BACKGROUND: Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills.

The revised drug labels will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products. The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.

RECOMMENDATION: Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.

Healthcare professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman’s risk for developing a blood clot before prescribing these drugs.

But thousands of people in central California, where Qnexa’s inventor ran a weight-loss clinic, and others across the country have not had to wait for the drug’s approval. Through a regulatory loophole of sorts, many obesity doctors prescribe two separate drugs that, when taken together, are essentially the same medicine.

“I can’t tell you how many people I sent to him because they saw the success I had,” said Lynn Adams, a retired teacher, referring to Dr. Thomas Najarian, the inventor of Qnexa who opened a weight-loss clinic here in 2001.

Ms. Adams said she took the two drugs for a year and lost about 80 pounds. She has taken the drugs from time to time since then but is off them now and has gained about half the weight back.

Qnexa, developed by the company Vivus, is a combination of two already approved drugs — a stimulant called phentermine and an anticonvulsant called topiramate — that seem to work together to quell appetite. Even though the F.D.A. declined to approve Qnexa two years ago, citing the risks of birth defects and cardiovascular problems, doctors are allowed to prescribe the components off-label as they see fit.

Many do. Dr. Christopher D. Still, director of the obesity institute at Geisinger Health System in Danville, Pa., estimated that 70 percent of obesity specialists prescribed the combination. “There is a subgroup of individuals that really feel satiated” when treated with the two drugs, said Dr. Still.

Only one drug, Roche’s Xenical, is currently approved for long-term use in treating obesity, and it is unpopular because of embarrassing digestive side effects. The F.D.A. rejected three obesity drugs, including Qnexa, in 2010 and 2011, citing different safety concerns for each.

On Friday, the F.D.A.’s staff released its analysis of the new Qnexa data and said it was still concerned about potential heart problems and birth defects in women who become pregnant while taking the drug. On Wednesday, an advisory panel will review the drug and make its recommendation. The staff will ask the committee to consider whether Vivus should do a large clinical trial to judge cardiovascular risks before the drug can be approved.

The F.D.A. will have until April 17 to make a decision about it.

Pradaxa Side Effects Include:

• Severe internal bleeding,
• Gastrointestinal bleeding,
• Brain hemorrhage,
• Kidney bleeding,
• Heart attack and
• Death

FDA Early Warning Notification

On December 7, 2011, the U.S. FDA sent out an early warning notification evaluating the postmarketing reports of serious bleeding events in patients taking Pradaxa.

Were you injured from the serious side effects of taking Pradaxa? You may be entitled to compensation.

Visit PradaxaLawsuit.org for more information.

In addition, a new Contraindication warning was added against use of Adcetris with the cancer drug bleomycin due to increased risk of pulmonary (lung) toxicity.

The signs and symptoms of PML may develop over the course of several weeks or months. They may include changes in mood or usual behavior, confusion, thinking problems, loss of memory, changes in vision, speech, or walking, and decreased strength or weakness on one side of the body.

BACKGROUND: Adcetris (brentuximab vedotin) is used to treat Hodgkin lymphoma and a rare lymphoma known as systemic anaplastic large cell lymphoma. At the time of Adcetris’ approval in August 2011, one case of PML was described in the Warnings and Precautions section of the label.

RECOMMENDATION: Patients who develop any signs and symptoms of PML should notify their healthcare professional immediately. Healthcare professionals should hold Adcetris dosing if PML is suspected and discontinue Adcetris if a diagnosis of PML is confirmed. See the Data Summary in the Drug Safety Communication for additional information.

The best-selling statin is atorvastatin, marketed as Lipitor and Torvast. A number of statins are on the market: atorvastatin (Lipitor and Torvast), fluvastatin (Lescol), lovastatin (Mevacor, Altocor, Altoprev), pitavastatin (Livalo, Pitava), pravastatin (Pravachol, Selektine, Lipostat), rosuvastatin (Crestor) and simvastatin (Zocor, Lipex)

A study published Monday adds to the evidence, finding a modest risk among older women who used a variety of statins. It’s a puzzling link, and specialists say people who most need statins because of a high risk for a heart attack should stick with the drugs.

Statins are one of the most widely prescribed drugs, and among the most touted with good reason. They can dramatically lower so-called “bad” LDL cholesterol. Studies make clear that they save lives when used by people who already have heart disease.

What is debated is how much the drugs help people who do not yet have cardiovascular disease but whose chances are higher because of other factors such as smoking or high blood pressure — or diabetes. In fact, long-term diabetes is so heart-risky that the American Diabetes Association urges fairly aggressive statin use by many diabetics. For everyone else, Nissen says the general rule is statins help people who have at least a 10 percent chance of a heart attack in the next 10 years, something a doctor can calculate.
All drugs have side effects that are important to consider while deciding whether they are a good bet for an individual. Statins have long been known to cause muscle pain that on rare occasions becomes a serious breakdown of muscle that can lead to kidney failure, even death.

But whether statins can make blood sugar rise enough that someone crosses the threshold to diabetes has been confusing.
After all, some of the same risks for heart disease — such as being overweight and sedentary — also increase the odds of developing Type 2 diabetes. And Ma says too many statin users wrongly assume the pills will let them eat whatever they want.

Ma’s team examined a huge U.S. government study that tracked the health of postmenopausal women for many years. They culled the records of more than 153,000 women who did not have diabetes when they enrolled in the Women’s Health Initiative in the 1990s. Just 7 percent were taking statins at the time.
Fast forward to 2005: Nearly 10 percent of the statin users had developed diabetes, compared with 6.4 percent of the older women who hadn’t used the drugs at the study’s start, Ma concluded. The findings were reported online Monday by the journal Archives of Internal Medicine.

This is what scientists call an observational study, which can hint at a risk but can’t prove it.
But it comes after a number of smaller but more precise studies — where patients were randomly assigned to take a statin or some other treatment — that also have found a link. The first to prompt doctor head-scratching was in 2008, a study of the drug Crestor. Last June, a report in the Journal of the American Medical Association analyzed five additional randomized trials and concluded the increased risk was small but real for people taking higher doses of any statin.

That report calculated that one fewer patient would experience a heart attack or other cardiovascular problem for every 155 patients treated for a year — and there would be one additional case of diabetes for every 498 patients treated.

At the National Institutes of Health, diabetes specialist Dr. Judith Fradkin says statins’ benefits outweigh the potential side effect, and that newly developed diabetes won’t harm right away.
“The danger here is alarming people and having them go off a medication that’s of proven benefit,” she says.

But Dr. Beatrice Golomb of the University of California, San Diego, welcomed the new study as a needed note of caution for women, saying there’s less certainty about the drugs’ overall effects in them. Stay tuned: Her own research aims to narrow down which statin users are more likely to experience a blood-sugar jump.

Source: Associated Press

Recent medical studies confirm that Actos can cause bladder cancer and other injuries. Actos (pioglitazone) is a Type 2 diabetes drug often prescribed as an alternative to Avandia. At one time it was believed that Actos was safer.

Actos lawsuits against Takeda Pharmaceuticals whoe manufactures the Actos drug, allege that patients who took Actos developed bladder cancer. Patients who have bladder cancer are urged stop using Actos, while the medication should be used with caution in patients who have a prior history of bladder cancer, the FDA warns.

Injuries caused by Actos

Bladder Cancer
Heart Attack
Congestive Heart Failure
Heart Disease
Rhabdomyolysis
Kidney Damage
Liver Damage
Bone Fracture

Actos Side Effects

Actos, or pioglitazone hydrochloride, is a commonly prescribed anti-diabetic medication used in combination with dietary constraints to control adult onset diabetes (diabetes II). The drug, a single-molecule chemical cousin of Avantia, is popular with medical professionals, for it succeeds at regulating blood glucose and reducing insulin resistance far more effectively than other medications. In a nation suffering an epidemic increase in diabetes II cases, a reliable and effective support to help control the central symptoms of the illness is welcome.

Nonetheless, Actos is not without side effects. The drug has both common, low-impact side effects and more serious ones – so serious that studies have led France and Germany to remove the drug from the market entirely, forbidding doctors to prescribe the medication.

Among the milder and less sinister side effects are headache, respiratory and sinus infections, sore throat, muscle pain, tooth problems and water retention. These are common to many drugs, and are seldom debilitating, though on a patient by patient basis, it is possible to find a degree of variation in response among patients. Most experience few, if any side effects.

Updated list of drugs with active ingredient of Actos.

The  data was obtained from ATHENA and PALLAS clinical trials.  New information and recommendations are being provided by FDA for the use of Multaq to manage the potential serious cardiovascular risks with dronedarone.

The Multaq drug label has been revised with the following changes and recommendations:

1. Healthcare professionals should not prescribe Multaq to patients with AF who cannot or will not be converted into normal sinus rhythm (permanent AF), because Multaq doubles the rate of cardiovascular death, stroke, and heart failure in such patients.
2. Healthcare professionals should monitor heart (cardiac) rhythm by electrocardiogram (ECG) at least once every 3 months. If the patient is in AF, Multaq should be stopped or, if clinically indicated, the patient should be cardioverted.
3. Multaq is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of non-permanent AF (known as paroxysmal or persistent AF)
4. Patients prescribed Multaq should receive appropriate antithrombotic therapy.

For more safety information please visit fda.gov.

Here is an updated list of drugs with active ingredient of Actos.

Common Symptops:

• Dark urine
• Frequent urination
• Painful urination
• Urinary tract infection

Drugs effected

Generic name: Pioglitazone
Actos
ACTOplus met
ACTOplus met XR
duetact

NDC numbers found on Actos packaging:

00247-1924-30
00247-1925-30
00247-1926-30
12280-0060-30
13411-0101-03
13411-0102-03
13411-0103-03
21695-0147-15
21695-0148-15
49999-0450-30
49999-0451-30
54569-4880-00
54569-4881-00
54569-4882-00
54868-4343-00
54868-4354-00
54868-4354-01
54868-4391-00
55289-0540-30
55289-0862-15
55289-0862-30
55887-0062-30
55887-0063-30
55887-0100-30
58864-0670-14
58864-0670-30
58864-0745-15
58864-0745-30
58864-0862-30
64764-0151-04
64764-0151-05
64764-0151-06
64764-0301-14
64764-0301-15
64764-0301-16
64764-0451-24
64764-0451-25
64764-0451-26
68115-0671-30
68115-0841-30

NDC numbers found on ACTOPlus met packaging:

35356-0130-60
54868-5500-00
54868-5500-01
54868-5553-00
54868-5553-01
64764-0155-18
64764-0155-60
64764-0158-18
64764-0158-60

NDC numbers found on ACTOPlus met XR packaging:

64764-0310-30
64764-0510-30

NDC numbers found on duetact packaging:

64764-0302-30
64764-0304-30

If you have been diagnosed with bladder cancer after taking any of these drugs, you may be entitled to monetary compensation!

To Submit a FREE case evaluation please use the link below.

Studies have shown that several commonly prescribed SSRIs – including Zoloft, Depakote, and Paxil – may be putting infants at risk for developing heart defects at the very beginning of their lives. The heart defects that have been tied to those drugs are as follows:

• Zoloft – transposition of the great arteries, tetralogy of fallot, hypoplastic left and right heart syndrome, atrial septal defect
• Paxil – atrial and ventricular septal defects (holes in the heart), tetralogy of fallot, double outlet right ventrical, transposition of the great arteries

Many of these conditions require surgery and put infants at risk for further health complications. Women should use caution when taking SSRIs or other medications during pregnancy to protect their children from heart defects and other health problems.