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

Paxil and Pregnancy

Back in 2006, the Food and Drug Administration (FDA) announced that research evaluations of the prescription antidepressant Paxil discovered that taking Paxil during pregnancy, specifically during the first three months of pregnancy, may significantly raise the risk of having an infant with birth defects. The most common Paxil birth defects found were congenital (present at…

Pradaxa FDA Alert

In December of 2011, the United States Food and Drug Administration (FDA) released a Safety Announcement regarding recent studies conducted about Pradaxa causing internal bleeding. The Food and Drug Administration (FDA) stated that they were evaluating post-marketing (after sale) reports of severe bleeding events reported in Pradaxa patients. Pradaxa is a popular anticoagulant on the…

Vaginal Mesh Erosion Warning by the FDA

On 7-13-2011, the FDA issued an update to warn of further complications and adverse effects connected to the transvaginal placement of surgical mesh. A previous warning was issued in 2008, but the emergence of new complications in numerous patients necessitated an official update to the original warning. The most up to date FDA warning also…

Bladder Cancer from Actos

Only a week after officials in both France and Germany began restricting the prescriptions of the diabetes drug Actos made by Takeda Pharmaceuticals, the US Food and Drug Administration (FDA) will now require additional warnings that the use of Actos for more than a year might be linked with an increased risk of developing bladder…

Topamax Birth Defect Lawsuit

A new study warning released by the Food and Drug Administration (FDA) states that taking the epilepsy medication Topamax while pregnant increases the risk of oral cleft birth defects like cleft palate and cleft lip. The research uncovers data which suggests that the risk of those oral cleft birth defects when taking Topamax during pregnancy…

Effexor Birth Defect Lawsuit

Children born with cardiac and other serious congenital birth defects have potentially been linked to use of the anti-depressant drug Effexor (venlafaxine). Research suggests serious Effexor side effects, including the increased risk of congenital heart defects and other congenital birth defects including: Coarctation of the Aorta Lawsuit Atrial Septal Defects Lawsuit Ventricular Septal Defects Lawsuit…

FDA Update on Tysabri PML

[04/22/2011] FDA has updated the Tysabri (natalizumab) Prescribing Information to give new information about the size of the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection, associated with use of Tysabri for the treatment of multiple sclerosis (MS) and Crohn’s disease. The update includes new safety information about patients who have…

FDA Alert: Topamax Oral Clefts Risk in Infants

FDA Drug Safety Communication: Risk of Oral Clefts in Children Born to Mothers Taking Topamax (topiramate) The U.S. Food and Drug Administration (FDA) is informing the public of new data that show that there is an increased risk for the development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated…

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…