Archive
August, 2014 Monthly archive

Expiration date on medications does not indicate that the medication is no longer effective or safe after that date. Having had extensive experience with the production and testing of Migralex, I can reassure you that medications remain safe and effective for years after the expiration date. An article just published in the Wall Street Journal’s “Burning Question” column addresses this issue.

The FDA has conducted a study for the Department of Defense testing 122 different drugs. The conclusion of the study was that 88% of the drugs remain effective for an average of 5 and 1/2 years after the expiration date. The main problem with expired drugs is not that they become dangerous to use, but that their efficacy slowly declines. A doctor quoted in the WSJ article says that there have been no reported cases of toxicity from expired medications. But a decline in efficacy could be a problem with life-saving drugs, such as nitroglycerin for heart, EpiPen for allergies, or insulin for diabetes.

It is very important to store the medications in a dry cool place, rather than in a medicine cabinet in the bathroom, which periodically gets hot and humid. Also, do not leave drugs in a car during the summer – the temperature in a locked car left in the sun can rise to 130 degrees and higher.

I usually advise not to use drugs beyond two years of the expiration date even if they were kept in a dry and cool place. Before using an expired drug inspect the tablet to make sure it hasn’t turned colors, smells bad, or became brittle and crumbling. Obviously, if it is an inexpensive generic drug, get a fresh bottle. However, with expensive drugs, such as some triptans (Relpax, Frova, Axert) and injections of Imitrex (sumatriptan) considerable amounts of money can be safely saved. A common scenario is a patient with cluster headaches who has a bout every couple of years and has only expired injections of Imitrex. It usually takes at least a few days to be seen by a doctor and to get a new prescription, while the attacks of cluster headaches can be devastatingly severe. Again, the worst that can happen is that the injection will be less effective, but usually it will still provide some relief.

There is a difference in how long expired drugs remain effective depending on the formulation. For example, tablets are the most stable, while creams and liquid drugs, such as drops, are least likely to last past the expiration date.

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A report from the Cleveland Clinic and Case Western Reserve describes 22 patients with new daily persistent headaches (NDPH) who were treated with Botox injections.

NDPH is a condition in which the headache begins suddenly without an obvious trigger and persists continuously without a break. Because NDPH is relatively uncommon, there have been no large studies of this condition. Patients with NDPH usually do not exhibit symptoms of migraine, such as throbbing pain, nausea, sensitivity to light, noise or physical activity. Because of its sudden onset, we suspect that these headaches may be the result of a viral or another type of infection. There are no treatments that consistently relieve these headaches, but we usually try all of the drugs and approaches we use in migraines.

A group of doctors from Cleveland, Ohio discovered that while Botox seems to help, only 32% of patients with NDPH showed improvement, confirming the refractory nature of this type of headaches. Twenty one of the 22 patients underwent more than one treatment with Botox and most were given a standard migraine treatment protocol with 155 units injected into 31 sites. The improvement was modest but it did result in headache-free days, which were not observed prior to this treatment. The disability improved slightly and when the improvement did occur, it lasted about 8 weeks. Some of our chronic migraine patients also require Botox injections every 8 to 10 weeks, instead of the usual 12. Considering that we do not have any better treatments, Botox should be offered to patients with NDPH.

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A new combination of two old drugs seems to provide relief for some trigeminal neuralgia (TN) sufferers. The first line drugs for TN are epilepsy drugs, carbamazepine (Tegretol) or oxcarbazepine (Trileptal). A presentation at the last annual scientific meeting of the American Headache Society by Saudi physicians described successful use of another epilepsy/pain drug, pregabaline (Lyrica) with an antidepressant/pain drug duloxetine (Cymbalta). Both Lyrica and Cymbalta are approved by the FDA for the treatment of some pain conditions, although not TN. The doctors compared Lyrica alone with Lyrica and Cymbalta in combination in 200 patients. The combination resulted in an 80% reduction of pain, which was observed within 10 days, while Lyrica alone produced a 60% reduction that started within 20 days. The dose of Lyrica was 150 mg twice a day (after a one week build up from 75 mg twice a day) and the dose of Cymbalta was 60 mg a day.

Since both Cymbalta and Lyrica have pain relieving properties, this appears to be a rational combination of medications to use in TN and possibly other painful conditions, including various types of headaches. However, as a general rule, we try to use a single drug whenever possible to reduce the potential for side effects. TN is such a severe and debilitating condition, that it may be justified to use a combination early, especially if the first line drugs, such as oxcarbazepine fail.

In my previous posts I have described the use of intravenous medications, Botox and other invasive treatments for TN.

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Post-concussion syndrome, which often includes headaches, can persist for many months especially after a minor injury (yes, mild injury is more likely to cause post-concussion syndrome than a severe one).
However, little is known about prognosis after the injury. The symptoms fall into three categories – cognitive (such as memory, concentration difficulties), somatic (headaches, dizziness, etc), and emotional (irritability, anxiety, depression). A study by French physicians recently published in JAMA Psychiatry, also took into account the fact that injuries are often sustained during psychologically distressing events (car accidents, assaults, falls) and looked for symptoms of post-traumatic stress disorder (PTSD) in those patients.

The authors conducted a study of patients seen at an emergency department for a mild head injury. They checked on these patients for persistent symptoms three months after the concussion. The study included 534 patients with head injury and 827 control patients with non-head injuries.

The study showed that three months after the injury, 21.2 percent of head-injured and 16.3 percent of nonhead-injured patients had post-concussion syndrome, while 8.8 percent of head-injured patients met the criteria for PTSD compared with only 2.2 percent of control patients.

Their conclusion was that it is important to differentiate post-concussion syndrome from PTSD because it has important consequences, in terms of treatment, insurance resource allocation and advice provided to patients and their families. They also stressed the importance of considering PTSD in all patients with mild traumatic brain injury who suffer persistent symptoms.

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Botox is FDA-approved only for chronic migraine headaches, however, it is being used “off-label” for other types of headaches as well. We find that frequent episodic migraines, cluster headaches, numular, and cervicogenic (neck-related) headaches improve with Botox. In our practice, post-traumatic headaches also seem to respond to Botox.

A report by neurologists from Stony Brook University describes five patients suffering from post-traumatic headaches, who responded to Botox. These patients sustained a traumatic brain injury and had suffered from post-traumatic headaches for years, despite trials of various prophylactic medications. After treatment with Botox, all of their five patients had greater than 50% improvement of their disability as measured by the MIDAS (MIgraine Disability Assessment Scale) questionnaire.

This is not a surprising observation because in many patients with a traumatic brain injury headaches have migraine features, suggesting similar underlying mechanisms. People with a family history of migraines who sustain a head injury seem to be more likely to develop post-traumatic headaches than those without such family history, which also suggests a link with migraines. Some patients with post-traumatic headaches and especially those with overt whiplash injury (almost all head injuries, to a varying degree, involve a whiplash neck injury) may respond to Botox because Botox relaxes tight muscles. We no longer think that this is the reason Botox helps migraines because there is evidence that in migraines Botox works by blocking sensory nerve endings rather than by relaxing muscles.

Because of the cost, insurance companies are often unwilling to pay for Botox to treat anything but chronic migraines. However, headaches that begin after a head injury and are accompanied by some migraine features can be correctly classified as post-traumatic chronic migraines, thus avoiding difficulties with the insurance companies.

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