Last December, not one, but two generic versions of Viagra (sildenafil) became available in pharmacies. As a result, men can now purchase the erectile dysfunction (ED) treatment for as low as $17 with GoodRx, compared to $72 for the brand version. And although Viagra is an extremely popular medication, with more than 60 million men worldwide having used it since 1998, it’s not the answer for everyone.
Below, Tim Aungst, PharmD and owner of The Digital Apothecary, shares his experience helping patients who are looking for ED treatment outside of Viagra and the class of drugs that work like it (PDE-5 inhibitors).
Consider the case of Mr. Jones, a patient I was helping in an outpatient cardiac clinic. Most of my patients are on multiple medications for their heart conditions and other complicated issues, so I often review their medications to make sure everything is all right. This includes screening labs, checking vitals, reviewing past reports, and conducting drug interaction checks related to therapy. If there are any concerns, I’ll meet with the patient and make recommendations to the healthcare team.
At his last visit, Mr. Jones was prescribed Imdur (isosorbide mononitrate) to help with his heart condition. Reading through the notes, it looked like the Imdur worked. He was feeling better – so much better that he wanted to start having sex with his wife again. And here was the problem: Mr. Jone’s doctor had renewed his Cialis (tadalafil) prescription.
The issue? Well, if you really listen to the advertisements on television for erectile dysfunction (ED) medications, ignoring the jazz from Viagra or the sunsets from Cialis, you may hear the line “Do not take if you take nitrates for chest pain, as it may cause an unsafe drop in blood pressure.” Viagra, Cialis, and Levitra belong to the same drug class called Phosphodiesterase 5 Inhibitors (abbreviated as PDE-5 inhibitors), and they all share the same interaction with nitrates. Many patients wonder how bad can a ‘drop in blood pressure’ be. The answer, as we learned after Viagra came out, is this reaction can lead to heart attack in patients and potentially cause death, leading to a black box warning for the whole class of drugs like Viagra.
Mr. Jones is on a nitrate, specifically Imdur. Fortunately for him, he had not yet used the Cialis. I advised him to avoid the combination, based on his significant cardiac history. But what can patients with ED and taking nitrates do to engage in an active sex life?
There is another drug that came out before Viagra, called alprostadil, available under two brand names: Caverject and Muse. It works by relaxing the penile tissue allowing for easier blood flow leading to an erection. The plus side is it works relatively quickly; the downside is that is not available as a pill.
And there’s the rub. Caverject must be directly injected into the base of the penis to work. Muse is an intraurethral (a fancy way of saying ‘insert via urethra’) version of alprostadil that comes as small pellets that have to be inserted into the urethra by the patient.
For many patients, when I mention there is another option to Viagra and other PDE-5 Inhibitors, their eyes light up, quickly followed by a nervous look as they find that it requires an injection to their penis or inserting something directly into their urethra. At this point, to not completely turn off the patient, I do try to get some information in to help them make a decision.
While both Caverject and Muse share the same active ingredient, there are some pros and cons of each. Caverject tends to work much faster (<10 mins) as it enters the bloodstream quicker, and has been found to work better. The drawback though is that it is an injection that needs to be applied to the base of the penis, and can cause irritation to the surrounding tissue. And let’s be honest, most men don’t want to engage in sex with a bruised member. It has a higher risk of causing priapism (basically an erection lasting for more than 4 hours, which incidentally is named after Greek god Priapus).
Muse, on the other hand, can cause a burning sensation to the penis along the urethra (this happens around 20% of the time) and it takes a little longer to work than the injectable formulation. But for men that don’t want a needle in their penis, it is an alternative. For this reason, I generally recommend starting with Muse prior to moving onto Caverject.
You’re probably wondering why alprostadil can’t just be applied directly to the penis as a topical agent instead of directly injecting or inserting it. A study conducted in 2006 in 1732 patients using a topical formulation did demonstrate some efficacy (though less than Caverject or Muse). Common side effects were burning sensation (for both men and women) though this was relatively low, with only 2.7% of subjects stopping its use. Currently, drug manufacturer Apricus Biosciences is looking to bring this formulation, named Vitaros, to market in the US (it’s currently available in Europe) but FDA approval has been slow. When and if this formulation makes it to the US market, it may be preferred by men who cannot take PDE-5 inhibitors.
Talking to Mr. Jones and those like him about these options takes some time and often requires some trial and error to find what works. At this point, I usually recommend most men to start with Muse and see if they have success with it, and if not they can move on to Caverject (they both run at about $75-$105 a dose). Some men are fine starting with Caverject right away and don’t mind the administration, but I would say it comes down to personal preference on what side effects are manageable for the patient.
Manufacturer Unichem Pharmaceuticals has issued a voluntary recall of divalproex, used to treat certain types of seizures, bipolar disorder, and migraine headaches.
This is a class II recall, the most common type of recall, which means that there is a situation where the use of the recalled medication may cause temporary or medically reversible adverse health consequences, but the likelihood of serious adverse effects is small. For more information on the different types of recalls, see our overview here.
Why was Divalproex recalled?
The manufacturer, Unichem Pharmaceuticals, has issued a nationwide voluntary recall of divalproex, with the knowledge of the FDA, due to possible contamination with another medication, metronidazole.
Metronidazole is an anti-fungal medication. Taking a contaminated medication can cause severe adverse effects.
What is affected by this recall?
The recall will affect the following:
- Drug: Divalproex delayed-release 500 mg tablets
- Manufacturer: Unichem Pharmaceuticals
- Bottle size: 100 count bottle
- National Drug Code (NDC) and Lot(s): NDC: 29300-140-01, Lot: ZDPH17040
Unichem Pharmaceuticals is notifying distributors and customers by letter and is arranging for return of all recalled products.
What should I do if I think I may have the affected product?
You should contact your physician or healthcare provider if you have experienced any problems that you think may be related to taking this medication.
You should not stop taking divalproex without talking to your prescribing physician.
In what appears to be the worst flu epidemic in years, prescriptions for Tamiflu (oseltamivir) are soaring – outpacing last year’s prescriptions by a factor of 10 or even 14 times higher this year in some states, with a nationwide rate that is more than 5 times higher than last year.
According to a GoodRx analysis of a nationally representative sample of US prescriptions, pharmacy fills for Tamiflu, the most popular medication to treat the flu, are increasing, with some notable geographic variations. In Arizona, Indiana, Wisconsin, and Michigan, prescriptions are up over 10-fold from last year, and other parts of the south and midwest are likewise seeing an exceptionally high prescription volume.
Though there is a vaccine available for the flu, Tamiflu is often prescribed if symptoms start to appear, which helps explain the rapid surge in prescriptions this year. If taken within the first 28 hours of getting the flu, Tamiflu can work to block the actions of influenza in your body, and shorten the duration of the virus. You can also take Tamiflu for up to six weeks to prevent you from getting the flu.
Despite the surge of prescriptions, there are some doubts about whether Tamiflu is even effective for treatment or prevention – more on that below.
The national pattern closely resembles data from the Centers for Disease Control and Prevention, which shows these same states are some of the hardest hit by flu so far this year.
According to CDC data, cases of the flu reached high levels in southern states like Texas and Louisiana in the days before Christmas and then spread through the Midwest and the entire United States.
At the present moment, all states except for Maine, Montana, Idaho, Utah, North Dakota, Hawaii, Alaska, and the District of Columbia are seeing high rates of flu activity. Flu activity has been consistently high over the past 9 weeks and doesn’t seem to be letting up anytime soon. Flu season can last anywhere between 16 and 20 weeks, so experts predict there is still more to come.
To see an interactive view of the flu around this country this year, visit The CDC FluView Map here.
On a national basis, prescriptions for Tamiflu are up more than 5 times last year’s rate. This is a stunning illustration of how bad the flu is – and how much worse it may still get.
A shortage in Tamiflu
The high volume of Tamiflu prescriptions at this point in the season has resulted in a shortage of the medication. While the FDA has not yet confirmed this shortage, doctors and pharmacists in both urban and rural areas are reporting difficulty in accessing Tamiflu for their patients.
Those unable to access Tamiflu this year do have other options. Besides Tamiflu, there are two other influenza medications: Relenza and Rapivab. Both are considered just as effective as Tamiflu and may be easier to access this year. For more information on these medications, see our post here.
Over the counter medications can also help ease symptoms. Read here for more details on over the counter flu medications.
Is it effective?
Tamiflu is sometimes treated as a cure for all cases of the flu, but recent studies call this reputation into question. According to a study-of-studies, or meta-analysis, performed by Cochrane Research of 46 studies involving more than 24,000 people, Tamiflu may provide a much smaller benefit than expected. At best, the analysis found that Tamiflu may only help patients recover one day faster, and may not reduce the number of flu-related complications, like pneumonia. Additionally, it may only reduce the risk of getting sick by 55%. At over $50 per prescription for generic oseltamivir, for some, the benefits may not outweigh the cost.
While these findings don’t negate the use of Tamiflu, they may indicate that it is less protective than we had previously thought.
Tamiflu side effects
There has been recent concern about Tamiflu’s side effects, especially in younger children. Recently, a 6-year-old girl reportedly attempted to jump out of her bedroom window during a hallucination while taking Tamiflu. The FDA has warned of similar side effects previously, noting that:
“Children and teenagers with the flu may be at a higher risk for seizures, confusion, or abnormal behavior early during their illness. These serious side effects may happen shortly after beginning Tamiflu of may happen in people when the flu is not treated. These serious side effects are not common but may result in accidental injury to the patient. People who take Tamiflu should be watched for sins of unusual behavior and a healthcare provider should be contacted right away if the patient shows any unusual behavior while taking Tamiflu.”
More common side effects include nausea, vomiting, headache, and pain. Be sure to speak with your doctor if you or a loved one experience any of these side effects for a prolonged period of time.
Why is the flu so bad this year?
This year’s flu is different from past years. The reason? Around 80% of flu cases this year involved H3N2, a strain of the influenza A virus that is more dangerous and results in more complications. H3N2 is generally also harder to prevent with the flu vaccine, and this seems to be true this year. Experts say that this year’s flu vaccine may be only 10% effective.
How can you protect yourself?
- You can still get your flu vaccine. Even though the flu shot may only 10% effective against this year’s flu, you may still want to consider getting it. Even if you get sick, a flu vaccine can also help ease the severity and duration of the virus.
- Visit your doctor immediately. When true flu symptoms hit, go to the doctor. The sooner you visit, the sooner you can get your prescription for an antiviral medication.
- Wash your hands. This may go without saying, but washing your hands is your best weapon against the flu virus.
- Exercising may help. While heavy exercise may predispose you to the flu, a moderate amount may be protective.
Methodology: Data represents a change in prescriptions for Tamiflu (and generic versions of Oseltamivir) from this season (Dec. 1, 2017, through Feb 11, 2018) compared to last season (Dec. 1, 2016, through Feb 11, 2017). Prescription volume based on a statistically significant sample of fills at US pharmacies. Data comes from several sources, including pharmacies and insurers, and provides a representative sample of nationwide US prescription drug volume.
On September 21, 2017, the FDA issued a drug safety communication for the medication, Ocaliva. The communication highlighted the increased risk of serious liver injury due to being incorrectly dosed in some patients with moderate to severe decreases in liver function.
In response to this safety communication, on February 1st, the FDA added a boxed warning to Ocaliva to highlight the dosage issues.
What is Ocaliva indicated for?
Ocaliva is indicated for the treatment of primary biliary cholangitis (PBC), a chronic liver disease resulting from progressive destruction of the bile ducts in the liver. PCB primarily affects women, as approximately 1 in 1,000 women have this condition. Bile in your liver aids in the digestion of fat and fat-soluble vitamins. When the ducts are destroyed, bile builds up and can lead to inflammation and scarring.
What confusion has Ocaliva dosing caused?
Ocaliva continues to be incorrectly dosed daily instead of weekly, which has led to liver decompensation, liver failure, and death. Healthcare professionals should follow the Ocaliva dosing regimen in the drug label.
Contact your prescriber immediately if you develop any of the following symptoms that may be signs of worsening liver problems: stomach swelling, yellow eyes or skin, bloody or black stool, coughing or vomiting up blood, or mental changes.
Does the FDA require Intercept Pharmaceuticals to do anything else at this time?
Yes. As a condition of approval, the FDA requires Intercept Pharmaceuticals to continue studying the medicine in patients with advanced PBC.
These clinical trials are currently ongoing and FDA expects to receive results in 2023.
You’ve likely heard there is a new shingles vaccine, Shingrix that is more effective than our existing vaccine Zostavax. The painful blisters of shingles are bad enough, but the complication known to occur in 20% of folks after their singles outbreak, called “postherpetic neuralgia” is even worse, and can be a chronic painful condition. With a new Vaccine always comes new questions and concerns: cost, side effects, and when or if you should get it.
A word about cost: Medicare Part D will likely be covering the new vaccine, Shingrix, as should Anthem, Blue Cross, and other plans. Whether you’ve been previously vaccinated with Zostavax or not, I’m hearing the same questions from my patients about Shingrix so let’s talk about it.
Is Shingrix THAT much better than Zostavax?
Yes. Shingrix is 97% effective at preventing herpes zoster (shingles) in folks over 50 whereas the Zostavax shot is 50-64% effective in preventing shingles in those 50-70 and even lower for those over 70.
When should I get the shingles vaccine?
For Shingrix, people 50 and over should receive the series of two vaccines. For Zostavax those 50 and over with a medical condition or 60 and over for all-comers.
What if I’m not sure if I’ve had chicken pox?
First, know that almost everyone born before 1980 tests positive for exposure to varicella –the virus that causes chickenpox, and reactivates to cause shingles. All published recommendations suggest that whether you remember having chicken pox or not, you should receive the Shingles vaccine (Zostavax or Shingrix). The shingles vaccine Zostavax is 19 times stronger than the chickenpox (varicella) vaccine.
Are the side effects for Shingrix different than Zostavax?
There is where the issue arises… yes, the side effects are quite a bit different, and I’ve been seeing this in my patients who get Shingrix.
Adverse Reactions of Zostavax (given as a single vaccine)
- Pain at injection site (≤34 to 54%)
- Redness at injection site (36% to 48%)
- Swelling at injection site (26% to 40%), localized tenderness (≤34%), itching at injection site (7% to 11%)
- Any other side effects are very uncommon (< 1%)
Adverse reactions for Shingrix (a series of two vaccines)
- Fatigue (37% to 57%
- Headache (29% to 51%)
- Shivering (20% to 36%)
- Gastrointestinal adverse effects (14% to 24%)
- Pain at injection site (69% to 88%)
- Swelling at injection site (23% to 31%)
- Muscle aches/Myalgia (35% to 57%)
- Fever (14% to 28%)
- Other side effects are uncommon (< 1%)
To sum it up, Shingrix is a much better vaccine, but with a twist. That twist? Shingrix has many more adverse reactions than Zostavax. This means we need to keep an eye on this vaccine because it is so new. If you get Shingrix be sure to be aware of what adverse effects you may feel and a 500 mg Tylenol (Acetaminophen) after the shot has helped for some of my patients.