Latest news with #amoxicillin
Medscape
14-07-2025
- Health
- Medscape
Direct Challenge Safe for Penicillin Allergy in Pregnancy
TOPLINE: In low-risk pregnant women with penicillin allergy, direct challenges with amoxicillin were as safe as penicillin skin testing while offering shorter completion times at a lower cost. METHODOLOGY: Researchers conducted a randomized trial that included 144 pregnant women (median age, 29 years) who were referred to the Rochester Regional Health allergy/immunology practice for routine penicillin allergy evaluation from April 2022 through September 2024. Patients were randomly assigned to undergo penicillin skin testing or a direct challenge. For the direct challenge, patients received oral amoxicillin 40 mg and were monitored for 30 minutes. If they did not react to this initial dose, they received 400 mg and were monitored for 30 minutes more. TAKEAWAY: Overall, 93.2% of women who underwent penicillin skin testing had a negative evaluation for penicillin allergy compared with 100% of women who underwent direct challenge. Direct challenges had a median completion time of 65 minutes and cost $422.61 each, whereas penicillin skin tests took a median of 75 minutes and cost $685.36 each. No participants in either group required medical treatment or epinephrine for reactions. Hospital length of stay postdelivery was not significantly different between the groups. IN PRACTICE: 'Although patients and healthcare professionals may be concerned about the risk of an adverse reaction with a [penicillin] allergy evaluation in pregnancy, particularly a [direct challenge], our study supports the safety of this approach in pregnant women in all trimesters,' the authors of the study wrote. SOURCE: Sara Patrawala, MD, with the University of Rochester School of Medicine and Dentistry, Rochester, New York, was the corresponding author of the study, which was published online on July 9 in The Journal of Allergy and Clinical Immunology: In Practice. LIMITATIONS: The study had a relatively small sample size and was conducted at a single site. DISCLOSURES: Two authors reported serving on speakers bureaus for pharmaceutical companies. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
CNN
03-06-2025
- Business
- CNN
Trump's tariff threat exposes China's tight grip on the global pharmaceuticals industry
It's the most prescribed antibiotic in the United States, used by tens of millions of people every year to treat bacterial infections including pneumonia, stomach ulcers, and strep throat. Yet, it isn't exactly common knowledge that amoxicillin, a relative of penicillin that has been in chronic short supply, has only one manufacturer in the US, or that China controls 80% of the raw materials required for its production. That's a major concern as US President Donald Trump threatens to impose tariffs on pharmaceutical imports, throwing a spotlight on America's dependence on critical drug supplies from abroad. 'Increasing trade hostilities or more protracted conflicts could devastate our access to amoxicillin or the ingredients used to make it should Beijing weaponize its supply chain dominance,' Rick Jackson, founder and CEO of Jackson Healthcare, which owns America's sole amoxicillin manufacturer, told CNN. Last year, 96% of US imports of hydrocortisone (the active ingredient in the anti-itch cream), 90% of imports of ibuprofen (found in common over-the-counter pain relievers), and 73% of imports of acetaminophen (in other kinds of pain relievers) all came from China, according to CNN calculations based on trade data from the Census Bureau. With the US already facing shortages of many essential medications, experts warn that Beijing could potentially exploit this reliance as leverage in an escalating trade war. Tensions between the two sides have soared since Trump unleashed his trade assault on the world's second-largest economy. While the two countries have announced a temporary truce that rolled back the three-digit tariffs for 90 days, relations remain tense with ongoing feuding over chip restrictions imposed by the US. Leland Miller, a commissioner at the US-China Economic and Security Review Commission, said the 'chokepoints' that China holds over the US pharmaceutical supply are 'detrimental to American security.' 'Simply by having this leverage … whether or not they ever pull the trigger, causes us to change our policy positions on a lot of things, and that's not good,' he said. So far, China has made no official public threat about weaponizing its dominant position in this segment of the pharmaceutical industry. But Trump's tariffs on the sector, if imposed, could worsen existing drug shortages and drive up prices for Americans, undermining his promise to lower health care costs. Generic drugs, which are designed to provide the same therapeutic effects as brand-name ones and are released after their patents expire, account for 90% of all prescriptions in the US. India produces many of those generics, often from ingredients imported from China. Even though industry insiders and experts widely acknowledge America's heavy reliance on Chinese pharmaceuticals, there is little comprehensive data on the full extent of this dependence across the sector, as major pharmaceutical firms have little incentive to disclose such information. That's part of the reason why last month, the Trump administration launched a probe into pharmaceuticals imports as part of efforts to impose tariffs on the sector on national security grounds. With China making 80% of the world's raw materials for amoxicillin, according to Jackson, it's a clear example of just how vulnerable the world could be to 'Chinese political or economic whims.' 'Any interruption by China along the lengthy amoxicillin supply chain could be catastrophic, particularly in the face of a potential bacterial epidemic,' he said. In 2021, Jackson purchased a bankrupt manufacturing site located in Bristol, Tennessee, and renamed it USAntibiotics. The facility, built in the 1970s, used to produce enough amoxicillin for the whole country at the time. After the amoxicillin patent expired in 2002, the Tennessee facility began to make generic equivalents. At that point, it began facing lower-cost competition from overseas and eventually went bankrupt. Concerns about America's dependence on Chinese pharmaceuticals aren't new. As early as 2019, the US-China Economic and Security Review Commission recommended that Congress assess America's pharmaceutical vulnerabilities. Two years later, when Jackson bought the amoxicillin factory, he cited national security and the need to ensure a steady supply of antibiotics as a major reason for the purchase. Still, progress in growing America's pharma supply chain has been slow. In late April, Trump said pharmaceutical companies were 'going to have to' produce drugs in the US or face a 'tariff wall.' A key goal behind Trump's threats of pharmaceutical tariffs is to 'onshore' drug production. An American study in 2021 found that the US imports 72% of its essential medicines. But experts said tariffs are unlikely to achieve that goal for generics, which have become commodities, with price being the main differentiator. So-called brand-name drugs, by contrast, are protected by patents and therefore command higher prices and bigger profit margins. Instead, tariffs would not only drive up medical costs for patients, but they could also exacerbate ongoing drug shortages by pushing generic drug makers out of the American market. Even if they are willing to build drug-making facilities in the US, the process could take years. China's dominance in the global drug supply chain is part and parcel of its position as the world's factory. Over decades, the pursuit of lower production costs has prompted drug makers to shift production from Western countries to places like China and India. China plays an outsize role in the drug supply chain for its significant production of the critical chemical compounds, called key starting materials or KSM, which are necessary to produce active ingredients, called active pharmaceuticals ingredients or API. China and India dominate the global manufacturing capacity for API. Together, they account for 82% of all API manufacturer filings to the US Food and Drug Administration, according to United States Pharmacopeia (USP), a nonprofit that sets official quality standards for medicines. The filings contain detailed information about the facilities and manufacturing processes submitted by API manufacturers. In the two years after 2021, according to the most recent data, India's share of the filings dropped to 50%, while China's surged to 32%. Chinese manufacturers have also benefited from Beijing's policy incentives and subsidies for the pharmaceutical sector since the early 2000s, which led to industry clusters springing up in the country, said Qingpeng Zhang, an associate professor at the University of Hong Kong's LKS Faculty of Medicine. 'These industry clusters, which help drive down overall costs while maintaining quality … ultimately made China an ideal location for the production of generics and APIs within a free trade environment,' he said. Besides lower costs, the environmental impact of drug production also contributed to China's rise in this sector, as the US and European Union often have stricter environmental regulation, according to Ronald Piervincenzi, CEO of USP. Even India, the world's top supplier of generics, relies on China for APIs and other key ingredients. In fact, 70% of India's API imports come from China, according to a 2023 report commissioned by the Indian government. Dinesh Thakur, a public health expert and author of 'The Truth Pill,' a book on Indian drug regulations, said that India's reliance on China for drug materials reflected the 'natural evolution' of the industry. At the time when Indian drug companies moved up the value chain toward higher-margin products like formulations and injectables, China's nascent pharmaceutical sector made inroads with API production at a lower price point, he said. The Indian companies then 'bought the API for a lesser cost from China and focused their money and their capacity in India on building competence for developing more complex finished formulations,' Thakur said. He added that China's well-established chemicals industry, built independently of pharmaceuticals, also gave its manufacturers a head start in producing drug-related chemicals. Besides its cost advantage, China's pharmaceutical industry also got a boost from the government. In 2015, Chinese leader Xi Jinping unveiled his signature 'Made in China 2025' industrial strategy, which identified biopharma and advanced medical products as key sectors for development in its broader push to reduce the country's reliance on foreign technology. The Covid-19 pandemic further exposed global dependence on China for pharmaceutical supplies – and served as a reminder to Beijing of the strategic advantage that that dominance provides. In a state-run magazine in 2020, Xi said China must consolidate its leadership in its advantageous industries, and 'tighten global industrial chains' dependence on China to build strong countermeasures and deterrent capabilities against deliberate external supply cutoffs.' In 2021, during the height of the epidemic, China's National Development and Reform Commission, the state planner, highlighted APIs as a 'key strength in China's pharmaceutical industry's participation in global competition.' Li Daokui, a professor of finance at Tsinghua University in Beijing and a Beijing adviser, even suggested that China, given its strategic position in the production of raw materials for vitamins and antibiotics, could limit drug supplies to the US as 'countermeasures' against American sanctions. While Trump is not the first US president to push for onshoring drug production, he is the first to attempt it through the threat of sweeping tariffs. Some companies have fallen in line. British firm AstraZeneca, for instance, is shifting production of certain medicines from Europe to the US, following a $3.5 billion investment plan announced late last year. Similarly, companies including Johnson & Johnson and Eli Lilly have pledged to expand their US operations. But these companies primarily focus on patented drugs. Stephen Farrelly, global head of pharma and healthcare at Dutch bank group ING, noted that the US accounted for 44% of global pharmaceutical sales in 2023, making it imperative for makers of patented drugs to maintain a presence in the country. The story is different for generics because their margins are often half those of branded ones. 'Given their margin profiles, they can't afford to make long-term investment decisions with so much uncertainty around,' he said. 'If even possible, it would take in excess of five years to begin reshoring.' Tariffs on pharmaceuticals would eventually fall on patients, experts say, widening health disparities in an already strained health care system. Because generics are as much as 85% cheaper than branded drugs, low-income patients and those without health insurance rely on them disproportionately. An April study commissioned by the main American pharmaceutical lobby group, the Pharmaceutical Research and Manufacturers of America, revealed that a 25% tariff will increase costs of imported pharmaceuticals by $50.8 billion annually, causing prices to rise by 12.9% if passed to consumers. ING also found that a 25% tariff on a common generic cancer medication could raise its price by up to $10,000 for a 24-week prescription. Rather than achieving the intended goal of onshoring production, experts said the tariffs could risk pushing generics manufacturers to abandon the US market altogether. Piervincenzi warned that even modest tariffs could disrupt the supply of generics. 'There's very little profit there and any tariff would just result in [generic drug makers] being underwater and just exiting,' he said. Incentives other than tariffs are necessary to create a resilient drug supply chain, Piervincenzi said. And unlike with other industries, drug supply disruption or shortages could have life-threatening consequences. 'Each of these drugs, people's lives depend on them, and a single drug goes into shortage and a child can't get their cancer therapy, and it becomes a disaster, which you don't see if your favorite brand of ketchup's out of stock,' he said. 'You may be annoyed, but your life is not in danger.'
Health Line
02-06-2025
- General
- Health Line
Side Effects of Amoxicillin
Amoxicillin may cause mild side effects, including stomach issues, headaches, and yeast infections. Less commonly, people may have more severe reactions like seizures. Amoxicillin is a penicillin antibiotic used to treat bacterial infections, including bronchitis, pneumonia, and infections of the ear, nose, throat, skin, and urinary tract. Though it can be highly effective in treating bacterial infections, it also comes with a list of potential side effects. Among the more common side effects of amoxicillin (Amoxil) are: diarrhea stomach upset headache abnormal taste sense skin rash vaginal yeast infection Less common side effects include: allergic reactions like itching or hives, swelling of the face, lips, or tongue breathing problems blistering, peeling, or loosening of the skin, including inside the mouth dizziness trouble sleeping seizures trouble passing urine, dark urine, or a decrease in the quantity of urine unusually weak or tired unusual bleeding or bruising yellowing of the eyes or skin Can you overdose? Taking more than your prescribed dose of amoxicillin is unlikely to cause harm, and treatment is not typically needed for an antibiotic overdose. While acute renal toxicity may occur, it is rare. According to an observation of 285 patients taking amoxicillin from 2014 to 2015, 10 people (18 percent) developed acute kidney issues related to the amoxicillin. It is important to note that this observation occurred in patients with severe infections who received IV amoxicillin at high doses. These patients were not receiving oral amoxicillin for more common infections. Diarrhea Diarrhea is loose, watery, and frequent stool. Diarrhea is considered chronic when you have had loose or frequent stools for more than 2 weeks. Drink plenty of fluids to avoid becoming dehydrated. Drinking milk or other fluids like water may be fine for mild diarrhea. For moderate and severe diarrhea, electrolyte solutions — available online and in drugstores — are usually best. Diarrhea is a common side effect of amoxicillin. All antibiotics kill off the normal bacteria in our guts, disrupting the gut and potentially leading to diarrhea. To treat diarrhea caused by amoxicillin, talk with a healthcare professional first to discuss the best first steps. Then, consider taking a supplement with probiotics, staying hydrated, and following the healthcare professional's recommendation. Diarrhea is typically considered a common side effect, but if you're becoming dehydrated or noticing streaks of blood in diarrhea, seek immediate medical attention. Stomach upset Abdominal pain is pain that you feel anywhere between your chest and groin. This is often referred to as the stomach region or belly. Almost everyone experiences abdominal pain at one time or another. Most of the time, it is not caused by a serious medical problem. Stomach discomfort or nausea is a common side effect of amoxicillin. Less common symptoms include abdominal pain and vomiting. Taking your dose of amoxicillin with a meal may help prevent this side effect. To cope with an upset stomach, eat bland, easy-to-digest foods like soups, crackers, and toast. Peppermint is thought to help upset stomach symptoms. You can take anti-nausea medication if necessary. If you experience severe, prolonged abdominal pain or see blood in your vomit or stool, seek immediate medical attention. Headache A headache is a pain or discomfort in the head, scalp, or neck. Tight, contracted shoulders, neck, scalp, and jaw muscles likely cause the most common headaches. Headaches are a common side effect of taking amoxicillin, and while less severe, are a frequent occurrence. Taking your dosages with food and drinking an adequate amount of water can help prevent headaches caused by amoxicillin. Headache and migraine medications, including Tylenol and Aleve, can help to relieve headaches caused by amoxicillin. Abnormal taste sense Antibiotics like amoxicillin can cause taste disturbances. Sometimes, a person may find foods taste metallic when taking amoxicillin. One possible reason is the medication can affect how well the body absorbs the mineral zinc. A zinc deficiency can cause a bad or metallic taste in the mouth. Other people may find they are more sensitive to sweet or salty tastes when taking amoxicillin. A person may also be dehydrated if they have a fever while taking antibiotics. A dry mouth can affect a person's taste sensations, too. Most of the time, these side effects go away when you stop taking amoxicillin. Drinking more water to stay hydrated can help. Talk with a healthcare professional if you're having difficulty eating anything because of taste. Skin rash Skin rashes when taking amoxicillin can be common. Sometimes, it's hard to tell if the rash is caused by an allergy. People may notice a skin rash after taking amoxicillin for several days. The rash may have small, flat, or raised discolored patches unevenly spaced on the skin. Sometimes, it's itchy, and it usually starts on the chest, stomach, or back. The rash from amoxicillin is different from an allergic reaction or hives. Hives are raised, itchy welts that usually pop up within hours after taking the medication. A person may also have symptoms such as trouble breathing or swallowing. If you have a true allergic reaction to amoxicillin, seek emergency medical attention if you are having problems breathing. If you take an antihistamine like diphenhydramine (Benadryl), it may help with the itching. Ask for a prescription for another antibiotic 'family' if you are truly allergic. The rash should go away after a few days if it isn't an allergy. Some people may find that an anti-itch cream helps. Vaginal yeast infection Amoxicillin works well because it can keep bacteria from growing. Unfortunately, sometimes that extends to 'healthy' bacteria that maintain pH balance in the vagina. As a result, a person's vaginal pH may become disturbed, where yeast can thrive, and a yeast infection can result. Signs of a yeast infection include itching, redness or other color changes, and cottage cheese-like discharge. Over-the-counter medications are available to treat yeast infections. If you aren't sure if it's a yeast infection or another infection type, you should talk with a healthcare professional. Less common side effects Allergic reactions Allergies are usually not the reason for an adverse reaction to a drug. In fact, allergic reactions are an uncommon occurrence. Though it may seem like an allergic reaction, it is really a nonallergic adverse reaction. Mild allergic reactions include itching and hives. They aren't too worrisome on their own but should be observed in case symptoms worsen. Antihistamines and hydrocortisone can treat mild symptoms. Swelling of the face, lips, or tongue and shortness of breath are signs of a severe allergic reaction. If you experience a severe allergic reaction, seek medical attention immediately. If an allergic reaction occurs, monitor the spreading of the rash or discoloration. Amoxicillin can cause delayed allergic reactions even after you've stopped taking it. Breathing problems Breathing difficulty involves a sensation of difficult or uncomfortable breathing or a feeling of not getting enough air. In some circumstances, a small degree of breathing difficulty may be normal. Severe nasal congestion is one example. Another example is strenuous exercise, especially when you do not exercise regularly. If you have difficulty breathing, you could be experiencing an allergic reaction to amoxicillin. If you're experiencing mild breathing problems, you can try to ease breathing by doing the following: Breathe through pursed lips, slowing breathing and allowing for deeper breaths. Perform activities at a comfortable pace; avoid rushing. Try not to hold your breath. If you are allergic to amoxicillin or penicillin, inform your healthcare professional so you can be prescribed another medication to prevent this reaction. If breathing becomes increasingly difficult, contact your healthcare professional right away. If you have difficulty breathing and swelling of your lips, face, mouth, or throat, call 911 or go to the emergency room. Blisters and other skin problems Blisters are small, raised lesions where fluid has collected under the skin. They may be caused by an allergic reaction, burns, frostbite, or by excessive friction or trauma to the skin. Blisters may also be a symptom of a systemic illness or of a specific skin disorder. This side effect is somewhat rare but serious when it does occur. If you experience discoloration, blistering, peeling, or loosening of the skin after taking amoxicillin, contact your healthcare professional immediately. Home treatments may be used to manage mild, non-itching rashes that are not severe. Treatment includes antihistamines or hydrocortisone, oatmeal baths, and drinking lots of water. However, if skin starts blistering, peeling, or loosening, seek medical attention immediately. Do not take amoxicillin if you're allergic to penicillin to prevent severe skin irritations. Dizziness Dizziness occurs when you feel lightheaded and unsteady, or you experience a loss of balance or vertigo (a feeling that you or the room is spinning or moving). Most causes of dizziness are not serious and either quickly get better on their own or are easily treated. Tell your healthcare professional about the medications you are currently taking before they prescribe amoxicillin. To prevent dizziness, avoid drinking alcohol when on amoxicillin. Avoid driving until you know how amoxicillin will affect you. If you get dizzy, sit down for a moment and see if it passes. If you lie down, keep your head elevated with a pillow. Dizziness may be a symptom of anemia or an allergic reaction. A severe allergic reaction could be present if dizziness is combined with symptoms like shortness of breath or swelling of the lips, face, or tongue. Seek immediate medical attention. Trouble sleeping Sleeping difficulty, called insomnia, can involve difficulty falling asleep when you first go to bed at night, waking up too early in the morning, and waking up often during the night. Everyone has an occasional sleepless night, and this is not a problem for most people. However, as many as 25 percent of Americans a year experience acute insomnia, and insomnia is a chronic problem for many people. Seizures A seizure is a sudden change in behavior characterized by changes in sensory perception (sense of feeling) or motor activity (movement) due to an abnormal firing of nerve cells in the brain. Epilepsy is a condition characterized by recurrent seizures that may include repetitive muscle jerking called convulsions. If you are experiencing this side effect, contact your healthcare professional as soon as possible. Dark urine Normal urine is often a pale or straw-yellow color. When urine strays from this color, it is considered abnormal. Abnormally colored urine may be cloudy, dark, or blood-tinged. Any changes in urine color or the presence of an abnormal urine color that cannot be linked to the consumption of a food or drug should be reported to your healthcare professional. This is particularly important if it happens for longer than a day or two or if you have repeated episodes. Dark urine can be caused by amoxicillin due to changes in blood, liver, and/or kidney function. Renal toxicity is rare, but when it does occur, it can be serious. Those at risk for kidney complications, in particular, should not use amoxicillin to prevent this side effect and potential kidney damage. Your healthcare professional can prescribe another type of antibiotic. If you are prescribed amoxicillin, make sure to only take the prescribed dose within the time suggested by your healthcare professional. It's also important to drink the recommended requirement of water. Dark urine is a severe side effect of amoxicillin. If you experience changes in your urine, talk to your healthcare professional. Difficulty urinating Painful urination describes any pain, discomfort, or burning sensation during urination. Pain during urination is a fairly common problem. A urinary tract infection most often causes it. Amoxicillin may cause crystals to form in the urine. These crystals are directly tied to amoxicillin and look very different than crystals otherwise commonly found in urine. It can also happen in rare cases where the kidney is negatively impacted. To prevent this, never take more than your prescribed dose and drink plenty of water. If you're experiencing slight discomfort when you urinate, drink water and reduce the amount of protein in your diet. Painful urination can also indicate renal failure or damage. Contact your healthcare professional right away if you experience this. Unusual bleeding or bruising Bleeding under the skin can occur from broken blood vessels that form tiny pinpoint red or discolored dots (called petechiae). Blood can also collect under the tissue in larger flat areas (called purpura) or in a very large bruised area (called an ecchymosis). Amoxicillin can increase the risk of bleeding. If you're experiencing either unusual bleeding or bruising, see a healthcare professional immediately. Internal bleeding may be occurring, which could lead to bleeding in the digestive system or, in rare cases, the brain. To prevent this, tell your healthcare professional if you're on anticoagulants or blood thinners before you start taking amoxicillin. If you experience this side effect of amoxicillin, it's considered a rare but serious side effect. Seek medical attention as soon as possible. Yellowing of the eyes or skin Jaundice is a yellow color in the skin, mucous membranes, or eyes. The yellow pigment is from bilirubin, a byproduct of old red blood cells. If you've ever had a bruise, you may have noticed that the skin went through a series of color changes as it healed. When you saw yellow in the bruise, you were seeing bilirubin. Amoxicillin can also cause this effect and liver damage or injury. The liver injury can even occur after amoxicillin doses have stopped. It is more likely to happen when taking amoxicillin with clavulanate. Recognizing early symptoms such as fatigue, poor appetite, and vomiting can help prevent jaundice from worsening. Talk with your healthcare professional if you experience any of these symptoms. Before taking amoxicillin, tell your healthcare professional if you have or have ever had liver damage. When is it an emergency? Taking an extra dose of amoxicillin will not typically cause harm, but there are certain symptoms to look out for that merit immediate medical attention. You should call 911 or the poison control helpline at 800-222-1222 if you experience any of the following symptoms after taking more than your prescribed dose of amoxicillin: stomach pain vomiting bloody or cloudy urine difficulty urinating decreased urination confusion How long do side effects last after taking amoxicillin? Amoxicillin's side effects typically resolve when treatment is stopped. However, the exact length of their duration depends on the side effects. Antibiotic-associated diarrhea may occur for a few hours for up to 2 months after antibiotic intake. Probiotic therapy may help to treat it. Vaginal yeast infections typically resolve after treatment with an antifungal medication, done over the course of 1 to 7 days. Sense of taste tends to return to normal when treatment is stopped. Skin rashes usually begin on the fifth day of taking the drug and last for a week or less. Mild allergic reactions typically stop upon discontinuation of use and treatment with antihistamines and hydrocortisone. Takeaway Amoxicillin is a commonly prescribed antibiotic in the penicillin family used to treat a range of bacterial infections. Side effects of amoxicillin are typically mild and include gastrointestinal issues like upset stomach and diarrhea, as well as headache, rash, abnormal taste, and vaginal yeast infections. Less common side effects like allergic reactions, breathing problems, and seizures have also been recorded.
