EU bans controversial diabetes pill

September 24, 2010 in Drug Information


It’s been a long time coming. Avandia, the controversial diabetes pill, has finally been pulled off European pharmacy shelves due to its heart attack risk for the majority of people. The US Food & Drug Adminstration (FDA) did not follow suit by banning Avandia, but they placed strict restrictions on its use. Doctors should only prescribe Avandia as a last-resort if other medications can’t control blood sugar and will be required to document that their patients are eligible and have been briefed on its risks. If you are currently taking Avandia, check with your doctor to determine whether you should continue it or not.

Is this popular diabetes drug on its way out?

February 21, 2010 in Drug Information

Avandia, which contains the chemical ingredient Rosiglitazone, is a popular drug used in diabetes; its fate to remain on pharmacy shelves is currently being debated as there are controversial studies linking Avandia with an increased risk of heart attacks.  The U.S. Food and Drug Administration are considering to ban Avandia from the market due to safety concerns.  It is not surprising to know that the pharmaceutical company GlaxoSmithKline reports that the drug is safe; who can blame them given the fact that Avandia is their third best selling drug in 2006, with revenue of $ 2.2 billion.   However, when reports surfaced the following year that Avandia was linked to heart attacks, the company’s earnings were cut in half by the end of 2008.  Other medications that contain Rosiglitazone are marketed under the names Avandamet and Avandaryl.

JFDA & US FDA pulls weight-loss drug off market!

January 26, 2010 in Drug Information

The Jordan Food and Drug Administration (JFDA) is pulling Reductil (chemical name Sibutramine) off the market due to a higher risk of heart complications.

I am extremely happy with this decision and I hope that all countries remove this product from their pharmacy shelves.  The FDA in the states has still not recalled this medication, but I am sure many outside groups will start putting the pressure. Reductil has already been banned across Europe following a six-year study that showed an increased risk of serious cardiovascular events in those taking Reductil compared to people not taking the drug.

Be aware that Sibutramine is also marketed under other brand names such as Meridia and Sibutrex.   JFDA also urges those taking similar products (not legally registered), such as Reduct to stop taking them for their own safety.

Another final warning, there are many different weight loss products marketed as “dietary supplements” that illegally contain undisclosed amounts of sibutramine, and similar cases pointing to Chinese “herbal supplements.”  Many of these products do not accurately list the ingredients and are not forced to meet the strict codes for medicine approval.

Sibutramine withdrawn from U.S. market

Abbott agrees to take Meridia off the market due to increased risk of heart attack and stroke.

Abbott Laboratories agreed last week to a voluntary withdrawal of Meridia (sibutramine) in the United States. The weight-loss drug has been linked to increased risk of heart attack and stroke, according to FDA.

FDA requested this withdrawal based on results from SCOUT (Sibutramine Cardiovascular Outcomes Trial), which was initiated after the European approval of the drug. Results from SCOUT indicated a 16% increase in the risk of serious heart events, including nonfatal myocardial infarction, nonfatal stroke, resuscitated cardiac arrest, and cardiovascular death, in patients given sibutramine compared with those given placebo.

“Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke,” said John Jenkins, MD, Director of the Office of New Drugs in the FDA Center for Drug Evaluation and Research Office, in a news release. Jenkins advised physicians to stop prescribing Meridia and patient to stop taking the drug and consult with a health professional about alternative weight loss and weight loss maintenance programs.

Meridia was approved in 1997 for weight loss and maintenance of weight loss in obese people and in certain overweight people with other risks for heart disease. FDA’s decision was based on an analysis of SCOUT results during a FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting on September 15.

Posted by Alex Egervary (aegervary@aphanet.org)
October 14, 2010, 5:00 pm

http://www.pharmacist.com/AM/Template.cfm?Section=Pharmacy_News&Template=/CM/ContentDisplay.cfm&ContentID=24468

Recalled medications from the States and United Arab Emirates

January 18, 2010 in Drug Information

For your information, in case your relatives shipped these medications to you from the states or UAE to Jordan.  Not a big deal, but good to know!

Massive OTC recall affects two dozen J&J products

Specific lots of more than two dozen nonprescription product lines are being recalled because of consumer complaints about an unusual moldy, musty, or mildew-like odor leading in some patients to transient gastrointestinal symptoms. FDA and McNeil Consumer Healthcare said on Friday that consumers should stop using the recalled products and contact the company for refunds.

This latest action expands a similar recall in December 2009 of all lots of Tylenol Arthritis Pain 100 count with EZ-Open Caps. The company says that the problematic smell resulted from presence of 2,4,6-tribromoanisole, a breakdown product of a chemical used to treat the wooden pallets on which the products were stored. Nausea, stomach pain, vomiting, and diarrhea have been reported by a small number of patients after using the products.

The recall includes Tylenol, Motrin, Benadryl, Rolaids, Simply Sleep, and St. Joseph products distributed in the United States, United Arab Emirates, and Fuji. A PDF file with all affected products and lots can be downloaded at http://www.fda.gov/downloads/Safety/Recalls/UCM197813.pdf

Source of this article: http://www.pharmacist.com/AM/Template.cfm?Section=Pharmacy_News&template=/CM/ContentDisplay.cfm&ContentID=22092

Difference between Tylenol/Panadol and Advil/Brufen?

January 16, 2010 in Drug Information

1. Aspirin was introduced in 1899 marking it as the oldest pain reliever.

2. Acetaminophen is the same as Paracetamol so if anybody ships you a bottle of Tylenol from the states, know that it is the same as Panadol and Revanin.

3.  Acetaminophen and Paracetamol is abbreviated APAP so pay attention to the labels on your medicines.

4. Advil, Nuprin, Motrin and Brufen are all the same stuff containing the chemical ingredient Ibuprofen.

5. Many over-the-counter cough, cold, flu, headache and even sleep medications contain aspirin, ibuprofen or paracetamol so watch out for duplication by looking at the ingredient list on medicine labels.

6. Acetaminophen is milder on the stomach, whereas Ibuprofen can cause upset stomach.

7. Ibuprofen is better at reducing inflammation than Acetaminophen.

8. Aspirin should not be used in anybody under 19 years old unless approved by the doctor (causes Reye’s syndrome which can be fatal).

9. Children should have the dose of medication calculated according to weight, rather than age.

10. Aspirin is also called acetylsalicylate, acetylsalicylic acid or abbreviated as ASA.

11. Aspirin and ibuprofen (Brufen) are both NSAID’s (non-steroidal anti-inflammatory drugs), whereas Panadol is not considered an NSAID.

12. NSAID’s, if taken excessively or chronically, can increase the risk of stomach bleeding.

13. NSAID’s should be taken with food or milk; Panadol can be taken on an empty stomach.

14. Ibuprofen has been assigned by the FDA to pregnancy category C prior to 30 weeks gestation and pregnancy category D at greater than or equal to 30 weeks gestation; acetaminophen is given a B pregnancy rating.

9 Myths about antibiotics

January 14, 2010 in Drug Information

It is not always easy to figure out if you need antibiotics when you are sick; even doctors have a hard time telling the difference. Here are the common myths associated with antibiotic use.

Virus vs. Bacteria
Antibiotics are solely used in treating bacterial infections. Antibiotics do not help, or cure, nor prevent viral infections. It is often difficult to distinguish between viral and bacterial infections because they share many symptoms but they are fundamentally different. Bacteria are 10-100 times larger than viruses, grow on about anything and have mostly beneficial roles in humans. In fact, ninety-nine percent of all bacteria are good such as Lactobacillus in the intestines which help us digest food. On the other hand, viruses are smaller, need a living host to survive and are mostly harmful.

Myth #1: Antibiotics are used for treatment of colds and flu.
Fact: All colds and the flu are caused by viruses (not bacteria) so antibiotics will not work. In fact, using antibiotics for viral infections leads to drug resistance which means some antibiotics will stop being effective. We are already seeing this with penicillin. Infections that were previously successfully treated with penicillin are now developing resistance. This means that stronger antibiotics are needed for the simplest of infections.

Myth #2: A bad cough always requires antibiotics.
Fact: Even if you have an awful sounding cough, do not pick up antibiotics without consulting your doctor. All respiratory infections cause cough and the severity does not indicate whether it is viral or bacterial. The cough is the last symptom to disappear in colds and flu, often taking 2 weeks to resolve on its own.

Myth #3: A sore throat always requires antibiotics.
Fact: People mistakenly believe a sore throat justifies an antibiotic. The majority of sore throats are caused by viruses. Only 35% of sore throats in children and 10% in adults require antibiotics due to Streptococcus bacteria which can only be detected by a laboratory throat test to determine if bacteria is present or not.

Myth #4: A high fever always requires antibiotics.
Fact: Any foreign body such as viruses and bacteria can trigger a fever and does not automatically warrant antibiotics. Fevers are a tool used by our body to get rid of the microbes causing disease, and does not signify whether the microbe is bacterial or viral.

Myth #5: Antibiotics will help me get better faster.
Fact: Taking antibiotics for colds and flu will not get rid of bothersome symptoms faster. These illnesses just need to take their toll and expect that colds can make you feel bad for a few days, while the flu can make you feel quite ill for weeks. Antibiotics will not lessen cold or flu symptoms and should not be taken on a “just in case” basis.

Myth #6: Antibiotics help the immune system fight colds and flu.
Fact: Some people wrongly assume that if they take antibiotics for a cold or flu, antibiotics would help their immune system fight the virus. Antibiotics do not strengthen the immune system, they only kill bacteria. The problem occurs when somebody takes an antibiotic and it does not help, they often switch to a stronger antibiotic and get better. They attribute the last antibiotic as successful when instead the immune system did all the work and the virus just ran its course.

Myth #7: Doctors who refuse to give antibiotics are incompetent.
Fact: It is an unfortunate social practice that patients demand antibiotics and do not feel satisfied without one. If your doctor feels an antibiotic is unnecessary, do not pressure him/her in prescribing one; chances are it is a virus and the doctor is saving you the headache of developing drug resistance in the future.

Myth #8: There is no harm in taking antibiotics.
Fact: Giving antibiotics in the absence of invading bacteria is like sending your troops to a battlefield and not finding the enemy so the antibiotic shoots aimlessly killing the good bacteria in your body. Not to mention unnecessary exposure to a list of side effects such as rash, diarrhea and yeast infections. An even more worrisome effect is the emergence of drug resistance. That’s why the World Health Organization has adopted a global awareness campaign to stop the misuse of antibiotics and halt the spread of drug resistance.

Myth #9: Antibiotics will always win the battle against bacteria.
Fact: Not always! Some antibiotics will stop working because drug companies can’t invent antibiotics quickly enough because bacteria are getting smarter much quicker due to overuse and misuse. There is no doubt antibiotics are life-savers when used correctly, but they should be only used for bacterial infections to avoid drug resistance.

Furthermore, there is no guarantee antibiotics will save you in the long-term if you are repeatedly taking them for viral infections. Let’s work together on keeping antibiotics working!