Advisory Panel Vote: Prevnar 13™ (11/17/09)

The Food and Drug Administration (FDA) Vaccines and Related Biological Products advisory committee voted in favor (10 to 1) of data presented to support the safety and effectiveness of Prevnar 13, a 13-valent pneumococcal conjugate candidate vaccine manufactured by Pfizer. The recommendation was based on data from 13 phase III studies carried out on more than 7000 children.¹ Although the FDA is not required to follow the recommendation of the advisory panel, it generally does so.

Prevnar 13 is a new version of the currently available pneumococcal vaccine Prevnar. While Prevnar treats illness such as sepsis, meningitis, and bacterial pneumonia caused by 7 strains of pneumococcal bacteria, the new vaccine is expected to block 13 strains, including the original 7. It is estimated that Prevnar 13 would cover 92% of invasive pneumococcal disease, compared with 81% covered by Prevnar.

Product Approval: Qutenza™ (capsaicin 8% patch) (11/17/09)

The FDA has approved the Qutenza (capsaicin) 8% patch to relieve the pain of postherpetic neuralgia (PHN), a serious complication that can occur after a bout with shingles.² Qutenza contains capsaicin, a compound found in chili peppers, and is the first pure, concentrated, synthetic capsaicin-containing prescription drug to undergo FDA review.

Shingles is an outbreak of rash or blisters on the skin that is caused by the varicella-zoster virus. PHN is a condition affecting nerve fibers and the skin that can cause excruciating pain for weeks, months, or even years. Approximately 10% to 15% of patients who have shingles experience PHN, and the complication is even more common in elderly patients.

Qutenza must be applied to the skin by a healthcare professional since placement of the patch can be quite painful, requiring use of a local topical anesthetic, as well as additional pain relief. The patient must also be monitored for at least 1 hour since there is a risk of a significant rise in blood pressure following patch placement.

Information for Healthcare Professionals (11/13/09)

The FDA has reviewed 35 reports of chondrolysis (necrosis and destruction of cartilage) in patients given continuous intraarticular infusions of local anesthetics (bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, and ropivacaine) with elastomeric infusion devices to control postsurgical pain. The significance of this injury to otherwise healthy young adults warrants notification to healthcare professionals.³

The local anesthetics (with and without epinephrine) were infused for 48 to 72 hours directly into the intraarticular space using an elastomeric pump; chondrolysis was diagnosed within a median of 8.5 months after the infusion. Almost all of the reported cases (97%) occurred following shoulder surgeries. Joint pain, stiffness, and loss of motion were reported as early as the second month after receiving the infusion. In more than half of these reports, the patients required additional surgery, including arthroscopy or arthroplasty (joint replacement).

The approved drug labels for local anesthetics do not include an indication for continuous intraarticular postoperative infusions or use of infusion devices such as the elastomeric pumps. The FDA has not approved any infusion devices for use in intraarticular infusion of local anesthetics and is requiring the drug manufacturers to update their product labels to warn healthcare professionals about this potential serious adverse effect. In addition, the FDA will require the manufacturers of all pumps that might be used to infuse local anesthetics—including elastomeric pumps—to include similar warnings.

Product Recall: Synthes USA (11/12/09)

Synthes USA (Westchester, PA) has recalled all lots of a device used to replace collapsed, damaged, or unstable vertebral bodies in the spine. The Class I recall affects 11 sizes of the device, called the Ti Synex II Vertebral Body Replacement, ranging from 14-19 to 97-123 mm. They are used in the T1 to L5 region of the spine, typically in patients with spinal tumors or fractures.⁴ Devices distributed from July 2, 2007, through September 8, 2009, are prone to failure of the central body component, resulting in loss of device height, the FDA reported. When this occurs, patients may suffer nerve injury, increased pain, spinal compression fracture, or failure of additional fixation, according to the FDA. Some patients may need additional surgeries to correct these problems and/or to modify the implanted device.

The FDA recommends that hospitals and surgeons should stop implanting the devices immediately. Doctors with questions may contact the company at: (800) 620-7025, extension 5375, week days from 8:30 AM to 4:30 PM EST or by e-mail at complaintunit@synthes.com.

1. Food and Drug Administration (FDA) [website]. Center for Biologics Evaluation and Research (CBER). Vaccines and Related Biological Products Advisory Committee, November 18, 2009: FDA Briefing Document. 2009. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM190734.pdf. Accessed November 24, 2009.
   
2. Food and Drug Administration (FDA) [website]. Highlights of Prescribing Information. Revised November 2009. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022395lbl.pdf. Accessed November 24, 2009.
   
3. Food and Drug Administration (FDA) [website]. Drugs. Information for Healthcare Professionals – Chondrolysis Reported with Continuously Infused Local Anesthetics (marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine). November 13, 2009. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm190302.htm. Accessed November 24, 2009.
   
4. Food and Drug Administration (FDA) [website]. Safety. Synthes USA, Ti Synex II Vertebral Body Replacement – Class I Recall. November 12, 2009. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190330.htm. Accessed November 24, 2009.