The FDA has issued a warning for the Daytrana topical patch, used to treat attention deficit hyperactivity disorder (ADHD).
According to the FDA, the Daytrana patch can cause permanent loss of skin color, which is a skin condition also known as chemical leukoderma.
How does the Daytrana patch work?
What is chemical leukoderma?
Chemical leukoderma is the permanent loss of skin color due to repeated exposure of a chemical.
What are the common signs and symptoms of chemical leukoderma?
The symptoms associated with loss of skin color from the Daytrana patch may include permanent loss of skin color in the areas where the patch was used, or even permanent loss of skin color in areas where the patch was never worn.
Is the loss of skin color associated with the Daytrana patch reversible?
No. The loss of skin color associated with the Daytrana patch is not thought to be reversible even if you discontinue using the patch.
Is this loss of skin color physically harmful?
No. The loss of skin color is not physically harmful, however, it can cause emotional and mental stress.
How large are the areas of skin color loss that have been reported?
The size of the areas of skin color loss associated with the Daytrana patch vary, up to 8 inches in diameter (comparable to the size of a large banana).
What are some alternatives to replace the Daytrana patch?
Methylphenidate is available in several different forms, including short and long acting tablets, capsules, and a liquid that could be used as possible alternatives to the Daytrana patch.
Some examples of the various forms of methylphenidate include:
- Ritalin (tablets)
- Concerta (tablets)
- Metadate CD (capsules)
- Ritalin LA (capsules)
- Aptensio XR (capsules)
- Quillivant XR (liquid oral suspension)
Should I stop using the Daytrana patch, or stop using it on my child?
No. Do not stop using the Daytrana patch without consulting with your doctor.
If my child uses the Daytrana patch, is there anything I should watch out for?
Yes. Keep an eye out for areas of lighter skin, especially under the drug patch. Any changes you notice should be reported immediately to your doctor.
More important information:
Let’s start with the fact that Marinol is FDA approved for chemotherapy-induced nausea and vomiting, and anorexia from AIDS or cancer. Currently there is no FDA approved medical indication for prescribing marijuana. So—why is one approved and not the other? Do they work? What are their differences?
What is dronabinol?
Oral delta-9-tetrahydrocannabinol (THC) is available as Marinol, and the generic is dronabinol. This pill is a synthetic (chemical) form of THC, a naturally occurring component of Cannabis sativa (marijuana). The onset of action is 30 minutes to 1 hour, with peak effect at 2 – 4 hours. This drug is approved by the FDA for two indications: chemotherapy-induced nausea and vomiting and anorexia associated with weight loss in patients with AIDS.
Marinol (dronabinol) is a pill that is available by prescription and has FDA approval to treat certain conditions. Dronabinol is also known as THC, and it is the primary psychoactive cannabinoid in the prescription medication. Cannabinoids are derived from the cannabis (marijuana) plant, which contains over 400 compounds, including more than 60 cannabinoids. Although there are more than 60 cannabinoids in marijuana, two in particular have been studied for medicinal uses: delta-9-tetrahydrocannabinol (THC or dronabinol) and cannabidiol.
Do they work for pain?
Prescription dronabinol has been studied for postoperative and neuropathic pain and was not found to be any better than placebo. For chronic non-cancer pain, it has been found to be only slightly better than placebo. There have been fewer studies of marijuana than cannabinoid pharmaceuticals, perhaps in part due to regulatory restrictions, but marijuana has better results for pain in the few studies that have been done. In all of these studies, smoked marijuana was found to be better than placebo in relieving pain. Another study examined the effects of marijuana that was vaporized (not smoked) and found that it too was better than placebo at relieving neuropathic/nerve pain.
What about for appetite and nausea?
Both marijuana and Marinol have been shown to help for nausea and appetite in studies on HIV patients.
What does marijuana have FDA approval for?
Nothing, yet. The use of medical marijuana for refractory cancer pain is very controversial as it hasn’t been well studied. As you know, marijuana use is still illegal in the United States at the federal level—the federal government considers marijuana a schedule I controlled substance. In the states where medical marijuana is legal, a healthcare practitioner provides an “authorization” for use that is considered by the federal courts to be protected physician-patient communication.
Why do people use medical marijuana?
Severe or chronic pain accounts for more than 90 percent of the qualifying conditions for use of medicinal marijuana among registered users in the states in which it is legal. While there have only been a few studies done, it appears that smoking marijuana along with traditional pain medications for patients with cancer-related pain may be effective.
If smoking marijuana isn’t good for the lungs, what are the other options for medical marijuana?
Marijuana can be used to make hashish and hash oil, which contain concentrated cannabinoids, and can be consumed by drinking as a tea or eating after mixing into foods. Know this though: absorption after oral administration has been described as “slow and erratic,” resulting in “low and irregular” plasma levels.
A new THC spray Nabiximols (sativex) is not yet available in the United States, but is on track to be approved for use in cancer pain and spasticity from multiple sclerosis.
This is a class II recall, the most common type of recall, which means that there is a situation where use of the recalled product may cause temporary or medically reversible adverse health consequences, but the probability of serious adverse effects is remote. For more information on the different types of recalls, see our overview here.
Who can recall a drug?
The manufacturer can voluntarily recall their medication or the Food and Drug Administration (FDA) can request or require that a manufacturer recall a particular medication. In this case, the manufacturer has voluntarily recalled one lot of enalapril/HCTZ 10 mg/25 mg tablets, and four lots of losartan 25 mg, 50 mg, and 100 mg tablets.
The recall is based on the discovery that the affected lots of both medications did not meet FDA regulatory requirements for blend uniformity specification. This means that the tablets can differ greatly from each other from one lot to the next, which is not acceptable by either FDA or manufacturing standards.
When was the recall initiated?
How long have the affected products been in pharmacies?
The recalled lot of enalapril/HCTZ 10 mg/25 mg tablets started shipping over a year ago, on February 13, 2014.
The recalled lots of losartan 25 mg, 50 mg, and 100 mg tablets started shipping almost two years ago, on September 20, 2013.
Are patients being notified who have taken either of these medications?
No. These are both class II recalls, which means that notification of patients is not necessary unless your doctor believes it may have an effect on your health.
If you have concerns that your prescription may be affected, contact your doctor or your pharmacist.
Which enalapril/HCTZ products were affected?
In this recall, only one lot and one strength were affected.
Drug: enalapril/HCTZ 10 mg/25 mg tablets, 100-count bottle
Lot: KP4529, expiration 10/2015
National Drug Code (NDC): 60505-0209-01
Which losartan products were affected?
In this recall, four total lots of three different strengths were affected.
Drug: losartan 25mg tablets, 90-count bottle
Lot: KP4726, expiration 09/2015
National Drug Code (NDC): 60505-3160-09
Drug: losartan 50mg tablets
Lot: KN1499, expiration 06/2015
National Drug Code (NDC): 60505-3161-09
Drug: losartan 100mg tablets
Lots: KT3819 and KT3821, expiration 11/2015
National Drug Code (NDC): 60505-3162-09
The most expensive prescriptions are usually the best, right?
That’s what many people think, but it isn’t always the case—not even close. There are many inexpensive drugs out there that work just as well for treating everything from arthritis to depression, and some even have fewer side effects than their high-cost counterparts.
In 2013, pharmacy benefits manager Express Scripts estimated that the United States wasted $418 billion on “bad medication-related decisions”—with $55.8 billion alone on high-priced medications when more affordable drugs could have been used instead.
Expensive is simply not always better.
Here are ten prescriptions that are usually very expensive, even with insurance. All of them have cheaper alternatives that work just as well.
- Vimovo. This is a mixture of the anti-inflammatory naproxen and generic Nexium, which is esomeprazole. Here’s an idea: instead of paying hundreds of dollars for this, get generic naproxen 500 mg tablets and 20 mg tablets of esomeprazole and there you have it: your own Vimovo for just pennies.
- Dexilant. This is a very expensive brand-name proton pump inhibitor (a class of drugs that includes Prilosec and Protonix). A number of studies have compared the various proton pump inhibitors to one another and while some differences have been reported, they have been small and of little clinical importance. Do yourself a favor and give lansoprazole or pantoprazole a try instead.
- Benicar. Used for high blood pressure, this is an expensive brand-name angiotensin receptor blocker (ARB) in a class that has many generic options. Benicar is certainly no better than the cheaper drugs in the class (valsartan and losartan are examples). Plus, Benicar can produce a “sprue-like enteropathy” which gives you severe chronic diarrhea and weight loss, and can occur months to years after starting the drug. Hmmm.
- Vytorin. This is a mixture of simvastatin and Zetia (ezetimibe). Unless you’ve recently had a heart attack, you don’t need to waste money on this and here is why: statins, like the cheap generic simvastatin alone, are the first choice in virtually all patients with high cholesterol in whom the goal is reduction of cardiovascular risk. People have been paying for Vytorin for years and yet it remains “uncertain” whether the combo of simvastatin and Zetia that makes up Vytorin provides additional clinical benefit. A recent study showed benefit in people hospitalized after heart attack but for most people, stick with just the simvastatin part and don’t bother with the combo.
- Bystolic. There is no evidence this beta blocker is better than two similar generic options, metoprolol and carvedilol. Bystolic is what is known as a “beta 1 selective” beta blocker used for the treatment of high blood pressure and it does provide a survival benefit in patients with heart failure. Sounds great, right—but wait. In heart failure patients, there are three beta blockers that have shown survival benefit. You guessed it: metoprolol, carvedilol, and Bystolic. Metoprolol and carvedilol are generic and much cheaper so there is no reason to pay money here.
- Zafirlukast (Accolate). Though available as a generic, it is still much pricier than the other option in the same class, montelukast (Singulair). There is no proof that zafirlukast is any better than montelukast for asthma, and in fact, montelukast is usually preferred because it is used once daily and can be taken at any time in relation to meals.
- Celecoxib (Celebrex). Celebrex, used for arthritis, has just recently become available as generic celecoxib so it’s still quite expensive and many folks pay a high price for it. However, meloxicam (Mobic), another Cox-2 inhibitor similar to celecoxib, is much cheaper and also works well for the treatment of osteoarthritis and rheumatoid arthritis.
- Pristiq. This is an expensive brand-name SNRI antidepressant used for depression and fibromyalgia. There is no evidence that Pristiq is any better than the cheaper generic duloxetine (Cymbalta) for fibromyalgia. For depression, there are two generic SNRI options in this class, venlafaxine and duloxetine. You should try those first before paying for Pristiq.
- Pataday. These antihistamine eye drops are used for red, itchy eyes related to allergies. Patanol and Pataday are expensive brand name eye drops in this class which includes azelastine (Optivar) as a good generic option that is much cheaper. Pataday carries the advantage of once daily dosing compared to twice a day but is it worth the cost?
- Avodart. Two 5-alpha-reductase inhibitors are approved in the US for symptoms related to enlarged prostate: Proscar (finasteride) and Avodart (dutasteride). One is cheap, one is not. In a large one-year study, finasteride and the more expensive Avodart worked just as well for reduction in prostate volume, urinary flow rate and urinary symptom scores, and adverse effects were similar. Don’t waste your money on Avodart when you can save on finasteride.
Glatopa, the new generic alternative to multiple sclerosis (MS) treatment Copaxone, was approved earlier this year, and its launch has been anxiously awaited. Now, the time has come, and Glatopa will be available in pharmacies soon!
Manufacturer Sandoz announced last Thursday, June 18, that Glatopa has began shipping following its recent FDA approval.
Is Glatopa an FDA approved generic?
How much will Glatopa cost?
Glatopa is expected to start out about 15% less expensive than Copaxone, but this is an estimate based on the average wholesale price—your cost may vary depending on the pharmacy where you fill and any discounts you may have. Insurance prices may also be lower for Glatopa if your plan places it in a different pricing tier.
Will I get Glatopa from my regular pharmacy?
Possibly. Since Glatopa and Copaxone are specialty medications, only pharmacies that offer specialty medication services will have Glatopa available locally. However, both should be available from most if not all mail-order specialty pharmacies (most specialty medications will be filled from this type of specialty pharmacy).
For more information on specialty medications please see our previous post.
If you are currently taking the Copaxone 20mg/mL injection and wish to switch to generic Glatopa, it would be helpful to reach out to the pharmacy where you are currently filling your Copaxone at and ask them to switch you to Glatopa for your next refill.
Are there any support programs for Glatopa?
Yes. You can enroll in the GlatopaCare program by calling 1-855-GLATOPA (1-855-452-8672). There isn’t currently a program website, but you can also call for more information.
How is Glatopa usually used?
Glatopa 20 mg/mL is injected subcutaneously once daily.
In what dosage forms and strengths is Glatopa available?
Glatopa is only available as a single-dose prefilled syringe in the 20 mg/mL strength.
Copaxone is available as a single-dose prefilled syringe in two strengths: 20 mg/mL (equivalent to Glatopa), and 40 mg/mL, which is still brand-only. The 40 mg/mL strength is used only three times per week.
What are the side effects of Glatopa?
Want more information on Glatopa?