House Call, MD: Health Carefully Explained

PharmD 2011 | houspian@myhousecallmd.com

You’ve may have noticed that your grandmother takes an aspirin everyday as part of her arsenal of medications. You may wonder why she’s taking aspirin when she’s in no apparent pain.  When you asked grandma she replied with her sagely tone, “The doctor said its good for my heart.” You nodded, pretending to understand, and wrote the answer off as another one of grandma’s “senior moments.” Well, it turns out that this time grandma is right. Although her answer is a simplified version of the truth, it is the truth nonetheless. Before you start popping aspirin yourself, read on to find out who should take daily aspirin and how it works to help your heart.

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by Tania Houspian, PharmD 2011

It’s inevitable and happens at least twice a month.  Plans will be made to go out to a bar with friends and, as the first cocktail is being ordered, someone remembers that they’re on antibiotics for an infection they’d rather not talk about. The question is raised about whether or not it’s OK to drink alcohol with that particular medication.  At that point, everyone turns to the friend with some form of medical training and asks, “So can I drink or what?” Members of the House Call, MD staff have experienced this so often we’ve started to avoid going out for drinks with infection-prone friends.  What a loaded question!  If the answer is, “No”, then the friend will spend the rest of the night pouting about not being able to drink and secretly blame the messenger for it.  To avoid those awkward conversations, we’d like to take a moment and explain why sometimes it better to put the drinks aside when on certain medications.  We apologize in advance for your drink-less night out.

Why does alcohol interact with certain medications?

Alcohol is broken down by two parts of your body: your stomach and your liver. When that shot of whiskey reaches the stomach some of the alcohol is broken down and the rest is absorbed into your blood stream. From your bloodstream, the alcohol is delivered to your liver via the portal vein.  In the liver, about 10% of the remaining alcohol is broken down. The remaining alcohol is passed back into your bloodstream and is free to create all those magical affects alcohol has on your brain (i.e. thinking you’re a better dancer than you really are, being exceedingly friendly with strangers, etc.).  At any of those stops that alcohol makes in your system (stomach, liver or brain) there is a possibility for it to interact with any medications that may possibly be taking the same path (1).  Below we’ll go through different classes of medications, covering specific medications from each class and how they interact with alcohol.

Class: Antibiotics/Antifungals

Medications: Metronidazole, Nitrofurantoin, Tinidazole, Ketoconazole, Cycloserine, Cefoperazone, Cefotetan, and Griseofulvin

Just a shot of vodka along with any of these medications and you may be hugging the porcelain throne earlier in the night than you had planned. When mixed with alcohol, these medications can cause a violent reaction in your stomach called a “disulfiram-like reaction.” This reaction results in a sudden increase in heart rate, turning beet red, upset stomach, nausea, vomiting and, in worst case scenarios, death (2).  Antabuse is the name of a medication whose main component is disulfram. When people want to quit drinking they are prescribed Antabuse so that if they do give in to their urge to drink they’ll have a violent reaction to the alcohol.  The smart alecks in the crowd are now thinking, “Well I’ll just make sure to separate my antibiotic and alcohol by a long enough interval so that they’ll never meet in my stomach! I win!”  We hope you can define a “long enough interval” (and if so, let us know) because everyone’s stomach empties these medications at different rates.  As such, we can’t even being to make recommendations as to how much time you should allow for so that none of the antibiotic will meet the alcohol.  The bottom line is that if you mix the above medications with alcohol, you’re asking for some serious punishment.  You can’t say we didn’t warn you.

Class: Antihistamines

Medications: Loratadine, Fexofenadine, Diphenhydramine, Desloratadine, Loratadine, Brompheniramine, and Cetirizine

Having read Attack of the Common Cold, you know that antihistamines can help with a lot of cold symptoms.  Since they’re available to buy at the pharmacy without a prescription, some people make the mistake of assuming they’re completely safe and won’t interact with other medications or alcohol.  We are sorry to say that this assumption is wrong.  On their own, antihistamines can cause some drowsiness.  When mixed with alcohol, you might as well tuck yourself in for the night.  Aside from making you drowsier, it’s also possible to become dizzy from a drop in your blood pressure.  Dizziness can lead to falling and falling leads to all sorts of serious injuries (i.e. broken bones, concussions, etc.)(2).  Antihistamines are found in all sorts of cough, cold, and allergy combination drugs like Nyquil so read the back of the label and see if any of the above medications are in there.  We don’t recommend that you take antihistamines and drive until you know their affect on your level of alertness.  If you’re going to drink and take antihistamines, absolutely do not drive (not that you need to be reminded that you should not drink and drive!).

Class: Cough Medications

Medication: Dextromethorphan (Robitussin)

If you’ve ever had a cough and taken Robitussin, you know how sedating it is.  Imagine mixing alcohol with that.  Two words: lights out.  Mixing the two can lead to hallucinations and strange behavior (more so than alcohol alone).  While this may sound like fun to some people, believe us when we tell you that it is dangerous and harmful to your brain (2).  Don’t do it.

Class: Heartburn Medications

Medications:  Nizatidine, Metoclopramide, Cimetidine, and Ranitidine

Heartburn is very unpleasant and we completely understand your need to alleviate that toxic feeling with medications. You pop a Zantac (Ranitidine) and start to feel better so you decide you will join your friends at the pub.  What can you expect to happen after your second vodka tonic?  Nothing good.  Your heart rate will increase suddenly and so will your blood pressure.  Imagine how the heartburn made you feel and amplify that ten-fold. In addition mixing alcohol with these medications can increase the affect alcohol has on you. If you’re someone who usually feels tipsy after six drinks you may start feeling not so great after two.  This happens because the heartburn medications decrease the breakdown of alcohol in your stomach so your body is exposed to more alcohol than it normally would be. In turn, alcohol inhibits the metabolism of the heartburn medications so you experience more severe side affects from those medications (the increased heart rate and blood pressure) (2).

Class: Pain Relief

Medications: Ibuprofen, Naproxen, and Aspirin

Whatever the source of pain (cramps, muscle pain, hangover, headache, etc.) most people reach for one of these trusty painkillers.  Aspirin has lost some of its popularity as a painkiller but Ibuprofen and Naproxen are gaining in popularity due to their anti-inflammatory properties that help with lots of different sources of pain.  How do these trusty pain-alleviating friends of ours interact with alcohol?  Ibuprofen, Naproxen, and Aspirin all disrupt the lining of your stomach and add to the erosive affects of alcohol.  Combine the two and you asking for some serious stomach pain. Together they can completely disrupt the lining of your stomach and allow the acidic contents of your stomach to reach the stomach tissue.  Long-term combination of alcohol and these agents can lead to bleeding in your stomach (a.k.a. gastrointestinal bleeding). Not fun and filled with long-term consequences.  It’s generally recommended that you separate these agents and alcohol by 8-10 hours or play it safe and don’t combine them in the same day (1).

Class: Antipyretic (Anti-Fever)

Medication: Acetaminophen (Tylenol)

Tylenol can be used for both pain relief and to reduce fever. It gets its own separate section from the other pain relievers because it comes with an entirely different risk when combined with alcohol. Tylenol, like alcohol, is broken down by the liver. When Tylenol and alcohol meet in the liver, the alcohol causes Tylenol to be broken down into a toxic compound.  This toxic compound causes the death of liver cells!  Did your liver just quiver out of fear? We don’t blame it.  Long-term combination of alcohol and Tylenol can cause liver failure, meaning that you’ll ultimately need a liver transplant.  Not good.  Avoid taking more than 4 grams of Tylenol a day and absolutely do not drink when taking Tylenol (1).

Class: Antidepressants

Medications: Phenelzine, Isocarboxazid, and Tranylcypromine

The antidepressants listed above are from the Monoamine Oxidase Inhibitor class (MAOI’s for short, we love acronyms in the medical world).  They have lost popularity in recent years because of the many interactions they can have with food and alcohol.  Aged foods (think salami, aged cheeses, etc.) and aged drinks (wine is the main culprit here) contain a compound called tyramine.  The metabolism of tyramine is prevented when someone is taking MAOI’s so the tyramine builds up in your body.  When tyramine builds up, it causes a sudden increase in heart rate and blood pressure that we call a hypertensive emergency (1). Yes, the kind of emergency people end up in the hospital for.  So if you are taking any of these antidepressants, do not drink aged alcoholic beverages.

Class: Sedatives

Medications: Diazepam, Lorazepam, Zolpidem, Eszopiclone, Estazolam, Ramelteon, Phenobarbital and Temazepam

The entire point of these medications is to help people fall asleep. Add on the sedating affects of alcohol and you’ll have an extremely un-alert person. This might not sound like reason enough not mix them with alcohol since being extra sleepy is something an insomniac may want.  However, the downside is that you may become completely unaware of your actions and experience amnesia. On the other hand some people become aggressive and anxious due to combining these medications with alcohol (2).  The reaction can vary from person to person.  Even with the variance among individuals, all the manufacturers of these medications clearly warn against taking these medications with excessive amounts of alcohol.

Class: Opioid Pain Killers

Medications: Morphine, Oxymorphone, Meperidine, Methadone, Propoxyphene, Oxycodone, Hydromorphone, and Codeine

Generally prescribed for serious pain, the consequences of mixing these medications with alcohol are serious.  Like with the sedatives, mixing these medications with alcohol can cause increased sedation, amnesia and loss of control.  If that’s not enough to scare you then maybe the fact that you may stop breathing will.  Opioid painkillers cause respiratory depression (decreased breathing) and alcohol adds to that affect (1).  It is this combination of painkillers and alcohol that has claimed the lives of several celebrities in the past.

There are a lot of other medications that interact with alcohol but the medications above are the most commonly used in our society.  Never assume it’s safe to combine medications or take medications with alcohol until you check with your pharmacist or doctor.  One night of fun is not worth any long-term damage you may cause your self.  The next time the answer is, “It’s probably best not to drink while on that medication,” trust us…we’re on your team.  We’ll even take you out for a drink when you’re medication-free.

Questions? E-mail the Author: houspian@myhousecallmd.com

References:

1.    Alcohol Related Drug Interactions. Pharmacist’s Letter/Prescriber’s Letter. Jan 2008. Vol 24.

2.    Harmful Interactions: Mixing Alcohol with Medicines. National Institute of Alcohol Abuse and Alcoholism. 2007.

by Georgina Lee, PharmD 2011 | lee@myhousecallmd.com

Have you ever played a game at the arcade where the more accurately a person fires a steady stream of water into a target, the faster their object rises to the top?  Imagine the person who sits down and pulls the trigger only to find the water stuck in the barrel.  Do you blame the player for their inability to get their object to rise or do you blame the faulty water gun?  For some men, having a faulty water gun can be both frustrating and debilitating, especially when it comes to bedroom activities.  That’s probably why those little blue pills, otherwise known as Viagra, are flying off pharmacy shelves.  These pills may not have Avatar-like abilities but they do serve as a miracle to some who suffer from one of nature’s most vexing problems.

What is erectile dysfunction (ED)?

The National Institutes of Health (NIH) defines male erectile dysfunction as the “inability to achieve or maintain an erection sufficient for satisfactory sexual performance.”  Let’s not confuse ED, however, with other disorders such as premature or delayed ejaculation, anorgasmia (inability to achieve orgasm) or infertility.  Essentially, there are four physiological systems that are necessary for a normal penile erection: vascular, neurologic, psychogenic and hormonal.

1. Vascular Stimuli

Erections are the result of shifting blood flow in the body.  Most of the blood that is contained in the penis during an erection is in the corpora cavernosa (erectile tissues that lay along the penis shaft).  Within the corpora cavernosa are multiple interconnected sinuses or sacs that can fill with blood to produce an erection.  In the flaccid state (i.e. not erect), the arterial and venous blood flow into and out of the corpora are balanced.  During an erection, however, arterial blood flow going into the corpora increases and blood fills the sinuses resulting in penile swelling and elongation.  A neurotransmitter known as acetylcholine helps this process by enhancing production of nitric oxide and cAMP, which are substances that induce smooth muscle relaxation and vasodilation (widening of blood vessels).  The erection is prolonged by a decrease in venous outflow from the corpora (so more blood stays in the penis).  The take home message is that sufficient blood flow into the penis will cause an erection.  Easy, right?

2 & 3. Neurologic and Psychogenic Stimuli

Of course blood flow is not the only important aspect of an erection.  If you ask most men (or their wives), chances are some will have an erection while they are sleeping.  This type of erection is mediated by a sacral nerve reflex arc.  In the conscious person, however, sexual stimulation mediates erections via the central nervous system (the motherboard of nerves).  In other words, someone who is awake can be stimulated by their senses (for example, if they see an attractive person, hear certain things, smell a particular scent, taste or touch a particular object…you see where this is going).  No wonder the adult entertainment business is a billion dollar industry!  The individual’s brain processes this sensory information and a nervous impulse is carried down the spinal cord to peripheral nerves (these nerves communicate via the neurotransmitter, acetylcholine).  These nerves trigger an increase in the blood supply to the corpora and, like that, an erection is born! So what happens after an erection?  The party has to stop at some point!  A different neurotransmitter called norepinephrine is released.  This chemical constricts vascular smooth muscle, decreasing arterial inflow to the corpora and increasing venous outflow (i.e. more blood leaves the penis).  The end result is your standard flaccid penis, as good as new.

4. Hormonal Stimuli

The fourth system that is involved in the process of an erection has to do with testosterone which stimulates libido or sexual drive in males (or “Mojo” in the words of Austin Powers).  Approximately one third of men older than 50 have a condition called hypogonadism that is characterized by low serum testosterone levels.  When libido is decreased, a person may not develop erections and erectile dysfunction is considered secondary to a decreased libido.  However, serum testosterone levels do not always correlate with ED so don’t kick down your doctor’s door demanding testosterone injections just yet.

Erectile dysfunction can manifest from any single or combination of abnormalities of the four systems necessary for a normal penile erection (and you used to think it was so simple).  In addition, diseases that compromise vascular flow such as arteriosclerosis (stiffening of blood vessels), impair nerve conduction to the brain (i.e. stroke) or nerve conduction in the periphery (i.e. diabetes), mental disorders, hypothyroidism and others can all cause ED.  Social habits such as smoking and drinking as well as certain medications have also been linked to performance problems (see it does happen to other guys).

How do I treat ED?

According to the American Urological Association (AUA), identifying underlying causes including disease states and psychosexual dysfunctions should be initiated followed by a heart-healthy lifestyle complete with a proper diet and regular exercise.  If the person’s ED is not reversed after such changes, then the following pharmacological treatments can be considered by you and your primary care provider.

Phosphodiesterase Type 5 Inhibitors (PDE-5)

Most of us know what Viagra, Levitra, and Cialis are used for (thanks to their cuddly commercials) but how do they work?  As mentioned earlier, acetylcholine helps release nitric oxide which causes vasodilation so more blood can flow into the penis in order to cause an erection.  Nitric oxide does this by stimulating an enzyme that makes a substance called cGMP, which helps to produce a penile erection.  Viagra, Levitra, and Cialis are all PDE-5 inhibitors meaning they block the enzyme (phosphodiesterase) that breaks down cGMP (making it inactive).  When you take one of these medications, cGMP stays around longer and more blood goes into the penis to maintain an erection.  In terms of efficacy, all three drugs are comparable depending on the person’s tolerance and satisfaction.  Approximately 30-40% of patients do not respond to PDE-5 inhibitors mainly due to noncompliance issues.  By “noncompliance issues” we mean:

• Patients must engage in sexual stimulation for the best response

• Sildenafil (Viagra) must be taken on an empty stomach at least 2 hours before meals (does not apply to Vardenafil (Levitra) or Tadalafil (Cialis))

• Taking Viagra or Levitra with a fatty meal can decrease the absorption rate (Cialis is not affected)

• Patients who do not respond to the first dose should continue with the drug for at least 5-8 doses before failure is declared, as increasing success rates are reported with sequential dose administration

• Some patients require dosage titration up to 100mg of Viagra, 20mg of Levitra or 20mg of Cialis for a response

In general, Viagra and Levitra are similar in that they have a 1-hour onset of action, short duration of action and oral absorption that is significantly delayed when the drugs are taken within 2 hours of a fatty meal.  In contrast, Cialis has a delayed onset of action of 2 hours, a prolonged duration of action of up to 36 hours and food does not affect its rate of absorption.  People taking these medications should avoid alcohol as it may result in orthostatic hypotension (low blood pressure upon standing up) and cause symptoms such as lightheadedness and dizziness.  The most common side effects for these medications include headache, facial flushing, dyspepsia (stomach irritation) and dizziness (super sexy, right?).  Also, people taking nitrates (nitroglycerin or isosorbide dinitrate) for chest pain should not take these medications.

Intra-Cavernosal & Intra-Urethral Alprostadil (Caverject, Edex, and MUSE)

Alprostadil is a drug that stimulates production of cAMP which causes smooth muscle relaxation of the arterial blood vessels of the penis, enhancing blood flow.  It can be injected either directly into the corpora cavernosum (side of the penis) or into the urethra (front of the penis). Yes, we did just say “injected.”  Although it is highly efficacious, 30-50% of patients voluntarily discontinue therapy during the first 6-12 months due to inconvenience of administration, an unnatural nonspontaneous erection, needle phobia, loss of interest, and cost of therapy.  We would wager that “needle phobia” is the big winner in that group.  Typically, the onset of action occurs within 5-15 minutes and the duration can last for up to an hour…assuming you don’t pass out from the needle.

Testosterone Replacement Agents

Testosterone replacement regimens restore testosterone levels to the normal range (300-1,100 ng/dL) which can correct symptoms of hypogonadism (symptoms include malaise, loss of muscle strength, depressed mood, and decreased libido).  In addition, testosterone can stimulate nitric oxide which can enhance blood flow into the penis.  Testosterone can be administered orally, parenterally (injection), or transdermally (gel or patch).  Injectable testosterone is the preferred treatment for symptomatic patients because the injections are effective, inexpensive, and not associated with major side effects.  Although convenient for the patient, testosterone patches and gels are much more expensive than other forms and should be reserved for patients who completely refuse injectable testosterone (you didn’t hear that from us).  Side effects from gels/patches include weight gain, high blood pressure, gynecomastia (man boobs).  Also, FYI, the patches and gels should not be used when in close contact with pregnant women.

Other Devices

Hopefully we’ve opened your eyes to solutions out there beyond the little blue pill.  That being said, we have a few more tricks up our sleeve before we wrap up.  First, the vacuum erection device (VED) is a pump that is activated by the patient producing a vacuum pressure to draw arteriolar blood into the corpora cavernosa.  The onset of action is comparatively slow (30 minutes), which requires patience and planning from both the patient and the sexual partner.  Not to mention the fact that VEDs are not very discreet (read: hard to hide).  Other unapproved agents include trazodone, yohimbine, papaverine and phentolamine.  The most invasive treatment for ED is the surgical insertion of a penile prosthesis used for people who do not respond to oral or injectable treatments.  Penile prostheses provide penile rigidity suitable for vaginal intercourse and are associated with a greater than 90% patient satisfaction rate (generally higher than that observed with any other drug treatment or VED).  Much easier to use, a number of device options to choose from but, at the same time, an invasive procedure to say the least.  We’ll let you make the final call.

A possible and potentially dangerous side effect of all of the above treatments is known as priapism (a prolonged and painful erection lasting for more than 1 hour).  This complication becomes most dangerous when an erection persist beyond 4 hours (sounds painful) and people are thus advised to seek medical attention immediately since priapism is considered an urological emergency.  Most importantly, seek professional medical advice from your primary care provider before starting any treatment.  Erectile dysfunction is a very personal issue and difficult to discuss yet the condition is very manageable with proper medical examination and treatment.  With your ED under control, we’ll leave you with one more valuable piece of medical advice: Always remember to practice safe sex (don’t be a fool, wrap your tool)!

Questions? E-mail the Author: lee@myhousecallmd.com

Resources

1. DiPiro, Joseph T. Pharmacotherapy: A Pathophysiologic Approach. 7th ed. New York: McGraw-Hill, 2008. 1369-385. Print.

2. American Urological Association Education and Research. “AUA Guideline on the Management of Erectile Dysfunction: Diagnosis and Treatment Recommendations.” AUA – Home. 2005. Web. 03 June 2010. <http://www.auanet.org/content/guidelines-and-quality-care/clinical-guidelines>.

3. NIH Consenus Conference. NIH Consensus Development Panel on Impotence. Impotence. JAMA 1993;270:83-90.

4. Stimmel & Gutierrez. Counseling about sexual issues. Pharmacotherapy 2006;26: 1608-1615.

by Tania Houspian, PharmD 2011 | houspian@myhousecallmd.com

You open your refrigerator door and take out a milk carton (non-fat of course) to top off  your morning cereal.  As you tilt the carton, expecting a stream of delicious white liquid, you instead get disgusting clumps of a cottage cheese-like substance. It’s safe to say that the milk has passed its expiration date. You, being the sensible human being that you are, throw away the expired milk and settle for a granola bar for breakfast instead and plan to buy a new carton of milk on your way home from work.

Let’s look at another scenario.  You open your medicine cabinet and take out a bottle of Motrin wanting to take a couple of tablets to alleviate the muscle pain from a rough game of basketball last night (those 16 years olds didn’t look so tough at first).  You scan the bottle looking for how many you should take and notice that it expired June 2009. You open the bottle and see that the pills look fine. There is no molding… they don’t smell funny…so you figure it’s fine to take. Besides, you have a stellar conspiracy theory that expiration dates are an evil ploy by pharmaceutical companies to get you to buy medication more often. You pop two tablets and go on with your day.

If you find yourself nodding emphatically saying,  “That’s so true.  I totally do that!” then you’re not alone.  One of the most common questions pharmacists are asked is “Can I take this medication even though it expired last year?” On the other hand, you don’t ever go back to the grocery store and ask the clerk, “Can I drink this milk even though its been expired for a year?”  This paradigm makes sense, though. When there’s proof of spoilage (i.e. stinky cottage cheese instead of milk) we’re way more likely to believe the expiration date. We don’t blame you, old milk tastes horrible but old Motrin still has that delicious sugary coating.

So, what’s the final verdict? Are expiration dates just a way to get you to buy more medications or did your Motrin become ineffective as of June 2009?

The Evil Ploy Side:  The main argument presented by the “Expiration Dates are for Pansies” faction of society is a study performed by the military and presented to the FDA in 2002. In the study, the military evaluated all of their expired stockpiles of medication and discovered that some were still considered stable and efficacious for up to 54 months after their noted expiration date.

Now you can take those results and run with them or you can look at the details of the military’s findings. The military noted that the “degree of stability” depended greatly on the medication, manufacturer, and lot number. They were not issuing a blanket statement saying all medications are good for 54 months after the printed expiration date.  They merely found that some drugs remain good after the date on the bottle.  This fact, though, may be enough for some to call into question the validity of the expiration date on that Motrin bottle.

Here is the take home message: You are not the military.  Earth-shattering, we know. What we mean by that is that you don’t store and care for your drugs the way the military does (just a guess).  The military stores their stockpiled medications in cool, dry, dark, and temperature controlled warehouse-type locations.  Where do most people store their medication?   A few common “store houses”:  medicine cabinet in the bathroom, spare cabinet in the kitchen and, last but not least, purses. Think about all the temperature and humidity changes those locations go through.  Repeated exposure to temperature variations and light affects the stability of medications.  Even though the pharmaceutical company knows the medication will be good for 10 years, they may decide to give it a 5 year expiration date to account for variations in how people store their medications.  The date printed on your bottle of Motrin takes into account all the abuse you dare inflict on your personal medication supply.

Now you say: “So what! I took some expired Motrin (Tylenol, Nyquil, etc.) and nothing bad happened to me!”  Okay, but there’s also a chance that nothing good happened either.  When a medication passes its expiration date it means that the company that manufactured it no longer guarantees it will work for you.  You may not get any relief from your muscle pain, sore throat, runny nose, or whatever symptom you were trying to treat.  Not the kind of medicine we endorse.  The treatment of the aforementioned mild conditions may not be life altering but the issue of efficacy is important with medications that are used to treat life-threatening conditions.  Medications like nitroglycerin, insulin or antibiotics should never be taken past their expiration date.  If these medications don’t work properly, the stakes are much higher (read hospitalization or, even worse, death).

Anytime you ask a health professional if it’s okay to take a medication past its expiration date the response you’re most likely going to get is, “No.” It’s just not worth the possibility of not receiving adequate treatment.  For the skeptics in the room, there is one time that you’ll hear of medications being used past their expiration date: severe shortages.  At those times, desperate times call for desperate measures and the medical community works with the limited resources available.   Next time you look at the back of your medication bottle and see its expired, ask yourself: Is this really a desperate time or can I easily get more medication that’s guaranteed to work?  I think we all know the answer.

Questions? E-mail the Author: houspian@myhousecallmd.com

by Tania Houspain, PharmD 2011 | houspian@myhousecallmd.com

You’re at the new happening lounge with your three closest model-looking girlfriends catching up on girl talk. Of course, in the tradition of female gossip, the subject turns to sex and then birth control.  One of your girlfriends starts gushing about her amazing new birth control that not only helped her avoid pregnancy but also decreased her PMS bloating and acne.  All your friends are in awe of this great new birth control and you all agree that you’re going to request it at your next doctor’s visit.  You buying all this?  While this may not be the most realistic dramatization, this is the scene painted by Bayer in advertisements for their birth control products, Yaz and Yasmin.  It’s this kind of casual, direct-to-consumer advertising that not only helped Yaz get on the list of the Top 200 Drugs sold in the US but also got Bayer in trouble with the FDA and, more recently, with the legal system.

Why is Bayer in trouble?

The class action lawsuit filed against Bayer claims that Yaz and Yasmin increase the likelihood of women forming blood clots more than other birth control pills. To make matters worse the lawsuit states that Bayer was aware of the increased risk with using these two birth control products but downplayed the risk with casual commercials that over exaggerated their uses.

Is it true?

First and foremost, all birth control pills with an estrogen component (refer to the article 28 Days a Month, 13 Months a Year… for the details of birth control) can increase the risk of blood clots forming. A clot is a clump of blood cells, tissue, and other parts of blood that stick together.  The problem with a clot is that once it starts to move through your arteries it may get stuck in narrower arteries and stop blood flow to the tissues beyond that point.  Imagine what would happen if blood supply were cut off from certain parts of your body due to a clot.  In case you don’t want to imagine the consequences, we’ve broken it down for you:

• Lungs (a clot here is called a Pulmonary Embolism):

  • Difficulty breathing

  • Coughing up blood

  • Sharp chest pain

  • Heart palpitations

• Heart (a clot here is called a Myocardial Infarction or heart attack)

  • Crushing chest pain (like an elephant standing on your chest)

  • Irregular heart beats

• Brain (a clot here is called a Cerebrovascular Accident or a stroke)

  • Inability to move or feel parts of your body

  • Inability to speak

  • Disorientation

• Leg (a clot here is called a Deep Vein Thrombus; an example is shown above)

  • Leg pain

  • Swelling of leg

  • Bulging veins in leg

  • Redness, inflammation, or discoloration of the skin of the leg

• Eyes (a clot here is called a Retinal Vein Occlusion)

  • Eye pain

  • Blindness in affected eye

In all of these tissues, if the clot isn’t taken care of right away the lack of blood and oxygen to the area can cause long-term damage and consequences. The take away: blood clots are a serious matter.  This risk of blood clots is why, when you ask for birth control, your doctor asks if you smoke (no, he doesn’t want to bum a smoke off of you), checks your age and takes a look at your medical history.  Women who smoke more than 15 cigarettes a day, who are over 35 and who have certain medical conditions are more likely to form blood clots. Using estrogen-containing birth control in these women is generally not recommended.

If all birth control pills cause blood clots (and this is a medically known fact), why is Bayer getting sued?

It seems as though Yaz and Yasmin may carry an extra risk of blood clots due to their second active ingredient, drosperinone.  Drosperinone comes from a family of compounds known as diuretics.  No, they don’t give you diarrhea but drugs in this class do make you pee more (they are often called “water pills”).  They’re usually given to people with high blood pressure causing them to pee out some extra water and decrease their blood volume and subsequently their blood pressure.  Drosperinone is a very mild diuretic and is given in very small doses in the birth control pill so you don’t lose that much body water.  The diuretic effect is thought to cause just enough water loss to decrease bloating-related symptoms.  Drosperinone also resembles certain hormones in your body so scientists believe that is may help curb the hormonal problems some women experience during their menstrual cycle (think irritability). Sounds great but here comes the catch: The problem with drosperinone is that it causes your body to hold on to more potassium that it usually would. Normally your body naturally maintains the ideal balance of electrolytes like potassium and sodium by either reabsorbing them in your kidneys or allowing you to pee them out (for a full breakdown of the kidney’s incredible electrolyte-regulating abilities, see the diagram below…are you as impressed with the kidney as we are?). Drosperinone has the potential to increases potassium levels to a dangerous level (referred to as hyperkalemia), which causes irregular heart rhythms.  It is medically proven that irregular heart rhythms increase the likelihood of forming blood clots.  The FDA knew about all of these side effects caused by Yaz and Yasmin before approving them and these potential risks are listed under the warnings section of the package inserts.

The Most Important Question: Did Bayer downplay the risks and over exaggerate the benefits of Yaz and Yasmin?

That question will have to be answered in a courtroom but some facts are available to us. In 2008 the FDA sent Bayer an eight page WARNING LETTER (bolded and all caps to emphasize the seriousness of the matter) telling the company that changes needed to be made to their commercials for Yaz and Yasmin.  The problems the FDA cited in regards to the commercials were the representation of the medications’ effects on PMS, acne, and the minimization of risks.

PMS Claims

In the letter, the FDA reminds Bayer that Yaz was never approved for treatment of PMS but for PMDD (Pre-Menstrual Dysphoric Disorder).  PMDD is a much more severe form of PMS that interrupts a woman’s ability to function in her normal life and needs to be diagnosed by a healthcare provider. Yaz and Yasmin were never evaluated for the treatment of PMS so any claims Bayer made about these medications helping with PMS are false.  During one commercial in particular, women can be seen pushing away giant floating words such as “irritability,” “bloating” and “fatigue.”  Obviously this is meant to imply that Yaz helps get rid of these symptoms.  Any woman watching that commercial will think “Yeah, I do feel that way when I’m PMS-ing.”  The commercials never take the time to explain that PMDD is a much more severe form of PMS and Yaz should not be taken for more mild symptoms.  Bayer’s boo-boo.

Acne

The FDA also sternly warned Bayer about claims regarding acne.  In one commercial the narrator says, “It can also help keep your skin clear” and the camera zooms in on the faces of women with clear skin.  Creepy, but it gets the message across.  The FDA never approved Yaz to “help keep your skin clear.” It was approved only for moderate acne vulgaris.  It was also never shown to produce completely clear skin like the commercial would have us believe.  The study data showed that it helped decrease the number of pimples when compared to doing nothing.  That being said, zooming in on faces with beautiful glowing skin may be a tad misleading compared to what the actual data shows.

Minimization of Risks

We’re all familiar with drug commercials with the voice over guy telling us all the possible side effects and risks, rapid-fire style, at the end.  So why is Bayer in trouble with the FDA when it seems everyone does that?  Well, in addition to skimming over the serious complications that can result from using this drug, the commercials seem to also try to distract the viewer’s attention away from the serious statements being made.  While the voice over guy is talking, music is playing and women are leaping around on screen (possibly overwhelmed with the joy that comes with using Yaz?). The FDA felt that this was way too distracting and did not convey the seriousness of the possible side effects.  The FDA felt that Bayer did not take their duty to warn consumers seriously, focusing solely on selling their product.

In response to the WARNING LETTER, Bayer changed their commercials and clarified the points the FDA had requested.  The commercials emphasized that Yaz only helps with PMDD and not PMS.  The edited version explained that Yaz and Yasmin don’t completely get rid of acne but can help decrease pimples. There is also more emphasis placed on the possible risks. See the new version of the commercial below.

It’s great that they complied with the FDA’s demands but this may be a case of too little too late.  The commercials were running for a significant amount of time before the FDA requested changes.  In the meantime, women saw these commercials and went to their doctors’ offices requesting Yaz and Yasmin for birth control.  Some of these women should not have been on Yaz and Yasmin due to the increased risk of blood clots but Bayer did not properly informed them of the increased risk that these drugs carried (although we would hope their doctors would discuss such issues).  Now many women who developed a blood clot while on Yaz are coming forward stating that they had no risk of forming blood clots before starting Yaz and were unaware that the medicine could cause clots.  Trouble in River City.

Who will win the lawsuit?

Three words: Settle, settle, settle.  In the past, when drug companies are sued for issues like this they try to settle.  They’ve spent millions of dollars developing and marketing their drug and lawsuits create bad press and bad karma for them and their drug.  In addition, the lawyers handling the lawsuit on behalf of the patients have every motivation to settle since they’re working on a contingency basis (meaning they don’t get paid unless they win or settle).  The physicians who prescribed Yaz or Yasmin for patients who didn’t necessarily qualify to be taking the medication (PMS and mild acne) are also being sued by some of their patients.  The outcome in those cases is a little harder to predict due to the case-by-case nature of the suit.

The Moral of the Story

Do NOT walk away from this article thinking that you should not take birth control or that new medications cannot be trusted.  The moral of the story is to ask questions and be informed. Drug companies are multi-million dollar corporations focused on increasing their bottom line.  While the FDA does everything it can to try to protect you, oversights like this do happen. That’s why, as the patient and as a consumer, you need to be informed (and by informed we mean information beyond direct-to-consumer commercials).  Commercials for drugs are just like commercials for anything else.  They are intended to sell you a product regardless of whether or not you need it.  Trust your health professionals and ask plenty of questions.  One more time for the people in the back of the room: Ask questions.

Questions?  E-mail Tania: houspian@myhousecallmd.com (It’s never too early start practicing for your next visit)

References:

Bayer Warning Letter.  Abrams, Thomas. Department of Health and Human Services. Oct 3, 2008.

Yaz Package Insert. Bayer Health Care. April 2007.