Lupin Pharmaceuticals has issued a voluntary recall for its metformin hydrochloride extended-release tablets in 500mg and 1000mg doses. The recall is due to a possible contamination of N-nitrosodimethylamine (NDMA) which is a possible carcinogen.
Batches of the medication that were tested revealed the presence of NDMA above the acceptable daily intake limit. Because of the results of the tested samples, Lupin decided to recall all batches of the medication. At this point, the company says it hasn’t received any reports of issues from the medication related to the recall.
NDMA has been classified as a probable carcinogen in humans, which means it could cause cancer. It is found in water and in some food products, especially meat as well as vegetables and dairy products. The FDA has determined an acceptable daily limit for how much of the impurity can be consumed and still be safe.
Metformin hydrochloride extended-release tablets USP is a prescription medication taken orally for patients who have been diagnosed with type 2 diabetes mellitus. It is designed to work with diet and exercise to help improve the blood glucose levels. The medication may be packaged in 60, 90 and 100 count containers.
How the Situation is Being Handled
Lupin has taken action for this medication by contacting wholesalers, distributors and others in the supply chain by phone as well as with the recall notification. The company is making arrangements to have all the product returned.
For patients who are currently taking the medication, the company advises them to continue and to contact their medical provider to find an alternative treatment rather than quitting abruptly. FDA says it could be risky for patients to stop the medication without notice since this is a serious health condition.
How Metformin Works
Metformin works by acting as an insulin sensitizer, which means it decreases the insulin resistance. Insulin is supposed to move the sugar you consume out of your body and into the cells, so they have the energy they need to do their jobs. When they can’t absorb the sugar enough because there is too much in the blood, it builds up and can lead to diabetes. Metformin allows the cells to absorb the sugar better and use it more efficiently.
Along with the sugar you get from the foods you eat, your body also makes its own sugar. Metformin reduces the amount your body makes, so the system can handle what comes in from the diet.
The combination of producing less sugar and using what sugar comes in more efficiently is what makes Metformin a popular drug for doctors to prescribe to patients who are newly diagnosed with diabetes. It’s also this reason that it’s not a good idea to stop abruptly because it could lead your system to having an overload of sugar, which could cause other complications.
If you have been taking metformin drugs that are part of the recall, you should contact your medical provider and ask them for an alternative medicine to help control your diabetes.
FDA Adds Nearly Two Dozen Drugs to Watch List
The US Food and Drug Administration (FDA) has released a new watch list for drugs and classes of drugs. They have included almost two dozen products which may have a serious risk for side effects or new safety information has been discovered.
New Drugs to Watch For
The drugs on the list aren’t necessarily a risk for patients, but the agency believes there may be a potential problem. Further review is necessary at which point the FDA can decide to take action. These actions include:
- Require changes to the label
- Restrict use of the drug
- Remove the drug from the market
Several proton pump inhibitors were included in the list. Multiple risks were identified for this class of drug. One group had 10 different drugs that could increase the risk for SIADH or syndrome of inappropriate antidiuretic hormone secretion.
Hydroxychloroquine sulfate has received a lot of media attention lately in connection to its use in treating COVID-19. The FDA listed products that contain the ingredient because it may carry a risk for phospholipidosis. This is a condition where phospholipids build up in the tissues of the system. There is concern in patients with this condition that their liver and kidneys are functioning properly.
Also on the list is Eucrisa, otherwise known as crisaborole. This drug is used to treat mild to moderate eczema, but it may carry a risk for developing contact dermatitis. The labeling for the drug was updated to indicate this possibility.
Lipiodol was on the list for the risk of hypothyroidism, and the FDA is currently evaluating the possibility of more action. Another area of concern is with vascular endothelial grown factor inhibitors. VEGF inhibitors include Avastin, Caprelsa, Cometriq, Lenvima, and many others. They may have an increased risk for the patient to develop an aneurysm or artery dissection. The FDA is currently determining the need for regulatory action on this class of drugs.
Aimovig is another drug on the list, which may increase the risk for hypertension. This medication is used in the treatment for migraines because it can prevent the activation of a specific protein that may lead to the headache.
Belsomra may lead to falls, resulting in serious injuries. This drug has been updated with labeling that indicates the increased risk for falls. This medication is prescribed by doctors to treat insomnia.
Impavido may lead to eye disorders. It is used to treat parasites. Vasostrict, which is used to treat diabetes insipidus, may actually increase the risk of the disease. The label for this drug was updated to indicate the issue.
While these drugs haven’t been proven to cause harm to the patient, they do carry the potential for risk. Anyone who is taking these medications can talk to their doctor about the concerns they may have. The doctor may alleviate their fears or prescribe an alternative treatment. They can also stay updated by visiting the FDA website to learn about any further research or action being taken by the FDA.
Study Indicates Steroid Use Even Short-term May Be Risky to Patients
Doctors prescribe steroids known as corticosteroids for chronic conditions, sometimes for an extended period or for just a few days to get inflammation under control. While it has been known that long-term use of these drugs may increase risk to patients for certain serious problems, new research suggests even short-term use can also cause harm.
Dangers of Prescription Steroid Use
Damage from extended use includes cataracts, osteoporosis, cardiovascular disease and diabetes. New information from a study also indicates that short-term use may increase risk for gastrointestinal bleeding as well as sepsis and heart failure.
The study conducted in Taiwan had a median of three days for treatment using these steroids. Researchers suggest that medical providers should consider the risks when determining if the benefits are worth it. While the risks are somewhat rare, they can have serious consequences. It is also advised that doctors monitor their patients within the first 30 days of starting steroid therapy.
The study included nearly 16 million adults with over 2.5 million between the ages of 20 to 64 who received steroids for 14 days or less. The majority of prescriptions were for various skin disorders and for respiratory tract infections. According to the researchers, short-term use of steroids is common among patients.
This study follows similar findings of an earlier one which was conducted at the University of Michigan. In that prior study, data was collected on adults with many of them taking prescribed steroids for up to 30 days. It was reported that there was a five-time greater risk for developing sepsis as well as almost double the risk for fractures within the first 30 days of beginning the drug therapy. There was also a threefold risk for developing a condition known as venous thromboembolism.
One of the things these studies reveal is that the increase in risk is to young and healthy patients and not just those with pre-existing conditions or other health problems. In light of this information, some doctors are recommending finding other treatment plans rather than using steroids even for short bursts.
How Steroids Work
These medications work by mimicking the natural hormones in a person’s system but at levels higher than what the body can produce. They can lower the symptoms that come with inflammatory conditions. The steroids can also suppress the immune system, which may be important when it attacks the body by mistake.
Doctors prescribe this type of treatment for a wide range of conditions, such as eczema, rheumatoid arthritis, asthma, bronchitis, lupus and more. They may be taken by mouth in pill form, by inhaler or spray, topically or through an injection.
Corticosteroids come with a host of health risks. Side effects often depend on the dosage and length of time of use, but they may include swelling in the legs, high blood pressure, pressure in the eyes, weight gain, mood swings, altered memory and more. Anyone who is prescribed these medications should discuss with the doctor the benefits versus the risks to determine if it is the best option for treatment.
Heartburn Medications May Increase Bone Fractures in Kids
A specific type of heartburn medications, proton pump inhibitors or PPIs, may increase the risk for bone fractures in kids, according to a study.
The Risk with PPIs
Doctors often prescribe PPIs for children who are more than one year old when they have been diagnosed with gastroesophageal reflux disease or GERD. This condition allows for stomach acid and food to be regurgitated, which causes discomfort for the child.
Researchers studied government records in Sweden of just over 230,000 children. Half of these children took PPIS which were prescribed by the doctors and half didn’t. After a follow-up of two years, data showed that of the children who had taken PPIs, just over 5350 of them had suffered a broken bone. For those who didn’t take PPIs, just under 4570 had a bone fracture.
According to the research, children who had used PPIs had a 11 percent higher risk for a bone fracture. Very few of them had fractures of the spine or skull. However, there were broken arms, broken legs and other fractures. Statistics showed that kids who had taken PPIs had an eight percent increase in the number of broken arms and 19 percent increase for broken bones in the leg.
The study didn’t account for physical activity differences or the amount of bone mineral density in each child, which could have an influence on the rate of fractures. The researcher said they didn’t conclude that all kids should stay away from PPIs. However, doctors should be aware of the potential risk when they prescribe the medications.
What is GERD?
Most babies spit up a little after taking a bottle or nursing. However, when they experience frequent spitting up along with feeding issues or loss of weight, it may indicate they have GERD. Normal spitting up should go away by the time they are one year old in most cases. If the issue continues or becomes worse, they may need treatment for GERD.
GERD can be caused by several factors, including a birth defect or medications. Secondhand smoke and obesity can also lead to GERD. Other factors include genetics, surgery on the abdomen and certain brain disorders.
Symptoms include vomiting, nausea and heartburn. In children, especially those who are younger, they may say they have stomach pain or pain in the chest. They may have hiccups or a feeling that food is stuck when they swallow. They may fail to gain weight or even lose weight. Children can eat less or avoid certain foods because of the GERD.
Treatment may include sleeping with the bed raised and not letting the child lie down for at least three hours after a meal. The doctor may recommend the child avoid sugar and spicy foods, chocolate, caffeine and acidic foods and drinks. They may also suggest the child eat more frequently and smaller portions.
Along with PPIs, a doctor may recommend H2 blockers or antacids. Many children do well with just the lifestyle changes, and it can prevent the need for medications which may have serious side effects.
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