In July 2015, Praluent (alirocumab) was approved by the FDA as the first drug in a new class known as PCSK9 inhibitors. It was joined by Repatha (evolocumab), which received approval on August 27, 2015. These new injectable medications are the first approvals in a long time that may be as effective as statins—or better—at lowering cholesterol.
For now, Praluent is only approved for use in two types of people with high cholesterol. The first: those who have heart problems caused by a buildup of plaque (atherosclerosis), and who need extra help lowering their cholesterol. It can also be used to treat a form of inherited high cholesterol known as heterozygous familial hypercholesterolemia (HeFH).
Repatha is approved for the same uses, with the inclusion of both types of familial hypercholesterolemia (inherited high cholesterol)—heterozygous (HeFH) and homozygous (HoFH).
This is good news if you have one of these hard-to-treat types of high cholesterol, but be aware. These are new drugs, and they will be very expensive. With the new approvals, prices for both Praluent and Repatha are expected to total more than $14,000 per year.
No word yet on what (if any) assistance programs will be available, or what kind of coverage many insurance companies will offer, but both manufacturers have said they’re committed to patient access and willing to work on cost management.
The FDA has issued a safety warning for Picato (ingenol) topical gel, used to treat actinic keratosis.
According to the warning issued August 21, 2015, there have been recent reports that Picato gel can cause severe allergic skin reactions and shingles.
Is there anything unique about Picato as an actinic keratosis treatment?
Picato gel only requires 2 to 3 consecutive days of dosing, which is the fastest course of therapy of any topical actinic keratosis treatment.
What is actinic keratosis?
Actinic keratosis or AK is a rough, scaly patch of skin that develops due to years of sun exposure. A small percentage of actinic keratosis spots can actually turn into skin cancer.
Common places for actinic keratosis to develop include face, lips, ears, scalp, neck, backs of hands, and forearms. You can lower your risk for AK by decreasing the amount of time you spend in the sun and shielding your skin with SPF sunscreen and protective clothing.
Why exactly was the FDA safety warning issued for Picato?
There have been reports of severe allergic reactions and shingles associated with the use of Picato gel. These reports included some cases of severe eye injuries and skin reactions, which has prompted the FDA to require the Picato label to be changed to include information on these new warnings and risks.
You should be aware though—several of the injuries were due to improper use. Picato is not to be applied in, near, and around the mouth, lips, or eye area. Also, be extra careful if you’re applying make-up or using contact lenses after applying Picato. Accidental transfer of the gel from the hands (even after washing) is possible, so you’ll want to be extra careful to prevent a reaction.
Should I stop using Picato?
No! Do not stop using your medication without speaking with your doctor. However, it’s important to remember to only apply Picato gel as it’s intended to be used, due to the possibility of severe skin reactions and eye injuries.
Want to find out more?
Some interesting news came out of a study done at MD Anderson Cancer Center, where a common high blood pressure medication was shown to improve survival in those with ovarian cancer. In addition to standard treatment with surgery and chemotherapy, women taking propranolol (Inderal) or other similar medications lived longer.
How do heart meds help with ovarian cancer?
- Adrenergic receptors: The two types are alpha or beta and when activated, result in growth and progression of ovarian cancer.
- Beta receptors: The beta adrenergic receptors respond to the substances norepinephrine or epinephrine (adrenaline) usually causing excitatory things like high heart rate and stronger heart contractions.
- Where are they found? Beta receptors are found in many places on the heart, in the smooth muscle of the bladder, in blood vessels to the heart and muscles, and so on.
- Beta blocker medications: There are two kinds of beta blockers some we call selective beta blockers (metoprolol, atenolol) and some we call non-selective beta blockers.
- Non-selective beta blockers: These block both types of beta receptors. Common options are propranolol (Inderal), nadolol (Corgard), and sotalol (Betapace). The survival benefit is seen with these non-selective beta blockers.
- Propranolol and cancer. Propranolol blocks the production of a protein which plays a role in forming new blood vessels—which is how cancer cells feed their blood supply and growth.
- Women with ovarian cancer (of all stages) had better overall survival if they were taking non selective beta blockers like propranolol.
- In fact, their median survival was 94.9 months compared to 42 months. That’s a big deal.
- This was true even though the women with ovarian cancer taking non-selective beta blockers presented at higher stage of disease, weighed more, and were more likely to have high blood pressure.
- More to come. There are currently two trials going on right now evaluating the combination of chemotherapy and propranolol on cancer biology.
For a cheap, safe medication this is exciting news.
New drug Keveyis (dichlorphenamide) received FDA approval on August 10, 2015. It is the first prescription approved to treat a rare genetic disorder known as periodic paralysis.
Periodic paralysis can be triggered by too much or too little potassium in your blood (hyperkalemic or hypokalemic), and involves periods of muscle weakness or paralysis. It is estimated to affect only 5,000 people in the United States; according to the Periodic Paralysis International, hypokalemic periodic paralysis (caused by too little potassium) is estimated to occur in only 1 per 100,000 people.
What type of medication is Keveyis?
Keveyis is in a class of medications known as carbonic anhydrase inhibitors. Carbon anhydrase inhibitors work by keeping the potassium level in your body balanced—so that you don’t have too much or too little.
Can I get Keveyis at the pharmacy of my choice?
How will Keveyis be taken?
The initial dose of Keveyis will be one 50 mg tablet taken twice daily (for a total of 100 mg), but the dose may be increased to a maximum of 200 mg daily based on your individual response.
When will Keveyis be available?
Keveyis is set to become available in the third quarter of 2015.
Will the manufacturer have any special programs for Keveyis?
Yes. Keveyis will have a program called Keys2Care which will provide a suite of patient support services to ensure people diagnosed with periodic paralysis can receive treatment as soon as possible.
What are the side effects associated with Keveyis?
The most common side effects of Keveyis include a tingling or pricking sensation, difficulty thinking and paying attention, changes in taste, and confusion.
Want more information?
Almost 10% of Americans will battle depression over their lifetime. Some people will find themselves depressed after a traumatic life event; for others, it’s a constant battle.
While depression can happen to anyone, here are some surprising statistics:
- People living in the southeast US tend to have a higher incidence of depression.
- People with lower levels of education tend to report more depression.
- Involuntary unemployment—aka someone who can’t get a job—is a frequent cause of depression.
- Women are twice as likely as men to report symptoms of depression, and 10% of women suffer from post-partum depression.
- Less than 50% of people who suffer from depression will seek medical help.
The Good News
Antidepressant medications, in conjunction with therapy, actually work for the majority of people that try them.
Before you start taking an antidepressant, keep in mind:
- You have to take it daily, not as-needed.
- Even if your depression gets better right away you may need keep taking it for four to nine months to prevent relapse.
- Don’t stop your prescription without talking to your doctor.
Ok, you’ve got it, so now—what works?
These 11 facts will help help you and your doctor figure out the most effective treatment for your depression.
- Starting two drugs at the onset of depression is no better than one.
- Antidepressants generally work. Initial treatment of mild to moderate major depression with antidepressants leads to response or remission in roughly 50 to 60 percent of patients.
- Will antidepressants help me? Treatment for 6 to 12 weeks with any SSRI, SNRI, atypical antidepressant, or serotonin modulator, results in remission of symptoms 47 percent of the time, with some improvement in 63 percent of people. “Remission of your depression” means you have no more symptoms, and it’s more likely if your treatment begins soon after your symptoms start.
- There are 4 common classes of antidepressants. Some examples to help you keep them straight:
- SSRIs: Celexa (citalopram), Lexapro (escitalopram), Zoloft (sertraline), Paxil (paroxetine), Prozac (fluoxetine)
- SNRIs: Pristiq, Cymbalta (duloxetine), Savella and Effexor (venlafaxine).
- Atypical antidepressants: Wellbutrin (bupropion) and Remeron (mirtazapine).
- Serotonin modulators: Serzone (nefazodone), Desyrel (trazodone).
- Surprise! Multiple reviews have shown that different antidepressants are generally comparable—both across and within classes. Side effects are what makes the difference—and cost. Some of these drugs are very expensive, especially those that are brand-only.
- Which is the best to start with? For patients with mild to moderate major depression, initial treatment should be an SSRI.
- Sertraline (generic Zoloft) is the most widely prescribed SSRI. There is some evidence that sertraline and escitalopram (generic Lexapro) provide the best combination of efficacy (how well they work) and acceptability (how well they are tolerated).
- Which has the “best” side effect profile? More people can tolerate citalopram, escitalopram, and sertraline than other antidepressants.
- Which antidepressants may not work as well? Some studies have shown response was more likely with escitalopram (Lexapro), mirtazapine (Remeron), sertraline (Zoloft), and venlafaxine (Effexor), compared with duloxetine (Cymbalta), fluoxetine (Prozac), fluvoxamine (Luvox), and paroxetine (Paxil).
- Use side effects to your advantage. Trazodone can be used for people with insomnia, bupropion for those who want to avoid sexual dysfunction or want to quit smoking. Weight gain may occur with mirtazapine, fluoxetine, paroxetine, trazodone and venlafaxine, but bupropion may actually result in weight loss.
- Patience is a virtue. Even if you seek help for depression, and receive a prescription, you may find it hard to stay on your antidepressant. Why? Side effects can be a huge factor—they’re at their worst during the first few days, but you should know they’ll likely get better, regardless of the drug you’re taking. Antidepressants may also seem like they aren’t working—but did you know there can be a 2 – 3 week lag before they start to take effect?
Tell us about your experience.