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[NAFDAC Public Alert, October 5, 2019] – The National Agency for Food and Drug Administration and Control (NAFDAC) has directed distributors, wholesalers and retail pharmacies in possession of stock of ranitidine containing products to immediately stop distribution and sale of the products. This follows findings of low levels of N-Nitrosodimethylamine (N-NDMA), a genotoxic impurity, in Zantac injection (50 mg/5 mL Batch No. 669) by Swissmedic, the National Medicines Regulatory Authority of Switzerland.

Genotoxic substances such as N-NDMA are known to be potentially carcinogenic when ingested, inhaled or penetrate the skin. The US FDA and other National Medicines Regulatory Authorities have taken similar steps in recalling and suspending further sale and distribution of ranitidine containing products.

The Marketing Authorization Holder (MAH) of Zantac in Nigeria, Glaxo SmithKline (GSK) has confirmed to the Agency that Zantac is no longer imported into Nigeria. The last batch of Zantac that was imported into Nigeria expired in November 2018.

NAFDAC implores all Pharmaceutical importers to stop importation of all ranitidine containing products until further notice.

NAFDAC has strengthened surveillance at ports of entry to prevent importation of ranitidine containing products until further notice.

Patients on ranitidine containing products are to contact their Healthcare Provider to advise them on alternative treatment.

Healthcare professionals and patients are advised to be vigilant and report any information on importation and distribution of ranitidine containing products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via pharmacovigilance@nafdac.gov.ng

Source: NAFDAC Public Alert No: 0017/2019, October 5, 2019

[FDA News Release, October 12, 2019] – The U.S. Food and Drug Administration has approved Reyvow (lasmiditan) tablets for the acute (active but short-term) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. Reyvow is not indicated for the preventive treatment of migraine.

Lasmiditan is the first serotonin (5-HT) 1F receptor agonist for the acute treatment of migraine. Reyvow will be available in oral doses of 50 mg, 100 mg, and 200 mg tablets.

Migraine headache pain is often described as an intense throbbing or pulsing pain in one area of the head. Additional symptoms include nausea and/or vomiting and sensitivity to light and sound. Approximately one-third of individuals who suffer from migraine also experience aura shortly before the migraine. An aura can appear as flashing lights, zig-zag lines, or a temporary loss of vision. Migraines can often be triggered by various factors including stress, hormonal changes, bright or flashing lights, lack of food or sleep, and diet. Migraine is three times more common in women than in men and affects more than 10% of people worldwide.

The effectiveness of Reyvow for the acute treatment of migraine was demonstrated in two randomized, double-blind, placebo-controlled trials. A total of 3,177 adult patients with a history of migraine with and without aura treated a migraine attack with Reyvow in these studies. In both studies, the percentages of patients whose pain resolved and whose most bothersome migraine symptom (nausea, light sensitivity, or sound sensitivity) resolved two hours after treatment were significantly greater among patients receiving Reyvow at all doses compared to those receiving placebo. Although patients were allowed to take a rescue medication two hours after taking Reyvow, opioids, barbiturates, triptans and ergots were not allowed within 24 hours of the study drug’s administration. Twenty-two percent of patients were taking a preventive medication for migraine.

There is a risk of driving impairment while taking Reyvow. Patients are advised not to drive or operate machinery for at least eight hours after taking Reyvow, even if they feel well enough to do so. Patients who cannot follow this advice are advised not to take Reyvow. The drug causes central nervous system (CNS) depression, including dizziness and sedation. It should be used with caution if taken in combination with alcohol or other CNS depressants.

The most common side effects that patients in the clinical trials reported were dizziness, fatigue, a burning or prickling sensation in the skin (paresthesia), and sedation.

Source: FDA News Release, October 11, 2019

There are several topical corticosteroid formulations (including combinations with anti-infectives) that are registered and approved for use in Nigeria. The TCS formulations are listed by their generic names only. Brand details and detailed therapeutic classifications can be found in EMDEX Print or Mobile.

Choosing topical corticosteroids (TCS)

Topical corticosteroids are widely used for a variety of inflammatory skin disorders. They suppress the inflammatory reaction and relieve symptoms, but their actions are not curative and symptoms can recur on discontinuation of therapy.

Safe and effective use of TCS requires careful consideration of the following:

• Accurate diagnosis.
• Choice of steroid preparation, relative potency and delivery vehicle.
• Frequency of application and duration of treatment
• Potential adverse effects, both local and systemic

Appropriate indications

Topical corticosteroids are generally indicated for symptomatic relief of acute and chronic skin eruptions, where anti-inflammatory, anti-allergenic and antipruritic activity is required.

Indications for TCS include contact dermatitis, eczema (atopic dermatitis), psoriasis, insect bites; symptomatic relief for burning and pruritic lesions, etc. See below for detailed listing of skin conditions that may be responsive to topical steroid therapy.

TCSs should be avoided in untreated tubercular, bacterial and fungal infections involving the skin and in certain viral diseases such as herpes simplex, chickenpox, and vaccinia due to concerns that immunosuppression may exacerbate the infection.

Dosing, frequency of application, and duration of treatment: “The Fingertip Unit Method”

A fingertip is from the very end of the finger to the first crease in the finger. The “Fingertip unit” (FTU) is a validated method of applying topical drugs in suitable safe quantities. One FTU is approximately 0.5 g, and is defined as the amount of topical steroid that can be squeezed out from a tube (with a stand-ard 5 mm nozzle) along an adult’s fingertip i.e., from the very end of the finger to the first crease of an adult’s index finger.

The frequency of application may vary with the product used and the condition being treated. Once or twice-daily application is recommended for most preparations. More frequent application is usually not needed, since the stratum corneum acts as a reservoir for these lipophilic compounds. An alter-nate day or even twice weekly application may be recommended in some chronic conditions due to this depot effect of TCS.

Duration of treatment for most conditions should not exceed 2-4 weeks, regardless of the potency of the TCS. Chronic application of topical steroids can induce tolerance and tachyphylaxis. High-potency steroids should not be used for more than three weeks continuously. If there is worsening of the le-sions or no change noticed, the product needs to be discontinued and re-evaluation of the diagnosis is indicated.

Selecting a vehicle

Topical corticosteroid preparations consist of an active ingredient and a vehicle (or solvent). In addition to being a carrier for the corticosteroid, the vehicle affects potency based on alterations of the steroid release rate and bioavailability.

The selection of vehicle depends on the type of lesions and the anatomical region. Some vehicles should be used only in certain parts of the body. Most topical corticosteroid preparations are available in several forms, including ointments, creams, gels, aerosols and lotions.

Ointments usually contain petrolatum, waxes, paraffin, propylene glycol, or mineral oil.

Preferred vehicle for Palm and Soles; nonhairy skin and also for dry or thick, hyperkeratotic lesions.

Most occlusive, provides better steroid absorption/penetration. Atopic skin conditions due to hydrating nature. Not suitable for hairy and intertriginous areas

Creams (oil-in-water emulsions) have good lubricating qualities and their ability to vanish into the skin make them cosmetically appealing.

May be used in any area of the body. Preferred vehicle for wet or weepy (exudative) lesions due to their drying effect; also for between skin folds.

Good lubricating and vanishing property, and cosmetic appeal. Generally, less potent than ointments. Suitable for use in intertriginous areas unlike ointments

Gels and lotions are the least greasy and occlusive of all topical steroid vehicles.

Gels may be used on the scalp and other hairy skin areas due to their drying & cooling qualities. Jelly-like effect makes it suitable for exudative inflammation (e.g., poison ivy) and for acne. Non-greasy and non-occlusive.

Lotions/Solutions contain alcohol, which has a drying effect on an oozing (weeping) lesion.

Preferred vehicles for the scalp and other hairy skin areas; between skin folds; moist, macerated lesions.

Easy to apply. Non-greasy and non-occlusive. Least potent topical therapies. Drying and cooling effects.

Topical corticosteroids, Combinations with antibacterials and/or antifungals

TCS combination with an anti-infective agent is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria or fungi will be present on the skin. The use of these combination products should be limited as some of the components can be sensitizing (e.g., Neomycin). These formulations are generally overused and sometimes, for cosmetic reasons. They allow for treatment without proper diagnosis and should be discouraged.

Recommendations for optimizing the use of topical corticosteroids

• Children generally require a shorter duration of treatment and a lower potency steroid.
• Prescribe for the right dermatoses, not as empiric therapy for every “rash”.
• Use appropriate steroid formulation and potency to achieve disease control.
• Initiate maintenance therapy with a lower potency steroid after achieving control of the acute inflammation.
• Taper off the treatment upon complete remission of skin diseases, after prolonged therapy.
• Limit the duration of use
• Caution when prescribing topical steroid for certain body regions (e.g., groin, face, axillae, and flexures).
• To be aware of the adverse effects and act immediately to counteract them.
• When infections necessitate the addition of an antibiotic or antifungal, systemic treatment should be considered.
• When the diagnosis is unclear or the condition is nonresponsive to standard treatment, refer to a dermatologist.

Comparison of topical corticosteroids

Ultra-high and High Potency TCS

Recommended for thick skin areas like Palm and Soles for: Atopic dermatitis (resistant); Discoid lupus; Hyperkeratotic eczema; Lichen planus; Lichen sclerosus (skin); Psoriasis; Severe hand eczema.

High-potency may also be used on the Trunk, Extremities, Scalp & Hairy skin areas for: Scalp dermatitis; Atopic dermatitis; Psoriasis, etc.

They pose the highest risk of systemic side effects. Avoid abrupt discontinuation; continuous daily use >3 weeks, and occlusive dressings.

Monitor for symptoms of adrenal suppression: weakness, weight loss, hypotension, and gastrointestinal distress.

Lower potency agents are preferred for the face, groin, armpits, or skin folds due to susceptibility to local side effects and systemic absorption

Ultra-high potency includes: Betamethasone dipropionate glycol (augmented) 0.05% Cream, Ointment, Lotion; Clobetasol 17-propionate 0.05% Cream, Ointment, Lotion; Halobetasol propionate 0.05% Ointment.

High potency includes: Amcinonide 0.1% Ointment, Cream, Lotion; Betamethasone dipropionate 0.05% Ointment, Cream, Lotion; Betamethasone valerate 0.1% Ointment; Fluocinonide 0.05% Cream, Ointment, Gel; Halobetasol propionate 0.05% Cream; Mometasone furoate 0.1% Ointment.

Moderate Potency TCS

Recommended for Trunk, Extremities, Scalp & Hairy skin areas for: Alopecia areata; Atopic dermatitis; Contact dermatitis (severe); Lichen sclerosus (vulva); Nummular eczema; Perianal inflammation (severe); Scabies (after scabicide); Seborrheic dermatitis; Severe dermatitis; Severe intertrigo (short-term); Stasis dermatitis.

Moderate to low potency agents should be used when treatment involves large body surface area.

Duration of treatment: May be used for up to 3 months when treating non-facial or non-intertriginous areas.

Occlusive dressings should be avoided.

Low Potency TCS

Recommended for thin skin areas like Face, Neck, Intertriginous or Genital areas for: Dermatitis (face, eyelids, diaper region); Intertrigo; Perianal inflammation.

These are agents of choice for children, pregnant women, elderly or for treating large areas.

Available TCS Combinations with Antibiotics

• Betamethasone + Neomycin (Topical)
• Hydrocortisone + Gentamicin (Topical)
• Hydrocortisone + Neomycin (Topical)

Available TCS Combinations with Antifungals

• Beclometasone + Clotrimazole
• Betamethasone + Clotrimazole
• Clobetasol + Clotrimazole
• Dexamethasone + Clotrimazole
• Diflucortolone + Isoconazole
• Hydrocortisone + Miconazole (Topical)

Available TCS Combinations with Antibiotics and Antifungals

• Beclometasone + Clotrimazole + Gentamicin
• Beclometasone + Clotrimazole + Gentamicin + Clioquinol
• Betamethasone + Clotrimazole + Gentamicin
• Betamethasone + Clotrimazole + Neomycin
• Betamethasone + Tolnaftate + Gentamicin
• Betamethasone + Tolnaftate + Gentamicin + Clioquinol
• Betamethasone + Tolnaftate + Neomycin + Clioquinol
• Clobetasol + Ketoconazole + Neomycin
• Clobetasol + Miconazole + Gentamicin
• Clobetasone + Miconazole + Gentamicin
• Dexamethasone + Clotrimazole + Gentamicin
• Dexamethasone + Clotrimazole + Neomycin
• Dexamethasone + Miconazole + Neomycin
• Fluocinolone + Miconazole + Neomycin
• Miconazole + Beclometasone + Neomycin
• Miconazole + Clobetasol + Neomycin
• Triamcinolone + Econazole + Gentamicin

Adverse effects of topical corticosteroids (TCS)

Risk factors for adverse effects

• Duration of treatment — long-term treatment is likely to result in systemic absorption.
• Area of the skin being treated — treating large areas of skin increases the risk of absorption.
• Condition of the skin — absorption is greatest in thin, inflamed skin.
• Potency of the topical corticosteroid — the greater the potency, the greater the risk of absorption.
• Occlusion — use of topical corticosteroids under occlusion increases the risk of systemic absorption.
• Age — children and elderly people are more susceptible to the adverse effects of topical corticosteroids because they have a thinner epidermis.

Local adverse effects

Common and mostly occur on the face, in skin folds, and in areas that are treated over the long term

• Transient burning or stinging — this is common, especially in the first 2 days of application on untreated, inflamed skin.
• Worsening and spreading of untreated infection.
• Thinning of the skin (atrophy) — the skin improves over a period after stopping treatment.
• Permanent stretch marks or striae. Most common in the groin, axillae, and inner thigh areas.
• Allergic contact dermatitis — due to the corticosteroid or the excipients. Lower potency agents like Hydrocortisone may be more allergenic.
• Acne (or worsening of existing acne) or rosacea. Common in the face with high potency agents.
• Hypopigmentation — More common in the blacks. May be reversible.
• Excessive hair growth at the site of application (hypertrichosis). Reversible.

Systemic adverse effects

Rare, but may occur more frequently in the presence of risk factors including infants and children

• Adrenal suppression.
• Cushing’s syndrome.
• Hyperglycaemia
• Growth retardation in children.

Minimizing adverse effects

• Prescribe the least potent formulation which is fully effective (advise the person to apply it thinly to affected areas, no more than twice daily).
• Consider prescribing an appropriate quantity of an emollient for use alongside the topical corticosteroid (for moisturizing purposes).
• Avoid prescribing potent corticosteroids for use on the face.
• Unless under specialist supervision, the use of potent (such as betamethasone valerate 0.1%) and very potent (such as clobetasol propionate 0.1%) topical corticosteroids, should be limited to: Use for up to 2 weeks, and No more than 50 g each week; Once–daily application is usually sufficient — maximum of twice daily.
• Avoid using occlusive dressings with topical corticosteroids (especially on large areas of the body).
• If a topical corticosteroid is needed for maintenance therapy, consider incorporating regular periods when they are withdrawn (for as long as possible) and emollients are used on their own.
• If the person is using large amounts of topical corticosteroid regularly, monitor them for signs of systemic adverse effects (such as adrenal suppression) and local adverse effects (such as areas of thin skin or striae).
• Monitor the height of children who are using large amounts of topical corticosteroid.

References

Available on request

Beginning an exercise program may help protect older adults’ brains or even reverse early mental decline, a small study suggests.

Researchers placed 34 inactive people, aged 61 to 88, on an exercise regimen. It included moderate-intensity walking on a treadmill four times a week for 12 weeks.

On average, heart/lung health improved about 8 percent over that time, the researchers found.

Brain scans also showed an increase in the thickness of the participants’ cortex, the outer layer of the brain that typically shrinks with Alzheimer’s disease. Those with the greatest improvements in physical fitness had the most growth in the cortex, the University of Maryland researchers found.

The thickening of the cortex occurred in both healthy people and those with mild cognitive impairment (MCI), an early stage of Alzheimer’s disease, the study showed.

The study was published recently in the Journal of the International Neuropsychological Society.

“Exercise may help to reverse neurodegeneration and the trend of brain shrinkage that we see in those with MCI and Alzheimer’s,” senior study author Dr. J. Carson Smith, an associate professor of kinesiology, said in a university news release.

“Many people think it is too late to intervene with exercise once a person shows symptoms of memory loss, but our data suggest that exercise may have a benefit in this early stage of cognitive decline,” Smith added.

The study can’t prove definitively that exercise led to the brain gains. However, previous studies have found that exercise can benefit other areas of older adults’ brains.

The authors of the new study said further research is needed to determine if moderate physical activity can delay or reverse mental decline and help people remain independent as they age.

Childhood cancer survivors can have poor mental and physical health as adults, according to two new studies.

These health problems may be related to some of the toxic medications needed to treat cancer, experts say.

“We are doing a lot better at curing childhood cancers, but there are a lot of late effects of treatment that need to be looked at,” said Dr. Karen Effinger, a pediatrics instructor at Stanford School of Medicine. Because they are so young when treated, children and teens with cancer are the most vulnerable to long-term effects of treatment, she noted.

In one study, Danish researchers found that cancer survivors were more likely to be hospitalized as adults. In the other, kids who survived bone cancer were more likely to have poor reading and thinking skills, investigators found.

Both studies were published Nov. 19 online in JAMA Oncology.

“Survivors after cancer in adolescence and young adulthood should be knowledgeable about their increased risk for health problems related to their treatment,” said Kathrine Rugbjerg, of the Danish Cancer Society Research Center in Copenhagen.

“Increased attention to symptoms that might indicate a disease and being treated early might prevent a disease from developing,” added Rugbjerg. She led a study of the hospitalization risk for more than 33,000 young cancer survivors who were diagnosed from 1943 through 2004.

Survivors of leukemia, brain cancer or Hodgkin lymphoma had the highest risk of hospitalization — roughly double — up to 34 years after their battle with cancer, the study found.

Overall, the researchers identified more than 53,000 hospitalizations for at least one of 97 diseases, including cancer; heart, lung or endocrine diseases; nervous system disorders, and infectious diseases, she said.

In the other and smaller study, lead researcher Kevin Krull, of St. Jude Children’s Research Hospital in Memphis, and colleagues examined the mental abilities of survivors of childhood osteosarcoma, a type of bone cancer.

These cancer survivors had lower scores in reading, attention, memory and the speed at which their brain processes information, Krull said.

But a powerful drug used to treat osteosarcoma — methotrexate — doesn’t seem to have caused that mental decline, the study concluded.

The study included 80 patients with an average age of nearly 39, whose cancer was diagnosed almost 25 years earlier. The researchers compared them with 39 people who had not had cancer.

Krull said that although methotrexate is linked to brain problems when given in high doses, the survivors’ mental impairment appeared related to current health conditions, not that drug.

But these patients also reported having heart problems, he said. “These problems could result from another type of drug these patients received, called anthracyclines, which can damage the heart, Krull said.

“These heart problems are producing reduced blood flow to the brain,” he said. “These heart difficulties seem to be causing the mental problems.”

Whatever the cause, the mental problems have real-world consequences, Krull said. Survivors with mental problems were less likely to graduate college. They were also almost four times more likely to be unemployed and three times more likely to earn less than $40,000 a year, he said.

“Care of the cancer patient doesn’t stop with the cancer,” Krull said. “We have to continue to monitor these chronic health conditions because they can impact brain growth and development and affect daily life skills.”

Effinger, who co-authored of an accompanying editorial in the journal, called for more study on the long-term consequences of cancer treatment in kids.

“We know that there are late effects that come from treatment, and we need to figure out what we can do to reverse those effects and protect patients and give them an improved quality of life,” she said.