Simvastatin 80mg Label Change
Following is information regarding label changes to Simvastatin 80mg. If you are currently on
Simvastatin 80mg, DO NOT STOP TAKING YOUR MEDICATION without speaking to your physician first.
On 6/9/11 the FDA notified healthcare professionals that it is recommending limiting the use of
the highest approved dose of the cholesterol-lowering medication simvastatin (80 mg) because of
increased risk of muscle damage also known as myopathy.
Simvastatin 80 mg should be used only in patients who have been taking this dose for 12 months
or more without evidence of muscle injury (myopathy). Simvastatin 80 mg should not be started in
new patients, including patients already taking lower doses of the drug.
Additional Information for Patients
Patients currently taking 80-mg simvastatin-containing medicines should:
- Not stop taking their medicine unless told to by their healthcare professional.
- Review their medical history with their healthcare professional, the currently prescribed
dose of simvastatin, and a list of their other current medications to determine if the medicines
they are taking are appropriate.
- Immediately contact their healthcare professional if they experience muscle pain, tenderness
or weakness, dark or red colored urine, or unexplained tiredness.
- Talk to their healthcare professional about any questions or concerns they have about
simvastatin-containing medicines.
- Report side effects from the use of simvastatin-containing medicines to the FDA MedWatch
program using the following contact information:
Metoclopramide Injection and Ondansetron Injection by Hospira: Recall - Glass Strand Particulates Caused By Glass Supplier
Hospira, Inc. announced it initiated a voluntary nationwide recall of one lot of Metoclopramide Injection, USP, 10 mg/2 mL (5 mg/mL) and two lots of Ondansetron Injection, USP, 4 mg/2 mL, (2 mg/mL). This action is due to a confirmed vial defect where glass particulate matter (glass strands) were identified as being affixed to the inside of the vial walls. There is potential for the glass particulates to dislodge into the solution. To date, Hospira has not received reports of any adverse events associated with this issue for these lots
BACKGROUND:
Metoclopramide Injection, USP, 10 mg/2 mL (5 mg/mL), NDC 0409-3414-01, Lot 28-104-DK (the lot number may be followed by a 01), is packaged in a 2 mL single-dose flip-top vial, with an expiration date of October 1, 2014. Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), NDC 0409-4755-03, Lots 29-484-DK and 29-510-DK (the lot numbers may be followed by a 01) are packaged in a 2 mL single-dose flip-top vial, with an expiration date of May 1, 2015. Both products are packaged as 25 units per carton/100 units per case in glass flip-top vials. The affected lots were distributed nationwide between June 2013 and September 2013 to wholesalers/distributors, hospitals and pharmacies.
The administration of an injectable with the presence of foreign particulates may potentially result in local inflammation, thrombophlebitis, and/or low-level allergic response. Signs and symptoms could include redness, pain, swelling at the site, fever, shortness of breath, tachycardia, nausea, and vomiting. Additionally, the particulate contaminants could potentially act as an emboli and impede blood flow causing tissue/organ damage, especially in vulnerable patients such as those undergoing surgery, immunosuppressed individuals, infants, children and the elderly, as well as patients with micro or macrovascular disease, such as cardiac and renal disease, who may be more at risk since their vasculature, and end organs, are already compromised.
RECOMMENDATION:
Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-877-497-3125 between the hours of 8am to 5pm ET, Monday through Friday, to arrange for the return of the product. Replacement product from other lots is available.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online at www.fda.go/MedWatch/report.htm
- Call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
If you have any questions or concerns regarding the above information please contact PrimeTime
Health Plan Member Services department at the numbers listed on this page.