Drugmaker Merck is facing a class-action lawsuit in Canada over the osteoporosis med Fosamax.
The lawfirm Siskinds LLP has launched the suit against Merck Frosst Canada, claiming that Merck failed to adequately warn patients and doctors that Fosamax may increase users' risk of developing osteonecrosis of the jaw (ONJ), also known as "jaw death." ONJ causes pain, soft-tissue swelling and infection, loosening of teeth and exposed bone in the mouth.
Attorney Michael Peerless says that he hopes the lawsuit forces Merck to disclose what the company knows or has known about Fosamax's link to the jaw condition.
If you're interested in reading more about the link between Fosamax and ONJ, you can read about what some doctors have observed about the connection here. Also, this article summarizes the Mayo Clinic's opinion on the connection between ONJ and osteoporosis meds.
Tuesday, May 29, 2007
Monday, May 28, 2007
FDA clamps down on timed-release cold meds
The U.S. Food and Drug Administration (FDA) is clamping down on the production of some timed-release cold medicines. Timed-release meds that contain an expectorant called guaifenesin are not officially approved, the FDA says. In fact, more than 20 companies make timed-release cold and cough meds that contain guaifenesin, including popular prescription medications such as Guaifenex, Crantex and Amibid, but only the over-the-counter meds marketed as Mucinex and Humibid have been approved by the FDA.
Companies making the meds must stop producing them by August 27, the FDA says, and they can be shipped no later than November 25, 2007.
The FDA is requiring that these medications be approved in order to ensure that the active ingredient is effective and is released safely over time, a spokesperson said. And from now on, any timed-release version of an existing medication must be separately approved by the agency.
Prescription and over-the-counter meds that contain guaifenesin in an immediate-release format are not part of the clampdown.
If you’d like more information, or would like to see a list of all medications not approved by the FDA, head here.
Companies making the meds must stop producing them by August 27, the FDA says, and they can be shipped no later than November 25, 2007.
The FDA is requiring that these medications be approved in order to ensure that the active ingredient is effective and is released safely over time, a spokesperson said. And from now on, any timed-release version of an existing medication must be separately approved by the agency.
Prescription and over-the-counter meds that contain guaifenesin in an immediate-release format are not part of the clampdown.
If you’d like more information, or would like to see a list of all medications not approved by the FDA, head here.
Thursday, May 24, 2007
Top News: May 21-25
This week's Top News concerns a warning from the U.S. Food and Drug Administration about the Type 2 diabetes drug Avandia.
The story began this week when the U.S. Food and Drug Administration (FDA) issued a safety alert for Avandia. The FDA cited a study that the Type 2 diabetes medicine increases users' risk for heart attack by 43 percent. But, the FDA stressed, patients taking Avandia should not stop taking the medication but should discuss the cardiovascular risks with their doctor.
Today, new information surfaced that the FDA was first warned about Avandia's risks in 2000. According to MSNBC:
"John Buse, president-elect of the American Diabetes Association and faculty member at the University of North Carolina in Chapel Hill, cited 'a worrisome trend in cardiovascular deaths and severe adverse events' among patients using the drug in a letter to the agency in March 2000."
The FDA responded in July 2001 by sending a letter to the drug's maker, GlaxoSmithKline Plc, asking that the company inform doctors about Avandia's risks. These letters were sent in September 2001, though Glaxo has continued to disagree with the results of the study that first found the increased cardiovascular risks.
You'll probably be hearing a lot about this story in the coming weeks. Remember that both the FDA and medical experts say that if you're taking Avandia, you should not stop taking the medication without first talking to your doctor and discussing the risks.
The story began this week when the U.S. Food and Drug Administration (FDA) issued a safety alert for Avandia. The FDA cited a study that the Type 2 diabetes medicine increases users' risk for heart attack by 43 percent. But, the FDA stressed, patients taking Avandia should not stop taking the medication but should discuss the cardiovascular risks with their doctor.
Today, new information surfaced that the FDA was first warned about Avandia's risks in 2000. According to MSNBC:
"John Buse, president-elect of the American Diabetes Association and faculty member at the University of North Carolina in Chapel Hill, cited 'a worrisome trend in cardiovascular deaths and severe adverse events' among patients using the drug in a letter to the agency in March 2000."
The FDA responded in July 2001 by sending a letter to the drug's maker, GlaxoSmithKline Plc, asking that the company inform doctors about Avandia's risks. These letters were sent in September 2001, though Glaxo has continued to disagree with the results of the study that first found the increased cardiovascular risks.
You'll probably be hearing a lot about this story in the coming weeks. Remember that both the FDA and medical experts say that if you're taking Avandia, you should not stop taking the medication without first talking to your doctor and discussing the risks.
Thursday, May 17, 2007
Top News: May 14-18
Researchers say that medications used to treat diabetes and obesity may also fight breast cancer.
Some of these diabetes and obesity medications work by blocking the PTP1B enzyme, which has been linked to both diabetes and body fat. Now Canadian researchers say that this same enzyme is also found in breast cancer patients. In their recent study, the researchers found that blocking the enzyme appeared to slow or stop breast cancer tumor growth.
(Source: The Daily Mail)
Some of these diabetes and obesity medications work by blocking the PTP1B enzyme, which has been linked to both diabetes and body fat. Now Canadian researchers say that this same enzyme is also found in breast cancer patients. In their recent study, the researchers found that blocking the enzyme appeared to slow or stop breast cancer tumor growth.
(Source: The Daily Mail)
Monday, May 14, 2007
The diabetes, Alzheimer's link
Patients with Type 2 diabetes are threatened by a host of related health conditions, such as blindness, amputation, kidney failure, heart disease, and strokes. But researchers say they may need to add Alzheimer's disease to the list as well.
Research suggests that people with Type 2 diabetes are twice as likely to develop Alzheimer’s than people without the disease. And with
1 in 5 Americans at risk for developing diabetes, that could lead to a major health crisis.
Diabetes and Alzheimer’s may be linked in many ways, scientists say. It may be that heart risks associated with diabetes prevent blood from getting to the brain. Or it may be that the plaque that forms in Alzheimer’s patients brains is the same type of plaque that forms in the pancreas of diabetes patients.
But whatever the cause, health care experts say that a few simple steps could reduce your risk of developing Type 2 diabetes and lower your risk of Alzheimer’s. The most simple and profound way is to lose excess body weight through a healthy diet and increased exercise. In addition to the healthy lifestyle changes, patients with diabetes should manage their condition with a diabetes medication. In fact, some research has shown that diabetes meds such as Actos, Avandia, and others may one day be used to treat or prevent Alzheimer’s disease.
Research suggests that people with Type 2 diabetes are twice as likely to develop Alzheimer’s than people without the disease. And with
1 in 5 Americans at risk for developing diabetes, that could lead to a major health crisis.
Diabetes and Alzheimer’s may be linked in many ways, scientists say. It may be that heart risks associated with diabetes prevent blood from getting to the brain. Or it may be that the plaque that forms in Alzheimer’s patients brains is the same type of plaque that forms in the pancreas of diabetes patients.
But whatever the cause, health care experts say that a few simple steps could reduce your risk of developing Type 2 diabetes and lower your risk of Alzheimer’s. The most simple and profound way is to lose excess body weight through a healthy diet and increased exercise. In addition to the healthy lifestyle changes, patients with diabetes should manage their condition with a diabetes medication. In fact, some research has shown that diabetes meds such as Actos, Avandia, and others may one day be used to treat or prevent Alzheimer’s disease.
Thursday, May 10, 2007
Top News: May 5-11
This week's Top News story is for people with Heart Disease, especially for those who love to listen to music.
A high school student working with doctors on a research study has found that iPods--the popular MP3 music players made by Apple--may cause heart pacemakers to malfunction.
Jay Thaker, a senior at Okemos High School, found that iPods caused heart pacemakers to malfunction in 50 percent of the study's patients. Because pacemakers store a history of patients' heart rhythms, the malfunctions could cause doctors to believe a patient's heart is beating irregularly. This could lead to incorrect diagnoses and treatments, experts say.
"In addition," Thaker says, "If an iPod stopped a pacemaker from working in a patient who was totally dependent on their pacemaker, it could cause the heart to stop."
Doctors have long known that electronic devices such as cell phones, microwave ovens, and other appliances can interfere with pacemaker function. But because iPods are often worn close to the heart devices--on the arm, at the belt, or around the neck--they could pose a particular risk.
Dr. Edwin Kevin Heist, a cardiac electrophysiologist at Massachusetts General Hospital, agrees that iPods can be a danger to patients with pacemakers.
Heist said he tells his patients that they can use any household device, including cell phones and iPods, but not to put them over their pacemaker. "Patients with a pacemaker could safely use an iPod, just don't put it over the device," he said.
Source: HealthDay News
A high school student working with doctors on a research study has found that iPods--the popular MP3 music players made by Apple--may cause heart pacemakers to malfunction.
Jay Thaker, a senior at Okemos High School, found that iPods caused heart pacemakers to malfunction in 50 percent of the study's patients. Because pacemakers store a history of patients' heart rhythms, the malfunctions could cause doctors to believe a patient's heart is beating irregularly. This could lead to incorrect diagnoses and treatments, experts say.
"In addition," Thaker says, "If an iPod stopped a pacemaker from working in a patient who was totally dependent on their pacemaker, it could cause the heart to stop."
Doctors have long known that electronic devices such as cell phones, microwave ovens, and other appliances can interfere with pacemaker function. But because iPods are often worn close to the heart devices--on the arm, at the belt, or around the neck--they could pose a particular risk.
Dr. Edwin Kevin Heist, a cardiac electrophysiologist at Massachusetts General Hospital, agrees that iPods can be a danger to patients with pacemakers.
Heist said he tells his patients that they can use any household device, including cell phones and iPods, but not to put them over their pacemaker. "Patients with a pacemaker could safely use an iPod, just don't put it over the device," he said.
Source: HealthDay News
Pharma Watch: OxyContin's maker will pay $600 million for misleading doctors, patients
Purdue Pharma LP, the maker of OxyContin, has agreed to pay $600 million as part of a plea deal with the U.S. Justice Department over a felony charge that the company misled and defrauded doctors and consumers about the addiction dangers of the painkiller. Three executives in the company, including its CEO, have also agreed to pay $34.5 million in penalties.
Purdue has acknowledged that it illegally marketed and promoted OxyContin by claiming that the narcotic pain medication was less addictive, less subject to abuse, and less likely to cause withdrawal symptoms in users than other painkillers.
U.S. Attorney John Brownlee had this to say about the settlement:
"With its OxyContin, Purdue unleashed a highly abusable, addictive and potentially dangerous drug on an unsuspecting and unknowing public. For these misrepresentations and crimes, Purdue and its executives have been brought to justice."
Source: CNNMoney
Purdue has acknowledged that it illegally marketed and promoted OxyContin by claiming that the narcotic pain medication was less addictive, less subject to abuse, and less likely to cause withdrawal symptoms in users than other painkillers.
U.S. Attorney John Brownlee had this to say about the settlement:
"With its OxyContin, Purdue unleashed a highly abusable, addictive and potentially dangerous drug on an unsuspecting and unknowing public. For these misrepresentations and crimes, Purdue and its executives have been brought to justice."
Source: CNNMoney
Thursday, May 3, 2007
Is your medication going generic in 2007?
There's no doubt about it -- generic formulas of medications can save users a lot of money. And while some medicines such as Lipitor aren't "going generic" this year, there are some other commonly used meds that are.
Here's a list of some of the brandname medicines that will be available in generic formulas this year along with the conditions they treat and the approximate time they'll be available.
Toprol® XL
Generic name: metoprolol extended release
Treats high blood pressure (second quarter)
Ambien®
Generic name: zolpidem
Treats insomnia (second quarter)
Paxil® CR
Generic name: paroxetine controlled release
Treats depression (third quarter)
Prilosec® 40mg
Generic name: meprazole 40mg delayed release
Treats gastroesophageal reflux disease (GERD) (fourth quarter)
Coreg®
Generic name: carvedilol
Treats high blood pressure (fourth quarter)
Norvasc®
Generic name: amlodipine
Treats high blood pressure (fourth quarter)
Precose®
Generic name: acarbose
Treats Type 2 diabetes (fourth quarter)
Source: Premera Blue Cross
Here's a list of some of the brandname medicines that will be available in generic formulas this year along with the conditions they treat and the approximate time they'll be available.
Toprol® XL
Generic name: metoprolol extended release
Treats high blood pressure (second quarter)
Ambien®
Generic name: zolpidem
Treats insomnia (second quarter)
Paxil® CR
Generic name: paroxetine controlled release
Treats depression (third quarter)
Prilosec® 40mg
Generic name: meprazole 40mg delayed release
Treats gastroesophageal reflux disease (GERD) (fourth quarter)
Coreg®
Generic name: carvedilol
Treats high blood pressure (fourth quarter)
Norvasc®
Generic name: amlodipine
Treats high blood pressure (fourth quarter)
Precose®
Generic name: acarbose
Treats Type 2 diabetes (fourth quarter)
Source: Premera Blue Cross