September First Time Generic Drug Approval

Levetiracetam Extended-Release Tablets 500 mg and 750 mg
Approved: September 12, 2011 - Actavis Elizabeth LLC; Par Pharmaceutical, Inc.; Apotex, Watson Laboratories, Inc.; Mutual Pharmaceutical Company, Inc.; Teva Pharmaceuticals USA
Generic for: Keppra XR

Levetiracetam is an anti-epileptic drug.

Levetiracetam is used to treat partial onset seizures in adults and children who are at least 4 years old.

Levetiracetam is also used to treat tonic-clonic seizures in adults and children who are at least 6 years old, and myoclonic seizures in adults and children who are at least 12 years old.

Do not stop taking levetiracetam without first talking to your doctor, even if you feel better. If you stop taking levetiracetam suddenly, you may have increased seizures. Tell your doctor if you have new or worsening seizures.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself. Carry an ID card or wear a medical alert bracelet stating that you are taking levetiracetam, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking levetiracetam. Levetiracetam can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

You should not use this medication if you are allergic to levetiracetam.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have kidney disease. You may need a dose adjustment or special tests during treatment.

You may have thoughts about suicide while taking this medication. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

FDA pregnancy category C. It is not known whether levetiracetam is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Levetiracetam can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child without the advice of a doctor.

TUESDAY Nov. 1, 2011 -- Age in itself should not be a factor in deciding whether blood cancer patients are candidates for stem cell transplantation, according to a new study.

Blood cancers include leukemia, lymphoma and myeloma.

For the study, researchers analyzed long-term outcomes among 372 blood cancer patients aged 60 to 75 who underwent a "mini-transplant," which is a "kinder, gentler" form of allogeneic (cells from another person) stem cell transplantation developed at the Fred Hutchinson Cancer Research Center in Seattle.

The five-year rates of overall survival and disease progression-free survival among the patients were 35 percent and 32 percent, respectively. Comparable survival rates were seen when the patients were divided into three age groups -- 60 to 64, 65 to 69, and 70 to 75 -- suggesting that age plays a limited role in the success of the mini-transplant.

While a survival rate of one-third may seem low, all of the patients would have died within months if they didn't have the transplant, Dr. Mohamed Sorror, an assistant member of the Hutchinson Center's Clinical Research Division, noted in a news release from the Center.

The investigators also found that greater cancer aggressiveness and having a larger number of medical problems not linked to cancer ("comorbidities") were two factors that affected survival, regardless of age.

For example, the five-year survival for patients with less aggressive cancer and fewer comorbidities was 69 percent, compared with 23 percent for patients with more aggressive cancer and a large number of comorbidities, according to the report in the Nov. 2 issue of the Journal of the American Medical Association.

Conventional stem cell transplants are generally not performed on blood cancer patients older than 60 because high doses of total-body radiation and potent chemotherapy are used to prepare patients for transplantation.

However, the mini-transplant relies on the donor's immune cells to kill the cancer, and low-dose radiation and chemotherapy is used to suppress the immune system rather than destroy it.

More information

The U.S. Centers for Disease Control and Prevention has more about blood cancers.

Uprizing 2.0: Recall - Undeclared Drug Ingredient: Synthetic Steroid

ISSUE: FDA notified the manufacturer that lab analyses found that the product, sold as a testosterone booster, contains superdrol, a synthetic steroid, making it an unapproved new drug. Acute liver injury is known to be a possible harmful effect of using products containing synthetic anabolic steroids. In addition, use of synthetic anabolic steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.

BACKGROUND: On August 5, FDA made Superior Metabolic Technologies Inc aware that Uprizing 2.0 contains superdrol, which is banned by the FDA. Uprizing 2.0 was distributed through retail health food stores in Alabama, Arizona, California, Georgia, Mississippi, New Jersey, South Carolina, and Texas.

RECOMMENDATION: Consumers who purchased Uprizing 2.0 are urged to return it to the place of purchase.

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

Chantix Study

Safety Announcement

[10-24-2011] The U.S. Food and Drug Administration (FDA) has reviewed the results from two FDA-sponsored epidemiological studies that evaluated the risk of neuropsychiatric adverse events associated with the smoking cessation drug Chantix (varenicline).

Facts about Chantix (varenicline)

A prescription medicine used to help adults quit smoking Increases the likelihood of abstinence from smoking for as long as one year compared to treatment with placebo. Works by blocking the effects of nicotine (from smoking) on the brain.1 From approval in May 2006 through July 2011, approximately 21.8 million Chantix prescriptions were dispensed and approximately 8.9 million patients received Chantix prescriptions from U.S. outpatient retail pharmacies.2

Neither study found a difference in risk of neuropsychiatric hospitalizations between Chantix and nicotine replacement therapy (NRT; e.g., NicoDerm patches). However, both studies had a number of study design limitations, including only assessing neuropsychiatric events that resulted in hospitalization, and not having a large enough sample size to detect rare adverse events (see Data Summary below for more information). Although these two studies did not suggest an increased risk of neuropsychiatric events that result in hospitalization, they do not rule out an increased risk of other neuropsychiatric events with Chantix.

Healthcare professionals and patients should continue to follow the recommendations in the physician label and the patient Medication Guide, and to monitor for neuropsychiatric symptoms when prescribing or using Chantix. Based on FDA’s assessment of currently available data, the Agency continues to believe that the drug’s benefits outweigh the risks and the current warnings in the Chantix drug label are appropriate.

The risk of serious neuropsychiatric events with Chantix is currently highlighted in theBoxed Warning and Warnings and Precautions section of the physician label and in the patient Medication Guide. Such events can include changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts or actions. These warnings were based on postmarketing reports describing changes in mood and behavior during and after Chantix use (see 2008 Public Health Advisory and 2009 Public Health Advisory).

FDA is continuing to evaluate the risk of neuropsychiatric events with Chantix. The drug manufacturer is conducting a large safety clinical trial of Chantix to assess neuropsychiatric adverse events, and results from this study are expected in 2017.

Additional Information for Patients 

• Some patients have experienced changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts or actions while using Chantix to help them quit smoking. Some patients had these symptoms soon after they began taking Chantix, and others developed them after several weeks of treatment, or after stopping Chantix.
• Before taking Chantix, patients should inform their healthcare professional if they have ever had depression or other mental health problems.
• If a patient develops agitation, hostility, depressed mood, or changes in behavior or thinking that are not typical for them, or if a patient develops suicidal ideation or behavior, they should immediately discontinue Chantix and report these symptoms to their healthcare professional.
• Patients should read the Medication Guide that they get along with their Chantix prescription. It explains the risks associated with the use of Chantix.
• Patients should report serious side effects from the use of Chantix to the FDA MedWatch program.

FDA Approves Juvisync

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The U.S. Food and Drug Administration has approved Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet for use in adults who need both sitagliptin and simvastatin.

Important information about Juvisync

Serious side effects can happen in people taking Juvisync, including inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis.

Before you start taking Juvisync:

Tell your doctor if you have ever had

• pancreatitis
• stones in your gallbladder (gallstones)
• a history of alcoholism
• high blood triglyceride levels
• kidney problems

Stop taking Juvisync and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

What is Juvisync?

• Juvisync is a prescription medicine that contains two medicines, sitagliptin and simvastatin, in one pill. Juvisync can be used in adults who need both sitagliptin and simvastatin.
• Sitagliptin can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
• Simvastatin can be used with diet and exercise in adults at high risk for heart attack or stroke to lower your chance of:
  • death from heart problems
  • having a heart attack or stroke
  • needing certain blood vessel procedures
• Simvastatin can be used in adults with certain cholesterol problems to lower levels of total cholesterol, LDL (bad) cholesterol, and fatty substances called triglycerides in the blood. In addition, simvastatin raises levels of HDL (good) cholesterol. Simvastatin is for people who cannot control their cholesterol levels by diet and exercise alone. You should stay on a cholesterol-lowering diet while taking this medicine.
• Sitagliptin is not for people with type 1 diabetes.
• Sitagliptin is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).
• If you have had inflammation of your pancreas (pancreatitis) in the past, it is not known if you have a higher chance of getting pancreatitis while you take sitagliptin.
• Juvisync has not been studied in people who have an increase of chylomicrons (Fredrickson types I and V).
• Juvisync is not for people with certain kidney problems.
• It is not known if Juvisync is safe and effective when used in children under 18 years of age.

For more information, see the sections called What is type 2 diabetes? and What should I know about high cholesterol?.