When a drug is recalled or removed from the market, we send letters to members affected by the event, advising them to:
- Consult their pharmacy if they're taking a recalled medication
- Speak with their doctor or pharmacist about any medical concerns or to find alternative treatments
- Report any adverse effects to their doctor
Here are the most recent drug recalls and warnings.
GlucoPro® Insulin Syringes: Nipro Medical Corporation voluntarily recalled ALL lots of GlucoPro Insulin Syringes. However, the recall did not include the GlucoPro Syringe specific for use with the Amigo Insulin Pump. The syringes were found to have needles that could detach from the syringe and become stuck in the insulin vial, pushing back into the syringe, or remaining in the skin after an injection.
OneTouch® SureStep® Test Strips: LifeScan voluntarily recalled eight lots of OneTouch SureStep Test Strips because of the possibility that they could provide falsely low test results when blood glucose is greater than 400 mg/dL. If patients use the falsely low test results to determine their insulin dose, they may give themselves too little insulin, which could result in poor blood glucose control. Patients with high blood glucose may or may not have certain symptoms including increased thirst, frequent urination, headaches, difficulty with concentration, blurred vision, and fatigue (weak, tired feeling). High blood glucose must be identified and treated promptly to avoid serious complications, such as coma and death.
Videx®/Videx EC®: The U.S. Food and Drug Administration (FDA) alerted healthcare professionals and patients about a rare, but serious, complication in the liver known as non-cirrhotic portal hypertension in patients using Videx or Videx EC (didanosine). Based on reports submitted to the FDA's Adverse Event Reporting System (AERS), the FDA has revised the didanosine drug label to include information about non-cirrhotic portal hypertension to help ensure the safe use of this drug.
Proton Pump Inhibitors (PPI): In May, the FDA revised the labeling information for all over-the-counter (OTC) and prescription PPIs. The label will include the new safety information under the "Warning and Precautions" section in the prescribing information as well as OTC "Drug Facts" about a possible increased risk of fractures of the hip, wrist, and spine in association with PPI use.
Avandia®: On July 14, 2010, the FDA's Endocrinologic and Metabolic Drugs advisory committee and Drug Safety and Risk Management advisory committee voted to allow Avandia to remain on the market after a two-year investigation which concluded that serious cardiovascular risks are associated with Avandia. The advisory committee's recommendations will be considered by the FDA in the final decision. Until the FDA reaches a decision, Avandia will remain available to patients. The exact date for the FDA decision is unknown.
Avandia and the FDA.
A senate report released earlier this year detailed a two-year investigation on GlaxoSmithKline (GSK)'s Avandia (rosiglitazone). The report concludes serious cardiovascular (CV) risks are associated with Avandia, and criticizes the FDA's role in the drug approval process.
The current FDA process allows members who make drug approval decisions to also be in charge of judging drug safety. Due to conflicts of interest, the investigators recommend establishing a separate, independent pharmacovigilance unit.
Lastly, senators are concerned about the clinical trial, Thiazolidinediones Intervention with Vitamin D Evaluation (TIDE), which compares Avandia with its competitive drug Actos® (pioglitazone). Concerns were raised because FDA documents stated safety officials thought this trial would be "unethical and exploitative" due to the link between Avandia and the risk of heart attack. Despite these conclusions, FDA officials mandated the new study and the clinical trial is still under way.
GSK issued a statement regarding the Senate Committee's conclusions and their report on Avandia. The company states conclusions on Avandia's safety are based on analyses that are not consistent with the scientific evidence supporting the safety of Avandia, and the report "cherry-picked" information from documents that mischaracterizes GSK. Since the FDA addressed questions about Avandia's CV safety, GSK has reported results from seven large, prospective randomized clinical trials, and none of the results showed a statistical significant associated between Avandia and heart attack or other ischemic CV events.
Confidential studies by FDA officials recommend Avandia, used for the treatment of type 2 diabetes, be removed from the market due to its link to heart attacks. However, the FDA announced on September 23 that it would significantly restrict the use of Avandia to patients with Type 2 diabetes who cannot control the condition with other medications.
The FDA can require a drug sponsor to issue a Risk Evaluation and Mitigation Strategy, or REMS, to impose certain restrictions on a drug so that the benefits outweigh its risks. When the REMS for rosiglitazone is implemented, patients will be able to take it only if they are unable to achieve glycemic control using other medications and, in consultation with their healthcare professional, decide not to take pioglitazone for medical reasons. Current users of rosiglitazone will be able to continue using the medication if they benefit from it, understand the cardiovascular safety concerns, and obtain their doctor's consent. The FDA anticipates that the REMS will limit use of rosiglitazone significantly.
Humana Pharmacy Solutions recommendation regarding Avandia
In the meantime, we recommend providers consider switching at-risk patients to another anti-diabetic agent. As always, members are discouraged from discontinuing any therapy without first consulting their physicians.
Humana Pharmacy Solutions' Rx3 and Rx4 plans are open formularies and do not exclude Avandia. For that reason, Humana will move Avandia to Tier 3 and add a step therapy utilization management requirement.
Humana Pharmacy Solutions will continue to monitor all available information surrounding Avandia to determine if action is needed as it relates to formulary or utilization management for these products.
The information contained in this article is for informational purposes only and does not constitute clinical advice.
