Dr. Andrew Hart, a senior lecturer at the University or East Anglia School of Medicine, presented his findings at the Digestive Disease Week conference in New Orleans earlier this month. Hart found that people who took aspirin on a daily basis were at an increased risk for developing Crohn’s disease, which is an inflammatory disease of the intestines that may affect any part of the gastrointestinal tract, causing a wide variety of symptoms.

Researchers looked at about 200,000 subjects from several European countries between the ages of 30 and 74. They found that regular aspirin use for more than a year increased the risk of developing Crohn’s disease by a factor of five.

Crohn’s disease is a form of inflammatory bowel disease (IBD) that affects all layers of the intestinal wall in the small and large intestines, as well as other digestive organs and can cause parts of the intestines to narrow, cause the formation of abnormal tunnels between digestive organs, and cause fissures in the anal skin. The ailment affects about 500,000 Americans and is believed to increase the risk of developing bowel cancer.

However, Dr. Hart warned that the number of people at increased risk was relatively small, and that aspirin’s beneficial effects on heart disease were still considerable and should be considered.

The researchers say the study does not create a direct causative link between aspirin use and Crohn’s disease. Hart estimated that the findings indicate that about one in 2,000 people who regularly take aspirin were at increased risk of developing the bowel disease.

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.

In a statement issued Wednesday, the FDA warned about the risk of Maalox problems and announced that Novartis will change the name and label of Maalox Total Relief to avoid confusion with other Maalox products, such as Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength. Maalox Total Relief is a medication intended to treat upset stomachs, nausea and diarrhea, whereas other Maalox products are sold as antacids.

The over-the-counter medications have entirely different active ingredients, with Maalox Total Relief (bismuth subsalicylate) being similar to aspirin. The FDA says that it is concerned that consumers will mistakenly take Maalox Total Relief, thinking that it is an antacid, which could lead to problems from Maalox for some users.

Regular Maalox products have the active ingredients of aluminum hydroxide, magnesium hydroxide and simethicone. They are intended for the relief of acid indigestion, heartburn and gas.

“Maalox Total Relief is not appropriate for individuals with a history of gastrointestinal ulcer disease or a bleeding disorder,’” the FDA warned in a press release. “Maalox Total Relief also should not be taken by children and teens if they are recovering from a viral infection, nor by individuals who are taking certain medications including: oral antidiabetic drugs (OADs), anticoagulation (thinning the blood) drugs such as warfarin (Coumadin) and clopidogrel (Plavix), non-steroidal anti-inflammatory drugs (NSAIDS), and other anti-inflammatory drugs.”

The FDA says Novartis has agreed to change the name of Maalox Total Relief to a new name that does not include the word Maalox, and will also change the label design, which is currently nearly identical to Maalox antacid products. In addition, the company will conduct an educational campaign to highlight the differences between the products for healthcare professionals and consumers.

Novartis will also monitor for adverse events and side effects caused by consumers mistakenly taking Maalox Total Relief when they intended to take one of the company’s antacid products. The new, renamed product will be released in September 2010.

The expanded Johnson & Johnson drug recall was issued on Friday, as FDA officials criticized the company for failing to promptly investigate the problems and issue the recall, noting that Johnson & Johnson has been receiving consumer complaints since 2008. In a warning letter issued last week, the FDA called the company’s investigation and response to the problem unjustifiable. The most recent recall came only after the FDA, which does not have the authority to force a mandatory recall, pressured the company.

The recalled products include Children’s Motrin, Children’s Tylenol, Motrin IB, Benadryl, Rolaids, Simply Sleep, St. Joseph’s Aspirin and a number of Tylenol products, including Tylenol Arthritis, Tylenol PM, and 8-hour Tylenol. About 500 lots in all of the drugs were recalled in the U.S., the United Arab Emirates and Fiji. A full list of the recalled products (PDF) is available from the FDA.

The drugs have been contaminated with a chemical called 2,4,6-tribromoanisole, which is believed to come from a pesticide and flame retardant used to treat wooden pallets. The FDA reports that about 70 people have complained of moldy smells from the medicines, many of whom experienced signs of gastrointestinal distress including nausea, stomach pain, vomiting and diarrhea.

The recall is an expansion of a prior Tylenol caplet recall issued late last year for the same problem. That recall was limited to Tylenol Arthritis Pain Caplets sold in 100-count bottles with a red EZ-Open cap.

On Friday, the FDA issued a warning letter to McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, saying that the company had failed to properly investigate numerous complaints, failed to expand its investigation when it knew cross contamination was possible and had to be pushed to recall products for consumer safety.

“Your initial investigation into the root cause of the odor was unjustifiably delayed and terminated prematurely. Numerous complaints were received over a four month period in 2008 before they were considered a trend and before actions were initiated to determine the root cause,” the FDA warning letter states. “When microbiological testing in August 2008 did not support an initial speculation that microbial contamination was the root cause of the odor, the investigation was closed. No other possible root causes were pursued.”

The FDA said it is concerned about the company’s treatment of the problem because it raises questions about how Johnson & Johnson handles the quality, safety and integrity of its products. The company has 15 days to respond to the letter.

Data from a Department of Veteran Affairs database indicated that more than 1,000 heart patients given a combination of aspirin-based drugs suffered upper gastrointestinal tract side effects, according to a report by HealthDay News. Those side effects included perforation and bleeding and required immediate medical attention.

The combinations identified as having GI side effects are anticoagulants and aspirin variations that include anticoagulant-antiplatelet (ACAP), aspirin-antiplatelet (ASAP), aspirin-anticoagulant (ASAC) or TRIP (aspirin-anticoagulant-antiplatelet). The combinations are sometimes referred to as Complex Antithrombotic Therapy when used to treat heart problems.

The study was authored by Dr. Neena S. Abraham of the Michael E. DeBakey VA Medical Center and Baylor College of Medicine in Houston. It looked at data on 78,084 patients from ages 60 to 99 from the VA’s national pharmacy and administrative database. About 30 percent were prescribed one of the drug cocktails between January 2003 and September 2006.

The study found that 1,061 experienced upper GI problems within a year of starting the drug therapy. The side effects often took the form of bleeding or gastrointestinal perforations that can lead to infection of the abdominal cavity. The upper GI tract includes the stomach, pharynx and esophagus.

The combination with the greatest risk was TRIP. According to the study, the risk of an upper GI side effect quadrupled with the use of the drug combination. Additionally, the youngest patients included in the study, those ages 60 to 69, were at a higher risk than older patients. This group was found to be the ones most likely to be prescribed the TRIP drug combination. Younger patients experiencing heart problems are more likely to have heart disease, hypertension and diabetes.

The results of the study will be presented next week at the Digestive Disease Week 2009 conference in Chicago.

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.