Is Your Daily Dose of Citrus Interfering with Your Medications?

Katherine Zeratsky wrote . . . . . . . . .

Grapefruit and certain other citrus fruits, such as Seville oranges, can interfere with several kinds of prescription medications.

Don’t take these interactions lightly. Some can cause potentially dangerous health problems. If you take prescription medication, ask your doctor or pharmacist whether your medication interacts with grapefruit or other citrus products.

You may need to eliminate grapefruit products from your diet. Simply taking your medication and grapefruit product at different times doesn’t stop the interaction. Alternatively, you can ask your doctor if there’s a comparable medication you can take that doesn’t interact with grapefruit.

Problems arise because chemicals in the fruit can interfere with the enzymes that break down (metabolize) the medication in your digestive system. As a result, the medication may stay in your body for too short or too long a time. A medication that’s broken down too quickly won’t have time to work. On the other hand, a medication that stays in the body too long may build up to potentially dangerous levels.

The list of medications that can interact with grapefruit includes commonly prescribed medications that:

  • Fight infection
  • Reduce cholesterol
  • Treat high blood pressure
  • Treat heart problems
  • Prevent organ rejection
  • Treat anxiety
  • Control seizures
  • Minimize motion sickness
  • Treat erectile dysfunction
  • Replace hormones
  • Reduce cough
  • Control pain

Another potential problem is that some foods and drinks may contain grapefruit but don’t say so in the name or on the ingredients list. For example, numerous citrus-flavored soft drinks contain grapefruit juice or grapefruit extract.

Play it safe with prescription drugs. Always ask your doctor or pharmacist when you get a new prescription if it interacts with any foods or other medicines. If the answer is yes, ask whether you need to eliminate that food from your diet.

Source: Mayo Clinic

Two More Heartburn Meds Recalled Due to Possible Carcinogen

The U.S. Food and Drug Administration is adding to a list of recalled lots of popular heartburn medications — including generic forms of Zantac — because the pills might contain small amounts of a suspected carcinogen.

The substance, called N-Nitrosodimethylamine (NDMA), is an environmental contaminant that can be found in water and foods and has been classified as a “probable human carcinogen” by the World Health Organization.

The presence of NDMA in minute quantities has already led to the recall of multiple types of blood pressure medications, such as valsartan and losartan.

NDMA’s potential presence in Zantac and generic versions of the drug were first announced in September.

The new recalls were announced Thursday by the FDA and include “all quantities and lots” of ranitidine hydrochloride capsules manufactured by Appco Pharma in the 150 milligram (mg) and 300 mg size with expiration dates of April/May 2021; and “all unexpired lots,” in the same dosages, of ranitidine tablets manufactured by Northwind Pharmaceuticals. Neither company has yet received any reports of “adverse events” tied to the medicines.

Ranitidine decreases the amount of acid created by the stomach. Over-the-counter ranitidine is approved to prevent and relieve heartburn, and prescription ranitidine is approved for a number of uses, including treatment and prevention of ulcers of the stomach and intestines, and treatment of gastroesophageal reflux disease (GERD).

Speaking at the time of the initial Zantac recall, one gastroenterologist said patients may want to switch their meds.

“Drug impurities remain a major national concern,” said Dr. David Robbins, associate chief of endoscopy at Lenox Hill Hospital in New York City. “While Zantac may prove safe in the long run, this latest statement adds confusion and concern, so my interim advice to patients is simple: switch to another drug… and, of course, confirm with your doctor the need for an antacid.”

In the meantime, scientists at one California lab believe they may be getting closer to understanding why NDMA is showing up in ranitidine tablets.

“What we found out was that NDMA is being generated as a result of heating of ranitidine,” chemist Ron Najafi, of Emery Lab, told CBS News.

His team found that, at room temperature, NDMA levels in tablets remain at about 25 nanograms — far below the threshold level of 96 nanograms that’s deemed unsafe by the FDA.

But heat changes that. When a pill was heated to 158 degrees Fahrenheit, NDMA levels rose to 142 nanograms.

“So if someone were to keep their ranitidine, Zantac, in their car, for example, and in the middle of summertime, that product is going to get heated up and it’s going to generate this compound,” Najafi told CBS. “So NDMA in this case… is not an impurity in the drug, it’s being formed from the drug itself.”

Najafi suspects that ranitidine tablets might be exposed to ambient heat somewhere in the long transport process between manufacturing plants and drugstore shelves.

The Emery lab has submitted their findings to the FDA and is advocating that pills be shipped under controlled temperatures.

Dr. Janet Woodcock, who directs drug evaluation and research at the FDA, responded to the lab results.

It does appear that some NDMA can form with significant heat, she told CBS. “However, these are pretty high temperatures, so the question about whether ranitidine would need to be kept cold to keep it from converting is something that still hasn’t been answered,” she added.

In the meantime, Woodcock stressed that at the levels found in recalled pills, the risk to users remains very small.

“For most of these contaminants that we’re talking about, the level of NDMA — or nitrosamine — in there is not much more than your daily diet, especially if you ate a lot of meat,” Woodcock said.

Source: HealthDay

New Spray Gel could Help Take the Bite Out of Frostbite

Mountaineers and winter sports enthusiasts know the dangers of frostbite –– the tissue damage that can occur when extremities, such as the nose, ears, fingers and toes, are exposed to very cold temperatures. However, it can be difficult to get treated quickly in remote, snowbound areas. Now, researchers reporting in ACS Biomaterials Science & Engineering have developed a convenient gel that could be sprayed onto frostbite injuries when they occur, helping wounds heal.

Frostbite causes fluids in the skin and underlying tissues to freeze and crystallize, resulting in inflammation, decreased blood flow and cell death. Extremities are the most affected areas because they are farther away from the body’s core and already have reduced blood flow. If frostbite is not treated soon after the injury, it could lead to gangrene and amputation of the affected parts. Conventional treatments include immersing the body part in warm water, applying topical antibiotic creams or administering vasodilators and anti-inflammatory drugs, but many of these are unavailable in isolated snowy areas, like mountaintops. Others, such as topical medications, could end up freezing themselves. Rahul Verma and colleagues at the Institute of Nano Science and Technology wanted to develop a cold-stable spray gel that could be administered on-site for the immediate treatment of frostbite injuries.

To develop their spray, the researchers packaged heparin, an anticoagulant that improves blood flow by reducing clotting and aiding in blood vessel repair, into liposomes. These lipid carriers helped deliver heparin deep inside the skin. They embedded the heparin-loaded liposomes in a sprayable hydrogel that also contained ibuprofen (a painkiller and anti-inflammatory drug) and propylene glycol, which helped keep the spray from freezing at very low temperatures. When the researchers tested the spray gel on rats with frostbite, they found that the treatment completely healed the injuries within 14 days, whereas untreated injuries were only about 40% healed, and wounds treated with an antibiotic cream were about 80% healed. The spray reduced levels of inflammatory cytokines at the wound site and in the blood circulation, which likely accelerated healing, the researchers say.

Source : American Chemical Society


Today’s Comic

FDA Approves New Type of Drug to Treat Migraines

Amy Norton and E.J. Mundell wrote . . . . . . . . .

Migraine sufferers who cannot get relief from existing medications have a new treatment option, the U.S. Food and Drug Administration announced Monday.

The pill, called ubrogepant (Ubrelvy) is for the immediate treatment “of migraine with or without aura [a sensory phenomenon or visual disturbance] in adults,” the agency said in a news release.

Ubrogepant is not to be used to prevent migraines, the FDA said, only to treat an attack once it strikes.

“Migraine is an often disabling condition that affects an estimated 37 million people in the U.S.,” said Dr. Billy Dunn, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “Ubrelvy represents an important new option for the acute treatment of migraine in adults, as it is the first drug in its class approved for this indication.”

According to the FDA, approval came after the results of two studies involving more than 1,400 adults.

“In both studies, the percentages of patients achieving pain freedom two hours after treatment [defined as a reduction in headache severity from moderate or severe pain to no pain] and whose most bothersome migraine symptom (nausea, light sensitivity or sound sensitivity) stopped two hours after treatment, were significantly greater among patients receiving Ubrelvy at all doses compared to those receiving placebo,” the FDA said.

The drug is not without side effects however. In the two trials, potential side effects included nausea, fatigue and dry mouth.

Ubrogepant belongs to a new class of medications called CGRP inhibitors that has come to the market in the past year.

CGRP is a small protein released by the trigeminal nerve during migraine attacks. It’s believed to play a key role in generating migraine misery, explained Dr. Richard Lipton, who directs the Montefiore Headache Center at the Albert Einstein College of Medicine in New York City.

The three approved CGRP inhibitors are all injection drugs that are used regularly, to prevent migraine attacks.

Ubrogepant is different because it’s a tablet that treats migraines in progress. Another oral “gepant,” called rimegepant, is also in the pipeline. Data on both drugs have been submitted to the FDA for approval, according to the companies developing them.

Lipton’s group published its own study on the drug, released last month.

The study involved nearly 1,700 patients and found that the pill worked better than a placebo pill at halting migraines in progress. Ubrogepant beat placebo treatment in easing pain and other migraine symptoms, such as nausea and sensitivity to light or sound.

Of patients who used the real drug to treat a migraine attack, 22% of those on a higher dose were pain-free within two hours. That compared with 14% of the placebo group. Similarly, 39% of ubrogepant users were free of their “most bothersome” symptom within two hours, versus 27% of placebo users.

The study, funded by drug’s maker, Allergan, was published in the Journal of the American Medical Association.

According to Lipton, the new gepants could make a “big difference” for certain migraine patients.

They include people who do not get relief from current acute treatments, and those who cannot take the medications because of side effects or safety concerns, Lipton said.

Right now, medications called triptans are the standard treatment for more severe migraine attacks. The drugs, which came out in the 1990s, stop migraines by stimulating receptors for the brain chemical serotonin, which reduces inflammation and constricts blood vessels.

But not everybody responds to the medications. And because of the blood vessel constriction, people at high risk of heart attack or stroke cannot take them.

Triptans also have side effects — like numbness, dizziness and sleepiness — that can make them difficult to take.

Gepants work through a “novel mechanism,” Lipton said, which means they might help some patients who do not respond to triptans. And they do not constrict blood vessels.

Lipton has financial ties to both Allergan and Biohaven Pharmaceuticals, maker of rimegepant.

It will be “exciting” to have new options for patients who cannot take triptans, said a neurologist who was not involved in the study.

“There haven’t been any new acute treatments in a long time,” Dr. Rachel Colman, of Mount Sinai’s Icahn School of Medicine in New York City, said in November.

Questions do remain, Colman pointed out. The latest trial tested the effects of only a single treatment, and it’s not clear how consistent patients’ responses will be over time, she said.

Long-term safety and side effects are also unknowns — though, Colman said, “so far, the tolerability data looks good.”

Nausea was the most commonly reported side effect in the JAMA study, affecting 2% of ubrogepant patients within two days of taking the drug.

In the United States alone, more than 37 million people suffer from migraines, according to the American Migraine Foundation. People with milder migraines may find relief with general pain relievers like naproxen and acetaminophen.

But for some migraine sufferers, Colman noted, “there’s a significant need” for new tactics.

Source: Healthday


Today’s Comic

FDA Gives Expanded Approval to Prescription Fish Oil for Heart Patients

Dennis Thompson wrote . . . . . . . . .

The U.S. Food and Drug Administration on Friday gave expanded approval to a prescription form of fish oil called Vascepa, to help prevent heart trouble in people at high risk who are already taking statins.

Vascepa (icosapent ethyl) was already FDA-approved for a small percentage of patients with exceptionally high blood levels of triglycerides, a type of blood fat.

The new approval greatly expands the potential pool of patients, because it now includes people with simply high levels of triglycerides — at or above 150 milligrams per deciliter — and multiple risk factors for heart disease and diabetes.

“Today’s approval will give patients with elevated triglycerides and other important risk factors, including heart disease, stroke and diabetes, an adjunctive treatment option that can help decrease their risk of cardiovascular events,” Dr. John Sharretts said in an FDA news release. He’s acting deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.

Vascepa is a drug derived from fish that contains pure EPA, a key nutrient in fish oil. A month’s supply of Vascepa costs roughly $300.

Friday’s approval follows on the positive results of a study on Vascepa presented in November at the annual meeting of the American Heart Association (AHA). Early findings from the clinical trial found that the drug slowed the development of artery-clogging plaques.

In the study, Vascepa appeared to put the brakes on key aspects of plaque formation in vessels after nine months of use, lead researcher Dr. Matthew Budoff, a professor at UCLA’s David Geffen School of Medicine, said at the time.

“We found significant slowing of progression among four different plaque markers, including total plaque,” Budoff noted in a presentation at the AHA’s annual meeting, in Philadelphia.

These early results provide some tantalizing hints why icosapent ethyl was found to reduce risk of heart-related disease and death by 25% in another study released last year, said Dr. Donald Lloyd-Jones, chair of preventive medicine at Northwestern University Feinberg School of Medicine.

EVAPORATE, the clinical trial reported on last month, is ongoing and will report final results after 18 months. Experts hope more data from the trial will show which aspect of the drug’s effect on plaque is reducing heart risk.

The EVAPORATE trial placed 40 people on high doses of icosapent ethyl and another 40 on a placebo. All participants were already taking statins and had developed at least one artery-clogging plaque. Amarin Corp., which makes Vascepa, paid for the trial.

Participants underwent CT scans at the beginning of the study and at nine months to track progression of arterial plaque in their bodies. They’ll undergo a final CT scan at 18 months.

Compared to the control group, people on icosapent ethyl experienced a slowdown in plague growth at nine months, including:

  • 42% less progression in total plaque,
  • 89% less new calcified plaque,
  • 57% less new fibrous plaque,
  • 19% less new non-calcified plaque.

Notably, the fish oil drug did not appear to actually melt away plaques, but only slowed down their growth, said Dr. Stephen Nicholls, a professor of cardiology at Monash University in Queensland, Australia.

“There was no evaporation. They all continued to progress,” said Nicholls.

There are several possible explanations why icosapent ethyl slows buildup of plaque in the arteries, Nicholls said.

The drug has been shown to reduce triglyceride levels, which contribute to plaque formation. In this study, triglycerides declined, Budoff said.

But the antioxidant and anti-inflammatory effects of the fish oil drug should also be considered as potential contributors, Nicholls said.

Newer trials have tended to support the value of fish oil drugs in controlling arterial plaques, after years of mixed results, Lloyd-Jones and Nicholls said. Both experts were not involved with the new trial.

That’s probably because earlier trials did not have people on high enough doses of purified fish oil supplements, Nicholls said.

Other high-dose fish oil clinical trials are ongoing, and will provide further evidence in the near future, Lloyd-Jones said.

Source: HealthDay