The use of stimulant medications for the treatment of Adult ADHD has increased tremendously. I now see many psychiatrists in the community prescribing them along with antidepressants in those without ADHD. Before you commit to the use of stimulant medications here are ten things you need to now—some reassuring and some not.
1. They’re popular: Adults now receive one third of all prescriptions for ADHD medications in the US, a pattern that is not seen in other countries.
2. Kids only? The bulk of the available data on the treatment of ADHD come from studies in children, which limits the ability to make evidence-based recommendations for adults.
3. Legit for adults? It surprises many of my patients to learn that only some of the stimulants, like Adderall XR, Concerta, Vyvanse, and Focalin XR, are FDA-approved for use in adults. Adderall XR and Concerta are available in generic form so will be much cheaper for you.
4. Warnings for women: The warnings issued along with Adderall, Ritalin, and Vyvanse acknowledge that women of reproductive age should not take these stimulant medications. Use of stimulant medications during pregnancy may lead to increased risk of premature delivery and low birth weight, infants may experience symptoms of withdrawal, and birth defects have been reported with women taking Adderall during the first trimester. So any woman on these meds who plans on conceiving will have to be weaned off of them.
5. The heart: While stimulants can increase heart rate and blood pressure a large study published in JAMA in December 2011 (http://jama.jamanetwork.com/article.aspx?articleid=1104778) showed there was no increased cardiovascular risk in middle-aged adults taking stimulant medications. This was reassuring.
6. Use and abuse: Abuse potential exists, and this is different for adults who require larger doses of stimulants than those prescribed to children.
7. The energy pill: Many people feel better on stimulants and have difficulty weaning off them and feeling the “normal” periods of fatigue during the day, along with the possibility they may not feel as productive as they did while on them. Stimulants improve cognitive function in most people. As an example, methylphenidate (Ritalin) has been found in studies to reduce driving errors in all adults, not just adults with ADHD. Thus, a person’s response cannot be used to confirm or exclude the diagnosis of ADHD.
8. The downsides: If you find yourself experiencing insomnia, anxiety, weight loss or elevated heart rate or blood pressure from your stimulant, ask your doctor about non-stimulant options.
9. Finally cheaper: There has been a run on the generic options for ADHD medications like Adderall XR (amphetamine salt combination XR) and Concerta (methylphenidate ER), so many pharmacies were experiencing a shortage. This was due to increased demand and a decrease in supply and is not expected to end anytime soon.
10. Heat: During exercise know that stimulants may potentially increase your risk of developing heat illness. During the hot months watch out for heat illness and stay hydrated.
So does my bupropion XL even work? That is the question my patients have been asking the last two weeks. I wonder too. Here is what we know thus far:
• On October 3, 2012, the FDA announced that Budeprion XL 300 mg (bupropion extended-release tablets), marketed by Teva Pharmaceuticals, is not therapeutically equivalent to Wellbutrin XL 300 mg and it was withdrawn from the market. So, it didn’t work the way Wellbutrin XL worked. That’s disconcerting.
• The same company makes Budeprion XL 150 mg and plans on continuing to make that dose.
• While there are 5 other generic versions of Wellbutrin XL 300 mg (bupropion XL 300 mg) here is the catch: each of these generics was approved on the basis of bioequivalence studies comparing the 150-mg strength of the products to Wellbutrin XL 150 mg.
• Studies were not performed directly on the 300-mg strength of the products. So make sure you understand this: the bioequivalence studies were performed using the 150-mg strength, and the results were extrapolated to establish bioequivalence of the 300-mg product.
Physicians and patients are now leery of whether Bupropion XL 300 mg is as effective as the brand name Wellbutrin. The brand name Wellbutrin costs our patients more than $300 a month and that’s a tall order to ask of patients. At this point those of you using bupropion XL 300 mg with good results should probably talk to your physician about staying on it, and those of you not finding it effective should think about a change.
A new long acting inhaler has been approved for the treatment of Chronic Obstructive Pulmonary Disease (COPD). The new inhaler, Tudorza Pressair, is due to come out this year and compete with Spiriva. The active ingredient in this new inhaler is aclidinium, a long-acting anticholinergic agent that was approved by the FDA for long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). This means you use this inhaler daily as maintenance treatment, not as a rescue inhaler. Aclidinium is shorter-acting than tiotropium (Spiriva) and is used twice a day. Studies have shown that Tudorza is just as good as, but no better than, Spiriva.
Bring it on.
Tudorza Pressair cash prices will be around $230 – $250 per 30 dose inhaler, while Spiriva is currently priced at around $250 – $270 per inhaler. Spiriva is covered by most insurance plans as a Tier 2 medication, meaning a moderate copay, and it’s likely that Tudorza will have similar coverage.
Many have been waiting for a pill for MS, and here it is. Injectables (Avonex, Betaseron, Copaxone and Rebif) are currently the mainstay of treatment for MS, so realize that most MS patients are currently injecting themselves once daily or once a week. Now, there may be a pill option. This month the Food and Drug Administration (FDA) announced the approval of Aubagio (teriflunomide), a once-daily tablet for the treatment of multiple sclerosis.
Aubagio is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for Aubagio is not fully understood, it helps reduce the number of lymphocytes (white blood cells) in the central nervous system.
Aubagio is approved for patients with the relapsing form of MS; these are patients who have flare-ups and then have almost complete recovery. Aubagio was approved because of promising studies that showed the use of Aubagio significantly reduced the relapse rate in MS patients and the time to disability progression.
Aubagio is now available now from some pharmacies, in 7 mg and 14 mg strengths. It runs about $3750 for a one-month supply, and if covered by insurance, it will likely fall under Tier 2 or 3, meaning a moderate to highly monthly copay.
Dilaudid is the short acting hydromorphone most people are familiar with. In August 2012, the Food and Drug Administration (FDA) approved a 32 mg strength of Exalgo (hydromorphone) extended-release tablets for use in opioid-tolerant patients with moderate-to-severe chronic pain who require opioids for an extended period of time. To give you an example of how high this dose is, the largest pill Dilaudid comes in is 8 mg. For some people though, this is a good thing.
Who would need Exalgo? Exalgo already exists in 8 mg, 12 mg, and 16 mg tableta. Now, there is a 32 mg tablet. Patients who are opioid-tolerant will benefit from this. For example, patients taking at least 60 mg of oral morphine per day, a 25 μg fentanyl patch per hour, 30 mg of oral oxycodone per day, or 8 mg of hydromorphone per day. I have many cancer patients on these doses.
What else is new about Exalgo? Exalgo uses a drug delivery system that allows the release of the opioid at a controlled rate. These properties of Exalgo also make it difficult to extract the active ingredient by chewing, crushing, or dissolving the pill.
Isn’t a high dose, 32 mg, kind of scary? Yes, even in people who are already on high doses of opioids. Respiratory depression may occur with Exalgo even when the drug has been used as recommended. Only health care professionals who are knowledgeable in the use of potent opioids for the management of chronic pain should be prescribing this. Also recognize that crushing, chewing or dissolving an Exalgo tablet can cause rapid absorption and may be fatal.
Scary or not?
When Exalgo is covered by insurance, it is typically a Tier 3 drug, meaning you’ll likely pay your highest copay. Cash prices typically run around $1250 for 30 tablets of the 32 mg strength, not significantly different from the cost of 60 tablets of 16 mg. Generic hydromorphone is a lower cost option, though the highest dose available is 8 mg. The manufacturer of Exalgo does offer a patient assistance program for patients who meet income and eligibility requirements, and other assistance programs may be available. You can find more information here: http://www.exalgo.com/patient/patient-assistance.aspx