Qsymia Side Effects

Qsymia Side Effects

Qsymia can cause serious side effects, including:
• Congenital malformations (cleft lip / palate). If you take Qsymia during pregnancy,
your baby has a higher risk of birth defects known as cleft lip and palate.
These defects can begin early in pregnancy, even before you know you are
pregnant.
Women who are pregnant should not take Qsymia.
Women who may become pregnant should:
1. Have a negative pregnancy test before taking Qsymia and monthly
while taking Qsymia.
2. Use effective birth control (contraception) while taking constant
Qsymia. Talk to your healthcare provider about how to prevent
pregnancy.
If you become pregnant while taking Qsymia, stop taking Qsymia
immediately, and tell your healthcare provider right away.Healthcare
providers and patients should report all cases of pregnancy:
 FDA MedWatch at 1-800-FDA-1088, and
 Program Qsymia pregnancy monitoring at 1-888-998-4887
• Increases in heart rate. Qsymia can increase your resting heart rate. Your
health care provider should check your heart rate while taking Qsymia. Say
your health care provider if you experience, rest, run or fight
feel in your chest that lasts for several minutes when taking Qsymia.
• suicidal thoughts or actions. Topiramate, an ingredient in Qsymia, may
cause you to have suicidal thoughts or actions.

Call your health care provider immediately if you have one of these
symptoms, especially if they are new, worse, or if you worry:
o thoughts of suicide or dying
o attempts suicide
o new or worse depression
o new or worse anxiety
o feeling agitated or restless
Panic attacks o
o difficulty sleeping (insomnia)
o new or worse irritability
o acting aggressive, being angry, or violent
o acting on dangerous impulses
o an extreme increase in activity and talking (mania)
o other unusual changes in behavior or mood
• The serious eye problems including:
o any sudden decrease in vision with eye pain and redness orwithout,
o blocking fluid in the eye causing increased pressure in the eye
(Secondary angle closure glaucoma).
These problems can lead to permanent vision loss if not treated. Say
your health care provider immediately if you have any new eye symptoms.
What Qsymia?
Qsymia is a prescription drug phentermine and topiramate thatcontains
extended release which may help some obese adults or overweight adults of some
also weight-related medical problems to lose weight and maintain weight.
Qsymia should be used with a reduced calorie diet and increased physical activity.
It is not known if Qsymia changes your risk of heart problems or stroke, or death
because of heart problems or stroke.
It is not known if Qsymia is safe and effective when taken with other prescription
over-the-counter, or herbal products for weight loss.
It is not known if Qsymia is safe and effective in children under 18.
Qsymia is a federally controlled substance (CIV), as it contains phentermine
and can be abused or lead to drug dependence. Keep Qsymia in a safe place
protect against theft. Never give your Qsymia to someone else, because it can
cause death or harm them. Selling or giving away this medicine is against the law.

Who should not take Qsymia?
Do not take if you Qsymia:
• you are pregnant, planning to become pregnant or become pregnant during Qsymia
treatment.
• have glaucoma
• The thyroid problems (hyperthyroidism)
• if you are taking certain drugs called monoamine oxidase (MAO) inhibitors or
have taken MAOIs within 14 days.
• you are allergic to topiramate, sympathomimetic amines such as phentermine or
any of the ingredients in Qsymia

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Qsymia: New weight loss drug which FDA approved

Qsymia: New weight loss drug which FDA approved

The U.S. Food and Drug Administration today approved Qsymia (phentermine and topiramate extended release) as a supplement to a reduced calorie diet and exercise management of chronic weight.

The drug is approved for use in adults with a body mass index (BMI) of 30 or more (obese) or adults with a BMI of 27 or more (overweight) who have at least one weight-related conditions such as blood pressure (cholesterol, hypertension), type 2 diabetes, or high (dyslipidemia).

BMI, which measures body fat based on weight of an individual and height, is used to define obesity and overweight categories. According to the Centers for Disease Control and Prevention, more than a third of adults in the United States are obese.

"Obesity threatens the well-being of patients overall and is a major concern of public health," said Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research. "Qsymia, used responsibly in combination with a healthy lifestyle that includes a reduced calorie diet and exercise, provides another treatment option for weight management in chronic Americans are obese or overweight and have at least one weight-related condition comorbidity. "

Qsymia is a combination of two FDA approved drugs, phentermine and topiramate in a sustained release formulation. Phentermine is indicated for weight loss in short-term in overweight and obese adults who exercise and a diet reduced in calories. Topiramate is indicated for treating certain types of seizures in people with epilepsy and to prevent migraine headaches.

Qsymia should not be used during pregnancy because it can cause harm to the fetus. The data show that the fetus exposed to topiramate, a component of Qsymia in the first trimester of pregnancy has an increased risk of oral clefts (cleft lip with or without cleft palate). Females of reproductive potential must not be pregnant at the time of starting treatment Qsymia or become pregnant while taking Qsymia. Females of reproductive potential must have a negative pregnancy test before starting Qsymia and every month while using the drug and must use effective contraception while taking Qsymia constantly.

The safety and efficacy of Qsymia were evaluated in two randomized, placebo-controlled trials that included approximately 3,700 obese and overweight patients with or without significant weight-related condition treated for one year. All patients received lifestyle modification, which consisted in a reduced calorie diet and regular physical activity.

The recommended daily dose of 7.5 milligrams Qsymia contains 46 mg of phentermine and topiramate extended release. Qsymia is also available at a higher dose (15 mg 92 mg phentermine and topiramate extended release) for some patients.

The results of both tests show that after one year of treatment with the recommended dose and the highest daily Qsymia, patients had a mean weight loss of 6.7 percent and 8.9 percent, respectively, compared to treatment with placebo. About 62 percent and 69 percent of patients lost at least five percent of their body weight at the recommended dose and the highest dose of Qsymia, respectively, compared to about 20 percent of patients treated with placebo.

Patients who have not lost at least three percent of their body weight by 12 weeks of treatment with Qsymia were unlikely to achieve and maintain weight loss with continued treatment at this dose. Therefore, the response to treatment with the recommended daily dose of Qsymia should be evaluated by 12 weeks to determine, based on the amount of weight loss, whether to terminate or Qsymia increase the higher dose. If after 12 weeks on higher dosage of Qsymia, a patient does not lose at least five percent of body weight, then Qsymia should be discontinued, as these patients are unlikely to reach a clinically significant weight loss with continued treatment.

Qsymia should not be used in patients with glaucoma or hyperthyroidism. Qsymia can increase heart rate, effect of this drug on heart rate in patients at high risk of heart attack or stroke is not known. Therefore, the use of Qsymia in patients with recent heart disease (during the last six months) or unstable or stroke is not recommended. Regular monitoring of heart rate is recommended for all patients taking Qsymia, especially when starting or increasing the dose Qsymia.

The FDA approved Qsymia with a risk assessment and mitigation strategy (REMS), which consists of a Medication Guide to advise patients about important safety information and elements to ensure safe operation, including training prescriber and pharmacy certification. The goal of REMS is to educate prescribers and patients about the increased risk of birth defects associated with exposure of the first quarter of Qsymia, the need for pregnancy prevention, and the need to discontinue treatment if pregnancy occurs. Qsymia will be distributed in pharmacies specially certified.

Vivus Inc. will be necessary to carry out 10 requirements for pharmacovigilance, including long-term cardiovascular outcomes trial to evaluate the effect of Qsymia the risk for major adverse cardiac events such as heart attack and stroke.

The most common side effects are tingling in Qsymia hands and feet (paresthesia), dizziness, altered taste, insomnia, constipation, and dry mouth.

Qsymia is marketed by Vivus Inc. in Mountain View, California

The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy and safety of medicinal products for human and veterinary vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety and security of food supply in our country, cosmetics, food supplements, products that emit electronic radiation, and to regulate tobacco products.

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