FDA Proposes Withdrawal of Low Blood Pressure Drug

Posted in Medicine on September 6th, 2010 by marie – Be the first to comment

News of August 16, 2010
From FDA Website

FDA Proposes Withdrawal of Low Blood Pressure Drug
Companies failed to provide evidence of clinical benefit of midodrine hydrochloride.

The U.S. Food and Drug Administration (FDA) proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done.

People who currently take this medication should not stop taking it and should consult their health care professional about other treatment options.

The drug, marketed as ProAmatine by Shire Development Inc. and as a generic by others, was approved in 1996 under the FDA’s accelerated approval regulations for drugs that treat serious or life-threatening diseases. That approval required that the manufacturer verify clinical benefit to people through post-approval studies.

Neither the original manufacturer nor any generic manufacturer has demonstrated the drug’s clinical benefit, for example, by showing that use of the drug improved a persons ability to perform life activities.

Orthostatic hypotension is a condition in which people are unable to maintain blood pressure in the upright position and, therefore, become dizzy or faint when they stand up.

Name: ProAmatine®(midodrine hydrochloride) Tablets
Dosage Form: 2.5 mg, 5 mg and 10 mg tablets for oral administration
Active Ingredient: Midodrine hydrochloride, 2.5 mg, 5 mg and 10 mg

For more information go to

Using Malaria Medication for Leg Cramps is Risky

Posted in Medicine on August 31st, 2010 by marie – Be the first to comment

People who use the drug Qualaquin to treat or prevent nighttime leg cramps may be at risk for serious and life threatening reactions, according to the Food and Drug Administration (FDA).

Qualaquin (quinine sulfate) is FDA approved only to treat a certain type of malaria (uncomplicated malaria) caused by the parasite Plasmodium falciparum. This infection, which is rare in the United States, is found mainly in travelers who have been to countries where malaria occurs. However, most of Qualaquin’s use in the U.S. is for the treatment or prevention of nighttime leg cramps – a use NOT approved by FDA.

FDA has received reports of side effects after people used Qualaquin to prevent or treat leg cramps or restless leg syndrome. Side effects included serious and life threatening reactions in 38 reports. Of these 38 reports, there were 24 blood related reactions, including a severe lowering of platelets in the blood. Some of the blood related side effects resulted in permanent kidney damage, hospitalization, and two deaths.

Advice for People

  • If you take Qualaquin for nighttime leg cramps, you should discuss other treatment options with your health care professional.
  • Contact your health care professional immediately if you experience easy bruising, severe nose bleeding, blood in your urine or stool, bleeding gums, or the appearance of unusual purple, brown, or red spots on your skin.
  • Read the medication guide given to you at the pharmacy when you pick up a prescription for Qualaquin.
  • Report any side effects with the use of Qualaquin to FDA’s MedWatch Adverse Event Reporting Program by using:
    • Online at
    • Regular mail – use postage paid, pre-addressed FDA form 3500 at
    • Fax 1-800-FDA-0178
    • Phone 1-800-332-1088

FDA Action
As part of a risk management plan, FDA requires that people receive a medication guide at the pharmacy when they pick up a prescription for Qualaquin. The medication guide explains what the drug is and is not approved for, as well as its potential side effects.

Source from July 8, 2010

FDA Reviewer Questions Results of Key Avandia Trial

Posted in General, Medicine on July 10th, 2010 by marie – Be the first to comment

July 10, 2010

FRIDAY, July 9 (HealthDay News) – One step ahead of a planned government review of the safety of Avandia, new doubts surfaced Friday on a key trial that helped keep the blockbuster diabetes drug on the market.

A medical reviewer for the U.S. Food and Drug Administration posted remarks on the agency’s Web site Friday suggesting that drugmaker GlaxoSmithKline’s “mishandling” of trial results may have masked some cardiovascular effects of Avandia (rosiglitazone).

The official’s posting was part of a safety reassessment package prepared for next week’s advisory panel meeting that could determine the future of the controversial drug.

At issue in the review posting were the results of the landmark RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes) trial, which was done by Glaxo at the FDA’s request. The results, announced in June of 2009, found that Avandia raised the risk of heart failure but not to a level of statistical significance. The study also concluded that the drug did not increase the risk of cardiovascular disease or overall death.

In his posting, Thomas A. Marciniak, medical team leader of the division of cardiovascular and renal products at the FDA’s Center for Drug Control and Evaluation, said that “RECORD was inadequately designed and conducted to provide any reassurance about the (cardiovascular) safety of rosiglitazone” and that “RECORD suggests the (sic) rosiglitazone increases the risk for (heart attacks).”

Last June, Glaxo used the trial results to tout the drug’s safety.

“RECORD provides important and reassuring information about Avandia for physicians fighting diabetes,” said Dr. Ellen Strahlman, Glaxo’s chief medical officer, in a statement released at the time. “We believe that the results showed that Avandia is safe.”

On Friday, the company, in a prepared statement, said, “The RECORD study was conducted according to good clinical practices and the data are reliable… RECORD demonstrated that Avandia was not associated with an overall increase in cardiovascular hospitalization or cardiovascular death compared to metformin and sulfonylureas.”

But Dr. Kirk Garratt, clinical director of interventional cardiovascular research at Lenox Hill Hospital in New York City, said Friday, “If the data from RECORD had truly been mishandled in some way, not only is it going to pretty well be the end of Avandia in the clinical world, but it’s going to put GlaxoSmithKline under the magnifying glass in an important way for clinicians going forward. They’ll lose credibility, and that’s tough to get back.”

“There is an alternative drug out there,” Garratt added. “From the clinical side, it’s a fortunate circumstance that we find ourselves in, since we have an alternative product that seems to have (little) risk associated with it.”

Actos (pioglitazone), made by Takeda, is in the same pharmaceutical class as Avandia. Both are medications known as thiazolidinediones (TZDs), which are blood-sugar-lowering drugs. Both are used by type 2 diabetics.

“The bulk of studies have suggested that Avandia is associated with greater cardiovascular mortality than the alternative, which is pioglitazone,” noted Dr. Ronald Goldberg, a professor of medicine at the University of Miami Miller School of Medicine, on Friday.

This is only the latest in a series of conflicting information about Avandia’s heart risks. In November of 2007, the FDA added a boxed warning to the drug, saying that there was a potential risk of increased cardiovascular ischemic events. Patients also began receiving a medication guide explaining the risks.

But just last week, three studies emerged with conflicting conclusions about the drug’s safety. Two of them, published in major medical journals, found that Avandia did raise heart risks, while the third, released at the American Diabetes Association meeting, found no such connection.

Next week’s meeting will shed much-needed light on the matter.

When the advisory panel meets Tuesday and Wednesday, its options “range from allowing the continued marketing of Avandia and revising the label to remove the boxed warning, all the way to withdrawal from the U.S. market,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, explained at a packed news briefing late Thursday. “We’re asking them to pick one, vote on it and explain the rationale.”

But, according to the The New York Times, the panel will also be asked to decide whether a currrent Glaxo study comparing the safety of Avandia and Actos is ethical. The study is being done at the FDA’s request.

The FDA is not bound to follow the recommendations of its advisory committees but usually does.

Much of the current controversy, Garratt said, “probably reflects dissent within FDA. They’ve been debating this internally for a long time. This is probably just turning up the heat on that argument.”

Dr. Joshua Sharfstein, principal deputy commissioner of the FDA, told reporters on Thursday, “Obviously, we’re going to have to look at a lot of information and really understand the advice that we’re getting and try to make a decision as quickly as we can under the circumstances. This is an FDA decision.”

Meanwhile, the European Medicines Agency announced Friday morning that it would also review Avandia’s safety for use in Europe. The Associated Press reports that the review will be conducted by the agency’s Committee for Medicinal Products for Human Use from July 19 to July 22.

More information:
The U.S. National Library of Medicine has more on Avandia and Actos.

SOURCES: Kirk Garratt, M.D., clinical director of interventional cardiovascular research, Lenox Hill Hospital, New York City; Ronald Goldberg, M.D., professor of medicine, University of Miami Miller School of Medicine; July 9, 2010, statement, GlaxoSmithKline; July 8, 2010 teleconference with Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Joshua Sharfstein, M.D., principal deputy commissioner, FDA, and Jill Warner, acting associate commissioner for Special Medical Programs, FDA; Associated Press; New York Times.
Copyright © 2010 HealthDay

Infant Overdose Risk With Liquid Vitamin D

Posted in Medicine, Vitamins - Supplements on June 16th, 2010 by marie – Be the first to comment

The Food and Drug Administration (FDA) is warning of the potential risk of overdosing infants with liquid vitamin D.

Some liquid vitamin D supplement products on the market come with droppers that could allow parents and caregivers to accidentally give harmful amounts of the vitamin to an infant. These droppers can hold a greater amount of liquid vitamin D than an infant should receive.

“It is important that infants not get more than the recommended daily amount of vitamin D,” says Linda M. Katz, M.D., M.P.H., interim chief medical officer in FDA’s Center for Food Safety and Applied Nutrition. “Parents and caregivers should only use the dropper that comes with the vitamin D supplement purchased.”

Vitamin D promotes calcium absorption in the gut and plays a key role in the development of strong bones. Vitamin D supplements are recommended for some infants – especially those that are breastfed – because deficiency of this vitamin can lead to bone problems such as thinning, soft, and misshaped bones, as is seen with the condition known as rickets.

The FDA advised manufacturers of liquid Vitamin D supplements that droppers accompanying these products should be clearly and accurately marked for 400 international units (IU). For products intended for infants, FDA recommends that the dropper hold no more than 400 IU.

The American Academy of Pediatrics (AAP) has recommended a dose of 400 IU of Vitamin D supplement per day to breastfed and partially breastfed infants. The easiest way to ensure that an infant will not get more than the recommended dose is to use a product supplied with a dropper that will give no more than 400 IU per dose.

Be aware that excessive vitamin D can cause nausea and vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, and fatigue, as well as more serious consequences like kidney damage.

FDA’s Recommendations

  • Ensure that your infant does not receive more than 400 international units (IUs) of vitamin D a day, which is the daily dose of vitamin D supplement that the American Academy of Pediatrics recommends for breastfed and partially breastfed infants.
  • Keep the vitamin D supplement product with its original package so that you and other caregivers can follow the instructions. Follow these instructions carefully so that you use the dropper correctly and give the right dose.
  • Use only the dropper that comes with the product – it is manufactured specifically for that product. Do not use a dropper from another product.
  • Ensure the dropper is marked so that the units of measure are clear and easy to understand. Also make sure that the units of measure correspond to those mentioned in the instructions.
  • If you cannot clearly determine the dose of vitamin D delivered by the dropper, talk to a health care professional before giving the supplement to the infant.
  • If your infant is being fully or partially fed with infant formula, check with your pediatrician or other health care professional before giving the child vitamin D supplements.

Remember: Any type of medication or dietary supplement can have adverse effects and must be taken according to the manufacturer’s directions.

This article appears on the Food and Drug Administration (FDA) Consumer Updates, which features the latest on all FDA-regulated products.
June 15, 2010

Find consumer updates at

Young People and Antidepressants

Posted in Children's Health, Medicine on May 7th, 2010 by marie – Be the first to comment

It may be safe for young people who suffer from depression to be treated with antidepressants, but drug companies who make antidepressants are required to post a “black box” warning label on the medication. A black box warning is the most serious type of warning on prescription medicines.

It may be possible that antidepressants make children, adolescents, and young adults more likely to think about suicide or commit suicide.

The warning says that individuals of all ages taking antidepressants should be watched closely, especially in young adults ages 18 to 24 during initial treatment, generally the first one to two months. read more »

Medications That Cause Constipation

Posted in Medicine on March 31st, 2010 by marie – Be the first to comment

Be aware that some medications can cause constipation. Here are some:

  • Pain medications – especially narcotics
  • Antacids – stomach acid neutralizers – that contain aluminum and calcium
  • Blood pressure medications – calcium channel blockers
  • Antiparkinson drugs – a drug intended to treat and relieve the symptoms of Parkinson’s disease (PD)
  • Antispasmodics – a drug that relieves spasms or cramps
  • Antidepressants – a drug to treat depression
  • Iron supplements
  • Diuretics – a drug that increases the flow of urine
  • Anticonvulsants – prevents convulsions or seizures


Posted in Medicine, Weight Loss - Weight Gain on February 27th, 2010 by marie – Be the first to comment

Sibutramine Hydrochloride (Meridia) – pronounced si-BYOO-tra-meen.

Sibutramine is a prescription drug that suppresses your appetite. Sibutramine was approved by the Food and Drug Administration (FDA) in 1997 for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with a reduced calorie diet.

Warnings about Sibutramine
When using sibutramine, people with a history of cardiovascular disease have an increased risk of heart attack and stroke, including:

  • History of coronary artery disease – for example – heart attack, angina.
  • History of stroke or transient ischemic attack (TIA).
  • History of heart arrhythmias.
  • History of congestive heart failure.
  • History of peripheral arterial disease.
  • Uncontrolled hypertension – for example – 145/90 mmHg.

Sibutramine may cause side effects:

  • Raise your blood pressure and heart rate.
  • Dry mouth, hoarseness, or sore throat.
  • Headache.
  • Constipation.
  • Anxiety, nervousness, extreme excitement, or restlessness.
  • Trouble sleeping.
  • Change in appetite.
  • Heartburn.
  • Weakness.
  • Back pain.
  • Stomach pain.
  • Chest pain.
  • Runny nose.
  • Flu-like symptoms.
  • Flushing.
  • Painful menstrual periods.
  • Confusion.
  • Nausea, or vomiting.
  • Depression.
  • Dizziness, lightheadedness, or fainting.
  • Uncoordinated or abnormal movement.
  • Muscle stiffness.
  • Shaking hands that you cannot control.
  • Seizures.
  • Shivering.
  • Excessive sweating.
  • Fever.
  • Large pupils, change in vision, eye pain, or swelling of the eyes.
  • Hives, or skin rash.
  • Itching.
  • Difficulty breathing, swallowing, or speaking, or shortness of breath.
  • Swelling of the face, tongue, throat, lips, hands, or lower legs, ankles, or feet.
  • Unusual bleeding or bruising.

Before taking Sibutramine, talk with your doctor about the benefits and the side effects. You should not take Sibutramine if you have a history of high blood pressure, heart problems, or strokes.


Posted in Medicine, Weight Loss - Weight Gain on February 1st, 2010 by marie – Be the first to comment

Orlistat – pronounced OR-li-stat. Orlistat is a weight control prescription drug that keeps your body from absorbing fat from the food you eat.

Alli and Xenical
The weight loss drugs Alli and Xenical both contain orlistat. Xenical contains 120 mg (milligrams) of orlistat, and is available by prescription only. Alli contains 60 mg of orlistat and is sold over-the-counter in stores without a prescription.

How Orlistat Works
Orlistat blocks the enzyme lipase. Lipase is responsible for breaking down dietary fats to prepare them for bile and absorption. When fat isn’t broken down, the body can not absorb it, so you will take in fewer calories. Also… the fat will go right through you, making you spend a lot of time in the bathroom. Eating a low-fat diet can help prevent this.

Side Effects of Orlistat
Orlistat may cause:

  • Severe liver damage – Signs of liver damage:
    • Itching
    • Yellow eyes or skin
    • Dark urine
    • Loss of appetite
    • Light colored stools
  • Diarrhea
  • Cramping
  • Gas with oily spotting
  • Leakage of oily stool
  • Loose stools
  • Oily or fatty stools
  • Increased number of bowel movements
  • Difficulty controlling bowel movements
  • Pain or discomfort in the rectum (bottom)
  • Irregular menstrual periods
  • Headache
  • Anxiety

Orlistat may prevent your body from absorbing the fat-soluble vitamins A, D and E from the foods you eat. Talk with your doctor about whether you should take a multivitamin.

Ask your doctor about the benefits and the side effects before taking Orlistat.

Plants and Medicine

Posted in Medicine on January 31st, 2010 by marie – Be the first to comment

Did you know that over 40 percent of medicines that are prescribed in the United States contain chemicals derived from plants. Without plants, most medicines you take would not exist!!

When our ancestors drank tea made from the bark of a willow tree, they noticed that their aches and pains went away. Scientists later found that the bark of a willow tree contains salicylic acid, the active ingredient in aspirin. And the native Pacific yew was burned for many years as trash in the Pacific Northwest by logging operations, then in 1975, taxol, a substance in its bark, was found to reduce the production of cancerous tumors.

It is an enormous task to search of known plants for medicinal chemicals, but chemists and botanists (those who study plants) continue to search the plant kingdom throughout the world, including the wild places in the United States, for new medicines.

Only 2 percent of the estimated 250,000 plant species on earth have been thoroughly screened for chemicals with potential medicinal use. Native plant habitats are destroyed almost daily, so before scientists can even investigate them, many medicinally valuable plants will be gone.

Source – PCA-MPWG (Plant Conservation Alliance – Medicinal Plant Working Group)

Avandia and Actos

Posted in Medicine on December 6th, 2009 by marie – Be the first to comment

Thiazolidinedione – pronounced THY-uh-ZOHL-ih-deen-DY-ohn – a class of oral medicines approved for the treatment of type 2 diabetes that helps insulin take glucose from the blood into the cells for energy by making cells more sensitive to insulin.

Brand Name – Avandia, Generic Name – rosiglitazone maleate.
Brand Name – Actos, Generic Name – pioglitazone.

Avandia and Actos medications helps treat insulin resistance.

With insulin resistance, your body doesn’t use insulin the way it should. Thiazolidinediones help your insulin work properly. Then your blood glucose levels stay on target and your cells get the energy they need.

If you have heart failure (very poor pumping ability of the heart), you should not take this type of medication, it can cause congestive heart failure or make it worse. Studies have shown that Avandia is associated with an increased risk for heart attacks and chest pain (angina) or discomfort from blocked blood vessels. Congestive heart failure is a condition in which your heart no longer pumps properly. Then your body keeps too much fluid in your legs, ankles, and lungs.

Call your doctor right away if you have signs of heart failure. Warning signs of heart failure include:

  • Having swelling in your legs or ankles.
  • Gaining a lot of weight in a short time.
  • Having trouble breathing.
  • Having a cough.
  • Being very tired.

Possible Side Effects of This Medicine

  • Congestive heart failure is the most serious side effect.
  • Anemia, a condition that can make you feel very tired.
  • An increased risk of getting pregnant even if you’re taking birth control pills.
  • Women who take Actos, Avandia, or combination diabetes pills containing pioglitazone or rosiglitazone may have an increased risk of bone fractures.
  • This type of pill doesn’t cause low blood glucose by itself, but your risk of having low blood glucose goes up if you also take:
    • Diabetes pills that cause low blood glucose
    • Insulin

Your doctor may ask you to take a lower dose of your other diabetes medicines while you take this type of medication.

You should talk to your doctor about whether to take this type of medication if:

  • You have heart failure or other heart problems.
  • You are on any medicines for high blood pressure, high cholesterol, or heart failure, or for prevention of heart disease or stroke.
  • You take insulin or nitrate medicines.
  • You are pregnant, planning to get pregnant, breastfeeding, or planning to breastfeed.
  • You have liver disease. If you take Actos or Avandia, your doctor should make sure your liver is working properly. Call your doctor right away if you have any signs of liver disease: nausea, vomiting, stomach pain, tiredness, dark-colored urine, or loss of appetite.
  • You have macular edema – a type of diabetic eye disease.