FDA Reports

All prescription drugs that desire to be marketed in the U.S. must gain the approval of the Food and Drug Administration (FDA). Through the Center for Drug Evaluation and Research (CDER), which assures that safe and effective drugs are available to the American people, a prescription drug must pass a series of trials. Please understand that the FDA does not develop, manufacture or test drugs. Drug manufacturers submit full reports of a drug's studies to the CDER so that the Center can evaluate its data. The studies answer the question, "Does this drug work for the proposed use?" By analyzing the data, CDER reviewers assess the benefit-to-risk relationship and determine if the drug will be approved. Once the drug has been placed on the market, the FDA continues to monitor it through post-marketing reports sent in by the manufacturer and through the MedWatch program - an FDA program that allows consumers and health care professionals to report serious side effects, quality control issues, and medical errors associated with drugs and products regulated by the FDA.

Sometimes, an unanticipated side effect manifests itself once the drug has been made available to the U.S. market. If the side effect is serious enough, the FDA may issue a warning to the public and request that changes be made to the drug's label. If the side effect is extremely serious and the FDA decides that the risks of the drug outweigh its benefits, then the FDA may recall the drug.

FDA Recalls
FDA Recalls

Information gathered from press releases and other public notices about recalls of FDA-regulated products.

FDA Warnings
FDA Warnings

This section includes drug marketing and advertising warning letters from the FDA to pharmaceutical companies.

FDA Alerts
FDA Alerts

MedWatch issues alerts from the FDA Safety Information and Adverse Event Reporting Program.



Food and Drug Administration

The FDA mission is to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act and other laws which are designed to protect consumers' health, safety, and pocketbook. Pharmaceutical drugs and medical devices must be safe and effective, radiation-emitting devices must meet established standards, and all products must contain informative and truthful labeling in English.

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Recent FDA Reports

Lexapro Birth Defect Lawsuit

Children born with cardiac and other congenital birth defects have potentially been linked to use of the SSRI class of antidepressant drugs, including Lexapro (Generic: escitalopram). Research suggests serious Lexapro side effects, including the increased risk of congenital heart defects and other congenital birth defects. This link between SSRI antidepressants like Lexapro (escitalopram) and congenital…

Celexa Birth Defect Lawsuit

Children born with cardiac and other congenital birth defects have potentially been linked to use of the SSRI class of antidepressant drugs, including Celexa (Generic: citalopram). Research suggests serious Celexa side effects, including the increased risk of congenital heart defects and other congenital birth defects. This link between Celexa (citalopram) and congenital heart defects has…

Wellbutrin Birth Defect Lawsuit

Children born with cardiac and other congenital birth defects have possibly been linked to use of the anti-depressant drug bupropion (Aplenzin, Wellbutrin, Wellbutrin SR, Wellbutrin XL, Zyban) during pregnancy, based on findings published in the American Journal of Obstetrics & Gynecology. The study found that mothers of infants born with a specific type of congenital…

Actavis Fentanyl Patch Recall

Morristown, NJ – Further to its previously announced voluntary recall of 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches, Actavis is encouraging consumers to return any product in their possession from the October 21, 2010 recall. Consumers with Actavis 25 mcg/h Fentanyl patches may call 1-877-422-7452 (24 hours/day, 7 days/week) for return instructions…

FDA Warning Letter to DePuy Orthopaedics – Hip Implants

Inspections, Compliance, Enforcement, and Criminal Investigations Depuy Orthopaedics, Inc. 8/19/10 Department of Health and Human Services Public Health ServiceFood and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 WARNING LETTER August 19, 2010 David Floyd President DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582 RE: TruMatch™ Personalized Solutions System Corail® Hip System…

LIFEPAK 15 Defibrillator Recall

FDA notified healthcare professionals of a Class I recall of LIFEPAK 15 Monitor/Defibrillator manufactured and distributed between March 26, 2009 and December 15, 2009. There is a potential for the device to unexpectedly: Power Off then On by itself. Power Off then NOT turn On. Power Off by itself requiring the operator to turn it…

FDA: Biogen Misleading Public on Risks of PML from Tysabri

      DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service   Food and Drug Administration Silver Spring, MD 20993   TRANSMITTED BY FACSIMILE March 25, 2010 Nadine D. Cohen Senior Vice President, Regulatory Affairs Biogen Idec, Inc. 14 Cambridge Center Cambridge, MA 02142 RE: BLA #125104 TYSABRI® (natalizumab) injection for intravenous use MACMIS # 18025…

Tysabri Label Update

New safety information will be included in the Tysabri (natalizumab) drug label and patient Medication Guide: The risk of developing progressive multifocal leukoencephalopathy (PML) increases with the number of Tysabri infusions received. PML is a rare brain infection that usually causes death or severe disability. This new safety information is based on reports of 31…

Baby Slings Can Cause Infant Suffocation

The U.S. Consumer Product Safety Commission (CPSC) is advising parents and caregivers to be cautious when using infant slings for babies younger than four months of age. In researching incident reports from the past 20 years, CPSC identified and is investigating at least 14 deaths associated with sling-style infant carriers, including three in 2009. Twelve…

Depakote Spina Bifida Lawsuit

Depakote, a widely used anti-epileptic and anti-seizure drug, is manufactered and marketed by Abbott Laboratories. Depakote was first approved by the US FDA and introduced in the US market in 1983.  Until 1995, Depakote was primarily used to treat the seizures associated with epilepsy.  In 1995 it was approved to treat the manic episodes associated with bi-polar disorder or manic…