This popular kind of heartburn medicine can increase stroke risk

Sara G. Miller
People who took these drugs had a 21 percent increased risk of stroke compared to nonusers.
A popular type of heartburn medicine may raise a person’s risk for a common type of stroke, a new study from Denmark finds.

People in the study who took proton pump inhibitors (PPI) faced an increased risk of ischemic stroke, compared with people who did not take these medicines, according to the study, presented recently at the American Heart Association’s annual meeting, called the Scientific Sessions.

Ischemic strokes are the most common type of stroke, according to the American Stroke Association. They occur when a blood clot blocks the flow of blood to the brain, preventing a region of the brain from receiving oxygen and nutrients.

In the study, the researchers examined data collected between 1997 and 2012 on more than 244,000 Danish adults who had never had a stroke. The average follow-up time was six years, the researchers said.

Nearly 9,500 people in the study had a stroke during the follow-up period, the researchers found.  Overall, the people who took PPIs faced a 21 percent increase in risk of ischemic stroke, compared with nonusers.

However, the dose of the medicine mattered, the researchers also found.
At the lowest doses, the increase in stroke risk was only slight, or there was no increase at all, depending on the specific drug, according to the study.

At the highest doses, however, the risk of ischemic stroke was much greater. For example, people who took a daily dose of more than 80 milligrams of a PPI called pantoprazole, which goes by the brand name Protonix, faced a 94 percent increase — in other words, a near doubling — in stroke risk, compared with people who not take a PPI, the researchers found. And those who took more than 40 mg a day of the PPI omeprazole (Prilosec) were associated with a 40 percent increased risk of stroke.

This is not the first study to suggest that PPIs should be used with caution, the authors said.
“PPIs have been associated with unhealthy [blood vessel] function, including heart attacks, kidney disease and dementia,” Dr. Thomas Sehested, a researcher at the Danish Heart Foundation in Copenhagen, and the lead author of the study, said in a statement.
“At one time, PPIs were thought to be safe, without major side effects. This study further questions the cardiovascular safety of these drugs,” Sehested said.

Although the study found an association between PPIs and stroke risk, it does not prove cause and effect. More studies are needed, and doctors should consider if and for how long patients should take these drugs, the researchers said.

PPIs are not the only medicines available to treat heartburn. The researchers noted that another type of heartburn medication, called a histamine H2 antagonist, was found to have no association with stroke risk in the study. Histamine H2 antagonists include famotidine (Pepcid) and ranitidine (Zantac).
The authors said that they couldn’t conclude whether these drugs were better for people than PPIs, however. Histamine H2 agonists can also have side effects, although they are rare, according to information about the drugs from the Mayo Clinic.

Source: LiveScience.com
Courtesy: The Huffington Post

 

FDA approves Intrarosa (prasterone) for dyspareunia

 

The U.S. Food and Drug Administration approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA).

During menopause, levels of estrogen decline in vaginal tissues, which may cause a condition known as VVA, leading to symptoms such as pain during sexual intercourse.

“Pain during sexual intercourse is one of the most frequent symptoms of VVA reported by postmenopausal women,” said Audrey Gassman, M.D., deputy director of the Division of Bone, Reproductive, and Urologic Products (DBRUP) in the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research (CDER).

“Intrarosa provides an additional treatment option for women seeking relief of dyspareunia caused by VVA.”

Efficacy of Intrarosa, a once-daily vaginal insert, was established in two 12-week placebo-controlled clinical trials of 406 healthy postmenopausal women, 40 to 80 years of age, who identified moderate to severe pain during sexual intercourse as their most bothersome symptom of VVA.
Women were randomly assigned to receive Intrarosa or a placebo vaginal insert. Intrarosa, when compared to placebo, was shown to reduce the severity of pain experienced during sexual intercourse.

The safety of Intrarosa was established in four 12-week placebo-controlled trials and one 52-week open-label trial. The most common adverse reactions were vaginal discharge and abnormal Pap smear.

Although DHEA is included in some dietary supplements, the efficacy and safety of those products have not been established for diagnosing, curing, mitigating, treating or preventing any disease.

Do not use the vaginal inserts if you have vaginal bleeding that has not been checked by your healthcare provider.
Before using the vaginal inserts, tell your healthcare provider about all of your medical conditions, including if you:
have, have had, or think you may have had breast cancer. Prasterone, the active ingredient in Intrarosa vaginal inserts, is changed in your body to estrogen. Estrogen medicines are not for use in women who have, have had, or think they may have had breast cancer.
are pregnant or plan to become pregnant. Intrarosa vaginal inserts are only for use in women who are past menopause. It is not known if the vaginal inserts will harm your unborn baby.
are breastfeeding or plan to breastfeed. Intrarosa vaginal inserts are only for use in women who are past menopause. It is not known if the active ingredient passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Use the vaginal inserts exactly how your healthcare provider tells you to use them.
Place one vaginal insert in your vagina one time each day at bedtime, using the applicator provided.

Intrarosa Side Effects
The most common side effects of Intrarosa are vaginal discharge and changes on Pap smear.
These are not all of the possible side effects. Call your doctor for medical advice about side effects.

Source: drugs.com

 

 

 

This popular kind of heartburn medicine can increase stroke risk

Sara G. Miller People who took these drugs had a 21 percent increased risk of stroke compared to nonusers. A popular type of heartburn medicine may raise a persons risk for a common type of stroke, a new study from Denmark finds. People in the study who took proton pump inhibitors (PPI) faced an increased risk of ischemic stroke, compared with people who did not take these medicines, according to the study, presented recently at the American Heart Associations annual meeting, called the Scientific Sessions. Ischemic strokes are the most common type of stroke, according to the American Stroke Association. They occur when a blood clot blocks the flow of blood to the brain, preventing a region of the brain from receiving oxygen and nutrients. In the study, the researchers examined data collected between 1997 and 2012 on more than 244,000 Danish adults who had never had a stroke. The average follow-up time was six years, the researchers said. Nearly 9,500 people in the study had a stroke during the follow-up period, the researchers found. Overall, the people who took PPIs faced a 21 percent increase in risk of ischemic stroke, compared with nonusers. However, the dose of the medicine mattered, the researchers also found. At the lowest doses, the increase in stroke risk was only slight, or there was no increase at all, depending on the specific drug, according to the study. At the highest doses, however, the risk of ischemic stroke was much greater. For example, people who took a daily dose of more than 80 milligrams of a PPI called pantoprazole, which goes by the brand name Protonix, faced a 94 percent increase in other words, a near doubling in stroke risk, compared with people who not take a PPI, the researchers found. And those who took more than 40 mg a day of the PPI omeprazole (Prilosec) were associated with a 40 percent increased risk of stroke. This is not the first study to suggest that PPIs should be used with caution, the authors said. PPIs have been associated with unhealthy [blood vessel] function, including heart attacks, kidney disease and dementia, Dr. Thomas Sehested, a researcher at the Danish Heart Foundation in Copenhagen, and the lead author of the study, said in a statement. At one time, PPIs were thought to be safe, without major side effects. This study further questions the cardiovascular safety of these drugs, Sehested said. Although the study found an association between PPIs and stroke risk, it does not prove cause and effect. More studies are needed, and doctors should consider if and for how long patients should take these drugs, the researchers said. PPIs are not the only medicines available to treat heartburn. The researchers noted that another type of heartburn medication, called a histamine H2 antagonist, was found to have no association with stroke risk in the study. Histamine H2 antagonists include famotidine (Pepcid) and ranitidine (Zantac). The authors said that they couldnt conclude whether these drugs were better for people than PPIs, however. Histamine H2 agonists can also have side effects, although they are rare, according to information about the drugs from the Mayo Clinic. Source: LiveScience.com Courtesy: The Huffington Post FDA approves Intrarosa (prasterone) for dyspareunia The U.S. Food and Drug Administration approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA). During menopause, levels of estrogen decline in vaginal tissues, which may cause a condition known as VVA, leading to symptoms such as pain during sexual intercourse. Pain during sexual intercourse is one of the most frequent symptoms of VVA reported by postmenopausal women, said Audrey Gassman, M.D., deputy director of the Division of Bone, Reproductive, and Urologic Products (DBRUP) in the Office of Drug Evaluation III in the FDAs Center for Drug Evaluation and Research (CDER). Intrarosa provides an additional treatment option for women seeking relief of dyspareunia caused by VVA. Efficacy of Intrarosa, a once-daily vaginal insert, was established in two 12-week placebo-controlled clinical trials of 406 healthy postmenopausal women, 40 to 80 years of age, who identified moderate to severe pain during sexual intercourse as their most bothersome symptom of VVA. Women were randomly assigned to receive Intrarosa or a placebo vaginal insert. Intrarosa, when compared to placebo, was shown to reduce the severity of pain experienced during sexual intercourse. The safety of Intrarosa was established in four 12-week placebo-controlled trials and one 52-week open-label trial. The most common adverse reactions were vaginal discharge and abnormal Pap smear. Although DHEA is included in some dietary supplements, the efficacy and safety of those products have not been established for diagnosing, curing, mitigating, treating or preventing any disease. Do not use the vaginal inserts if you have vaginal bleeding that has not been checked by your healthcare provider. Before using the vaginal inserts, tell your healthcare provider about all of your medical conditions, including if you: have, have had, or think you may have had breast cancer. Prasterone, the active ingredient in Intrarosa vaginal inserts, is changed in your body to estrogen. Estrogen medicines are not for use in women who have, have had, or think they may have had breast cancer. are pregnant or plan to become pregnant. Intrarosa vaginal inserts are only for use in women who are past menopause. It is not known if the vaginal inserts will harm your unborn baby. are breastfeeding or plan to breastfeed. Intrarosa vaginal inserts are only for use in women who are past menopause. It is not known if the active ingredient passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Use the vaginal inserts exactly how your healthcare provider tells you to use them. Place one vaginal insert in your vagina one time each day at bedtime, using the applicator provided. Intrarosa Side Effects The most common side effects of Intrarosa are vaginal discharge and changes on Pap smear. These are not all of the possible side effects. Call your doctor for medical advice about side effects. Source: drugs.com