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.

Speak to a Drug Lawsuit Lawyer & Attorney

If you've been injured by a dangerous drug or medical device, contact our law firm and tell us what happened. Talking to one of our lawyers is completely free, has no obligaton, is held in the strictest of confidence and will help you get answers to important questions. We collect facts about your potential case and will explain what you need to do to protect your rights. Talk to our drug attorneys now and learn what legal options are available to you and your family.

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Recent FDA Reports

FDA IVC Filter News

Almost since it became known that IVC filters designed to fight blood clots could instead cause serious injuries to patients, FDA news of IVC filters has arisen. Indeed, such FDA warnings and reports about IVC filter defects and side effects has been common for several years. History of IVC Filters and the FDA First, you…

Essure FDA Investigation

What is a clear sign that Essure birth control devices are defective? The U.S. Food and Drug Administration is launching a probe of the contraceptive device. This Essure FDA investigation began in mid-April of 2015 and also concerns alleged deceit by Essure manufacturer Bayer Healthcare Pharmaceuticals Inc. A petition which was filed on behalf of…

Uterine Leiomyosarcoma from Morcellator Device

Unforeseen Cancer Development After Morcellation Financial compensation may be available to females who have been diagnosed with uterine leiomyosarcoma following a laparoscopic hysterectomy or uterine fibroid removal surgery.  To qualify, the female must have undergone a surgery in which the procedure included the use of a morcellator, a power device used to cut the uterine…

Johnson and Johnson (J&J) Morcellator Recall

 Morcellators Recalled by Manufacturer Johnson and Johnson (J&J) A morcellator is a laparoscopic power device used in fibroid and hysterectomy surgeries. Laparoscopic surgeries are an innovative way to remove tissue or cells out of the body without having to perform the procedure by entering abdominally or vaginally.  During a laparoscopic hysterectomy, a mechanical morcellator is…

Johnson & Johnson’s Morcellator a Hysterectomy Device and Cancer

J & J Power Morcellator Spreading Unobserved Cancers The Willis Law Firm is investigating cases of women who underwent a laparoscopic hysterectomy and have been diagnosed with cancer following their doctor’s use of a morcellator.  A morcellator is a high-powered medical device used to cut and remove uterine fibroids.  The rotating blades grind the uterus…

Long-Term Side Effects of Benicar

Serious Side Effects of Benicar As Benicar is being investigated and safety warnings have been issues by the Food and Drug Administration (FDA), individuals are seeing lasting consequences of the detrimental side effects that were not properly warned of when the drug was placed on the market.  Benicar, a hyperextension drug taken to regulate and…

Risperdal Side Effects in Men

Lawsuits have recently been filed against the pharmaceutical giant, Johnson & Johnson, for manufacturing a prescription drug named Risperidone.  The shelf name of this drug is Risperdal.  In 1993, the Food and Drug Administration (FDA) approved this drug as a treatment for autism, schizophrenia and mania.  Risperdal was designed to alter certain hormones and substances…

FDA WARNING Concerning Laparoscopic Hysterectomy Device

FDA Wants Cancer Warning on J& J’s Morcellators Women around the nation are developing cancer after doctors performing a laparoscopic hysterectomy used a morcellator manufactured by Johnson & Johnson (J&J).  A morcellator is a power devised used to cut up the uterus and surrounding tissue and cells to make removal less complicated. When this type of…

Dangerous Side Effects of Benicar

FDA Warns of Benicar Diarrhea Side Effects Benicar is a drug used to monitor and reduce hypertension, or high blood pressure (HBP).  Common side effects of Benicar that are listed on the label include: back pain, headaches, dizziness and bronchitis, flu-like symptoms and hematuria.  All drugs approved by the Food and Drug Administration (FDA) are required…

Zofran Birth Defects Lawsuit

Zofran Birth Defects Due to Zofran During Pregnancy Zoftran, an anti-nausea drug and vomiting for chemotherapy and surgery patients. Zofran is also prescribed to women for pregnancy complication of morning sickness. The Zofran for pregnancy side effects has been linked to a thirty (30) percent increase risk of congenital birth defects and a more than 2 x…