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Multiple Sclerosis Drug Gilenya Can Cause Rare Brain Infection, FDA Warns

Filed August 7th, 2015 F.A. Kelley

Multiple Sclerosis Drug Gilenya Can Cause Brain Infection

Multiple Sclerosis Drug Gilenya Can Cause Brain Infection


Two cases of a rare but serious brain infection have resulted in a new Food and Drug Administration (FDA) warning on the label for the multiple sclerosis drug Gilenya.

The agency has received reports of one definite case and one probable case of progressive multifocal leukoencephalopathy (PML) in patients taking Gilenya (fingolimod) for multiple sclerosis (MS). These cases are significant because they are the first reported PML cases in patients taking Gilenya who had not been previously treated with an immunosuppressant drug. Information about these cases is being added to the drug label. Approximately 54,000 patients received Gilenya prescriptions from September 2010, when the rug was approved, through July 2015. Continue Reading »

Indiana Woman Suffers Violent Reaction to Tylenol

Filed July 28th, 2015 Julie

Indiana Woman Suffers Violent Reaction to Tylenol

Indiana Woman Suffers Violent Reaction to Tylenol


An Indiana woman who took Tylenol to treat mild symptoms of malaise is now at Vanderbilt University Medical Center in Nashville, Tennessee, fighting to save her eyesight and recovering from severe burns after experiencing a rare reaction to the drug, known as Stevens-Johnson syndrome (SJS).

Donna Emley was vacationing near Bowling Green, Kentucky, when she started to feel sick. She took a couple of Tylenol, like millions of people do every day in this country, and tried to get some sleep. Now, the Fort Wayne, Indiana, business-owner has burns over 40 percent of her body, due to Stevens-Johnson syndrome, according to CBS46 in Atlanta, Georgia. The drug reaction can be caused by virtually any drug, but is most commonly linked to anticonvulsants, antibiotics like penicillin and sulfonamides, and common anti-inflammatory drugs such as aspirin, naproxen and ibuprofen. Continue Reading »

Viagra, Other ED Drugs Linked to Higher Risk of Melanoma in New Study

Filed July 21st, 2015 Lillian Chiu

Viagra, Other ED Drugs Linked to Higher Risk of Melanoma

Viagra, Other ED Drugs Linked to Higher Risk of Melanoma


A new study published in the Journal of the American Medical Association (JAMA) shows that phosphodiesterase type 5 (PDE5) inhibitors, which include erectile dysfunction drugs such as Viagra, Cialis and Levitra, are associated with “a modest but statistically significant increased risk of malignant melanoma.”

This is not the first time Viagra and other similar drugs have been linked to an increased risk of melanoma. In fact, the authors noted in the abstract that “The target for the oral erectile dysfunction drugs, phosphodiesterase type 5 (PDE5) inhibitors, is part of a pathway implicated in the development of malignant melanoma. An increased risk of melanoma in sildenafil users was recently reported.” JAMA published a study last June indicating that Viagra was associated with an 84 percent increased risk of melanoma. Researchers analyzed data from 25,000 men in the healthcare industry over a 10 year period. The study was correlational, meaning it does not prove a cause-and-effect relationship. Dermatologist Dr. Brian Horvath commented that “It may be that people who take Viagra are more likely to be out in the sun or more active in some way,” according to CBS Miami. “The problem with that idea, though, is that the other types of skin cancer risks were not increased. So if was just sun exposure, you’d expect all skin cancers would increase. In this situation, just the melanoma risk was increased.” Continue Reading »

The Antidepressant Drugs Prozac and Paxil May Cause Birth Defects

Filed July 15th, 2015 Julie

Antidepressant Drugs Prozac & Paxil May Cause Birth Defects

Antidepressant Drugs Prozac & Paxil May Cause Birth Defects

The antidepressant drugs Prozac and Paxil may cause serious birth defects, according to a new study by the U.S. Centers for Disease Control and Prevention (CDC).

For the study, CDC researchers analyzed federal data on more than 38,000 women who gave birth between 1997 and 2009. Scientists looked at the number of birth defects among babies and asked women whether they took any antidepressants in the month before getting pregnant or during the first three months. The team found an association between fluoxetine (Prozac) and heart wall defects and irregular skull shape. Paroxetine (Paxil) was associated with heart defects, abdominal wall defects, and missing brain and skull defects, according to NPR.org. Continue Reading »

FDA is Updating Safety Information Included in Prescription and Over-the-Counter NSAID Drugs

Filed July 14th, 2015 Julie

 FDA is Updating Information in Prescription & OTC NSAID

FDA is Updating Information in Prescription & OTC NSAID

On July 9, the U.S. Food and Drug Administration (FDA) said in a Safety Alert posted on its website that the agency is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the risk of a heart attack or stroke.

The FDA said the alert was in response to the agency’s comprehensive review of new safety information. Both prescription and over-the-counter (OTC) NSAID drugs already contain information on heart attack and stroke risk, but the agency will request updates to the OTC non-aspirin NSAID Drug Fact labels. The updated prescription NSAID safety warning labels will reflect the following new information: Continue Reading »

FDA Orders Companies to Stop Making and Distributing Unapproved Ear Drops

Filed July 7th, 2015 Julie

FDA Orders Companies to Stop Making Unapproved Ear Drops

FDA Orders Companies to Stop Making Unapproved Ear Drops


On July 1, the U.S. Food and Drug Administration (FDA) announced the agency will take action against companies that manufacture and/or sell unapproved prescription ear drop products (otis products) because they contain ingredients that have not been evaluated by federal health officials.

In a press release posted to the FDA website, the agency said the affected otis products contain benzocaine and hydrocortisone, and that the government has not evaluated either drug for safety, effectiveness or quality. The labels do not disclose that they lack FDA approval and health care professionals may not be aware of their unapproved status. Continue Reading »

The FDA Says it Will Evaluate the Risk of Serious Side Effects in Codeine-Containing Medicines in Children

Filed July 6th, 2015 Julie

The FDA Says it Will Evaluate the Risk of Codeine Use

The FDA Says it Will Evaluate the Risk of Codeine Use


The U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication last week informing family doctors, pediatricians, surgeons and patients that the agency is evaluating the potential risk of serious side effects in codeine-containing medicines in children under 18.

The FDA said it is investigating the safety of the drugs, which are used to treat coughs and colds in children under 18, because of the potential for serious side effects including slowed or difficult breathing. Children may be more susceptible to serious side effects, especially those who already have breathing problems, the agency said. Continue Reading »

When the FDA Declines to Approve a New Drug, the Public Rarely Finds Out Why

Filed June 15th, 2015 Julie

When the FDA Declines Drug, the Public Rarely Finds Out Why

When the FDA Declines Drug, the Public Rarely Finds Out Why


It is not uncommon for the U.S. Food and Drug Administration (FDA) to decline to approve a drug. What is uncommon, however, is for a drug company to tell the public why their product was rejected.

Forbes reported last week that the FDA declined to approve a new drug seven times between August 11, 2008 and June 27, 2013 because patients were more likely to die when taking the drug than in a control group. Only one of the drug makers informed investors and the public about the finding. Continue Reading »

Minnesota Girl, 12, Awarded $23 Million in Punitive Damages for Birth Defects Caused by Depakote

Filed June 8th, 2015 Julie

 Minnesota Girl, Awarded $23M for Defects Caused by Depakote

Minnesota Girl, Awarded $23M for Defects Caused by Depakote

A state-court jury in St. Louis, Missouri, has ordered Abbott Laboratories to pay $23 million in punitive damages to a Minnesota girl whose family alleges the drug maker’s epilepsy drug Depakote caused her birth defects. It was the first verdict against the company over the medication.

The jury handed down the punitive damage award after deciding the family of Maddison Schmidt deserved $15 million in compensatory damages for spina bifida tied to her mother’s use of Depakote during pregnancy. Abbott currently faces more than 800 lawsuits filed by individuals who accuse Abbott of hiding the drug’s links to birth defects. Abbott won the first case, which went to trial in Illinois in April, according to Insurance Journal. Continue Reading »

Women Taking Newer Formulations of Birth Control Pills Found to be at Greater Risk for Blood Clots Than Those Taking Older Ones

Filed June 2nd, 2015 Julie

Greater Risk for Blood Clots with Newer Birth Control Pills

Greater Risk for Blood Clots with Newer Birth Control Pills


Newer forms of birth control raise the risk of blood clot by as much as older formulations, if not more so, a new study finds.

Researchers say that women who take newer formulations of birth control pills have about four times the risk of a blood clot, of venous thromboembolism, as a woman not taking birth control. “In layman’s terms, it makes the blood a little thicker,” Dr. Barbara Levy, vice president for health policy for the American College of Obstetricians and Gynecologists, told NBC News. “Pregnancy is a high estrogen state that really increases the risk of blood clots.” Continue Reading »

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