HHP Medication Safety Watch: September 2020

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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

Male enhancement pill contains an undeclared prescription medicine

Red-E male enhancement tablet (maker: The Protein Shoppe, LLC)

Comment: This product has been voluntarily recalled because it contained undisclosed sildenafil, the active ingredient in the erectile dysfunction (ED) medicine Viagra. Side effects of sildenafil include an interaction with drugs containing nitrates that may cause a dangerous drop in blood pressure. Nitrates are found in nitroglycerin and other prescription medicines most commonly taken for cardiovascular disease.

Hand sanitizers may be contaminated with methanol (wood alcohol)

bio aaa Advance Hand Sanitizer (maker: AJR Trading LLC)
M Hand Sanitizer (maker: Medek, LLC)
Cleaner Hand Sanitizer (maker: Estado de México, México, DMM VISSION, S.A. de C.V.)

Comment: Drinking a product that contains methanol can cause vomiting, headache, or blurred vision. More severe toxicity includes permanent blindness, seizures, coma, or death. In rare cases, toxicity could develop from applying contaminated hand sanitizer to the skin. Infants and young children are at particular risk of accidental poisoning by these products. People with alcohol addiction and adolescents are also at high risk.

Hand sanitizer labeled as containing "edible alcohol"

Leafree Instant Hand Sanitizer-Aloe Vera (maker: CorgioMed LLC)

Comment: Drinking a product that contains alcohol can lead to alcohol toxicity with symptoms of poor coordination, slurred speech, drowsiness, a drop in blood sugar, coma, or death. Drinking alcohol during pregnancy may cause birth defects or developmental disabilities. Labeling a hand sanitizer as containing edible alcohol may encourage people with alcohol addiction to drink it.

See additional FDA recalls and alerts for more than 190 hand sanitizer products in recent months due to methanol contamination or other issues.

Prescription medicines

Thyroid medicines may contain less than labeled amount of thyroid hormone

Nature-Throid and WP Thyroid (maker: RLC Labs, Inc.)
NP Thyroid 15 & NP Thyroid 120 (maker: Acella Pharmaceuticals, LLC)

Comment: These products are being voluntarily recalled because they may contain less than the amount of medication on the label.

Thyroid hormone is usually prescribed for people who have had their thyroid gland removed or have a condition called hypothyroidism (an underactive thyroid gland). Taking too little thyroid hormone if you have these conditions could lead to fatigue, constipation, hair loss, depression, weight gain, or other symptoms. Risks also include miscarriage, fetal thyroid disease, and developmental abnormalities. Elderly people with undertreated hypothyroidism may be at higher risk of cardiovascular disease, including heart attack.

Metformin may be contaminated with a compound that may cause cancer

Riomet ER Metformin Hydrochloride, Extended-Release, Oral Suspension, 500 mg/5 ml (maker: Sun Pharmaceutical Industries, Inc.)

Comment: Metformin is prescribed for type 2 diabetes. One lot of this medicine contained a higher than acceptable level of N-Nitrosodimethylamine (NDMA), a known carcinogen (a compound that may cause cancer).

Labels on medicines known as benzodiazepines updated to highlight risks

Benzodiazepines: These include commonly prescribed medicines, such as alprazolam (Xanax), clonazepam (Klonopin), diazepam (Valium), lorazepam (Ativan), temazepam (Restoril), and triazolam (Halcion). See FDA announcement here.

Comment: Benzodiazepine medicines are commonly prescribed for anxiety, insomnia, and seizures. The FDA has updated labeling of these drugs to emphasize certain risks, including misuse, abuse, potential for addiction, withdrawal reactions, and dangerous interactions with opiates, alcohol, or other drugs. Labels on benzodiazepine medicines must now include a prominent boxed warning provided by the FDA.

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HHP Medication Safety Watch: September 2020

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