Drug Safety

News & Analysis as of

Makena Drug Compounding Lawsuit Against FDA Gets New Life

On January 7, 2014, a three-judge panel of the United States Circuit Court for the District of Columbia unanimously vacated the dismissal of claims against the U.S. Food and Drug Administration (“FDA”) and others by K-V...more

Illegal And Unwise: Latest Synthetic Drugs Not The Spice Of Life

Often mischaracterized as synthetic cannabis, the effects of a newer drug called spice or K2 bears little resemblance to actual marijuana. Spice was first introduced a few years ago as a legal version of marijuana, since the...more

U.S. House Introduces Bill on Federal Oversight of Compounding Pharmacies

On September 12, 2013, U.S. Representative Morgan Griffith (R-Va.) introduced H.R. 3089 ("the House Bill"), which proposes a structure for federal oversight of compounding pharmacies. The House Bill is the latest federal...more

Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2013)

Contraceptives were the subject of the Federal Circuit's recent decision in Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc. But, unfortunately, it's a rather fact-specific case with nothing of prurient...more

Compounding Animal Drugs from Bulk Ingredients

Recent public discussion about the federal role in regulating compounding pharmacies has focused on compounded drugs for human use. Compounded drugs are also vital to companion animal health (like pets). In the world of...more

You Should Know - April 2013

In This Issue: - Ask Congress to Hold Generic Drug Makers Accountable - Ruling May Leave You Vulnerable to Unsafe Generic Drugs - By the Numbers - Bookmark Favorites - What's Your Drug Safety IQ? -...more

Quitting Smoking? How Chantix May or May Not Be Able to Help

Individuals looking to quit smoking may turn to popular smoking-cessation drugs like Chantix (varenicline). Almost everyone has seen the commercials for Chantix, where a handful of people indicate that the drug has helped...more

Beware Of Topamax — It Can Be A Dangerous Drug

Topamax (topiramate) was first approved by the United States Food and Drug Administration (FDA) in 1996 as an anti-convulsant for the treatment of seizures. Topamax was widely used to treat epilepsy in children and adults....more

Filing A Lawsuit For Damages Caused By A Dangerous Drug

Pharmaceutical companies manufacture, test and introduce new drugs regularly. Despite rigorous testing by the drug companies and monitoring by the United States Food & Drug Administration (FDA), lawsuits are an inevitable...more

China Amended Good Supply Practices for Pharmaceuticals

The Chinese Ministry of Health (“MOH”) published the long-awaited amendment of Good Supply Practices for Pharmaceuticals (the “Amended GSP”) on January 22, 2013, to be effective as of June 1, 2013. After three rounds of...more

Zoloft Use During First Trimester of Pregnancy Can Increase Risk of Birth Defects

Use of the selective serotonin reuptake inhibitor (SSRI) antidepressant Zoloft during the first trimester of pregnancy can increase a child’s risk of being born with serious heart defects or other birth defects. ...more

Use of Depakote During Pregnancy Can Lead to Birth Defects

The Food and Drug Administration has warned that women who use the seizure and migraine drug Depakote while pregnant are more likely to give birth to a child with major birth defects than those who use other seizure drugs. ...more

Zoloft Birth Defects Studies

Several leading medical journal have published studies about the risk of birth defects associated with taking antidepressant such as Zoloft during pregnancy. ...more

Zoloft Birth Defects Lawsuit FAQ

Answers to frequently asked questions about birth defects lawsuits filed concerning the antidepressant Zoloft....more

FDA Warns Of Birth Defects Risk with Diflucan

The FDA is warning the public that treatment with chronic, high doses of Diflucan (fluconazole) during the first trimester of pregnancy may be associated with a rare and distinct set of birth defects in infants. Diflucan is...more

Topamax During Pregnancy Increases Risk Of Cleft Lip And/Or Cleft Palate Birth Defects

Topamax During Pregnancy Increases Risk Of Cleft Lip And/Or Cleft Palate Birth Defects Oral Clefts In Babies Are 20 Times More Likely With Women Who Used Topamax (topiramate) After Getting...more

FDA Seeks Information About Topamax-Related Oral Cleft Birth Defect Cases

FDA Seeks Information About Topamax-Related Oral Cleft Birth Defect Cases Request For Historical Incidence Data Made In Connection With NDA For New Obesity...more

Glaxo to Pay $1 Billion to Children with Birth Defects from Mothers who took Paxil

Bloomberg News reported that GlaxoSmithKline P.L.C. has agreed to pay $1 billion to injured consumers to resolve more than 800 cases involving the antidepressant Paxil. The medication has been in use in the U.S. since 1992....more

Fertility Drugs Clomid And Serophene Have Long Been Associated With Birth Defects

Fertility Drugs Clomid And Serophene Have Long Been Associated With Birth Defects Should These Drugs Have Stronger Warning About Increased Risk Of Fetal Abnormality After Clomiphene...more

September 2009 Update On Paxil Lawsuits Alleging Birth Defects

September 2009 Update On Paxil Lawsuits Alleging Birth Defects Reports About Paxil Cases In Boston, Philadelphia, And...more

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