drug-Induced Disease

In most cases – but not all – stopping the drug or tweaking the dosage may reverse the negative effects of a drug-induced disease and return the body to its usual functioning. In others, additional medical treatment and monitoring may be necessary.

If you or a loved one develop any new or unusual symptoms while taking a medication, write them down and share that information with your healthcare team. In fact, Dave Walker, PharmD, a pharmacist in Oregon, says that all patients should be on high alert when beginning a new drug.

“Patients need to be super-conscious of how they are affected by a medication when they first start taking it,” Walker says. He advises patients to keep notes, so that both the patient and the healthcare team can note the timing and trends of symptoms. People who develop obvious and alarming symptoms – such as difficulty breathing – should call their healthcare provider and seek medical attention ASAP. Less dramatic symptoms should also be reported to your healthcare provider, either via a phone call or at a follow-up visit. You can also call your pharmacist.

“Pharmacists are probably the most accessible healthcare providers out there,” Walker says. They are also the most knowledgeable regarding medications and their side effects.

How to Protect Yourself

You can’t eliminate the risk of drug-induced disease, but you can take steps to decrease your risk. Ask your healthcare provider these 5 questions whenever a new medication is prescribed:

  1. Why are you prescribing this drug? “Every patient should be absolutely crystal clear on what they are actually taking,” Guglielmo says. Make sure you know the name of the medication and its expected effects.
  2. What are the primary cautions with this medication? Many drugs have known toxicities. This information will help you watch for adverse effects.
  3. Are there any tests that could predict my response to this drug? Such testing isn’t yet commonplace, but it’s worth asking about.
  4. How should I take this medication? With or without food? First thing in the morning, or late at night? For how long? By what route?
  5. How is this drug eliminated from the body? If your healthcare provider says, “by the kidneys,” (or liver) and you have kidney (or liver) disease, speak up.

“One of the key things is for patients to be conscious and aware of the medications they’re taking, and ask questions,” Walker says.

The Dark Side of Medications

Everyone has a story about the negative side effects of taking medications, both prescribed and over-the-counter. But when it happens to you as a patient in the hospital, the last place you would think of this happening, it gives you pause. At least it did for me. Here’s my story.

It began in the ER, with all the symptoms of my having a heart attack. Not the unusual symptoms, as most women might have, but spot-on symptoms similar to that of a man having a heart attack: severe pain in the middle of my chest radiating out my back, left-arm numbness, profuse sweating, nausea, irregular heartbeat, lightheadedness. Basically, the norm for someone having a heart attack. My EKG showed a few inverted T waves of concern, but was not showing that I was having a heart attack. This did not rule out a heart attack.

Even though my blood pressure was not considered high, the emergency room staff gave me nitroglycerin “just in case.” Because I naturally have low blood pressure, my blood pressure plummeted to an all-time low. Bells and whistles began going off alerting ER staff that something was wrong. I learned that day that nitroglycerin was the “go-to” drug for patients suspected of having, or actually having, a heart attack, withstanding any other medical factors that would make using nitroglycerin a bad idea, if not a deadly one.

This is where that medical textbook they used back in medical school should have just been thrown out the window, as I was not their normal textbook patient. Low blood pressure can kill a patient just as quickly as high blood pressure, but many cardiologists and others in the medical field, especially ER staff, fail to recognize this.Sadly, this would not be the only time nitroglycerin would be overprescribed for me during my stay, after being admitted to the hospital with confirmation of having had a myocardial infarction.

Hospitals should not be seen as security blankets, and patients need to be aware of medications being handed out at all times, and ask questions before ever taking any medication.

Once on the cardiac floor of the hospital, the nurse on duty hooked me up to all the usual equipment that is necessary for a heart attack patient. She then placed a nitroglycerin patch on my right arm, and although I did meekly protest after what happened in the ER, I wasn’t patient-advocate enough to make demands just yet. Why would I? I was in a hospital, after all, where they were supposed to know how to care for me, the patient. My electronic medical chart, which they had access to, should have made it clear that I had hypotension, and not hypertension, sending out a bold warning to all those treating me that the use of any form of nitroglycerin would have negative, if not devastating, side effects.

All the normal tests for a heart attack patient were ordered and performed, and I was into my second day as a hospital patient. I kept telling each nurse, as their shifts changed, that I was feeling unusually lightheaded, to which most replied, “That’s normal for what you’ve experienced.” Vitals were checked frequently, but not one nurse or cardiologist appeared to be concerned that my blood pressure continued to decline with each check. By time the night nurse came on, I couldn’t even get out of bed to use the bathroom because I was so lightheaded.

Sometime around midnight, I pushed the button to notify the night nurse that I needed her. Thank God I did, and didn’t just go to sleep. I told the nurse that something was just not right — I was feeling dizzy and somewhat out of it while lying in bed, and was concerned. She took my blood pressure again, even though it wasn’t time to. It took her several tries, as she couldn’t believe what she was seeing.

My blood pressure had plummeted to 72/49, which, in her words, were “ICU numbers.” She ran out of the room, notified the on-call cardiologist, and him know about my dangerously low blood pressure. He suspected the nitroglycerin patch was at fault, and asked for his approval to remove it. It was after midnight on a Saturday, and the cardiologist was upset with the nurse for calling him at that hour for something so minor. He instructed her not to remove the patch and said he would come by first thing in the morning.

I heard the nurse running back down the hall toward my room, where she relayed everything the cardiologist had said, and then quietly asked me, “Do you believe you need that nitroglycerin patch on your arm? Do you think it is helping you at all?” I was stunned, as I was the patient, and what did I know? Well, it turned out this nurse — and I, the patient — obviously knew more than the cardiologist on call. As she turned and was walking out of my hospital room, she looked back at me and said, “If that nitroglycerin patch somehow falls off on its own while you’re sleeping, oh, well.” It was clear to me what she was really saying, so once she was gone, I ripped the nitroglycerin patch off my arm, throwing it on the floor. Within 10 minutes, I began feeling much better, and within a half hour, my lightheadedness was completely gone.

The nurse, who was closely monitoring me from her desk, came back an hour after she had left my hospital room to check my vitals. It was low, but what was considered a normal low for me, not a life-threatening level any longer. As the nurse placed the blood pressure cuff back in its holder, she noticed the nitroglycerin patch was no longer on my arm, then looked at me and winked. I slept.

The wrong medications, or in my case, too much of a medication, can have negative results, and even lead to death if not caught in time. I still to this day believe that had I gone to sleep that night without calling for the nurse, I would not be here today. Hospitals should not be seen as security blankets, and patients need to be aware of medications being handed out at all times, and ask questions before ever taking any medication. What’s this for? What are the side effects? Did my own physician prescribe this medication? And if you are uncomfortable with taking a medication, then don’t. You have the right of refusal when it comes to ingesting any medication into your body, even while in a hospital.

Vaccine Side Effects Not Likely to Recur With Subsequent Doses

Children who receive a vaccine and suffer side effects or adverse events following immunization are not likely to have them recur after a second dose of the vaccine, according to a new study published in the journal Pediatrics.

The finding is significant in that it reaffirms the overall safety of vaccines. Some parents have questioned the safety of vaccines and have refused to have their child immunized. However, the new research, which examined 29 studies on vaccinations mostly involving children, demonstrates that the benefits of vaccines in preventing many serious diseases outweigh the risk of adverse events happening again.

In order for vaccines to be fully effective, all doses of a vaccine must be taken. People who receive the first dose of the vaccine and experience a side effect or adverse event are most often afraid to receive a second or multiple doses, and that can “lead to avoidance or delay of subsequent immunizations,” according to the study.

Many parents fear that if a child who has been recently vaccinated shows signs of side effects or adverse events, the child is allergic to that vaccine.

“Our research shows that that is not the case,” Gaston De Serres, MD, an epidemiologist with the Canadian Immunization Research Center and a co-author of the study, told Consumer Reports. “Most of these events are one-off. They’re transient, they don’t recur, and they don’t cause permanent damage — especially compared with the diseases against which we are trying to immunize.”

People who receive vaccines and suffer serious side effects like anaphylaxis (characterized by swelling of the face or trouble breathing), seizures or hypotonic-hyporesponsive episodes (body goes limp, pale face and unresponsiveness) after the first dose are not likely to have a recurring episode. Results showed only 0-0.8% of those who had experienced such events had them recur after another dose. For milder side effects like fever, swelling limbs, pain at the injection site and vomiting, the study showed that the risk of recurrence was 4-48%. But upon receiving a second or multiple vaccinations, the symptoms were no more severe than the first.

Sean O’Leary, MD, a pediatric infectious diseases specialist at Children’s Hospital Colorado, told Consumer Reports that the study is very reassuring. “It confirms for parents and providers that in the vast majority of cases, it’s okay to revaccinate — even if there were some apparent reactions to the last shot,” he says.

How to Report Side Effects to the FDA

This week, MedShadow founder Su Robotti and content manager Jonathan Block take a look at the FDA’s reporting system for side effects from medications, medical devices, food, cosmetics and more. They walk us through the online MedWatch form for reporting, while mentioning that there are 3 other ways to get your information to the FDA if the form doesn’t work for you.

Su Robotti: Hello, and welcome to MedShadow TV. My name is Su Robotti, and I’m the founder of MedShadow.

Jonathan Block: Hi, I’m Jonathan Block, and I’m the content editor at MedShadow.

SR: Today, Jonathan came up with the idea for our MedShadow TV. He was looking at the FDA reporting site for when you have an adverse event or a very negative side effect for a drug or a medical device, and realized, it’s maybe not as easy as it looks. So he went through the process and he’s here to tell us a little bit about what it’s like.

JB: Sure, first of all, if you do experience an adverse event or a very serious side effect, the first thing you should do is to not report to the FDA but to contact your doctor or healthcare professional immediately so that they could take immediate action.

The system that Sue was talking about is known as the MedWatch system. This is the database that the FDA compiles from reports of side effects and adverse events from both patients as well as healthcare professionals. The good news is that you can actually access the MedWatch site by going to our homepage at medshadow.org, and on the right side of the page you will find a link to the MedWatch reporting site, which will allow you to submit a report to the FDA.

The first thing that you should know when doing this is that you should, if possible, have the medication available in front of you, because you’re going to have to enter in information such as the expiration date. You’re going to need to know the dosage that you are taking. Obviously, the name of the drug. The name of the manufacturer. This is all information that the FDA is going to want to know about when you are making your report.

When you do go to the MedWatch page, the first thing you’re going to do is, after clicking on making a report as a patient — because there’s another way to make a report, but that is for healthcare professionals — is they’re going to want to know a little bit more about the problem. They’re going to ask a series of questions where most of which you’re only going to have check boxes, such as — provide details as to why it happened, the date that it occurred, and if you have any test or lab data that are related to your condition and thus might be connected to the medication.

SR: But that’s a little bit tricky, as I was looking at it, just because you said it was so interesting. I noticed that if you report online, they don’t accept any attachments, so you’ll have to write down the information, any lab test that you got. However, there are 4 different ways to report adverse events to the FDA through Med Watch, and the easiest way is online, as Jonathan said. However, you can also printout the form, you can call the FDA with an 800- number, that’s on our screen now, and you can have your doctor report for you. That will be reported for you.

JB: Exactly, and the next step after, there’s a page where you describe your problem is to talk about the product that you’ve been taking. Just to go back a little bit, the reporting site is not just for prescription drugs–

SR: Prescription medicines, any food, because it’s FDA, Food and Drug Administration, biologics, things like blood, plasma, tissue, human cells, medical devices, any combination devices, special nutritionals, they do want to hear about infant formula or food for seniors. And cosmetics. You can complain about cosmetics there too.

I noticed when I was going through the form, that they seem to, they have check boxes on the website that ask were you hospitalized, did you die — presumably, did someone die. Were you disabled. The implication, if I were filling it out, and I wanted to complain that this pill made me extremely nauseous, or this pill give me a full body rash, or some complaint of that nature, that is a very valid adverse event or side effect to report to the FDA and to Med Watch. It doesn’t quite seem like that because it’s not one of the check boxes. They really want to find the big events. But those not so big events, are incredibly important for doctors to know about, and for the FDA to know about, so that they can really determine if these side effects are worth the benefits of the drugs over the long term.

JB: Exactly, exactly. As I was saying before, you do want to keep the medication that you’re using because another thing you’re going to have to fill out is the dosage that you’re taking, the name of the drug, how frequently you are taking it, the manufacturer, that sort of thing. And there’s a field to put that information in. And then there’s another page where they want to know more about you, as far as your age, your sex, obviously, your ethnicity, as well as any medical conditions that you might be suffering from as well as other medications that you are taking, as well as any nutritional supplements because there is a possibility that the side effect or adverse event that you’re experiencing could be related to an interaction with one of those other products that you are taking.

SR: Don’t forget to include everything even if it’s not asked about, if you’re taking herbal supplement–

JB: Correct–

SR: If you’re taking vitamin pills, those are all products that can interact, and don’t forget this also covers medical devices. So if you’re having a problem with knee replacement, a shoulder replacement or a hearing aid is a medical device, a crutch is a medical device, all legitimate to file here.

JB: Exactly, and then the last part that you’ll have to do is actually very simple. They’re going to ask for your name. You don’t have to give them your address, but I would suggest that you do that because they may want to, you know, be in contact with you via mail. I guess the bottom line is that if you do have an adverse event and it’s serious, absolutely, do report it.

It’s through this reporting that the FDA can investigate and take potential action against drug manufacturers in regards to a particular drug and by doing that you may very well be helping other people out, in terms of getting more research done on the medication.

SR: Well put, Jonathan. Thanks, and I think that’s it for MedShadow TV today.

JB: It is. Thanks very much, and don’t forget to check out our website at www.medshadow.org for more information. Thank you.

Will Stem Cell Tests Predict Your Drug’s Side Effects?

Every drug has side effects, and the question is usually how to assess the risk of the side effects vs. benefit of the particular medication.

But what if a stem cell test could predict how a particular patient would react to a particular drug? What if physicians knew this before starting a treatment regimen, and could swap one drug for another or alter the dosage of a drug?

“Essentially, such identification will allow clinicians to begin at lower drug doses, and to increase as needed,” says Dr. Min-Han Tan, an oncologist and principal research scientist at the Institute of Bioengineering and Nanotechnology (IBN) in Singapore.

Adverse reactions to prescription drugs send hundreds of thousands of people to emergency rooms each year, often leading to hospitalizations, and their numbers continue to rise. Why is this happening?

Because there are more drugs available to treat patients today than ever before, and people often take drug combinations for a particular ailment. Many patients also take a cocktail of drugs for multiple health issues, which increases the risk of adverse reactions.

Potential for Screening Harsh Cancer Drugs

Tan’s team at IBN have devised a stem cell test they used to screen a kidney cancer drug to see if it will cause liver damage, and how it causes damage.

As part of a 4-year-long research project, researchers drew the blood of 5 patients, and using induced pluripotent stem (IPS) cells that can transform into different types of cells, they created liver cells which were then exposed to Votrient (pazopanib), a chemotherapy drug for late-stage kidney cancer (advanced renal cell carcinoma) that can cause liver damage.

They found that 3 patients reacted badly, while 2 had no liver damage. The stem cells that were tested mirrored the reaction that patients actually had post-treatment.

“We were able to figure out how the drug works from the [patients’ reaction] to the liver cells, which was unknown to doctors, even after many years of using this drug,” Tan says.

Pazopanib causes adverse reactions such as hepatotoxicity (liver damage), hypertension, hand and foot rash, and fatigue. Drugs that damage the liver can lead to organ damage and chronic disease.

Personalized Testing Trumps Generic Tests

The researchers pointed out that currently, new drugs are tested for toxicity using generic liver cells, which can’t model a patient’s specific reaction. By personalizing liver cells from individual patients’ blood, the stem cell test can help doctors prescribe safer and more effective therapies. The team is planning on a formal clinical trial for further testing.

“We are already working on expanding the patient cohort (test group) and targeting different types of organs, other than the liver, to evaluate drug toxicity in these organs,” Tan says. “The reliability of such testing is best determined in larger cohorts and studies, which we look forward to reporting.”

‘The whole idea of patient-specific therapies, including for cancer, is an exciting new trend’

This is a good start and looks encouraging, says Paul Knoepfler, a biomedical scientist at the University of California, Davis, who focuses on stem cell and cancer research.

“While I have not seen exactly this kind of stem cell-based test before, the big picture idea of using IPS cells for drug testing has already generated a lot of excitement, and I think has tons of promise,” Knoepfler says. “The patients’ own cells, particularly liver cells, are ideal for gaining insights on predicted patient drug reactions.”

While it’s too soon for patients to be asking for this test, if it’s scaled up and adopted by healthcare providers following clinical trials, it won’t hurt to ask he says, since he always encourages patients to ask questions.

A Combined Approach

However, physicians typically won’t rely on a single test to decide which patients should be given which drugs. Instead, they would use this test in combination with other data such as genomic testing, which could provide the best predictions.

“The whole idea of patient-specific therapies, including for cancer, is an exciting new trend, and I see this kind of stem cell technology, perhaps together with patient genomic testing, as a major step forward,” Knoepfler says.

Tan’s team is working on scaling up the test for wider adoption, so it can reliably detect and avoid side effects, which he says would be reduced by at least 90%.

But a big question is cost. Would it be an affordable test? “It’s still in the proof of concept stage, but if commercialized, we hope to make the test affordable for the average patient,” Tan said. The current process takes 6 months, but we’re working on reducing the cost and the turnaround time to take it from lab to clinic.”

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Genetic Testing May Predict Side Effects to Drugs

What if you could find out if a drug would cause you side effects or wouldn’t work at all before you started taking it? That now may be possible for 150 drugs used for depression, cholesterol, heart disease and pain through a swab of the cheek as part of a genetic test.

The test, which costs about $266, is called the mygeneRx. It was developed by a South African company, DNAlysis. It works by examining genetic variation in genes that influence enzymes involved in the metabolizing of medications.

The enzymes control how fast the drug is used by the body. If a drug is metabolized too quickly, it won’t have time to work. But if it metabolizes too slowly, it can provoke an overdose or side effects.

The testing is part of the field of pharmacogenomics, which can help to predict a person’s likelihood to have a bad reaction to a drug.

However, some medical experts say the tests are not yet advanced enough to be used regularly by patients.

“Most of the [laboratories] only test for a few genetic markers‚ as also indicated in this test‚ which are not enough for personalized treatment,” Mamoonah Chaudhry‚ PhD, a postdoctoral fellow at the University of Pretoria’s Institute for Cellular and Molecular Medicine, told the Sunday Times.