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pravastatin FDA Alerts

The FDA Alert(s) below may be specifically about pravastatin or relate to a group or class of drugs which include pravastatin.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for pravastatin

Pravastatin Sodium Tablets by International Laboratories: Recall - Mislabeling

Aug 10, 2017

Audience: Pharmacy, Patient

ISSUE: International Laboratories, LLC is voluntarily recalling one (1) Lot of Pravastatin Sodium Tablets USP 40 mg packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg tablets. The affected product is NDC# 54458-925-16; Lot# 115698A

This lot of Pravastatin Sodium Tablets USP 40 mg was recalled when International Laboratories, LLC was informed by a pharmacist that one 30ct bottle of this product was mislabeled and contained Bupropion Hydrochloride XL 300 mg tablets.

If a subject mistakenly takes bupropion, common side effects include: nausea, vomiting, dry mouth, headache, constipation, sweating, sore throat, diarrhea, dizziness, restlessness, blurry vision. These are typically minor and reversible issues. However, individuals with epilepsy are at higher risk of seizure on bupropion due to it lowering the seizure threshold. Also, people on MAOIs can have a risky drug interaction with bupropion (hypertensive crisis). Finally, allergic reactions are also possible and could be life threatening.

BACKGROUND: Pravastatin Sodium Tablets USP 40 mg are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate. It is used to treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy.

Bupropion hydrochloride extended-release tablets (XL) 300 mg are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD) in children, adolescents, young adults and adults.

RECOMMENDATION: International Laboratories, LLC is notifying its distributors and customer by letter and is arranging for return of all recalled products.  Consumers who have purchased this product should not open the package or use the contents. Instead, they should return the product to the location of purchase for a full refund, or call a Customer Complaint phone number at International Laboratories, LLC 727-322-7146 (Monday – Friday 8 AM – 5 PM EST).

Consumers with questions regarding this recall can contact International Laboratories, LLC by phone 727-322-7146 or e-mail address sutka.veselinovic@internationallabs.com on Monday - Friday 8AM – 5PM EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

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:

[08/09/2017 - Press Release - International Laboratories]

Statin Drugs - Drug Safety Communication: Class Labeling Change

Feb 28, 2012

Audience: Cardiology, Family Practice, Patients

ISSUE: FDA has approved important safety label changes for the class of cholesterol-lowering drugs known as statins. The changes include removal of routine monitoring of liver enzymes from drug labels. Information about the potential for generally non-serious and reversible cognitive side effects and reports of increased blood sugar and glycosylated hemoglobin (HbA1c) levels has been added to the statin labels.

The lovastatin label has been extensively updated with new contraindications and dose limitations when it is taken with certain medicines that can increase the risk for muscle injury.

Read the FDA Drug Safety Communication for more information.

 

BACKGROUND: Statins are a class of prescription drugs used together with diet and exercise to reduce blood levels of low-density lipoprotein (LDL) cholesterol (“bad cholesterol”). Marketed as single-ingredient products, including Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin). Also marketed as combination products, including Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release),and Vytorin (simvastatin/ezetimibe).

RECOMMENDATION: Healthcare professionals should perform liver enzyme tests before initiating statin therapy in patients and as clinically indicated thereafter. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment, therapy should be interrupted. If an alternate etiology is not found, the statin should not be restarted.

Healthcare professionals should follow the recommendations in the lovastatin label regarding drugs that may increase the risk of myopathy/rhabdomyolysis when used with lovastatin.

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: www.accessdata.fda.gov/scripts/medwatch/index.cfm
  • Download form or 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


[02/28/2012 - Drug Safety Communication - FDA]
[02/28/2012 - Consumer Update - FDA]

Statin drugs and amyotrophic lateral sclerosis (ALS)

Sep 30, 2008

Audience: Neurologists, cardiologists, consumers

[Posted 09/30/2008] An FDA analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The FDA analysis, undertaken after the agency received a higher than expected number of reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo.

The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use. Results from this study should be available within 6-9 months. FDA is also examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins.

Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins.

[September 29, 2008 - News Release - FDA]

More pravastatin Resources