HHP Medication Safety Watch: December 2024

This list contains selected items from the full FDA list of recalls, withdrawals, and alerts for medicines and certain health products. We've provided links to FDA information for each product and its maker. Unless otherwise noted, these actions apply only to the specific brand name of the product listed. Talk to your healthcare provider before stopping or changing any medicines or treatments that they have recommended for you.

• Over-the-counter products and medicines
• Prescription medicines

Over-the-counter products and medicines

Dietary supplement recalled due to contamination with prescription drugs

• Force Forever (maker: GNMART, Inc.)

Comment: The maker of this product has recalled all lots due to contamination with two prescription drugs, diclofenac and dexamethasone. Diclofenac is an anti-inflammatory medicine in the same family as ibuprofen. Its side effects include stomach upset, stomach ulcers, and kidney injury. Dexamethasone is a corticosteroid medicine which may, among other side effects, reduce the ability to fight infections, increase blood sugar, elevate blood pressure, and weaken muscles and bones. If taken for more than a couple of weeks, serious withdrawal symptoms (called adrenal crisis) may develop.

Both of these prescription medicines can interact with other drugs, increasing the risk of side effects.

Force Forever is sold as a dietary supplement to treat joint pain.

Eye drops recalled due to fungal contamination

• Systane Lubricant Eye Drops Ultra PF (maker: Alcon Laboratories)

Comment: One lot of this product was recalled after a user complaint describing "foreign material" in the vial. Testing revealed that the eye drops were contaminated with a fungus. Use of these contaminated eye drops could cause sight-threatening or even life-threatening infection. The risk is highest for people with impaired immune function.

The recalled product is marketed as a treatment for symptoms of dry eye such as burning or irritation.

Dietary supplement recalled because it contains prescription drugs

• Fouzee Sugarlin Herbal Formula (maker: Shoppers-Plaza)

Comment: All lots of this product have been recalled because they contain two prescription medicines, metformin and glyburide.

When taken accidentally or in excess dosage, metformin may cause a serious accumulation of acid in the blood leading to nausea, body aches, shortness of breath, and abdominal pain. Both prescription medicines may cause symptoms of low blood sugar, especially when taken together. Symptoms of low blood sugar include sweating, anxiety, and rapid heartbeat. Severely low blood sugar may cause seizures, coma, or death.

The recalled product has been marketed as a dietary supplement to provide "glucose or blood sugar support." Of note, people with prediabetes or diabetes may already be taking metformin and/or glyburide by prescription to lower their blood sugar, so the contamination described in this recall could be especially dangerous for these individuals.

Dietary supplement recalled due to contamination with three unlabeled medications

• Nhan Sam Tuyet Lien Truy Phong Hoan dietary supplement capsules (maker: Buy-herbal.com)

Comment: The maker of this product recalled all lots after FDA testing revealed contamination with two prescription medications (furosemide and dexamethasone) and one over-the-counter (OTC) medicine (chlorpheniramine).

Furosemide is a diuretic (a medication that causes increased urination) prescribed for heart failure or leg swelling to remove excess fluid from the body. Inadvertent use of this medicine could cause an allergic reaction, dehydration, low blood pressure, kidney damage, and loss of electrolytes.

Dexamethasone is a corticosteroid medicine which may, among other side effects, reduce the ability to fight infections, increase blood sugar, elevate blood pressure, and weaken muscles and bones. If taken for more than a couple of weeks, serious withdrawal symptoms (called adrenal crisis) may develop.

Chlorpheniramine is an OTC antihistamine contained in many cold, flu, and allergy products. Inadvertent use could lead to an excessive dosage, especially if combined with another chlorpheniramine-containing product. Side effects could include drowsiness, loss of consciousness, or seizures.

Each of these prescription medicines can interact with other drugs, increasing the risk of side effects.

This product is marketed as a dietary supplement for multiple ailments, including gout, back pain, and arthritis.

Prescription medicines

Immune suppressant for organ transplant recipients recalled because capsules may be empty

• Prograf (tacrolimus), 0.5 mg capsules and Astagraf XL (tacrolimus extended-release), 0.5 mg capsules (maker: Astellas Pharma US, Inc.)

Comment: The maker of these products is recalling one lot of each because the bottles may contain empty capsules. Tacrolimus is an immune suppressant prescribed to prevent rejection of transplanted organs, such as a heart, kidney, liver, or lung. Taking empty capsules instead of tacrolimus could lead to life-threatening organ rejection.

FDA issues a safety alert for liver disease treatment

• Ocaliva (obeticholic acid) (maker: Intercept Pharmaceuticals)

Comment: The FDA has received new reports of liver injury among people taking Ocaliva (obeticholic acid) and has issued recommendations to reduce this risk.

Ocaliva is an FDA-approved drug for the treatment of people with a rare and potentially fatal liver condition, primary biliary cholangitis (PBC). PBC can cause severe scarring in the liver (cirrhosis) and liver failure, which may require a transplant. This medicine is approved for people with PBC who do not improve with the standard initial treatment (ursodeoxycholic acid), do not already have cirrhosis, and are considered at low risk for death or liver failure.

The alert describes the results of a recent study that found a higher rate of death and liver failure requiring transplant among those treated with Ocaliva compared with those receiving placebo.

People taking Ocaliva should review the risks of benefits of taking this medication with their health care providers. In addition, they should have regular blood tests to check liver function, and close monitoring for symptoms or signs of worsening liver disease such as:

• mental status changes, such as confusion or slurred speech
• persistent nausea or vomiting
• abdominal swelling
• yellowing of the skin or eyes (jaundice)
• vomiting or coughing up blood
• bloody or black, tarry stools. 

Read additional issues of HHP Medication Safety Watch