The American Academy of Pain Medicine

Latest News for March 2008

FDA Alerts Healthcare Professionals that Severe Pain can occur with Bisphosphonate Drugs

The FDA is alerting healthcare professionals that severe bone, joint, or muscle pain can occur in patients taking bisphosphonate drugs such as Fosamax (alendronate sodium), Actonel (risedronate sodium), Reclast (zoledronic acid) and Boniva (ibandronate sodium). These drugs are used to treat osteoporosis and certain other diseases.

This severe, sometimes incapacitating musculoskeletal pain has occurred within days, months, or even years after starting bisphosphonates. In the most serious cases, the pain was so severe that patients could not continue their normal activities. Some patients have complete relief of symptoms after they stop taking the drug, while others have reported slow or incomplete resolution. These symptoms may occur after the initial dose.  Warnings of these pain symptoms are included in the package inserts for the bisphosphonates, but are often overlooked.
 
For more information, see the following FDA website: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Bisphosphonates

FDA Recalls Potentially Defective Fentanyl Patches

Potentially defective fentanyl patches have been recalled according to the FDA:
Actavis Inc. announced a nationwide recall of certain lots of Fentanyl transdermal system CII Patches sold in the United States and labelled with an Abrika or Actavis label. The product may have a fold-over defect which can cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. The lots covered by this recall include doses of 25, 50, 75, and 100 mcg/hr.
 
The lots covered by this recall are: 27261 (exp 05/09), 27317 (exp 05/09), 27318 (exp 06/09), 27319 (exp 06/09), 27391 (exp 06/09), 27409 (exp 06/09), 27475 (exp 07/09), 27476 (exp 06/09), 27488 (exp 06/09), 27514 (exp 07/09), 27536 (exp 07/09), 27537 (exp 08/09), 27538 (exp 08/09), 27545 (exp 07/09), covering the following strengths: 25 mcg/hr, 50 mcg/hr, 75 mcg/hr and 100 mcg/hr.

Please note: Actavis South Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc. The pouches containing the patches are labelled with an Abrika Pharmaceuticals label, but the outer carton bears the Actavis logo with the following product names:

Actavis Fentanyl Transdermal System, 25 mcg/hr. NDC 67767-120-18.
Actavis Fentanyl Transdermal System, 50 mcg/hr. NDC 67767-121-18.
Actavis Fentanyl Transdermal System, 75 mcg/hr. NDC 67767-122-18.
Actavis Fentanyl Transdermal System, 100 mcg/hr. NDC 67767-123-18.

Anyone who has fentanyl patches labelled with an Abrika or Actavis label should check them for these lot numbers.

Affected patches should not be handled directly.

Anyone with Actavis Fentanyl transdermal system patches with the above listed lot numbers should call 1 877-422-7452

Latest News for February 2008

FDA Recalls Certain Medtronic SynchroMed EL Implantable Infusion Pumps

FDA issued a Class I Recall of Medtronic Inc, SynchroMed EL Implantable Infusion Pump Models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. The models were recalled because there is a potential pump motor stall issue that affects SynchroMed EL infusion pumps with motors manufactured before September 1999. If a pump motor stalls, drug delivery will stop suddenly and without warning, potentially triggering drug withdrawal and severe pain. Pain Specialists implanting these devices should contact the manufacturer. For additional information, please see the following link:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#SynchroMed

FDA Issues Warning about Varenicline (Chantix)

On Feb.1st, the FDA issued a health professionals alert on the Pfizer tobacco smoking cessation aide, varenicline (Chantix). Chantix was approved in September of 2006. Varenicline (Chantix) is a partial agonist for the nicotine receptor. In November of 2007, an initial warning was delivered by the FDA suggesting a possible link with behavioral changes, suicidal ideation and behaviors with varenicline. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. While some patients may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy. For more complete information visit FDA Medwatch:

http://www.fda.gov/cder/drug/InfoSheets/HCP/vareniclineHCP.htm

FDA warns some anti-seizure, psychiatric medications may increase risk of suicidal thoughts, behaviors

CBS Evening News (1/31, story 9, 0:30, Couric) reported that on Thursday, the Food and Drug Administration (FDA)" sent an alert to doctors warning that epilepsy drugs may increase the risk of suicidal thoughts or behavior." The agency's "investigation involved 11 well-known anti-seizure medications," but the FDA "says the risk applies to every epilepsy drug, and it plans to work with manufacturers to add new warning labels."

The Wall Street Journal (2/1, B6, Dooren) reports that the FDA stated on its website that "it looked at nearly 200 clinical studies involving the 11 drugs, and found a doubling of the risk of suicidal thinking or behavior." According to the agency, "patients receiving any of the 11 drugs had approximately twice the risk of suicidal behavior or ideation, or 0.43 percent, compared to 0.22 percent of patients receiving placebo in studies involving about 44,000 patients." Furthermore, the increase in risk "was observed as early as one week after starting an anti-epileptic drug, and continued through 24 weeks."

According to the New York Times (2/1, A22, Harris, Carey), the "medications are primarily used to help epileptics control seizures," as well as "to calm the surges in energy and mood that, along with bouts of depression, characterize bipolar disorder." Several of the drugs (for example, Topamax [topiramate] and Neurontin [gabapentin]) "are sometimes prescribed for chronic pain and headaches, as well."

In the On Deadline blog in USA Today (1/31), Michael Winter wrote that the studies reviewed by the FDA " tracked almost 28,000 people who took the medications." After comparing the medication group against "16,000 others who took placebos," the agencyfound that among people taking the drugs, four "committed suicide," whereas no one in the placebo groups did.

The FDA " said it expected the risk was shared by all anti-epileptic drugs," Reuters (2/1) adds. The FDA further stated that "changes to the drugs' prescribing instructions would be applied broadly throughout the class."

The AP (2/1) points out that anticonvulsant " drugs are used for a variety of illnesses in addition to epilepsy, including migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder, that themselves carry a risk of suicide." While the agency " found drug-treated patients were at increased risk no matter their diagnosis," the suicide risk " was highest for epilepsy sufferers."

According to HealthDay (2/1, Reinberg), the medications cited in the FDA warning include "carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR), felbamate (marketed as Felbatol), gabapentin (marketed as Neurontin), lamotrigine (marketed as Lamictal), levetiracetam (marketed as Keppra), oxcarbazepine (marketed as Trileptal), pregabalin (marketed as Lyrica), tiagabine (marketed as Gabitril), topiramate (marketed as Topamax), valproate (marketed as Depakote, Depakote ER, Depakene, Depacon), and zonisamide (marketed as Zonegran)." Many of these drugs also have generic versions.

MedPage Today (2/1, Peck) add that the FDA "said it has not established a causal relationship between the antiepileptics" and the increased risk of suicide, nor is the agency " advising healthcare professionals to discontinue prescribing these products."

The Doctor's Guide (2/1) urges " [h]ealthcare professionals" to " closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts, or behavior, or depression." WebMD (2/1, DeNoon) also covers the story.