In a Drug Safety Communication posted today, the FDA warns that "injection of corticosterioids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death."  The injections in question (methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone) are given to treat neck, back, arm, and leg pain.  The FDA has not approved corticosteroids for this use.  The FDA is requiring an additional Warning to the drug labels of injectable corticosteroids to describe these risks.  
[1] FDA Drug Safety Communication "Epidural Corticosteroid Injection: Drug Safety Communication - Risk of Rare But Serious Neurologic Problems", April 23, 2014.

Yesterday, the FDA  approved Evzio, the first naloxone product that is given with an easy-to-use auto-injector, without having to use a separate needle and syringe.  This new combination drug/device will allow anyone (e.g. a family member, friend, responding police officer) to inject the life-saving drug into a person who has overdosed on opioids.  In addition to coming in a more convenient form, Evzio also gives recorded instructions to the user describing how to deliver the medication.  

Opioids include prescription drugs such as OxyContin (oxycodone) and Vicodin (hydrocodone with acetaminophen) as well as illegal drugs such as heroin.  Every year more than 16,000 people die from opioid overdoses.  Naloxone temporarily reverses the life-threatening  slow breathing caused by opioid overdoses and has been the standard treatment for overdoses.  However, because using a syringe to draw naloxone up from a vial requires special training, the vial form was only available to specially trained emergency personnel.  

By making the drug more widely available in the easy-to-use auto-injector, the drug can be more rapidly administered by anyone.  Although the patient still needs immediate medical care (naloxone only temporarily reverse the effects of overdose), it is expected that the extra time gained by the more immediate administration of Evzio will save thousands of lives.

[1] FDA approves new hand-held auto-injector to reverse overdose (April 3, 2014).
[2] FDA Commissioner Margaret A. Hamburg Statement on Opioid Abuse.
[3] Throckmorton, Douglas "Opioid Auto-Injector Can Help Prevent Overdose Deaths," FDA Voice (April 3, 2014).

The FDA has approved Topamax (topiramate) for prevention of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The medication is taken daily basis to reduce the frequency of migraine headaches.
 
Topamax is manufactured by Janssen Pharmaceuticals and was first approved by the FDA in 1996 to prevent seizures. It was approved for migraine prevention in adults in 2004.  The safety and effectiveness of Topamax in preventing migraine headaches in adolescents ages 12 to 17 was established in a clinical trial that enrolled 103 participants. Those treated with Topamax experienced a decrease in the frequency of migraine of approximately 72 percent compared to 44 percent in participants that took an inactive drug (placebo).  
 
The most common adverse reactions with the approved dose of Topamax (100 milligrams) were paresthesia (a burning or prickling sensation felt in the hands, arms, legs, or feet), upper respiratory infection, anorexia (loss of appetite), and abdominal pain. However, Topamax and all anti-epileptic drugs may increase the risk of suicidal thoughts and behavior, and patients should be advised of the need to be alert for the emergence of, or worsening of, the signs and symptoms of depression, or unusual changes in mood or behavior.
 
Additionally, Topamax has been shown to  increase the risk of the development of cleft lip and/or cleft palate (oral clefts) in infants born to women who take the drug during pregnancy. If a woman of childbearing age uses Topamax, effective birth control should be used.


[1] FDA News Release "FDA approves Topamax for migraine prevention in adolescents," March 28, 2014.
[2] FDA Drug Safety Communication: Risk of oral clefts in children born to mothers taking Topamax (topiramate) (03/04/2011).
 

The FDA has approved Xartemis XR extended release tablets for the management of acute pain severe enough that it requires opioid treatment.  Xartemis XR is a strong prescription pain medicine that contains the opioid (narcotic) oxycodone and the medicine acetaminophen.
[1] FDA New and Generic Drug Approvals (March 11, 2014).
[2] "Mallinckrodt receives FDA approval for Xartemis XR", DrugStoreNews (March 18, 2014).

The FDA has issued a Class I recall for Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps.  The pumps are used to treat primary or metazoic cancer, chronic pain, and severe spasticity by delivering prescribed drugs to a specific site in the body.  Flaws in the pump may lead to too much or too little medication being delivered.  Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.  


Fourteen patients have died since 1996 while using the SynchroMed System.  Eleven patients died due to inadvertent injection of a drug into their subcutaneous tissue instead of into the pump.  Two patients died from a blockage and one died from an electrical short.  Patients may also been harmed by the dilution or extra delivery of medication.

[1] FDA Recall "Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps - Feed Through Failure" (June 3, 2013).
[2] Cortez, M. "Medtronic Recalls Infusion Pump Linked to 14 Deaths," Bloomberg News (June 27, 2013).