Archive for the 'FDA Alert' Category

Merck Closes Down Its Propecia Website

Wednesday, February 15th, 2012

The Propecia webpage owned by Merck Pharmaceuticals provided links to current prescribing information, patient product information, and a link encouraging visitors to report any adverse effects associated with use of Propecia to the FDA’s MedWatch program.

Merck has abruptly shut down this website, which has prompted speculation that new or additional warnings may be on their way to consumers regarding the sexual side effects that have been reported with the use of Propecia.

Several lawsuits have been filed against Merck Pharmaceuticals, manufacturer of Propecia,

Propecia is used to treat benign prostatic hypertrophy (BPH, enlargement of the prostate gland) and baldness.  The lawsuits accuse Merck of downplaying the risks associated with Propecia and failing to warn patients about the severity of sexual side effects.

The side effects that have plagued men are:  decreased libido, decreased semen output, and depression.  Because so many men feel embarrassment about the side effects of Propecia, scores have chosen to remain anonymous or to not report their conditions.  In June 2011, the FDA issued a warning that Propecia could be linked to an increased risk of high-grade prostate cancer.

 

Dangerous Chemicals Found In Johnson & Johnson Products

Monday, January 9th, 2012

Carcinogenic (cancer causing) materials have been discovered in baby shampoo products made and distributed by Johnson & Johnson Company. These chemicals include Quarternium-15 which prevents products from spoiling and contamination by releasing formaldehyde to kill bacteria.

There is an argument as to how much risk these chemicals pose to users of these products. Johnson and Johnson claims that using a single dose of any of their products cannot cause a bad reaction in children. But the question remains as to how much risk repeatedly using these products can pose.

Johnson & Johnson has only taken corrective steps after threatened boycotts from the Campaign for Safe Cosmetics and proddings from thousands of consumers.

Drugmaker announces recall of Topamax

Monday, October 10th, 2011

Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., announced it is voluntarily recalling two lots of TOPAMAX 100mg Tablets.

These two lots were shipped and distributed in the U.S. and Puerto Rico.

While the recall encompasses approximately 57,000 bottles of TOPAMAX, the company believes there are fewer than 6,000 bottles remaining in the marketplace. The recall stems from four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA.

TBA, a chemical preservative sometimes applied to wood often used in the construction of pallets on which products are transported and stored. An internal investigation is underway to evaluate the potential source of this TBA issue.

In addition, the company is working with peer companies to better understand how and where TBA is entering and impacting the supply chains and what can be done to further mitigate this exposure.

Are the drugs your hospital uses safe?

Tuesday, October 4th, 2011

Everyone wants to believe that if they are admitted to the hospital, the staff is adequately equipped to give you proper care.  That may not be certain today, though.  There is a current shortage on certain drugs leading to the endangerment of patients, disruption of hospital care, and raising the cost of care.

The primary drugs that are in short supply are injectable generic drugs that are ordinarily cheap.  These shortages cause a delay in surgeries and cancer treatments, leave patients in unnecessary pain, and cause hospitals to give less effective treatments, which often results in complications and longer hospital stays.

According to the Associated Press, the shortages could cost hospitals at least $415 million per year.  So far, hospitals have been absorbing the extra costs but they’ll soon have to start passing them on to insurers and patients.

The FDA says the primary cause of the shortages is production shutdowns and manufacturing problems.  Other reasons cited were theft of prescription drugs from warehouses and “gray market” vendors who buy scarce drugs from small regional wholesalers or pharmacies and then sell them to hospitals at many times the normal price.  These “gray market” sellers may not be licensed, authorized distributors.

The average price markup on drugs sold by secondary distributors is 650 percent.  In one extreme case, a vendor was offering a generic beta blocker for dangerously high blood pressure.  The normal price per dose is $25.90, but it was being sold for $1,200 (per dose).

The primary problem with buying stolen drugs is that hospitals can’t always tell whether a medication has been properly refrigerated or is expired.  Using these defective drugs can be dangerous because the active ingredient might have degraded and the drug might not work well or could even harm or kill the patient.

Although the Hospital Association urges hospitals not to buy from unaccredited vendors and to insist on proper documentation of the drug’s source if they must, only three states (Kentucky, Maine, and Texas) have price-gouging laws that specifically cover medicines.

 

 

Provigil could have adverse side effects

Monday, September 19th, 2011

How tired are you? Do you work night shifts? If so, you probably heard of the drug Provigil.

Some say it is the miracle drug, allowing pilots and military personal the ability to stay up and be alert during their shift.

Provigil is also used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift work sleep disorder by affecting the central nervous system. That means this medication can also impair your thinking or reactions.

The FDA warned physicians that Provigil might cause mania, delusions, hallucinations, suicidal ideation and aggression, some resulting in hospitalization. It can also cause Steven Johnson Syndrome, a rare and deadly disease.

So really how tired are you? Do we as Americans turn to medications for energy to easily? Does the extra money we could make outweigh the psychological risks?

If you or someone you love has suffered adverse side effects from taking Provigil, contact one of our defective drugs attorneys today.

Chantix dinged with public health advisory

Monday, September 19th, 2011

Is the physical risks of smoking worth the mental and psychological problems that may arise by using Chantix? Changes in behavior, agitation, depressed mood, suicidal thoughts or actions make Chantix dangerous.

Chantix is a prescription anti-smoking drug designed to lower nicotine cravings and ease nicotine withdrawal symptoms. Chantix received FDA approval in 2006 after the drug was proven to block the brain receptors responsible for the pleasurable effects of smoking.

In February 2008 the FDA issued a Chantix public health advisory and warning. Prescribing physicians and Chantix users were cautioned that the drug had been linked to neuropsychiatric symptoms, including depression, agitation, and actualized suicidal behavior. In the statement issued by the FDA, the public was also alerted that Chantix may raise the reoccurrence risk of past psychiatric illness or may aggravate current mental illness.

If you have suffered adverse side effects from taking Chantix, call our defective drugs attorneys today and set up a no-cost consultation.

 

 

Lexapro linked to birth defects

Wednesday, August 31st, 2011

Lexapro is prescribed to treat patients with depression and generalized anxiety disorder. However, the drug is not without its problems. The FDA has issued two alerts concerning injuries caused by Lexapro.

The first alert is that Lexapro has been known to cause persistent pulmonary hypertension (PPHT) in babies whose mothers used the drug during pregnancy.

Babies with PPHT have an inadequate blood supply to the lungs which causes oxygen depleted blood to return to the heart. Although some infants can recover quickly, others can have complications and require care throughout the rest of their lives. Statistics show that if the mother was on Lexapro while pregnant they are six times more likely to have a child with a birth defect.

The second FDA alert is regarding serotonin syndrome. Serotonin controls moods, emotions, sleep cycles and appetite. Some drugs like Lexapro can contribute to having too high of levels of serotonin in your body.

Serotonin syndrome can be fatal. Symptoms of this syndrome may include: restlessness, increased heart beat, loss of coordination, nausea, vomiting, tremor, muscle spasms, and several others.

If you believe you have suffered injury by taking Lexapro please call one of our defective drug attorneys today. You may have a case against the makers of Lexapro.