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.

Infants’ TYLENOL is an over-the-counter (OTC) product indicated as a pain reliever/fever reducer. The product was distributed nationwide in the United States.

RECOMMENDATION: If the flow restrictor is pushed into the bottle, the parent or caregiver should not use the product. See the Press Release for lot number and UPC codes of affected product. Consumers can visit www.tylenol.com for additional information.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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.

Pictures of the counterfeit version of Avastin are shown below:

Avastin is an injectable medicine used to treat cancer and is administered to patients in clinics, hospitals, and doctors’ offices. Roche is the company that manufactures Avastin approved for marketing outside of the United States. Roche conducted laboratory tests that confirmed the counterfeit version of Avastin. Packages or vials may be counterfeit if they:

• are labeled with Roche as the manufacturer
• display batch numbers that start with B6010, B6011 or B86017

Medical practices that have obtained products from Volunteer Distribution and QSP should stop using them and contact the FDA. These products should be retained and securely stored. To report suspect counterfeit products and other suspect products obtained from Volunteer Distribution or QSP/Montana Health Care Solutions:

• Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989,
• Visit OCI’s Web site (www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm), or
• Email – DrugSupplyChainIntegrity@fda.hhs.gov

Healthcare professionals and patients are encouraged to report adverse events related to the use of suspect injectable cancer medications to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the FDA Counterfeit Statement, letters to medical practices, and the company Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm291968.htm

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.

Pfizer is recalling about a million packets of birth control pills in the United States because they may not contain enough contraceptive to prevent pregnancy.

The birth control pills posed no health threat to women, Pfizer said, but it urged consumers affected by the recall to “begin using a non-hormonal form of contraception immediately.”

According to Pfizer the pills were manufactured by Pfizer and marketed by Akrimax Pharmaceuticals and shipped to warehouses, clinics and retail pharmacies nationwide.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Lot numbers of affected packs of Lo/Ovral®-28 (norgestrel and ethinyl estradiol)Tablets and Norgestrel and Ethinyl Estradiol Tablets (generic) follow on the table below:

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.