FDA Pulls 500 Cold Medicines From the Market

March 3rd, 2011

WebMD

By: Denise Mann

The FDA today announced steps to remove more than 500 prescription cold, cough, and allergy products from the market because of potential safety concerns.

The FDA asked companies to stop manufacturing the 500 products within 90 days and stop shipping them within 180 days. Some manufacturers must stop making and shipping their products immediately, the FDA warns.

There are no data on how often these now-banned medications are prescribed today, but many doctors may be unaware that they contain unapproved ingredients because these drugs are listed in the Physicians’ Desk Reference and may be advertised in medical journals.

Questions on Drug Safety

The FDA does not know if these prescription drugs are safe or not largely because they were grandfathered in before changes to the FDA’s drug approval process were enacted.

“We don’t know what they are, whether they work properly, or how they are made,” said Deborah M. Autor, director of the FDA’s Office of Compliance at the Center for Drug Evaluation and Research (CDER) in Silver Spring, Md., during a teleconference. “The problem is that we don’t know what the problem is.”

For example, some of these cough, cold, and allergy drugs are labeled as “time-release.” These are complicated to manufacture, and the FDA has not reviewed whether the active ingredient is released in a consistent matter over a period of time, she says. “They may be released too slowly, too quickly, or not at all.”

Kids Under Age 2

Others contain an “irrational” combination of the same types of products, such as two or more antihistamines, and some are inappropriately labeled for use by infants and young children, she says. Many contain the same ingredients as the over-the-counter cough and cold products that are no longer supposed to be used in kids under 2.

Yolandra Hancock, MD, a pediatrician at Children’s National Medical Center in Washington, D.C., praises the FDA’s move.

“The new FDA decision supports modern-day pediatric practice to avoid cough syrups in children under 2 because they do more harm than good,” she says. Some may slow down breathing, and others decrease cough and allow mucus to sit in the chest, where it can cause other problems such as lung infection, she says.

“I fully support the FDA’s move in controlling access to these medications in children; it is highly appropriate and long overdue,” she says.

As to the risks these drugs pose, “for the most part, [these adverse reactions] are not serious,” says Charles E. Lee, MD, medical officer of the division of new drugs and labeling compliance at the CDER.

After the FDA crackdown on the use of over-the-counter cough and cold medicine in children younger than 2, the number of emergency room visits for adverse events decreased by 50%, he says.

“We also know that 15% of these events came from prescription cough, cold, and allergy products and included sedation/drowsiness and irritability,” Lee says.

Click here for the full report from WebMD

Coffee Helps Working Women, But Holds Back Men

February 2nd, 2011

The Telegraph

By: Richard Alleyne

A study by psychologists at Bristol University found drinking caffeinated coffee boosts a woman’s performance in stressful situations but has the opposite effect on men.

They become less confident and take longer to complete tasks once they have downed several cups of coffee.

The findings, published in the Journal of Applied Social Psychology, suggest the beverage may have radically different effects on the sexes in high-pressure situations.

According to the British Coffee Association, UK consumers drink approximately 70 million cups of coffee a day.

Some of the potential health benefits include protection against diabetes, Alzheimer’s disease, liver damage and even gout.

Caffeine in coffee is a known stimulant which works on the brain and can combat drowsiness and fatigue.

But researchers wanted to examine what coffee does to the body when it is already under stress, especially when large quantities are consumed in high-pressure meetings.

They recruited 64 men and women and put them in same-sex pairs. Each pair was given a range of tasks to complete, including carrying out negotiations, completing puzzles and tackling memory tasks.

To add to their stress, they were told they would also have to give a public presentation relating to their tasks.

Researchers then gave the pairs either caffeinated or decaffeinated coffee and monitored them throughout the experiment.

They found the men’s ability to perform well under stress was ‘greatly impaired’ if they had drunk the caffeinated coffee.

For example, they took an average of 20 seconds longer to complete puzzles than those on the decaffeinated coffee.

Women, on the other hand, completed them 100 seconds faster if they had been given caffeine.

Experts think the key to coffee’s effects on the sexes lies in the way men and women respond differently to stress.

Men are inclined to exhibit ‘fight or flight’ behaviour, whereas women are more inclined to work together to solve the problem they face, something psychologists call ‘tend and befriend’.

In a report on their findings the researchers said unlimited coffee supplies at high-level meetings might not be a good idea, especially for men.

“They might unintentionally sabotage the partnerships forged to solve stressful issues,” the report said.

“Many such meetings, including those at which military and other decisions of great importance are made, are likely to be male-dominated.

“Because caffeine is the most widely consumed drug in the world, the global implications are potentially staggering.”

Click here for the full report from the Telegraph