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.
Elmiron Linked to Vision Damage
New studies indicate that the drug Elmiron, a medication already linked to health issues, may also cause vision problems in women with long-term use. The medication is often prescribed as treatment for urinary tract infections as well as osteoarthritis and other conditions.
Studies on Eye Damage
Several studies have been done on the side effects of Elmiron with more investigations underway. Information links Elmiron and vision damage. The amount of damage correlates with the quantity of the medication taken.
Elmiron was approved by the US Food and Drug Administration (FDA) to treat interstitial cystitis, which is a chronic condition of the bladder. It can cause pressure in the bladder along with pain. With long-term use, research indicates that it may be possible for Elmiron to cause pigmentary maculopathy.
This condition impacts the part of the retina known as the macula, which is the central part of the eye. It can cause issues with changes to light. The job of the macula is to protect the retina from UV light, which allows the person to see details better.
The Emory Eye Center, based in Atlanta, GA, made a report that showed that patients who had been taking the drug for about 15 years had changes in their macula. Another 10 patients had a diagnosis of interstitial cystitis and had been prescribed Elmiron. They also showed symptoms that corresponded with pigmentary maculopathy.
Another study was done by Kaiser Permanente which showed that about 24 percent of patients who had been prescribed Elmiron for a minimum of five years had damage to the eye.
Signs of Damage to the Eye
Symptoms associated with this condition include the following:
- Vision loss
- Difficulty with reading
- Vision that is distorted
While the condition can be preventable, it may not be treatable if it develops. This condition is just the latest to be related to Elmiron. Other conditions include the following:
- Optic neuritis and
- Retinal hemorrhage
Even after the patient discontinues the mediation, damage may occur. They may have difficulty adapting to an environment with low lighting. The condition can mimic macular degeneration in its later stages.
Anyone experiencing these symptoms after taking Elmiron should talk to their doctor about treatment. While it is never advised to stop taking prescription medication without consulting with their doctor first, it is important to arrange an appointment to discuss their symptoms with a medical professional right away. If they have taken Elmiron in the past and are experiencing vision changes, they will want to present that information to their doctor.
As the only FDA-approved treatment for IC, it must be continually taken, which means that thousands of patients may have been using Elmiron for years or even decades without knowing about the potential for vision damage. Even with the studies being conducted, Janssen Pharmaceuticals failed to warn the public until regulatory agencies applied pressure. Even when warnings were required in Europe and Canada, no changes were made to the labels in the US until June 2020. It is expected that more people will come forward with evidence of vision damage as the public becomes aware of the situation.
Changes in Priority List for COVID-19 Vaccine
Supplies for the COVID-19 have been limited in California. At this time, only health care workers, staff and residents in long-term care facilities have been getting it as well as people who are age 65 and older. However, the list for who may be top priority in the future could be changing in the state.
Governor Gavin Newsom has announced who will be top priority for the next phase of vaccination. The plan is to switch to an approach based on age. This is a change from the earlier tier plan where workers who were in commercial and residential settings as well as those who were in transportation and manufacturing would be the next priority. It also included homeless people and those who are incarcerated.
No details about how the groups would be divided by age have been given. Some speculate that it may start with those age 50 and up. Many groups have pushed to have these changes made. However, there are other groups who don’t support the age-based approach. Labor unions are critical because they say essential workers should be protected by getting access to the vaccine right away since they are put at risk for doing their jobs.
Groups that support people with disabilities say that those who are at highest risk aren’t being prioritized. The changes don’t consider those who have the most risk for complications with the virus.
When Vaccinations Will Occur
California state officials have indicated that it may be June before everyone who is 65 and older have been able to get the vaccine. The state is getting about 300,000 to 500,000 doses per week. For Los Angeles County, that many doses would be needed each week just to get the adult residents vaccinated by the middle of summer. It is expected that it will be mid-2022 before everyone is vaccinated.
When it comes to priority by industry, healthcare workers are the top priority. Teachers come next because they are the key to getting schools open again for in-person learning. After teachers, it is workers based in the food and agriculture industries with those in emergency services coming next. There is no current timeline for when those workers are able to sign up for vaccinations.
Vaccinations are going slow in part because a significant portion are going to people getting their second dose. That takes away from those who are seeking their first dose. Adding to the complications is the weather. In Orange County, strong winds caused the Disneyland vaccine site to close, which made thousands of people have to reschedule.
Right now, residents age 65 and older are able to sign up for appointments for vaccination in the state. The goal for Orange County is to get all residents their vaccinations by July 4th. Ventura County is allowing residents age 75 and older to sign up for the vaccine. Other counties have their own restrictions for the vaccine and vaccination sites set up for administration based on the number of doses they receive.
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.
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