On April 20th, the FDA issued a consumer update for the use of products containing codeine and tramadol (Ultram) in children. The FDA warns that tramadol and codeine can cause life-threatening breathing problems in adolescents less than 18 years of age.
What are tramadol and codeine indicated for?
Tramadol and codeine are both opioids indicated for the treatment of pain. Codeine is also indicated for cough. For a more detailed look at what these medications are and how they work, check out Iodine for tramadol here, and codeine here.
Why is the FDA updating their restrictions?
This safety alert is an update to two evaluations from 2012 and 2015 where the FDA was determining the potential risk for codeine and tramadol use in children.
Back in 2012, the FDA made a safety announcement regarding the use of codeine, as there were reports of children who developed serious adverse effects, or died, after taking codeine for pain relief. After that, in 2015, the FDA made a safety announcement about the use of tramadol in children 17 years of age and younger due to the rare but serious risk of slowed or difficult breathing that had been reported.
Since 1969, the FDA has received 64 adverse breathing events from patients taking codeine and 9 cases of adverse breathing events from patients taking tramadol. Of these cases, 27 resulted in death.
What is the FDA doing about these restrictions?
In response to these reported cases, the FDA is restricting the use of codeine and tramadol medications in children.
The FDA is also requiring several changes to the labels of all prescription medications containing these drugs. The FDA is requiring manufacturers of these products to have labeling that reflects the following:
- A new contradiction section update. This update will be added to the drug labels of codeine and tramadol to alert patients that codeine and tramadol should not be used to treat pain or cough in children younger than 12 years of age.
- A new warning section update. This update will be added to the drug labels of codeine and tramadol to recommend against their use in adolescents between 12 and 18 years of age who are obese or have breathing related problems. This label update will also include a warning to mothers that breastfeeding is not recommended when taking codeine or tramadol, as this could increase the risk of serious adverse reactions in breastfed infants.
What signs and symptoms should parents and caregivers look out for?
If you child has been prescribed codeine or tramadol, the signs and symptoms you should seek medical attention for include; slow or difficult breathing, noisy breathing, confusion, sleepiness, trouble breastfeeding, and limpness. Breathing problems can occur after a single dose of these medications.
Should any adults stay away from these products?
Yes. The FDA is recommending against the use of single-ingredient codeine and tramadol-containing products in breastfeeding mothers. These medications pass into breast milk and can harm breastfeeding infants.
What does the FDA recommend prescribers do?
The FDA recommends that prescribers not recommend tramadol and codeine:
- To treat pain in children less than 12 years of age.
- In children younger than 18 years of age to treat pain after a tonsillectomy and/or an adenoidectomy
- In adolescents 12-18 years of age who are obese or have breathing related problems.
The FDA also recommends that providers counsel parents and caregivers on how to recognize the signs of opioid toxicity if the use of codeine or tramadol is determined to be appropriate. Parents and caregivers should know to seek medical attention immediately if their child is exhibiting any of these signs.
The FDA also recommends that providers prescribe Tylenol or ibuprofen instead of codeine or tramadol.
Eczema, also known as atopic dermatitis, is a skin condition that affects nearly 18 million Americans. The signs and symptoms of eczema differ from person-to-person but may include symptoms like dry sensitive skin, itchiness, dark colored patches of skin, or areas of swelling.
On March 28th, the FDA approved Dupixent (dupilumab), the first biologic injection medication used to treat severe cases of eczema. In the past, Eczema treatments have only consisted of topical medications and steroid creams, so this new injection is a potential breakthrough for many people who have been suffering for years without treatment. Read our post here for more information about biologics.
What is atopic dermatitis?
Atopic dermatitis (eczema) is a long-term inflammatory skin disease characterized by dry, itchy skin. It usually affects babies and children, but the condition can carry over into adulthood.
Common symptoms of atopic dermatitis include red, scaly bumps and itchiness. These symptoms are exacerbated when patients itch the affected skin – as that can cause swelling, cracking, crusting, and “weeping” clear fluid.
What is Dupixent indicated for?
Dupixent is indicated for the treatment of adult patients with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies. Dupixent can be used with or without topical medications.
How is Dupixent to be used?
Dupixent is available as a single-dose pre-filled syringe to be administered under the guidance of a healthcare provider. However, after patients are trained in the subcutaneous injection technique by a healthcare provider, they may self-inject Dupixent.
The initial dose of Dupixent is 600 mg of the subcutaneous injection (two 300 ml syringes) followed by 300 mg injections every other week.
What are the common side effects associated with Dupixent?
Side effects include injection site reactions, cold sores, and eye and eyelid inflammation.
How can I save on Dupixent?
Like many other new biologics, Dupixent does not come cheap. Luckily, Sanofi has created the Dupixent MyWay program to help patients with injection training and guidance through the insurance process. This program also offers commercially eligible insured patients a $0 copay card for Dupixent. For more information about eligibility and to enroll, visit the Dupixent MyWay program website here, or call 1-844-387-2936.
Almost half of Americans have used a prescription medication in the past 30 days, for a wide variety of benefits. The benefits of medications are the helpful effects you get when you use them, such as lowering blood pressure, treating infection, or relieving pain. Turns out there are some standout medications that can accomplish two or more things, sometimes with very different effects. More than one benefit? That’s a nice upside . . . so what are these multitasking medications?
- Propranolol (Inderal) is a beta blocker that wears many hats. Chest pain, irregular heart rhythm, improved mortality after a heart attack, and lowering blood pressure are some key benefits. A small dose of Inderal LA (long acting) may also be used to lower anxiety before public speaking. Propranolol helps for essential/resting tremor (shaking of the hands) and for symptoms related to hyperthyroidism. Propranolol taken daily works for migraine prevention in both kids and adults, and lowers the risk of bleeding from the esophagus in people with liver cirrhosis. Whew.
- Amitriptyline (Elavil) is a tricyclic antidepressant with several known benefits. Common uses are for migraine headache prevention in kids and adults, chronic pain management, and improving pain and sleep disturbance in fibromyalgia patients. Amitriptyline was initially approved by the FDA in 1961 for the treatment of depression.
- Gabapentin (Neurontin) is commonly prescribed for the treatment of seizure disorder as well as postherpetic neuralgia, the pain after a shingles outbreak. Gabapentin is also used in folks with diabetic neuropathy (nerve pain in their feet and legs) and for those with pain radiating from the low back down the legs (lumbar radiculopathy). Alcohol withdrawal, hot flashes from menopause, and social anxiety disorder are among the other areas where gabapentin has shown benefit.
- Topiramate (Topamax) is another seizure medication that was discovered to have multiple benefits. In addition to use in patients with seizure disorder, topiramate is prescribed for the prevention of migraine headaches. Weight loss, binge eating disorder, and alcohol dependence are other potential uses for topiramate. In fact the new weight loss drug Qsymia is a combination of topiramate and phentermine.
- Spironolactone (Aldactone) is a diuretic used for heart failure and high blood pressure. Spironolactone, a jack of all trades, is an anti-androgen, so it is beneficial for excess hair growth in women and acne, especially in those with PCOS (polycystic ovary syndrome). Spironolactone also helps reduce the accumulation of fluid in the abdomen (ascites) in liver disease patients.
- Metformin (Glucophage) is widely prescribed for the management of type 2 diabetes. Metformin also improves insulin sensitivity in non diabetic women with polycystic ovary syndrome (PCOS) and regulates ovulation in those with PCOS. Metformin has the awesome upside of weight loss. The coolest new buzz surrounding metformin: in mice studies it extended lifespan. Women with ovarian cancer taking metformin also had improved survival—stay tuned on this.
- Aspirin saves lives when given during a heart attack. Aspirin is also widely taken for stroke and heart disease prevention. Aspirin is well known as a pain and fever reducer, and blood thinner in those with atrial fibrillation. In folks at risk of colon cancer, aspirin decreases your risk. However—the pro-tip of using aspirin to keep flowers fresh doesn’t appear to be true, and commercially available flower food (Chrysal) is much better for making a bouquet last.
- Bupropion (Wellbutrin) is an atypical antidepressant that has multiple roles. Benefits include the treatment of depression and seasonal affective disorder. Smoking cessation and weight loss are two other perks of bupropion; in fact Zyban is the brand name of bupropion specifically approved for smoking cessation. The new weight loss medication Contrave is a mixture of bupropion and naltrexone. Bonus.
- Valproic acid (Depakote) is used for seizure disorder, migraine prevention, and for mania associated with bipolar disorder. Diabetic neuropathy (nerve pain) is another condition where valproic acid is often prescribed.
- Carbamazepine (Tegretol) is primarily used for seizure disorder, bipolar disorder, and for the treatment of trigeminal neuralgia—a painful condition that causes severe facial pain. Carbamazepine is being studied for restless leg syndrome.
- Hydroxychloroquine (Plaquenil) has two very different benefits. Plaquenil is prescribed for the treatment of malaria, as well as for the treatment of two autoimmune diseases: lupus and rheumatoid arthritis. Wait, what? Yep. Plaquenil, an antimalarial, diminishes the formation of proteins required to stimulate CD4+ T cells, which result in down-regulation of the immune response. Random.
What did I miss?
Whether from a new injury or an aggravated old injury, stiffness and soreness in the neck and back at night may lead to disrupted sleep and more pain in the morning. Muscle relaxants have been shown to help relieve this pain and get you through these tough days—used at night, these medications may improve acute neck and back pain.
Your first line treatment will still be acetaminophen (Tylenol) and NSAIDs (ibuprofen, Advil, naproxen, Aleve, etc) which do work better for neck and back pain than muscle relaxants. But there may be benefit to taking both, especially at night, where a muscle relaxant added to acetaminophen or an NSAID works better than either alone.
Let’s compare them. How well do they work and what are their side effects ? Oh, and are they affordable?
- Methocarbamol (Robaxin). An inexpensive and less sedating option, methocarbamol has been well studied for use in back pain. In recent studies where it was used for up to 8 days, 44% of folks had complete pain relief with methocarbamol (compared to 18% who did nothing) without any serious side effects. Taken as needed, 1500 mg every 6 to 8 hours is a cheap and well-tolerated option for sufferers of acute neck and back pain. Think of trying this first, as it is less sedating than cyclobenzaprine and carisoprodol.
- Cyclobenzaprine (Flexeril). At the standard dose of 10 mg to 30 mg a day, cyclobenzaprine will make you sleepy. If used during the day you’ll want to break your 10 mg tab in half and take 5 mg to lessen the drowsiness. Interestingly, 5 mg three times a day has been shown in studies to work as well as 10 mg taken three times a day. Cyclobenzaprine is a reasonable first choice because it’s a cheap generic, but the sedation side effect limits its use during the day. Cyclobenzaprine has anticholinergic properties, similar to Robaxin (methocarbamol) and Soma (carisoprodol), so it may cause more sedation and dry mouth, especially in older folks. If this is a concern, consider a better non-sedating option.
- Carisoprodol (Soma) has an abuse potential so should not be used if there is a history of substance abuse. For this reason, it is a schedule IV drug similar to the benzodiazepines (Ativan, Valium, Xanax, etc). General opinion is that carisoprodol should be phased out as a muscle relaxant in favor of much better options. If prescribed, carisoprodol should only be used for short periods (2-3 weeks) due to lack of evidence for effectiveness with longer use. It may cause drowsiness and dizziness, and should not be used in folks over 65.
- Metaxalone (Skelaxin). Taken as 800 mg tablets, three to four times a day, metaxalone has the fewest reported side effects and less sedation in studies. Simply put, it is the best tolerated of the muscle relaxants. Metaxolone is a generic alternative for Skelaxin, but it is still pricey and insurance companies don’t like to cover it because there are cheaper alternatives.Having said that, it works as well as cyclobenzaprine and carisoprodol with fewer side effects and less sedation—so paying cash may be worth it.
- Tizanidine (Zanaflex). Tizanidine is used more for spasticity in patients with multiple sclerosis or cerebral palsy. In head to head studies with Baclofen for those conditions, it tends to be better tolerated (it has fewer side effects)—but they both work just as well. This is not a first line choice for acute neck or back muscle pain though.
- Baclofen. Similar to tizanidine, Baclofen is primarily used for spasticity in spinal cord injury patients or those with multiple sclerosis. Drowsiness occurs in up to 20% of folks taking it, and there are better options for neck and back muscle pain. Also not a first choice.
- Oxazepam. Benzodiazepines like oxazepam and diazepam (Valium), are sometimes prescribed as muscle relaxants. However, these really aren’t recommended because they don’t work well, are sedating, and can be habit forming. Avoid benzodiazepines for neck and back muscle pain because there are much better options.
- Chlorzoxazone (Lorzone). This one is not well-studied for acute low back and neck pain in adults, and when investigated for pain after spine surgery, it wasn’t found to be effective. Chlorzoxazone has also been reported as a rare cause of acute liver toxicity. Don’t choose this until you’ve exhausted all other options.
- Orphenadrine (Norflex). For neck and back pain in adults, the first four medications on this list (cyclobenzaprine, carisoprodol, methocarbamol, and metaxalone) work better than Norflex so save this as another last resort in the event the others don’t work. It just hasn’t been well studied for this purpose.
If you have ever experienced a serious reaction to a medication, you are not alone. In 2000, the Institute of Medicine reported that more than 2 million serious adverse drug reactions occur each year. The FDA keeps track of these serious events through a reporting system and releases them quarterly. This system, the FDA Adverse Event Reporting System (FAERS), is a database that contains information on adverse events and medication error reports that have been submitted.
As of March 31st, 2017, the FDA released their current list of medications that have potentially serious risks or new safety information. If you are currently taking a medication on this list, feel free to speak with your doctor or pharmacist about the risks.
- Contrave is prescribed to help with weight loss, and has been reported to cause loss of consciousness. The FDA is currently evaluating the need for further action.
- Coumadin (warfarin, jantoven), Eliquis, Pradaxa, Savaysa, Xarelto are all blood thinners. There have been reports that they can cause female menstrual periods with abnormally heavy or prolonged bleeding. At this time, the FDA has decided not to do anything based on available information.
- Depo-Provera (medroxyprogesterone) is a contraceptive injected for pregnancy prevention. There have been reports of it being confused with Depo-Medrol (methyprednisolone acetate), a steroid used to treat inflammation. In order to help differentiate between the two, the Depo-Provera carton and container labeling have been changed.
- Diabeta is a tablet used to treat type 2 diabetes that has been seen to cause skin reactions. Because of this, the “adverse reaction” section of the labeling as been updated.
- Imbruvica is a treatment for types of lymphoma. There have been reports of it causing Pneumocystis jirovecii pneumonia (PJP), a fungal infection that can lead to lung problems and pneumothorax. The “warnings and precautions” section of the labeling has been updated to reflect this side effect.
- Nitropress (sodium nitroprusside) is generally used to reduce blood pressure during surgery, or for congestive heart failure. It can cause carboxyhemoglobinemia, or carbon monoxide poisoning. The FDA is evaluating these reports to see if further action is needed.
- Northera is used to treat dizziness, light-headedness, or the feeling of passing out. There have been reports of it causing strokes, so safety information on the labeling has been updated to reflect these side effects.
- Nucala is indicated to treat severe asthma. Some patients have reported that has caused life-threatening allergic reactions. The “warnings and precautions” section of the labeling has been updated to reflect these reports.
- Opsumit is used to treat pulmonary arterial hypertension, or PAH, a type of high blood pressure that affects arteries in the lungs and heart. It can cause excess fluid build-up. The “warnings and precautions” section of the labeling has been updated to reflect this side effect.
- Otezla is indicated for the treatment of psoriasis, or arthritis due to psoriasis. There have been reports of it causing diarrhea, nausea, and vomiting. The FDA is currently evaluating the need for further action.
If you ever experience any serious reactions to a medication, you can report your event to the FDA’s MedWatch website. MedWatch allows you to voluntarily report a serious adverse event, product quality problem, product use error or therapeutic inequivalence/failure that you suspect is associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic. You can report suspected counterfeit medical products to MedWatch as well.