While the effectiveness of any mental health medication varies from person to person, newly approved Rexulti is now available as another option—both for the treatment of schizophrenia, and as an additional tool to work with antidepressants.
What is schizophrenia?
Schizophrenia is a chronic and severe disabling brain disorder that affects around 1% of the population in the US, and more than 21 million people worldwide according to the Who Health Organization (WHO). However, it is treatable.
Some symptoms people with schizophrenia may experience include hearing voices, being suspicious or withdrawn, and a belief that other people are reading their minds or controlling their thoughts.
What is major depressive disorder?
Major depressive disorder (MDD), one of the most common mental disorders in the United States, causes a persistent feeling of sadness and loss of interest. Many people commonly refer to major depressive disorder as “depression.”
The symptoms of MDD can be different in each individual, and can range from mild to severe. Some examples include loss of interest in usual activities, a significant change in weight or appetite, the inability to sleep or excessive sleeping, restlessness, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or suicidal thoughts.
How is Rexulti to be taken?
What are the most common side effects associated with Rexulti?
Side effects of Rexulti may include weight gain and an urge to move (a sense of restlessness).
Is there anything unique about Rexulti?
Not really. Although Rexulti doesn’t have any especially unique attributes that might make it more stand out when compared to the other atypical antipsychotics, it can help have multiple options for patients with mental illnesses such as schizophrenia and MDD.
The effectiveness of a drug can vary from person to person, and finding the best medication for you, personally, may take some trial and error. Rexulti will offer you and your doctor another tool to try.
Is there any reason not to take Rexulti?
Cost. If any of the other atypical antipsychotics work for you, you may want to stick with a different option. All of the other drugs listed above have generics available, including Abilify. Rexulti is a new, brand-name only drug, and you’ll pay less through your insurance or out of pocket with a generic.
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*Prices as of September 22, 2015.
Will the manufacturer offer a prescription savings card to offset the cost?
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If you have high cholesterol you likely take a statin medication (atorvastatin (Lipitor), simvastatin (Zocor), Crestor) to help you manage it. Statins have been the mainstay of treatment for high cholesterol since their initial approval in the late 1980s—and recent data from the National Health and Nutrition Examination Survey (NHANES) shows that approximately 22% of Americans 45 years of age and older now take a statin.
Having high cholesterol can increase your risk of cardiovascular events like heart attack or stroke, so it’s important to take it seriously even if you don’t feel any effects.
You’ve probably also heard about “good” and “bad” cholesterol. Your good cholesterol, high density lipoproteins, is also known as HDL. Your bad cholesterol has a few different parts, with the most common being your triglycerides and low density lipoproteins (also known as LDL).
Statins can work to help lower your total cholesterol, triglycerides, and LDL, while modestly raising your good cholesterol or HDL.
What’s up next in the treatment of high cholesterol? The FDA advisory committee has just recommended the approval of two new experimental cholesterol-lowering medications that work just as well as statins if not better.
What are the names of the two experimental medications?
- Praluent (alirocumab) is from Sanofi and Regeneron Pharmaceuticals
- Repatha (evolocumab) is from Amgen Inc
Are there any advantages to these new drugs?
Yes. These medications are potentially more potent than statins, with fewer side effects.
Are there any disadvantages?
Yes. First, they will be expensive, brand-name-only drugs. The estimated cost of Praluent, depending on the dose, may range from approximately $5000 to $10,000 per year, and Repatha may be around $10,000 per year for both the bi-weekly and once-monthly doses.
In addition, both medications will need to be injected every two to four weeks using devices similar to insulin FlexPens.
Yes. Cost—while both may be very expensive, Praluent may cost as little as half as much based on your dose.
However, Repatha will offer more dosing options. If approved by the FDA, Repatha will be marketed as a 140 mg bi-weekly or 420 mg monthly injection, while Praluent will only be offered as a bi-weekly injection of 75 mg or 150 mg.
Who would benefit from these new cholesterol medications?
You may benefit from Praluent or Repatha if you have experienced side effects from statins such as muscle pain or weakness known as rhabdomyolysis, or if you have the genetic disease known as familial hypercholesterolemia. Familial hypercholesterolemia is characterized by high LDL (bad cholesterol) levels remaining high despite treatment with a statin, and these two new drugs may be more effective.
Does the FDA have to approve these medications based on the advisory committee’s advice?
No. The FDA does not have to approve medications although they usually will take the recommendations of the committee.
When will these medications be approved?
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This is a class II recall, the most common type of recall, which means that there is a situation where 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.
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 four lots of three strengths of lisinopril tablets: 2.5 mg, 10 mg, and 20mg.
Why are the lisinopril tablets recalled?
The recall was initiated following an inspection in March 2015. It was determined that more extensive research into previous complaints about the affected tablet strengths was needed. There have been several recalls of other Wockhardt products over the past couple of years, including metoprolol, another heart medication.
When was the recall initiated?
The affected lots of lisinopril tablets were recalled by the manufacturer on July 17, 2015.
How long have the affected products been in pharmacies?
The recalled lots of lisinopril 2.5 mg, 10 mg, and 20 mg tablets started shipping about three years ago, on July 20, 2012. The recalled lot for the 2.5 mg strength has actually already expired, so it’s less likely that you would still have it on hand. The others are due to expire by January 2016.
Are patients who have taken this medication being notified?
No. This is a class II recall, 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 products were affected?
In this recall, four lots and three strengths were affected.
Drug: lisinopril 2.5mg tablets, 100-count bottle
Lot: DM10573, expiration 04/2015
National Drug Code (NDC): 64679-927-01
Drug: lisinopril 10mg tablets, 1000-count bottle
Lots: DM13052 and DM13053, expiration 09/2015
National Drug Code (NDC): 64679-929-06
Drug: lisinopril 20mg tablets, 1000-count bottle
Lots: DN10485, expiration 01/2016
National Drug Code (NDC): 64679-941-06
There are 8 million new cases of Alzheimer disease (AD) each year—and while new headlines appear every week about potential cures, it may discourage you to know that many recent AD trials have been unsuccessful, though not for a lack of trying. In fact, there have been no new medication approvals for this currently untreatable disease in over ten years.
Solanezumab is making news this week because the drug company has hinted that trials show it may help in a small group of AD patients.
Here is the bleak update on what’s new in AD treatment.
- Antibodies against amyloid-beta: Misfolded proteins result in plaques of amyloid and tau proteins in the brain, leading to AD. Some very high profile phase 3 clinical trials yielded disappointing results for three new antibodies against the amyloid-beta protein: crenezumab, bapineuzumab and solanezumab. None of these drugs improve clinical outcomes in patients with late onset AD, sadly adding them to a long list of unsuccessful attempts to treat AD with anti-amyloid therapies.
- But wait . . . The drug company that makes solanezumab has reported that results coming at the end of next year may show potential benefit in those with mild AD. Stay tuned on this.
- Vaccines against AD. Three of the peptide vaccines for active immunizations (CAD106, ACC001, and Affitope) are in phase 2 clinical trials. Phase 2 means the vaccines are being given to a larger group of people to see if they are effective and to further evaluate their safety. Again, stay tuned, but there is a long way to go on this.
Though there are other treatments available to help manage symptoms, cystic fibrosis does not currently have a cure. That’s part of what makes Orkambi (ivacaftor/lumacaftor) exciting—this new medication targets the two defective genes that are the underlying cause of the disease.
Now, after receiving FDA approval on July 2, 2015, Orkambi is available in pharmacies.
What is cystic fibrosis?
Cystic fibrosis (CF) is an inherited and life-threatening disease that affects the respiratory and digestive systems. It mainly affects the lungs, but can also involve the pancreas, liver, intestine, sinuses, and sex organs.
Symptoms can include coughing with thick mucus or blood, lung infections, and diarrhea, though these vary from person to person.
What causes cystic fibrosis?
Cystic fibrosis is caused by a mutation of the CFTR gene.
A child will develop cystic fibrosis if they inherit two copies of a mutated gene, one from each parent (neither of whom is likely to have the disease themselves).
How does the gene mutation affect someone with CF?
The mutation causes interference with the transportation of water and chloride in the body. That interference leads to the buildup of thick, sticky mucus that can damage many of the body’s important organs.
How is Orkambi taken?
What are the most common side effects associated with Orkambi?
Some common side effects include shortness of breath, upper respiratory symptoms, nausea, diarrhea, rash, and increased menstrual bleeding.
Will Orkambi be available at my pharmacy?
No. Orkambi will be available exclusively at specialty pharmacies—you won’t be able to go to your regular retail pharmacy to fill a prescription. You can see a list of the specialty pharmacies that will offer Orkambi here and here.
More worrisome? Orkambi comes with a very high price tag, at an estimated $259,000 per year. Vertex, Orkambi’s manufacturer, does offer support for getting coverage, and may offer assistance for patients in need. See their website for more information.
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