NDA lists drugs, vaccines with adverse side effects

The NDA secretary, Dr David Nahamya, speaks at the pharmacovigilance stakeholder meeting in Kampala yesterday. PHOTO / NDA

What you need to know:

  • NDA report indicated that 605 adverse drug reaction reports were filed this year’s first quarter and that from this, 41 percent (253) were classified as serious. 

The National Drug Authority (NDA) has registered a 50 percent increase in cases of adverse reactions after taking medicines and vaccinations in the country.

In the drug safety monitoring report released yesterday at the pharmacovigilance stakeholder meeting in Kampala, the majority of adverse drug reactions reported were those used in the treatment of HIV/Aids and tuberculosis (TB).

NDA report indicated that 605 adverse drug reaction reports were filed this year’s first quarter and that from this, 41 percent (253) were classified as serious. Of this, 153 were life-threatening, 76 involved disability (76), and others resulted in prolonged hospitalisation.

Tenofovir, Lamivudine and Dolutegravir, a combination of drugs in antiretroviral therapy for HIV/Aids had 334 cases of undesirable reactions, the highest.

Here, the side effects included erectile dysfunction, testicular retraction, increased blood sugar, bone pains and insomnia –a sleeping disorder.

Others were Dolutegravir for HIV/Aids (148 cases), isoniazid for TB treatment (25) cases, Tenofovir alone (23 cases), and another combination of drugs for TB treatment rifampin, isoniazid, pyrazinamide, and ethambutol (RHZE) which had 10 cases and ethionamide for TB (8 cases).

Common among the undesirable reactions were breast enlargement in men, skin hypersensitivity often manifesting as irritation or pimples, kidney, liver and bone toxicity, among others.

“Except for the hyperglycaemia (increased blood sugar) and erectile dysfunction, which are recently validated new signals for Dolutegravir, the rest of the reactions are expected undesirable side effects of the suspected drugs according to the manufacturers’ summary of product characteristics,” NDA wrote in the safety report.

On the issue of breast enlargement in men caused by ethionamide, the report said three of the eight cases were recovering while five were still ongoing but that breast tissue shrinks and returns to normal after two weeks of discontinuing.

 Other drugs with issues of adverse events were ceftriaxone, an antibiotic, artesunate, an antimalarial, and doxycycline, a broad spectrum antibiotic.

From vaccines, a total of 2,253 cases of Covid-19 vaccine side effects between April and September 2021 were reported. Up to 181 “adverse events” after the jab and 51 “serious cases” including blood clots after the vaccine were reported.

At least 21 men reported cases of the erectile dysfunction, which persisted for about one week, after taking the jab. Ten women also reported irregular menstruation after the vaccine.

Dr Helen Byomire Ndagije, the director of product safety at NDA, while commenting on the issues of side effects and adverse reactions, said monitoring is important for the safety of patients.

She said they registered 2,600 reports of side effects in the 2020/2021 financial year, which is 50 percent higher than those registered the previous financial year.

Asked about the actions they are taking after receiving the reports, she said: “When we receive the reports, we assess them, we look at the information we already have because when these drugs are coming in, we approve them to be on the market.”

Dr Ndagija added: “After the assessment, we get back to the manufacturers for more information. We can inform the health workers that when they are dealing with patients on a particular medicine, they should look out for this kind of information or problem that they have begun to see. If there is any risk we try to mitigate it.”