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Lipitor FDA Alerts

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

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 atorvastatin

Atorvastatin Calcium Tablets by Ranbaxy Inc.: Recall - Presence of Foreign Substance

Nov 28, 2012

Audience: Pharmacy, Patient, Health Professional

ISSUE: On November 9, 2012, Ranbaxy Inc. initiated a voluntary recall of 41 affected lots of Atorvastatin Calcium Tablets (10 mg, 20 mg and 40 mg) which is a solid oral dosage form, to the retail level. The Company is taking this voluntary action as a precautionary measure due to the fact that we cannot exclude the possibility that the affected lots may contain very small glass particles resembling a fine grain of sand (less than 1 mm in size). Because of the size of the particles which may be present in the affected lots it is unlikely to cause a significant safety concern. However, the possibility of adverse experiences arising primarily due to physical irritation cannot be ruled out.

BACKGROUND: The product is used to lower blood cholesterol and is packaged in plastic bottles, as 90 and 500 tablets per bottle. The affected lots of Atorvastatin Calcium Tablets and their respective NDC code, expiration date information can be found in the Firm Press Release. The recall does not affect or relate to the 80 mg dosage strength of Atorvastatin Calcium Tablets.

RECOMMENDATION:  Consumers should immediately 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:

[11/28/2012 - Firm Press Release - Ranbaxy Inc.]

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]

Lipitor (atorvastatin) 40 mg: Recall Specific Bottles

Dec 23, 2010

Audience: Family Practice, Patient, Pharmacy

UPDATED 12/23/2010: Pfizer announced a recall of one lot — 19,000 bottles — of Lipitor 40 mg tablets (atorvastatin calcium) distributed in the U.S. There were three earlier recalls of Lipitor, implemented in August, October and November of 2010, in response to complaints of uncharacteristic odor. The odor is consistent with the presence of 2, 4, 6 tribromoanisole (TBA), found at a very low level during the investigation leading to the first product recall. Research indicates that a major source of TBA appears to be 2, 4, 6-tribromonophenol (TBP), a chemical used as a wood preservative.

 

[Posted 10/10/2010]

ISSUE: Pfizer recalled specific bottles of Lipitor (40 mg only) due to a small number of reports of an uncharacteristic odor related to the bottles in which Lipitor is packaged.

BACKGROUND: A medical assessment has determined that the odor is not likely to cause adverse health consequences in patients taking Lipitor.

RECOMMENDATION: If you take Lipitor 40 mg and experience an uncharacteristic odor associated with your medication, please return the tablets to your pharmacist. If you have any concerns, call your doctor or pharmacist or call 1-888-LIPITOR (1-888-547-4867) if you need any further information.

[12/22/2010 - Press Release - Pfizer]
[10/09/2010 – Firm Public Notice – FDA]

    

Lipitor (atorvastatin) 40 mg: Recall specific bottles

Oct 10, 2010

Audience: Family Practice, Patient, Pharmacy

ISSUE: Pfizer recalled specific bottles of Lipitor (40 mg only) due to a small number of reports of an uncharacteristic odor related to the bottles in which Lipitor is packaged.

BACKGROUND: A medical assessment has determined that the odor is not likely to cause adverse health consequences in patients taking Lipitor.

RECOMMENDATION: If you take Lipitor 40 mg and experience an uncharacteristic odor associated with your medication, please return the tablets to your pharmacist. If you have any concerns, call your doctor or pharmacist or call 1-888-LIPITOR (1-888-547-4867) if you need any further information.

[10/09/2010 – Firm Public Notice – 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]

Counterfeit "Lipitor" Sold in the United Kingdom

Aug 2, 2005

Audience: Consumers and healthcare professionals

[Posted 08/02/2005] FDA alerted U.S. residents to the recent recall of a batch of counterfeit "Lipitor" (atorvastatin) sold in the United Kingdom (U.K.). The medicine is used to treat high cholesterol. The counterfeit Lipitor 20mg tablets were recalled in the U.K. on July 28, 2005.  Health authorities in the U.K. stated that initial results of tests performed on the counterfeit drugs do not indicate that this product poses an immediate risk to patients. Some U.S. residents may have obtained prescription drugs from the U.K. through on-line or storefront operations that do not supply legitimate, FDA-approved products, or through state-run drug importation programs that facilitate the purchase of unapproved foreign drugs. Consumers who purchase drugs through these arrangements may have received these counterfeit products. U.S. patients who have the identified U.K. drugs should stop using them and should consult their physician or pharmacist if they have any questions or concerns.

Counterfeit Drugs Purchased in Mexico

May 11, 2005

Audience: Healthcare professionals and consumers

The FDA warned the public about the sale of counterfeit versions of Lipitor, Viagra, and an unapproved product promoted as "generic Evista" to U.S. consumers at pharmacies in Mexican border towns. The "generic Evista" was analyzed by FDA in coordination with the National Association of Boards of Pharmacy and was found to contain no active ingredient. The counterfeit Lipitor and counterfeit Viagra were analyzed by Pfizer, Inc. and were also found to contain no active ingredient. Consumers who have any of these counterfeit products should not use them and should contact their healthcare provider immediately.

[May 10, 2005 - Talk Paper - FDA]

Lipitor (atorvastatin)

May 29, 2003

Audience: Pharmacists and consumers

(May 23, 2003) FDA announced that Albers Medical Distributors, Inc voluntary recalled 3 lots of 10 mg 90-count bottles of the cholesterol-lowering drug Lipitor and is warning healthcare providers and others that these three lots of counterfeit Lipitor represent a potentially significant risk to consumers. FDA's investigation into this matter is continuing.

(June 9, 2003) Albers expanded their original voluntary recall to include all lots of Lipitor that Albers purchased, which were packaged by Med-Pro.

[UPDATE June 9, 2003 - Press Release - Albers Medical Distributors, Inc.] PDF Format
[UPDATE June 3, 2003 - Talk Paper - FDA]

[May 23, 2003 Talk Paper - FDA]
[May 22, 2003 Press Release - Albers Medical Distributors, Inc.]

More Lipitor Resources