Yaz, Yasmin, Ocella

YAZ, Yasmin, and Ocella are birth control pills manufactured by Bayer Pharmaceuticals. Ocella is the generic form of Yasmin and is manufactured by Barr Laboratories. What makes these three medications different from other birth control pills is the addition of a new progestin called drospirenone. It has now been shown that drospirenone causes an increase/imbalance of the potassium levels in the body. Some of the side effects which have been noted by individuals taking Yaz, Yasmin or Ocella are the following:

  • Blood Clots
  • Deep Vein Thrombosis (DVT)
  • Pulmonary Embolism (PE)
  • Stroke
  • Gallbladder Disease/Removal
  • Death

If you or someone you care about has suffered from any of the above symtoms after taking YAZ, Yasmin or Ocella, contact us.  We would like to help.

FDA – Mesh Used in Repair of Pelvic Organ Prolapse Poses Risk

The FDA recently issued a safety alert regarding a common method of repairing a condition called pelvic organ prolapse. 

So what exactly is pelvic organ prolapse?  Pelvic organ prolapse (POP) occurs in women when the normal support of the vagina is lost.  This results in dropping or sagging of the cervix, urethra, bladder or rectum.  As the dropping or sagging progresses, women can feel bulging tissue protruding through the opening of the vagina.  This condition can cause women to experience pelvic pain and discomfort as well as disruption of their sexual, urinary and defecatory functions.  Obviously, a woman’s quality of life can be severely affected by POP. 

Unfortunately POP is a fairly common problem.  According to the American Urogynecologic Society, approximately 50% of all women between the ages of 50 and 79 have some sort of pelvic organ prolapse.  The risk that a woman will have surgery for correction of prolapse or urinary incontinence in the U.S. is about 11%.  Of that 11% who have surgery about one-third will have to undergo a second surgery.  The American Urogynecologic Society estimates that approximately 300,000 surgical procedures are done each year to correct pelvic organ prolapse in the United States.

Because of the significant number of women affected by POP, when the FDA issued a news release on July 13,2011 regarding one of the common surgical repairs performed to correct POP, people paid attention.  The FDA issued a safety communication regarding serious complications associated with transvaginal placement of surgical mesh for treatment of pelvic organ prolapse (POP). 

According to the FDA in 2010 there were at least 100,000 POP repairs involving the use of surgical mesh.  About 75,000 of these involved transvaginal procedures.  Some of the complications being reported to the FDA include the following:

  • Mesh being exposed or protruding through the vaginal tissue (erosion)
  • Pain
  • Infection
  • Bleeding
  • Pain during intercourse
  • Organ perforation
  • Urinary problems

If you have suffered from any of these symptoms following a transvaginal mesh surgical procedure you are not alone.  According to the FDA there are many woman who are suffering as a result of this procedure.  It is bad enought to suffer from POP.  It is even worse if the surgery that was supposed to repair the problem causes additional harm.  Contact us if you have experienced any of the above symptoms.  We would like to help. 

 

WHAT MEDICATIONS MAKE THE MOST MONEY?

The most prescribed medications in the United States are generic medications.   However, generic medications do not make the most money for pharmaceutical companies.   Pharmaceutical companies make the most money from medications new enough where the patents on them are still in effect.  Because of the patents still in effect, these drugs can only be manufactured by the company holding their patent.  

It isn’t surprising that the companies can, and do, charge significantly more for these non-generic, name brand drugs.   Americans spent $307 billion on prescription medications in 2010 according to a report from IMS Institute for Healthcare Informactics.  So what 10 medications did patients in the U.S. spend their money on? 

  1. 7.2 billion – Lipitor, a cholesterol-lowering statin drug
  2. $6.3 billion – Nexium, an antacid drug
  3. $6.1 billiong – Plavix, a blood thinner
  4. $4.7 billion – Advair Diskus, an asthma inhaler
  5. 4.6 billion – Abilify, an antipsychotic drug
  6. 4.4 billion – Seroquel, an antipsychotic drug
  7. 4.1 billion – Singulair, an oral asthma drug
  8. 3.8 billion - Crestor, a cholesterol-lowering statin drug
  9. 3.5 billion – Actos, a diabetes drug
  10. 3.3 billion – Epogen, an injectable anemia drug

 

 

WHAT ARE THE MOST COMMONLY PRESCRIBED MEDICATIONS IN THE U.S.?

Recently we blogged about a report generated by a division of the Centers for Disease Control (CDC) which showed that 1 in 10 of Americans over age 12 take some sort of anti-depressant medication.  That lead to another question for us.  What are the most commonly prescribed medications in the U.S.?    According to a report from IMS Institute for Healthcare Informactics, a pharmaceutical market intelligence firm, the top ten prescribed medications for 2010 were as follows:

  1. 131.2 million prescriptions  – Hydrocodone (combined with acetaminophen) pain medication
  2. 94.1 million prescriptions  – Generic Zocor (simvastatin), a statin medication designed to lower cholesterol
  3. 87.4 million prescriptions – Lisinopril (include the brand names Prinivil &Zestril) – used to treat blood pressure
  4. 70.5 million prescriptions – Generic Synthroid (levothyroxine sodium) – a synthetic thyroid hormone
  5. 57.2 million prescriptions – Generic Norvasc (amlodipine bysylate), used to treat angina/blood pressure
  6. 53.4 million prescriptions – Omeprazole (generic Prilosec) an antiacid medication – over-the-counter sales are not included in this figure
  7. 52.6 million prescriptions – Azithromycin (includes Zithromax and Z-Pak) an antibiotic
  8. 52.3 million prescriptions – Amoxicillin (includes various brand names) an antibiotic
  9. 48.3 million prescriptions – Generic Glucophage (metformin) – a diabetes medication
  10. 47.8 million prescriptions – Hydrocholorthiazide (includes various brand names) – diuretic, water pill used to lower blood pressure

 Did you notice something about all of the above?  They are all generic medications.  According to the IMS report, nearly 78% of the 4 billion prescriptions written in the U.S. in 2010 were for generic medications.

Generic medicines do not generate as much money for the pharmaceutical companies as do name brand medications.  The list for the most prescribed medications differs greatly from the biggest money maker list.  So what medications make the most money for the pharmaceutical companies?  We will look into that question.

CDC – 1 IN 10 AMERICANS AGES 12 AND OVER USE ANTI-DEPRESSANT MEDICATION

A report was recently released by the National Center for Health Statistics, a division of the CDC, regarding anti-depressant usage in the United States.    Many facts regarding anti-depressant use in the United States were discussed.   The authors of the report based their results on data collected from 12,637 people ages 12 and older. 

Some of the key findings discussed in the report include the following:

  • Over a 20 year period, anti-depressant usage in the United States rose over 400%
  • 11 % of all Americans, aged 12 years and over take anti-depressant medication.  That is 1 person out of every 10.
  • 60% of the Americans taking an anti-depressant medication have taken it for over 2 years.   14% of those who take these medications have taken the anti-depressants for over 10 years.
  • Of those Americans taking an anti-depressant, less than 1/3 have seen a mental health professional in the last year.  Less than 1/2 of those taking multiple anti-depressants were seen by a mental health professional within the past year.
  • Women are more likely than men to take anti-depressant medication.

There are other interesting statistics discussed in this report.  To see the entire NCHS Data Brief from the CDC click onto the following link:  http://sjlaw.info/AntidepressantData

 

 

CLEAN OUT YOUR MEDICINE CABINET EVENT – October 29, 2011

Don’t do it!  No don’t!  Do NOT dump that unused medication down the toilet or down the drain.    This message is urgent.   Why?

A few years ago studies started showing that more and more prescription and over-the-counter medications were showing up in water supplies around the country causing potential for environmental issues. Water treatment plants do not have the ability to effectively filter drugs out of the water we drink.  As a result, medications, everything from antibiotics to antidepressants to pain medications, are contaminating our water systems. The medications flushed down toilets and dumped down drains goes straight into our water systems and add to this growing problem.    http://sjlaw.info/CBSMedicationWaterSupplyVideo    This video was made in 2009.  Since then the matter of medications in our water supply has only gotten worse.

An estimated 17 percent of all medications in this country are never used.  So if you haven’t dumped medications down the toilet or drain, how many of you reading this have some unused portion of a prescription medication laying around your home right now?

This leads to the next issue involving unused medications.  Medications simply left to gather dust are a danger.  Unfortunately, government reports show that one in five, especially teens,  intentionally misuses someone else’s medication in an attempt to get high.  Nearly half of those say they get these medications for free simply by raiding medicine cabinets and homes for unused medications.   According to Utah’s Governor Herbert, more people in Utah die every year from prescription misuse than from auto accidents.  Also, Utah ranks 4th nationally for misuse of prescription medication.  

So that leads to the big question,

 ”If I can’t safely get rid of medications by flushing or dumping them down a drain and I shouldn’t leave left over medication around my home, what in the world should I do with these unused drugs?” 

Because of rising concerns regarding the effects of unused medications, in 2010 Congress passed the Secure and Responsible Drug Disposal Act.  This fostered the National Drug Take Back Initiative.  In April and October of each year the DEA and other government agencies sponsor a community event to assist in getting unused drugs out of our homes and disposed of properly. 

On Saturday October 29, 2011 between 10 AM and 2 PM this event will be held in Utah.  To take part, first make sure that you take these medications out of the pill bottles and put them into a plastic bag or other container. Then destroy the information on the bottle the medication came in. This prevents anyone from using your information to get additional medication or information about you that could be used in other ways.  Then use this link to find a location close to you where you can take your medications to get rid of them safely:          http://sjlaw.info/UtahCleanOutCabinetEvent   

Too busy on the 29th?  No problem.  The Utah Department of Health has a list of sites on its website which will accept unused medications all year long.  Again there are several.  Just go to this link to find one:   http://sjlaw.info/UtahSafeDropOffLocator

Just can’t find time to make a special trip to dispose of your medications?  If you must, here is a link to a video on proper instructions to use as a last resort if you wish to dispose of these medications yourself.   http://sjlaw.info/HomeDisposalMedications

 

 

 

Listeria, Listeriosis and Cantaloupe – What’s the Big Deal?

Another news alert, another food illnesses, FDA warns - yada yada yada.  We listen to these types of news reports most of the time as a type of background noise.  So why are we posting about the current Listeria and Cantaloupe warning?   This is bad.  This is widespread.  Sadly, this is more deadly. 

The FDA and CDC first started reporting cases of listeriosis, an infection caused by the bacteria listeria, mid-September.  The bacteria was linked back to cantaloupe grown and shipped from a large farming operation  in Colorado, Jensen Farms.  The cantaloupe had been shipped to 25 states including Utah.  On September 14, Jensen Farms issued a recall on all cantaloupe grown on their farms. 

This week updates were issued by both the CDC and FDA regarding the spread of listeria.  The news was grim.  On Wednesday, September 28th Dr. Tom Frieden, director of the Center for Disease Control (CDC) stated in a news conference,

In fact, as has been accurately reported in the media, this is the deadliest outbreak of foodborne disease that we’ve identified in more than a decade.

To date, there have been 84 documented cases of listeriosis nationwide with 15 deaths. 

So if the cantaloupes have been recalled for couple of weeks, why are the CDC and FDA still talking about listeria?  What makes this outbreak scary is the fact that this bacteria will live both at room and refrigerated temperatures. It doesn’t like to die. Also symptoms can first appear up to 60 days after ingesting. With most people infected symptoms first appear between 20 – 30 days after eating the contaminated cantaloupe but can appear earlier or later. Symptoms include fever, stiff neck, confusion, weakness, vomiting, sometimes preceded by diarrhea. Infection is usually confirmed via blood test as this bacteria just doesn’t stay in the digestive tract but gets into the blood stream.  Because of the long incubation period with listeria infections, the CDC is expecting to see increases in the present numbers of documented cases through the end of October.

As with most bacterial infections, the older, the more fragile and immunosurpressed are the most vulnerable.  However, the listeria bacteria has a nasty twist with pregnant woman. Below find an excerpt from the FDA regarding pregnancy and listeria -

“Listeriosis, an infection caused by Listeria, can pose major risks during pregnancy.

Pregnant women are approximately 20 times more likely than other healthy adults to get listeriosis. In pregnant women, it is typically a mild, flu-like illness. In the child, listeriosis can lead to miscarriage, stillbirth, or life-long health problems.

  • During the first trimester, listeriosis may cause miscarriage .
  • As the pregnancy progresses to the third trimester, listeriosis may lead to premature labor, the delivery of a low-birth-weight infant, or infant death .
  • Infected newborns may develop serious health problems, such as:
    • Mental retardation
    • Paralysis
    • Seizures
    • Blindness
    • Impairments of the brain, heart, or kidney.”

We have attached photos to this blog showing the labeling on the affected cantaloupe.  If you have any cantaloupe with this label throw it out immediately!  If you are unsure call your grocer and ask if the cantaloupe you purchased from them is part of this recall.  

If you or someone you care about has been diagnosed with listeriosis, please contact us.  

Below find links for more information from the FDA and the CDC: 

 http://sjlaw.info/FDACantaloupeListeriaSafetyCommunicationhttp://sjlaw.info/FDACDCPressConferenceCantaloupeListeria; http://sjlaw.info/CDCListeriosisInfo

 

 

 

 

 

 

 

 

 

 

 

 

 

Yaz, Yasmin, Ocella – FDA Meeting Scheduled

Given the prior safety concerns in connection with the birth control medications, Yaz, Yasmin and Ocella, it was no surprise this week when the FDA issued a brand new “Safety Communication” regarding these types of medications. 

What makes these medications different than most?  Birth control medications usually contain two types of hormones, estrogen and progestin.  Yaz, Yasmin and Ocella contain a newer form of progestin, drospirenone.  Concern regarding drospirenone first came to light in 2009.  In 2009, a couple of studies were published that indicated that patients using birth control medications containing drospirenone, such as Yaz, Yasmin or Ocella, were suffering a higher incidence of blood clots than those patients using birth control pills containing other forms of progestin.

That was back in 2009.  So why did the FDA come out with the safety communication this week?  There are now additional studies showing similar results to those first published in 2009.   One of these studies is currently being conducted by the FDA.  The FDA’s own preliminary results suggest a 1.5 fold increase in the risk of blood clots for women who use birth control pills such as Yaz, Yasmin and Ocella which containing drospirenone.

Because of these more recent studies and their findings, the FDA has decided to schedule a joint meeting of the Reproductive Health Drugs Advisory Committe and the Drug safety and Risk Managment Advisory Committee.  They will meet on December 8, 2011 to discuss the risks of blood clots with drospirenone containing birth control pills such as Yas, Yasmin and Ocella. 

As soon as we know the results of this meeting we will share them with you in this blog.  Stay tuned.   

 

 

 

Actos (pioglitazone) and Bladder Cancer – FDA Warning

Actos (pioglitazone) is one of the largest-selling oral medications sold to control blood sugar levels.   Millions of prescriptions for this medication are filled each year by diabetics.  Because of the millions of prescriptions written for this medication, when the FDA recently issued an alert in connection with Actos (prioglitazone) it generated a lot of attention.

Five years ago a ten year  study of Actos was started.  The study was designed to focus in on potential safety issues in connection with usage of this drug.  In reviewing the data generated by this study, the FDA determined it would not wait for the full ten years to lapse before issuing their warning.  Five years into this ten year study the data was already showing safety issues.  The interim data suggested that, with long term use, patients using this medication had an increased risk of developing bladder cancer.   A separate study which was conducted in France also showed the same results.

So how long is the long term usage referred to by the FDA?  If you or someone you care about was diagnosed with bladder cancer after taking Actos (proglitazone) for one year or more contact us.  We would like to help.

If you wish to read the FDA Safety Communication regarding Actos in its entirety use the following link:  http://sjlaw.info/ActosFDAWarning

 

Prescription Medications and Birth Defects

 

It can’t get any more heart-wrenching.  Your baby is born, the doctor turns to you and says, “we have a problem”.    Your baby has a birth defect.  Questions flood into your mind.  Eventually one your questions will be “What caused this to happen to my baby?” 

The answer may be that a prescription medication which was taken while you were pregnant caused the birth defect.   The list of prescription medications which may cause birth defects seems to be growing.  These medications are used to treat a wide range of conditions, including migraines, seizures, depression and pain.   The following is a list of the current medications under review in connection with causing birth defects if taken while pregnant:

  • Depakote
  • Hydrocodone
  • Oxycodone
  • Codeine
  • Celexa
  • Lexapro
  • Luvox
  • Paxil
  • Pexeva
  • Prozac
  • Zoloft
  • Wellbutrin

Recent label changes, testing that was and was not done, as well as FDA warnings are reasons the above medications have made it onto this list.   If you were taking any of these prescription medications while pregnant and your child was born with a birth defect, contact us immediately.  We would like to help.