The FDA has recently approved Xermelo (telotristat ethyl), a new prescription medication for adults with carcinoid syndrome diarrhea. Xermelo is the first and only oral treatment for carcinoid syndrome diarrhea – so this is exciting news for those who suffer from the signs and symptoms of carcinoid syndrome.
Carcinoid syndrome is caused by a rare tumor that can lead to symptoms like skin lesions, difficulty breathing, and diarrhea.
How should I take Xermelo?
Xermelo must be used in conjunction with a somatostatin analog (SSA) like Sandostatin (octreotide) or Somatuline Depot (lanreotide). It is now available in pharmacies as a tablet in a strength of 250 mg. Patients should take one 250 mg tablet by mouth, three times daily with food.
Note that Xermelo is a specialty medication. This means that you must get Xermelo through a specialty pharmacy. Your doctor will fill out an enrollment form for you, which will be sent directly to a specialty pharmacy. Once the pharmacy receives the enrollment form from your doctor, you will be contacted by the LexCares program within 24 hours to set up delivery. Xermelo’s manufacturer, Lexicon Pharmaceuticals, created the LexCares program to get patients their medication without hassle.
What are the common side effects associated with Xermelo?
The most common side effects include a headache, nausea, increased liver enzymes, depression, swelling, gas, decreased appetite, and fever.
The FDA recently ruled that Pylera will now require a boxed safety warning on its labeling. A boxed warning or “black box warning” is the most serious warning regarding potential side effects and is used to call attention to serious or life-threatening risks.
What is Pylera indicated for?
Pylera is used in combination with omeprazole to treat stomach and intestinal ulcers in patients with helicobacter pylori (h.pylori).
Why was Pylera given a boxed warning?
The boxed warning on Pylera is due to its potential for carcinogenicity, or the ability to cause cancer. During recent testing, Pylera has been shown to be cancer causing on mice and rats
If you are concerned about this boxed warning, be sure to talk to your doctor about other medications on the market for h.pylori. In fact, Prevpac and Omeclamox-Pak are both prescribed for h.pylori, and do not have a boxed warning.
What should I do if I experience an adverse effect to a medication?
An adverse effect to a medication should be reported to the FDA MedWatch program here. MedWatch is the FDAs safety information and adverse event reporting program. You can use MedWatch to report adverse events like serious side effects, product use errors, product quality problems, and therapeutic failures for human medical products, cosmetics, and prescription or OTC medications.
Call 1-800-332-1088 for more information on how to report an adverse effect.
The approval has caused some outrage, and has many people questioning why the FDA would allow such a powerful and addictive medication to be prescribed for young children.
On the other hand—children usually don’t experience the chronic type of pain that adults do, so the use of Oxycontin will be limited to a few specific, medically necessary situations. For example, it may be used to treat pain following surgery, or cancer pain.
Who can be prescribed Oxycontin?
Now, Oxycontin may be prescribed for adults and opioid-tolerant pediatric patients 11 years and older who are already receiving (and have a tolerance for) a daily dose of at least 20 mg of another pain medication, like oxycodone.
Can Oxycontin be addictive?
Yes. Oxycontin is classified by the DEA as a schedule II http://www.deadiversion.usdoj.gov/schedules/ controlled substance. Schedule II controlled substances have a high potential for abuse which may lead to severe psychological and physical dependence.
Why would the FDA approve a medication like this for children?
Many of the medications indicated for pain relief in adults don’t conduct clinical trials in children. This means that there just isn’t enough information for health care professionals to be able to determine dosing and side effect profiles in younger age groups, even if the medication may be needed.
In the past, if your child’s doctor felt a strong pain medication was necessary, they were often left to base the dose on interpretation of the adult recommendations. This recent FDA approval comes following recent data from clinical trial specifically studying the use of Oxycontin in children.
Oxycontin is still not meant to be prescribed for children the same way as it is for adults. It’s meant to be reserved for major surgery or trauma—and for pediatric patients who have already been taking opioid medications to manage that severe pain.
For more information on the approval, and pain management for children, please see this Q&A from the FDA.
In 2016, 1,685,210 new cases of cancer are projected to occur in the United States. Hard to believe, but that actually means it’s getting better. Something’s working. Whether it’s more appropriate screening or the effects of diet- and exercise-shaming finally soaking in, death rates from cancer have declined and are continuing to go down. Here is what we learned from the American Cancer Society (ACS) this month.
- The decline in cancer death rates in the US over the past 20 years has resulted in an overall drop of 23%, with more than 1.7 million cancer deaths averted.
- There are three principal reasons for the decline: reduction in cigarette smoking, improvements in treatment (surgery, chemotherapy, radiation), and the success of age-appropriate screening.
- Despite this, cancer is still the leading cause of death in 21 states . . . partially because we’ve gotten better at treating heart disease, the previous #1.
- It’s not all good. Incidence rates have increased for liver, pancreas, thyroid, tongue, tonsil, kidney and some leukemia subtypes. Liver and pancreas cancer are two of the most deadly cancers.
- Good news for the colon. In 2012, 55% of people between the age of 50 and 75 had a screening colonoscopy compared to only 19% in 2000. Colon cancer rates have declined 3% per year because of this and changes in risk factors (smoking, diet).
- Bad news for the uterus. One of the surprises in the data released was an increase in uterine lining cancer, called endometrial cancer. Deaths from uterine cancer are now just short of deaths from ovarian cancer in the US. Why? Excess weight increases endometrial cancer risk by 50% for every 5 body mass index (BMI) units. More obesity = more endometrial cancer.
- What about the prostate? As you know, current consensus is to not routinely screen all men with the prostate cancer blood test, the PSA. So half of the drop in cancer cases is related to declines in prostate cancer diagnoses as PSA testing decreases.
- Which is the most rapidly increasing cancer? Thyroid. Thyroid cancer rates have increased in both men and women 5% each year—but that’s partially due to overdiagnosis due to increased use of advanced imaging techniques.
- Tobacco is still a problem. Despite some of the progress seen, 80% of deaths from lung cancer and half of deaths from esophageal, oral and bladder cancer are from cigarette smoking.
- What are the chances you’ll have cancer? With these new statistics, we know the lifetime probability of developing invasive cancer for Americans is 42% for men and 38% for women.
Chronic myeloid leukemia or CML is a rare blood-cell cancer that begins in the bone marrow, and causes your body to produce too many white blood cells. CML typically occurs in adults but it can (very rarely) affect young children.
How will generic imatinib be available?
When was imatinib mesylate approved by the FDA?
When will generic Gleevec be available?
What are the side effects of imatinib tablets?
The most common side effects include water retention, muscle cramps, stomach pain, loss of appetite, vomiting or diarrhea, decreased hemoglobin, abnormal bleeding, nausea, fatigue, and rash.
What else should you know about Gleevec?
Gleevec (imatinib mesylate) is a specialty medication. Specialty medications are typically very expensive, and may require extra monitoring by your doctor. For more information on specialty medications please check out our two previous posts on what you should know about specialty meds and what makes specialty drugs different.
While you’re taking Gleevec, your doctor may need to check your blood to see if the medication is working properly. Your doctor may also monitor your liver function, thyroid levels, kidneys, heart, or growth. If Gleevec is prescribed for a child, it can potentially slow down or stop their growth, and extra monitoring is recommended.