Yaz Increases Blood Clot Risk by 75%

Within the past year, popular birth control pills Yaz and Yasmin have come under fire from medical professionals and the Food and Drug Administration (FDA) for safety concerns.  The FDA has now released a new study, which suggests the pills pose an even greater risk of blood clots than previously thought.

Yaz and Yasmin are considered fourth generation birth control pills because of a synthetic hormone they contain called drospirenone, which is similar to the natural female hormone progesterone and increases potassium levels in the blood.  The pills have been touted by manufacturer Bayer as designer drugs that eliminate premenstrual symptoms (PMS). Of course, Bayer was forced to pull the advertisements claiming this back in 2009.

Based on recent studies about these birth control pills, medical experts believe drospirenone could be the culprit of increased blood clots seen in women taking these pills.  The most recent studies evaluated data from more than 800,000 women ages 10 to 55 who took the pill over a period of six years.  The results of the studies were alarming--women taking Yaz were 75 percent more likely to experience a blood clot than women taking birth control pills that do not contain drospirenone.

Despite the safety concerns with these pills, Yaz, Yasmin, and other drospirenone-containing birth control pills accounted for $1.6 billion in world-wide sales last year alone.

The FDA also analyzed data from studies conducted on the Ortho Evra patch and the Nuvaring vaginal ring.  Results from those studies found that women using those forms of birth control experienced more complications than women using traditional or third generation birth control pills.

Although none of these products have been pulled off the market, the FDA will be meeting December 8th to determine the safety of these drugs.  For now, consumer safety advocates are calling on the FDA to stop approving newer, less safe drugs when cheaper, safer generics are widely available on the market.

1 in 10 Americans Takes an Anti-Depressant

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Over the past 10 years, anti-depressant use in the United States has risen a staggering 400 percent.  According to findings recently released by the Center for Disease Control & Prevention (CDC), 11 percent of Americans ages 12 and older are taking an anti-depressant, and at least 8 percent of them are doing so without exhibiting depressive symptoms.

The findings from the study found that females were more than two and a half times more likely to take anti-depressants as males.  This is especially worrisome, because some anti-depressants are known to cause serious birth defectsA quarter of all women ages 40 to 59 are currently taking anti-depressants.

Perhaps more alarming than the statistics, is the fact that only a third of people taking anti-depressants have seen a mental health professional in the past year.  Instead, patients are seeking out help from their primary care physicians for treatment.  There is growing concern that primary care doctors are not as well-informed about the risks of taking anti-depressants.

Despite the potential lack of knowledge by the prescribing doctor, anti-depressants have skyrocketed to become the second most prescribed drug in the United States, second only to cholesterol-lowering pills, according to IMS Health.

In 2010 alone, 255 million prescriptions were dispensed for anti-depressants in the United States.  Many of these drugs are being prescribed for off-label uses, such as for the treatment of anxiety, neurological pain, fibromyalgia, sleep problems, and menopausal hot flashes.

More recently, popular anti-depressant drug Cymbalta was approved by the FDA for the treatment of musculoskeletal pain.  Since being approved initially in 2004, Cymbalta has been used by 30 million people.

Before being cleared, critics worried that approval would bring more direct-to-consumer advertisements, convincing Americans that drugs like Cymbalta are a major breakthrough not only for the treatment of depression, but also for chronic pain.

While the impact of these antidepressant advertisements has yet to be fully determined, it seems that Americans are turning to anti-depressants to resolve symptoms associated with other ailments, not just depression.

FDA Updates Warning for Reclast

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The Food and Drug Administration (FDA) has issued an update to the drug label for Reclast, an injection used to prevent or treat osteoporosis.  The new warning is in regards to the risk of renal failure.

Reclast, generic name zoledronic acid, is a bisphosphonate that is used to treat or prevent osteoporosis in women who are in menopause and to increase bone mass in men with osteoporosis.  The injection is given in a single dose every one to two years.

The FDA has recently received reports of patients experiencing kidney failure while taking Reclast.  These patients reporting kidney failure either required dialysis or died from the complication.

While kidney failure is a rare condition in patients using Reclast, it is more likely to occur in those patients who have a history of or risk factors for kidney problems.  Risk factors include an underlying moderate to severe renal impairment, use of kidney-damaging or diuretic medicines, and severe dehydration before or after receiving Reclast.

The risk of developing renal failure increases with age.  Your doctor should screen you for any kidney problems prior to giving you Reclast.  You should tell your doctor about any medications you are taking so that he or she can better identify whether these medications will adversely react with Reclast.

Earlier this year, Reclast was identified as a drug that is likely to cause a femur fracture in patients.  The FDA has sent out a safety announcement warning patients about the risks bisphosphonates pose and is continuing to review data regarding the risk of femur fractures in patients.

Prescription Drug Abuse Costs Medicare $148 Million

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Prescription drug abuse is on the rise in seniors and the disabled who rely on Medicare Part D to get their prescriptions. A report issued by Senate Homeland Security and Governmental Affairs Committee Chairman Tom Carpenter, along with senior Republican Scott Brown, found that nearly 170,000 people enrolled in the program went “doctor shopping” for powerful pain killers like oxycodone and hydrocodone.

In terms of prescription drug abuse, “doctor shopping” is where patients go to different doctors to get multiple prescriptions. The report found that some patients had gone to at least five doctors for prescriptions of drugs that are often abused. In all, these patients accounted for 1.8 percent of the total number of patients enrolled in the program.

Senator Scott Brown called the program “taxpayer-funded drug dealing,” and the Government Accountability Office (GAO) called for more strict control of the program to prevent Medicare fraud.

Why Older Patients are more at Risk

Today, older patients are being prescribed more long-term prescriptions and as many as 30 pills a day, which can lead to unintentional misuse of prescription drugs. For many seniors, the difficulty lies in simply being able to keep track of the pills and dosages they are taking.

According to the National Institute on Drug Abuse (NIDA), Americans ages 65 and older account for 13 percent of the population, but are prescribed one-third of all medicines prescribed in the United States. Combine their multiple prescriptions with over-the-counter medicines and dietary supplements, and the risk that they will have negative drug interactions soars.

Additionally, some seniors take medications that are not medically necessary or use medications for conditions that the medications were not originally prescribed. Seniors also tend to self-medicate for depression.

Benzodiazepines like Valium and Xanax are especially dangerous for seniors because they are more likely to feel stronger effects from the drugs than are younger people. These drugs can lead to falls and motor vehicle accidents for seniors, which can cause dangerous hip and thigh fractures.

Despite the risks these medicines pose, the government is expected to expand Medicare’s $62 billion drug program to cover benzodiazepines and other sedatives, both of which are commonly abused drugs.

To learn more about prescription drug abuse in the United States, read my article entitled “America’s Growing Addiction,” available at www.vanweylaw.com.