The study, published this month in the American Journal of Medicine, found that men who took acetaminophen, the active ingredient in Tylenol, or other pain relievers known as nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin and Ibuprofin, face an increased risk of hearing loss. Scientists found that the longer the pain killers are used, the higher the risk in most cases.

“Regular use of analgesics, specifically aspirin, NSAIDs, and acetaminophen, might increase the risk of adult hearing loss, particularly in younger individuals,” researchers concluded. “Given the high prevalence of regular analgesic use and health and social implications of hearing impairment, this represents an important public health issue.”

The study included nearly 27,000 men between the ages of 40-74 who worked in the health profession. Researchers found that, overall, men under 60 years old who take Tylenol or other acetaminophen-based medications at least twice a week were 22% more likely to suffer hearing loss than those who do not. Men who took NSAIDs like Ibuprofen were 21% more likely to suffer hearing loss, and men who took aspirin were 12% more likely. The most at-risk group included men between the ages of 45 to 50 years old, who had a 99% increased risk of hearing loss if they took Tylenol. Men from the same age group had a 61% increased risk of hearing loss if they took Ibuprofen regularly, and a 33% increased risk if they took aspirin regularly.

Researchers found that there was no appreciable difference in hearing loss after the age of 60.

Scientists who conducted the Tylenol and NSAID hearing study pointed out that there have been tests in animals that found that the use of some pain killers can decrease blood flow to the cochlea, the part of the inner ear which is the primary source of human hearing. It contains tiny hair cells suspended in fluid that move when sound vibrations enter the inner ear. The nerves in the cochlea transmit the motions to the brain, which interprets them as sound.

The researchers said that the study was the first time acetaminophen had been studied for hearing loss.

The study comes as the FDA is taking a closer look at over-the-counter pain killers. In April 2009, the FDA announced that it would require more stringent liver injury warnings on Tylenol and NSAIDs, which include aspirin (marketed as Bayer), ibuprofen (marketed as Advil and Motrin), naproxen (marketed as Aleve, Naprosyn, Anaprox and Naprelan) and ketoprofen (marketed as Orudis and Oruvail).

Millions of Americans, both adults and children, use these drugs for pain relief and to reduce fevers. They are also commonly combined with other ingredients in many common cold medicines.

The study, published earlier this month in the Journal of General Internal Medicine, found that the side effects of Oxycontin, Vicodin, morphine and other opioids can lead to frequent dizziness and sedation when used over long periods of time, making older adults more susceptible to falls and serious bone fractures. Researchers found that the higher the dosage, the higher the risk.

Researchers from a number of institutes from Washington and California performed a cohort study involving 2,300 adults age 60 or older who suffered from chronic pain that was unrelated to cancer. The study found that subjects not taking some form of opioid pain medication had an annual fracture rate between 3 and 4 percent. However, subjects who were prescribed a daily opioid dose of less than 50 milligrams per day had a 6 percent annual fracture rate. Those taking at least 50 milligrams, considered a moderate dose, or more saw that fracture rate jump to 10 percent.

Opioids have already been connected to a number of painkiller side effects, such as nausea, constipation, dizziness and sedation. They are also frequently associated with a high risk of drug addiction and drug overdose.

Oxycontin is a form of the narcotic oxycodone which is designed to release the painkilling medication into the bloodstream gradually over a 12-hour period. Approved by the FDA in 1996, drug abusers quickly discovered that the pill could be crushed and snorted or inhaled for an instant high. Often referred to on the street as “Hillbilly Heroin” or “Killers,” the drug has been linked to hundreds of drug overdoses and deaths.

The pill is the best-selling prescription pain medication in the U.S., with more than $2 billion in annual sales.

Last summer, an FDA advisory panel went as far as recommending that a Vicodin and Percocet ban be issued on use of the opioids due to the risk of overdose, particularly when used with acetaminophen. The FDA has not acted on the Percocet and Vicodin recall recommendations and is not bound to follow the advisory panels’ recommendations.

Vicodin and generics that use the same active ingredients are prescribed more than 100 million times a year in the United States. However, safety issues are a serious concern, as more than 400 people per year die, and 42,000 are hospitalized, from overdoses due to drugs that use acetaminophen.

Canadian researchers performed an analysis of existing medical studies dealing with asthma and acetaminophen use, determining that the widely used pain reliever may be linked to an increased risk of asthma and wheezing in adults and children. Results of the study are published in the November 2009 issue of the medical journal CHEST.

Acetaminophen, the generic name for Tylenol, is a pain killer and anti-inflammatory medication found in a number of over-the-counter and prescription drugs. It is widely marketed for use among infants and children for the treatment of fever, aches and pain.

Asthma is a chronic condition where the airways could occasionally constrict and become inflamed, causing breathing problems. This can cause symptoms like wheezing, shortness of breath, chest tightness and coughing, which can be life-threatening in severe cases.

The new research looked at data from 19 different studies conducted over the years that met their requirements for being scientifically sound. The analysis revealed that adults and children who used acetaminophen were 63% more likely to have asthma than those who did not use the medication. The analysis also revealed that children who were given acetaminophen before they were one year old had a 47% increased chance of developing asthma, pregnant women who used acetaminophen were 28% more likely to have a child with asthma, and children who took acetaminophen were 60% more likely than other children to be diagnosed with asthma within the year following the medication’s use.

While the analysis does show an association between asthma and acetaminophen, researchers cautioned that it does not establish a cause and effect relationship. They also noted that asthmatic children may be more likely to have been taking acetaminophen to treat infections or other illnesses that were being caused by their undiagnosed asthma. Additional research is needed to fully determine the nature of the connection.

According to a report by WebMd Health News, McNeil Consumer Healthcare, the subsidiary of Johnson & Johnson that markets Tylenol, released a statement in response to the study saying that Tylenol has a proven safety record and that there are no studies which show a causal relationship between side effects of Tylenol and asthma.

FDA regulators are currently weighing recommendations from an FDA advisory panel that would restrict the maximum allowed dose of acetaminophen allowed in over-the-counter medications like Tylenol and NyQuil. The recommended restriction would limit the OTC painkillers to 325 milligrams per dose, down from 500, due to concerns about acetaminophen liver side effects. The panel also recommended that the maximum daily dosage be lowered to less than 4,000 milligrams.

The program will create partnerships with federal agencies, healthcare professionals, hospitals, pharmacies and consumer organizations to identify specific, preventable medication risks and implement plans to mitigate those risks. Preventable medication risks can include medication errors, accidental exposure, intentional misuse or abuse and drug quality problems.

The details of the program were outlined in a report released on Wednesday, called “FDA’s Safe Use Initiative: Collaborating to Reduce Preventable Harm from Medications.” The agency released the report at the annual Science Writers Symposium in Silver Springs, Maryland.

The federal drug regulatory agency intends to schedule public meetings to get feedback on the report and the “Safe Use Initiative.” A public docket will also be opened to allow the public to submit comments on the report.

New FDA guidance in association with the initiative has already been released, which targets drug makers who manufacture over-the-counter liquid medications. The guidance aims to standardize dosage delivery devices, like cups, droppers, syringes and spoons, so that dosages are easily understood by consumers. The FDA hopes the new guidance will cut down on accidental overdoses with such medications, particularly acetaminophen problems, which the FDA says results in 55,000 emergency room visits each year, primarily due to medication errors that result in liver damage.

According to the Institute of Medicine and FDA, there are 1.5 million preventable medication injuries in the U.S. each year, which add an additional $4 billion to the cost of healthcare. About 60,000 children are seen in emergency rooms nationwide each year due to accidental drug ingestion.

“Only through coordinated interventions across all sectors of the health care system can we substantially reduce preventable injuries from using medications,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a press release announcing the program. “All participants in the health care community have a role to play in reducing the risks and preventing injuries from medication use.”

The FDA announced this week that Brookstone Pharmaceuticals LLC issued a concentrated acetaminophen infant drop recall for their 16-ounce bulk containers because they do not contain dosing instructions or a dosage delivery system, which could cause an overdose.

The agency indicated that they are aware of several reports of life-threatening or fatal adverse events in children under three years old due to confusion over dosage.

Brookstone’s recalled acetaminophen drops are a generic version of Tylenol’s concentrated drops for infants. They contain 80 mg of acetaminophen per every 0.8 ml. However, there are regular strength drops on the market that contain only 160 mg per 5 ml, which the FDA believes may cause dosage confusion.

Brookstone distributed 344 bottles in the United States, and donated 5,301 bottles to charities for international use.

Receiving too much of the medication could increase the risk of acetaminophen liver damage and other injuries. Recent research has shown that acetaminophen is the leading cause of liver failure in the United States, resulting in 56,000 emergency room visits, 26,000 hospitalizations and over 450 deaths annually between 1990 and 2001. Acetaminophen overdoses can also cause kidney damage and blood disorders.

An FDA Advisory Panel was recently convened to review the safety of acetaminophen and the risk of liver injury caused by receiving too much of the medication. The panel recommended that certain limits be placed on the maximum allowed daily dosage for acetaminophen to reduce the risk of injury, and also also recommended a ban on Percocet and Vicodin, as well as other medications that combine acetaminophen with narcotic painkillers.

The FDA has not yet made a decision on their advisory panel recommendations.

A Vicodin and Percocet recall would have to be approved by FDA, but the agency usually follows the recommendations of their advisory panels.

FDA research has shown that acetaminophen, the active ingredient in Tylenol, is the leading cause of liver failure in the United States. The advisory panel said users of medications that combine acetaminophen with narcotics increase the danger of acetaminophen liver damage and overdose because patients who take the drugs for long periods often need higher and higher doses to achieve the same effect. This means that their livers are receiving higher and higher doses of acetaminophen.

Following a meeting that began Tuesday to examine 11 different drugs that contain acetaminophen, the panel narrowly voted 20-17 in favor of the recall for Vicodin, Percocet and five other prescription painkillers that combine narcotics with acetaminophen. If the drugs are kept on the market, the panel voted 36-1 that they should carry a “black box” warning, which is the strongest warning that can be placed on a prescription medication.

Vicodin and generics that use the same active ingredients are prescribed more than 100 million times a year in the United States. However, safety issues are a serious concern, as more than 400 people per year die, and 42,000 are hospitalized, from overdoses due to drugs that use acetaminophen.

Panelists who disagreed with the recommended Percocet and Vicodin recalls said that withdrawing the popular medications would create an additional burden on people who deal with severe and chronic pain. Industry critics of the decision also say that the restrictions would lead to more health problems as people were suddenly forced to switch to different, less proven, pain medications.

In a separate vote, the panel voted 24-13 to restrict the maximum allowed dose of acetaminophen allowed in over-the-counter medications like Tylenol and NyQuil. The recommended restriction would limit the OTC painkillers to 325 milligrams per dose, down from 500, due to concerns about acetaminophen liver side effects. The panel also recommended that the maximum daily dosage be lowered to less than 4,000 milligrams.

The report was released by an FDA working group studying over-the-counter acetaminophen, to provide information for the panel of outside experts convened by the FDA to weigh the drug’s risks and make recommendations about what, if any, regulatory actions are necessary. Although the FDA is not required to follow the recommendations of their advisory panels, they often do.

FDA officials indicated in the report that more stringent warnings about Tylenol liver damage risks are necessary because high doses of acetaminophen can cause serious injuries. Such high doses could occur unintentionally, when consumers do not realize they are taking multiple medications with the drug as the active ingredient, which is common in pain relief and cold medications. In addition, the use of alcohol together with Tylenol or other acetaminophen drugs also could increase the risk of liver damage.

The working group also suggests that an adult daily dose limit on Tylenol should be set at 3250 mg, and that pills be capped at 325 mg each.

If the Tylenol recommendations are adopted, acetaminophen-based medications would have several new warnings, including:

• Warnings that taking more than recommended amounts can cause liver damage
• Warnings that the products should not be combined with other medications that include acetaminophen
• Highlighting acetaminophen as the active ingredient
• Warnings for alcohol users and people with liver disease regarding increased liver damage risk
• Warnings regarding the need for prompt medical attention after an overdose, even if no symptoms of a health problem are present.

Aceteminophen or Tylenol overdoses are a leading cause of acute liver injury in the United States, resulting in 56,000 emergency room visits, 26,000 hospitalizations and over 450 deaths annually between 1990 and 2001.

These drugs are used by millions of Americans, both adults and children, for pain relief and to reduce fevers and combat cold and flu symptoms.

The advisory panel is scheduled to meet June 29 and June 30, 2009, to review the safety issue.

The warnings will apply to any medications that include acetaminophen, the active ingredient in Tylenol, or drugs that are in a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs), which include aspirin (marketed as Bayer), ibuprofen (marketed as Advil and Motrin), naproxen (marketed as Aleve, Naprosyn, Anaprox and Naprelan) and ketoprofen (marketed as Orudis and Oruvail).

Millions of Americans, both adults and children, use these drugs for pain relief and to reduce fevers. They are also commonly combined with other ingredients in many cold medicines.

Tylenol side effects have been associated with an increased risk for severe liver damage when more of the drug is taken than the label recommends or if multiple different drugs containing acetaminophen are taken together. The use of alcohol together with Tylenol or other acetaminophen drugs also could increase the risk of liver damage.

NSAID side effects could increase the risk for stomach bleeding when the drugs are used by people who are also taking blood-thinning drugs or steroids. The risk can also be increased if multiple different NSAIDs are taken at the same time, if they are taken longer than they are supposed to or if they are used together with alcohol.

“The risk associated with (the use of acetaminophen and NSAIDs) need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause,” said Charles Ganley, M.D., director of the FDA’s Office of Nonprescription Drugs, in a statement issued April 28, 2009. “It is important that they know how to take these medications safely to reduce the risk.”

Research has suggested that many users of these drugs often take more than the recommended dose contained on the warning label and often do not know that they are taking multiple products with the same ingredients. Many users are also unaware of the risk of using alcohol together with these over-the-counter pain killers.

In addition to requiring all manufacturers to warn about the risk of severe liver injury from acetaminophen and possible stomach bleeding with aspirin, ibuprofen, naproxen and ketoprofen, the FDA’s new rules will also require that labels placed on the bottles and packaging prominently display the active ingredients of these drugs.

The FDA is requiring all manufacturers to relable their products within one year. In addtion, an FDA advisory panel wll meet this summer to review the risk of liver damage associated with acetaminophen overdoses and to discuss what further steps may be necessary.

The research is published in the September 20 issue of The Lancet, finding that infants treated with Tylenol (acetaminophen) during the first year of life are 46% more likely to develop asthma by the time they are 6 or 7 years old. The risk of developing severe asthma was found to increase by about 22% to 38%.

The study involved the evaluation of data for 205,487 children from 31 countries who took part in the International Study of Asthma and Allergies in Childhood.

Although the data does not establish definitively that Tylenol causes childhood asthma, researchers indicate that it may explain why asthma has become more common in recent years.

Asthma is a chronic condition where the airways could occasionally constrict and become inflamed, causing breathing problems. This can cause symptoms like wheezing, shortness of breath, chest tightness and coughing, which can be life-threatening in severe cases.

According to the Asthma and Allergy Foundation of America, the prevalence of asthma has been increasing since the early 1980s, currently impacting about 1 in 4 Americans.

Acetaminophen is the active ingredient in Tylenol, which is widely marketed for use among infants and children for treatment of high fevers and minor aches and pains. For children it is administered as a liquid.

Researchers have pointed out that the study does not indicate that the use of Tylenol for children should be changed, but that acetaminophen should not be used for routine fevers. The findings support the guidelines of the World Health Organization, which recommends that acetaminophen should only be used for high fevers.