The FDA has just approved the first topical gel for the treatment of overactive bladder (OAB) and this could bring relief for those experiencing side effects from the current oral medications. A topical oxybutynin 3% gel called Anturol will be available in the upcoming months for the treatment of overactive bladder associated with urinary urgency, frequency, and urge incontinence.
Anturol is a clear gel available in a metered-dose pump. The active ingredient is delivered through the skin (transdermally), so it is not metabolized by the liver, which results in fewer side effects, such as dry mouth and constipation.
Currently, Vesicare, Toviaz, Detrol LA, and Ditropan XL (oral oxybutynin) are medications taken by mouth for overactive bladder that tend to have side effects like constipation and dry mouth, so this may be a good alternative.
The approval of this Anturol (oxybutynin) gel was granted because studies showed patients who used it had less OAB symptoms including urinary incontinence.
Anturol was well-tolerated in the study. The most frequently reported treatment-related adverse events were dry mouth (12.1% vs. 5% with placebo) and redness at the site, which was rare. It is applied once daily to the thigh, abdomen, upper arm, or shoulder.
While I imagine it will be more expensive when it first launches (though Toviaz and Vesicare are pricey too), it is a tempting switch for those experiencing dry mouth and constipation from their current oral OAB meds.
Oxybutynin and oxybutynin er are currently available in liquid and tablet form, for as little as $4 for a 30-day supply. They’re considered Tier 1 drugs by most insurance companies, falling under the lowest co-pay. Ditropan XL may not be covered by some insurance companies, as oxybutynin is available as a generic alternative, but Toviaz and Vesicare are typically Tier 2 or Tier 3 medications, meaning a moderate to high co-pay. Cash prices for Ditropan XL run about $125 – $150 for a 30-day supply, while Toviaz and Vesicare are a bit more expensive at $150 – $200 for a 30-day supply.
Whether you take atorvastatin (Lipitor), simvastatin (Zocor), or Crestor (rosuvastatin), the statins have a very similar risk and benefit profile. Here are answers to the top questions I am asked about statin drugs by my patients:
1. Will they hurt my liver? Liver test abnormalities occur in less than 1 in 100 patients taking statin drugs and resolve if you stop the medication. If the liver tests (AST and ALT) are greater than 3 times normal we stop your statin drug. If this is going to happen it usually does in the first three months of therapy, so you have monitoring blood tests 12 weeks after you start your cholesterol medication and every 6 – 12 months after that.
2. What about that scary muscle problem? It is scary, but very rare. Rhabdomyolysis, as rare as it is, will be what your doctor and pharmacist warn you about. If your muscles start to ache or feel very weak (usually the muscles closest to your body which we call proximal muscles, like the ones in your hips and shoulders), stop your medication and talk to your doctor. This is not a subtle ache—this is an impressive aching and weakness and you will know if it happens.
3. Do they work? Yes, they work well . . . really well. Your LDL cholesterol (the “bad cholesterol”) will drop on average 40 – 60%, along with a nice drop in your triglycerides.
4. Can I stop them once my LDL Cholesterol comes down? Patients often ask me this and the answer is no. If you stop your statin drug your cholesterol will go back up in two months. It’s not like an antibiotic for strep throat where you treat it and it’s gone. You are on it for life.
5. Are there any other good options for lowering my bad cholesterol (LDL)? Not really, but Zetia (ezetimibe) is your current best non-statin option. Zetia will lower LDL cholesterol by about 13% and is well tolerated. It is also set to become generic soon so will be cheaper than the current cost.
6. Do I have to take it at night? No, you don’t have to take it at night. Blood levels of the statins are lower following evening doses compared with morning dosing and LDL cholesterol reduction is the same regardless of the time of day the drug is administered.
7. Do I have to take it on an empty stomach? No, LDL cholesterol reduction is similar whether the drug is given with or without food.
8. What’s the deal with grapefruit juice? This is one difference among the statin drugs. Unlike atorvastatin and simvastatin, the CYP3A4 enzyme does not metabolize Crestor (rosuvastatin). Grapefruit juice → inhibits that enzyme → which inhibits the breakdown of your statin → which results in higher statin levels in your body. You can’t have grapefruit juice while on atorvastatin or simvastatin, but you can with Crestor.
9. What about Coenzyme Q10? Statin drugs lower the level of CoQ10 in our body, but the effect of this is unknown. Studies have tested CoQ10 supplementation to prevent muscle problems from statins but have not been shown to be of any benefit. While the present evidence does not support use of Coenzyme Q10 for statin induced myopathy, many patients still take it. It can’t hurt.
10. Are the statin drugs all the same? The easy answer is yes. Whether it’s atorvastatin, simvastatin, or Crestor, you can count on a 40 – 60% drop in LDL depending on dose. They are very different in cost because atorvastatin and simvastatin are generic and Crestor is still a brand-name drug only.
Atorvastatin (generic Lipitor) and simvastatin (generic Zocor) are considered Tier 1 drugs by most insurance plans, meaning your lowest copay will likely apply. While atorvastatin is new to the market and may cash prices may be $100 or more for a 30-day supply, all strengths of simvastatin are available for as low as $3.50 per month. Crestor, without a generic equivalent, is typically considered a Tier 2 drug by insurance companies, meaning a moderate copay, and can usually be found for around $150 for a 30-day supply.
Three to four years ago those of us in primary care started to see more and more of our adult and elderly patients on Risperdal (risperidone) for many different uses. As it turns out, the drug company making that drug, Johnson and Johnson, will now be paying $158 million to settle claims that it inappropriately marketed Risperdal for non-FDA-approved uses. They aren’t the only ones; several other antipsychotic drug makers are paying big bucks for doing the same thing, specifically for Geodon and Zyprexa.
So how did we get so many prescribers to drink the Kool-Aid and prescribe Risperdal for off-label use? Marketing. Which is why at many academic centers, including mine, pharmaceutical reps are no longer allowed in hospitals, nor are any items with drug names on them (pens, pads, lights, thumb drives).
Risperdal is a member of a class of drugs known as atypical antipsychotics (Seroquel and Zyprexa are two others). Risperdal is approved and works well for the treatment of schizophrenia, bipolar disorder, and irritability associated with autism. Those are the three FDA-approved indications for risperidone. Period.
Many risperidone prescriptions are written for non-FDA-approved indications, also known as “off-label use”. Some others include behavioral disturbances (agitation and aggression) in adults with dementia, the treatment of tics associated with Tourette’s syndrome, severe behavior disorders associated with Tourette’s or attention-deficit hyperactivity disorder (ADHD), severely disruptive behaviors in children with developmental disability, and psychotic depression in adults.
The problem here is that physicians are taking a leap of faith and prescribing a drug for non- approved use based on information (“marketing”) from the company making the drug. You can see the danger there, I’m sure. Off-label use of atypical antipsychotics like risperidone is associated with benefits yes . . . but also harms.
For the downside, a Rand study this year found that off-label use of atypical antipsychotics was associated with several types of adverse events in older adults. These events included death, stroke, urinary tract symptoms, and weight gain.
Risperdal is typically considered a Tier 3 drug by insurance companies if it is covered, meaning that you would pay your highest copay. The generic equivalent, risperidone, is usually considered a Tier 1 drug, falling under the lowest copay. Risperdal runs from about $150 for 30 0.25mg tablets to around $400 – $500 for 30 4mg tablets. Risperidone, in contrast, can be as much as $100 for 30 tablets, while some strengths are included in reduced price generic programs and may be as little as $4 for 30 tablets.
A new combination pill targeted at diabetes and cholesterol is hitting the market and you will be hearing about it. Juvisync is a combination medication that contains two previously approved medicines: the generic cholesterol medication simvastatin, and Januvia (sitagliptin) a diabetes medication.
What are the upsides of Juvisync?
1) First off, you kill two birds with one stone and treat diabetes and cholesterol in one pill.
2) The diabetes medication Januvia (sitagliptin) enhances the body’s own ability to lower elevated blood glucose.
4) Simvastatin works well to lower your LDL cholesterol.
What are the downsides of Juvisync?
2) Cases of pancreatitis have been reported with Januvia, though it is a rare complication.
3) As with any combination drug, if you have a side effect, we don’t know which medication is the culprit.
Jump in with your thoughts.
Generic simvastatin should be covered by most insurance plans as a Tier 1 generic, meaning you’ll pay your minimum copay. Simvastatin may also be available for as little as $4 for a 30-day supply. Januvia and Juvisync are typically considered Tier 2 or 3 drugs by many insurance plans, meaning you’ll pay a moderate to high copay. Januvia is typically $200 – $300 out of pocket for a 30-day supply, and according to the manufacturer Juvisync will be similarly priced. You can find Juvisync prescription savings and free trial information on the Juvisync website.
Is the generic the same as the brand name? What standards do generic drugs have to meet?
Doctors and patients alike need to feel assured that the generic prescribed is equivalent to the brand name. So, what exactly does that mean? FDA-approved generic drugs have to meet the same rigid standards as the innovator drug (the “brand name”).
To gain FDA approval, a generic drug must:
- Contain the same active ingredients as the brand name drug. However, inactive ingredients may vary, and that is important to know.
- Be identical in strength, dosage form, and route of administration (by mouth, under the tongue, on the skin).
- Have the same use indications (prescribed for the same conditions).
- Be bioequivalent (deliver the same amount of the same active ingredient).
- Meet the same batch requirements for identity, strength, purity, and quality.
- Be manufactured under the same strict standards of the FDA’s good manufacturing practice regulations required for the brand name.