Examining the Carvedilol Recall and How It Impacts High Blood Pressure Patients
In September 2022, the U.S. Food and Drug Administration (FDA) announced a voluntary recall of several lots of carvedilol tablets manufactured by Novell Pharmaceutical Laboratories. Carvedilol is a beta blocker medication used to treat high blood pressure, heart failure, and other heart issues. This latest recall has left many hypertension patients wondering what it means for them and if they need to make any changes to their treatment regimen.
Details of the Carvedilol Recall
The carvedilol tablets affected by the recall were distributed between May 2022 and August 2022. The 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg tablets were shipped to various U.S. wholesalers and distributors nationwide.
The reason listed for the recall was that testing found the amount of carvedilol in some tablets may exceed approved specifications. Having too much or too little active drug can potentially impact the effectiveness and safety of the medication.
As of the FDA announcement on September 8, 2022, Novell Pharmaceutical Laboratories had not received any reports of adverse health effects related to the recalled carvedilol. However, improper drug concentrations create a risk of patients not receiving the correct therapeutic dose of the beta blocker.
Risks of Too Much or Too Little Carvedilol
Carvedilol works by relaxing blood vessels to improve blood flow and reduce heart strain. When taken as prescribed, it is generally well tolerated with minimal side effects. However, too much or too little carvedilol in the body can cause moderate to serious issues.
Potential risks and side effects of excessive carvedilol levels include:
- Dizziness, lightheadedness
- Fatigue, weakness
- Nausea, diarrhea
- Breathing difficulties
- Slow or irregular heartbeat
- Fainting or seizure
Having inadequate carvedilol in the system can also be problematic. The medication may not provide its full intended benefits, such as:
- Lowering high blood pressure
- Preventing chest pain (angina)
- Improving heart failure symptoms
- Reducing risk of hospitalization
- Decreasing mortality rates
Patients who receive carvedilol tablets with improper dosing from the recalled lots should contact their doctor promptly. Their blood pressure and other health markers should be monitored to determine if medication adjustments need to be made.
Identifying Recalled Carvedilol Tablets
The recalled carvedilol was packaged in 100-count bottles under the following National Drug Codes (NDCs):
- Carvedilol 3.125 mg tablets: NDC 6904-0026-01
- Carvedilol 6.25 mg tablets: NDC 6904-0027-01
- Carvedilol 12.5 mg tablets: NDC 6904-0028-01
- Carvedilol 25 mg tablets: NDC 6904-0029-01
The expiration date printed on the bottles ranges from September 2023 through March 2025. The recall notice advises patients taking carvedilol from the impacted lots to continue using the medication until their doctor provides replacement tablets or a different treatment option.
Frequently Asked Questions About the Carvedilol Recall
Patients understandably have many concerns and questions surrounding the carvedilol recall. Here are answers to some of the key issues on hypertension patients' minds.
How will I know if I received the recalled carvedilol?
Check the prescription bottle label for the manufacturer (Novell Pharmaceutical Laboratories), NDCs, and expiration dates corresponding to the recall. The dates the medication was dispensed may also indicate if it was distributed during the May 2022 to August 2022 time frame covered by the recall.
What should I do if I have the recalled carvedilol?
Contact your physician or cardiologist immediately. They will advise you on safely transitioning to unexpired replacement carvedilol or an alternate medication until supplies of good quality carvedilol become readily available again.
How serious is this recall?
The FDA categorized this as a Class II recall, indicating the probability of serious health consequences is not very high, but that some adverse effects could potentially occur. While no bad health outcomes have been reported, improperly dosed tablets are still considered a moderate health risk.
Could I get cancer from taking the recalled carvedilol?
There are no indications that the recall was initiated due to traces of cancer-causing nitrosamine impurities. Routine testing found the carvedilol content was out of specification, not due to contamination issues. Patients are not thought to be at increased risk of cancer from taking the tablets.
Is all carvedilol being recalled?
No, only certain lots manufactured by Novell Pharmaceutical Laboratories between May and August 2022 are affected. Carvedilol from other drug makers or different lot numbers should be unaffected. Check bottle labels closely to confirm if your tablets are part of the impacted lots.
When will more carvedilol be available?
The timeline for replenishing supplies of quality carvedilol depends on manufacturing and distribution factors. There may be a period of shortage while drug makers ramp up production. Work closely with your pharmacist and doctor to check availability if your carvedilol prescription needs refilling.
Can I switch to another medication easily?
Your doctor will determine the best substitute option based on your medical history and response to carvedilol. Transitioning hypertension drugs requires close monitoring as blood pressure control can be impacted. Some options may include metoprolol, bisoprolol, or losartan as alternates within the beta blocker and ARB drug classes.
Is my health in immediate danger if I keep taking the recalled carvedilol?
The FDA and drug manufacturer state that the medication can continue to be taken as directed until a replacement can be obtained. However, monitor closely for any new side effects and follow up urgently with your cardiologist if any develop. Seek emergency care for fainting, chest pain, trouble breathing, or allergic reactions.
Other Recalls of Blood Pressure Medications
The carvedilol recall is one of many recalls of blood pressure medications in recent years due to various manufacturing issues. Some other notable recalls include:
Valsartan Recalls
Starting in 2018, several manufacturers recalled valsartan, a drug used to treat high blood pressure and heart failure. The reason for the multiple recalls was traces of probable carcinogens called nitrosamines in the active pharmaceutical ingredient from China.
Losartan Recall
Also in 2018, the FDA issued a recall for some lots of losartan potassium tablets made by Torrent Pharmaceuticals. Nitrosamine impurities were again discovered in losartan's API. Additional losartan recalls by other makers followed in 2019 and 2020.
Irbesartan Recall
In 2019, the FDA recalled irbesartan, another popular hypertension medication, for containing nitrosamine impurities above safe levels. Two years later in 2021, more lots of irbesartan were recalled for being incorrectly labeled.
Metoprolol and Bisoprolol Recalls
Nitrosamine contamination triggered recalls starting in 2020 for the beta blocker blood pressure drugs metoprolol and bisoprolol. Multiple metrotprolol recalls have been issued affecting both brand name Lopressor and generic forms.
Quinapril Recall
Most recently in July 2022, the FDA recalled quinapril tablets used to manage high blood pressure. The drug was found to carry potentially harmful levels of nitrosamines. Prior recalls occurred in 2021 and 2020 for the same issue.
Maintaining Blood Pressure During Shortages
The numerous recent recalls of hypertension medications have undoubtedly caused difficulties for providers trying to prescribe appropriate treatment alternatives. Patients may experience frequent medication switching, shortages, and unstable blood pressure during this period.
If your carvedilol or other high blood pressure prescription is affected by a recall, work closely with your healthcare team to maintain continuity of care. Be sure to monitor your blood pressure frequently when transitioning between drugs. Alert your doctor promptly about any readings that are excessively high or low.
Other ways to help stabilize your blood pressure until supplies normalize again include:
- Following a heart-healthy diet with limited salt and fat
- Exercising regularly
- Limiting alcohol intake
- Quitting smoking
- Losing excess weight
- Reducing stress through relaxation techniques
Report any concerning symptoms after a medication switch, like chest pain, racing pulse, swelling, or shortness of breath. Work as a team with your medical providers to resume consistent blood pressure control once replacement tablets can be obtained.
Looking Ahead After the Carvedilol Recall
While disruptive in the short term, the carvedilol recall serves as an important safeguard to ensure patients do not take improperly formulated medications that could pose health risks. Inconveniences related to switching prescriptions and dealing with shortages are outweighed by the avoided potential consequences of ineffective or unsafe drug concentrations.
Going forward, more scrutiny is being placed on manufacturing processes and quality control to prevent nitrosamine and other impurities from contaminating drug products. The series of blood pressure medication recalls appears to be stimulating improved oversight across the pharmaceutical industry.
Patients impacted by the carvedilol recall should rest assured knowing the FDA and manufacturers are acting responsibly to correct the issue and prevent future occurrences. Although finding alternate high blood pressure treatments may currently be challenging, this supply disruption will likely incentivize better long-term control over drug production and quality.
Disclaimer: This article is for informational purposes only and does not constitute medical advice. Always consult with a healthcare professional before starting any new treatment regimen.
Add Comment